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Erozkan K, Liska D, Oktem A, Alipouriani A, Schabl L, Valente MA, Miller JA, Purysko AS, Steele SR, Gorgun E. The role of combining interim and final analysis by using endoscopic and radiologic methods in total neoadjuvant treatment. Am J Surg 2025; 241:116104. [PMID: 39577038 DOI: 10.1016/j.amjsurg.2024.116104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2024] [Revised: 11/07/2024] [Accepted: 11/18/2024] [Indexed: 11/24/2024]
Abstract
BACKGROUND We aim to compare the relative performance of flexible sigmoidoscopy (FS), rectal magnetic resonance imaging (MRI), and their combinations during interim (i) and final (f) analysis to evaluate concordance with complete response (CR) following total neoadjuvant treatment (TNT) in rectal cancer. METHOD Patients who opted TNT and underwent restaging with FS and MRI between 2015 and 2022 were evaluated. Concordance between the assessment methods and CR was analyzed using the weighted-κ test. RESULTS A cohort comprising 208 patients revealed CR rate of 42.3 %. When evaluating individual methods, fFS alone demonstrated the most heightened sensitivity (68.2 %) for CR detection, with a moderate level of concordance (κ = 0.46). Only the combinations of iFS-fFS and fFS-fMRI reached a comparable level of concordance to that achievable by fFS alone. CONCLUSION Among the available diagnostic tools, the combination of final MRI and FS still appears to offer the highest concordance with CR, with relatively higher sensitivity. Additionally, interim MRI may not add significant clinical value and could be omitted.
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Affiliation(s)
- Kamil Erozkan
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - David Liska
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Ayda Oktem
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Ali Alipouriani
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Lukas Schabl
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Michael A Valente
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Jacob A Miller
- Department of Radiation Oncology, Cleveland Clinic, Cleveland, OH, USA
| | - Andrei S Purysko
- Section of Abdominal Imaging and Nuclear Radiology Department, Imaging Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Scott R Steele
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Emre Gorgun
- Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA.
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2
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Williams H, Lee C, Garcia-Aguilar J. Nonoperative management of rectal cancer. Front Oncol 2024; 14:1477510. [PMID: 39711959 PMCID: PMC11659252 DOI: 10.3389/fonc.2024.1477510] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2024] [Accepted: 11/21/2024] [Indexed: 12/24/2024] Open
Abstract
The management of locally advanced rectal cancer has changed drastically in the last few decades due to improved surgical techniques, development of multimodal treatment approaches and the introduction of a watch and wait (WW) strategy. For patients with a complete response to neoadjuvant treatment, WW offers an opportunity to avoid the morbidity associated with total mesorectal excision in favor of organ preservation. Despite growing interest in WW, prospective data on the safety and efficacy of nonoperative management are limited. Challenges remain in optimizing multimodal treatment regimens to maximize tumor regression and in improving the accuracy of patient selection for WW. This review summarizes the history of treatment for rectal cancer and the development of a WW strategy. It also provides an overview of clinical considerations for patients interested in nonoperative management, including restaging strategies, WW selection criteria, surveillance protocols and long-term oncologic outcomes.
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Affiliation(s)
| | | | - Julio Garcia-Aguilar
- Colorectal Service, Department of Surgery, Memorial Sloan Kettering Cancer
Center, New York, NY, United States
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3
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Anker CJ, Tchelebi LT, Selfridge JE, Jabbour SK, Akselrod D, Cataldo P, Abood G, Berlin J, Hallemeier CL, Jethwa KR, Kim E, Kennedy T, Lee P, Sharma N, Small W, Williams VM, Russo S. Executive Summary of the American Radium Society on Appropriate Use Criteria for Nonoperative Management of Rectal Adenocarcinoma: Systematic Review and Guidelines. Int J Radiat Oncol Biol Phys 2024; 120:946-977. [PMID: 38797496 DOI: 10.1016/j.ijrobp.2024.05.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2024] [Revised: 04/15/2024] [Accepted: 05/17/2024] [Indexed: 05/29/2024]
Abstract
For patients with rectal cancer, the standard approach of chemotherapy, radiation therapy, and surgery (trimodality therapy) is associated with significant long-term toxicity and/or colostomy for most patients. Patient options focused on quality of life (QOL) have dramatically improved, but there remains limited guidance regarding comparative effectiveness. This systematic review and associated guidelines evaluate how various treatment strategies compare to each other in terms of oncologic outcomes and QOL. Cochrane and Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) methodology were used to search for prospective and retrospective trials and meta-analyses of adequate quality within the Ovid Medline database between January 1, 2012, and June 15, 2023. These studies informed the expert panel, which rated the appropriateness of various treatments in 6 clinical scenarios through a well-established consensus methodology (modified Delphi). The search process yielded 197 articles that advised voting. Increasing data have shown that nonoperative management (NOM) and primary surgery result in QOL benefits noted over trimodality therapy without detriment to oncologic outcomes. For patients with rectal cancer for whom total mesorectal excision would result in permanent colostomy or inadequate bowel continence, NOM was strongly recommended as usually appropriate. Restaging with tumor response assessment approximately 8 to 12 weeks after completion of radiation therapy/chemoradiation therapy was deemed a necessary component of NOM. The panel recommended active surveillance in the setting of a near-complete or complete response. In the setting of NOM, 54 to 56 Gy in 27 to 31 fractions concurrent with chemotherapy and followed by consolidation chemotherapy was recommended. The panel strongly recommends primary surgery as usually appropriate for a T3N0 high rectal tumor for which low anterior resection and adequate bowel function is possible, with adjuvant chemotherapy considered if N+. Recent data support NOM and primary surgery as important options that should be offered to eligible patients. Considering the complexity of multidisciplinary management, patients should be discussed in a multidisciplinary setting, and therapy should be tailored to individual patient goals/values.
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Affiliation(s)
- Christopher J Anker
- Division of Radiation Oncology, University of Vermont Cancer Center, Burlington, Vermont
| | - Leila T Tchelebi
- Northwell, New Hyde Park, New York; Department of Radiation Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.
| | - J Eva Selfridge
- Division of Solid Tumor Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio
| | - Salma K Jabbour
- Department of Radiation Oncology, Rutgers Cancer Institute, New Brunswick, New Jersey
| | - Dmitriy Akselrod
- Department of Radiology, University of Vermont Larner College of Medicine, Burlington, Vermont
| | - Peter Cataldo
- Department of Surgery, University of Vermont Larner College of Medicine, Burlington, Vermont
| | - Gerard Abood
- Department of Surgery, Loyola University Stritch School of Medicine, Maywood, Illinois
| | - Jordan Berlin
- Division of Hematology Oncology, Department of Medicine Vanderbilt-Ingram Cancer Center, Nashville, Tennessee
| | | | - Krishan R Jethwa
- Department of Radiation Oncology, Mayo Clinic College of Medicine, Rochester, Minnesota
| | - Ed Kim
- Department of Radiation Oncology, University of Washington, Seattle, Washington
| | - Timothy Kennedy
- Department of Surgery, Rutgers Cancer Institute, New Brunswick, New Jersey
| | - Percy Lee
- Department of Radiation Oncology, City of Hope National Medical Center, Los Angeles, California
| | - Navesh Sharma
- Department of Radiation Oncology, WellSpan Cancer Center, York, Pennsylvania
| | - William Small
- Department of Radiation Oncology, Stritch School of Medicine, Cardinal Bernardin Cancer Center, Loyola University Chicago, Maywood, Illinois
| | - Vonetta M Williams
- Department of Radiation Oncology, Memorial Sloan Kettering, New York, New York
| | - Suzanne Russo
- Department of Radiation Oncology, MetroHealth, Case Western Reserve University School of Medicine, Cleveland, Ohio
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4
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Jin L, Zheng K, Hong Y, Yu E, Hao L, Zhang W. Local excision versus total mesorectal excision for rectal cancer patients with clinical complete or near-complete response after neoadjuvant chemoradiotherapy. Int J Colorectal Dis 2024; 39:157. [PMID: 39379611 PMCID: PMC11461786 DOI: 10.1007/s00384-024-04720-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/12/2024] [Indexed: 10/10/2024]
Abstract
PURPOSE Local excision is an effective approach for managing rectal cancer exhibiting substantial regression after neoadjuvant chemoradiotherapy. The purpose of this study is to compare the outcomes between local excision and total mesorectal excision in rectal cancer patients achieving clinical complete or near-complete response after neoadjuvant chemoradiotherapy. METHODS This is a retrospective cohort study that includes a consecutive series of rectal cancer patients who responded well to neoadjuvant chemoradiotherapy followed by surgery. A total of 180 rectal cancer patients at a single institution during a 12-year period are included. The main outcomes include short-term outcomes, oncological outcomes, and functional outcomes between the two groups. RESULTS A total of 180 patients were included in the study. Sixty-one (33.9%) received local excision and 119 (66.1%) received total mesorectal excision. The baseline characteristics were generally balanced between the two groups. The local excision group demonstrated a significantly shorter operative time, less blood loss, and shorter hospital stay (p < 0.001). 3-year overall survival rates were 97.5% (95% CI, 0.93-1.00) and 95.5% (95% CI, 0.91-1.00) between the two groups (p = 0.38). The local excision group exhibited significantly higher 3-year local recurrence rates 15.7% (95% CI, 0.74-0.97) vs 4.2% (95% CI, 0.92-1.00) (p = 0.017), yet lower 3-year distant metastasis rates 9.6% (95% CI, 0.82-1.00) vs 12.6% (95% CI, 0.81-0.94) (p = 0.33) and lower 3-year disease-free survival rates 76.8% (95% CI, 0.64-0.92) vs 84.7% (95% CI, 0.78-0.92) (p = 0.56) comparing with the total mesorectal excision group. The local excision group demonstrated significantly better functional outcomes compared with the total mesorectal excision group (p < 0.001). CONCLUSION Patients who achieve either clinical complete or near-complete response after neoadjuvant chemoradiotherapy are suitable candidates for local excision. The local excision group demonstrated superior short-term and functional outcomes, and the oncological outcomes were not compromised.
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Affiliation(s)
- Lu Jin
- Department of Anorectal Surgery, The First Affiliated Hospital of Naval Medical University, Shanghai, 200433, China
| | - Kuo Zheng
- Department of Critical Care Medicine, Jinling Hospital of Medical School of Nanjing University, Nanjing, 210016, Jiangsu, China
| | - Yonggang Hong
- Department of Anorectal Surgery, The First Affiliated Hospital of Naval Medical University, Shanghai, 200433, China
| | - Enda Yu
- Department of Anorectal Surgery, The First Affiliated Hospital of Naval Medical University, Shanghai, 200433, China
| | - Liqiang Hao
- Department of Anorectal Surgery, The First Affiliated Hospital of Naval Medical University, Shanghai, 200433, China.
| | - Wei Zhang
- Department of Anorectal Surgery, The First Affiliated Hospital of Naval Medical University, Shanghai, 200433, China.
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5
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Ali A, Lee WF, O'Leary MP, Whealon M. Great Debates: Surgery or Watch and Wait After Total Neoadjuvant Therapy for Rectal Cancer. Am Surg 2024; 90:2362-2366. [PMID: 38655585 DOI: 10.1177/00031348241248812] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/26/2024]
Abstract
Locally advanced rectal cancer has traditionally been treated with multimodal therapy including neoadjuvant chemoradiotherapy followed by surgical resection. More recent data suggests that in appropriate patients, total neoadjuvant treatment (TNT) makes it possible to adopt a "watch and wait" approach. Advocates for watch and wait argue that patients with a complete or near-complete clinical response to TNT have comparable overall and disease-free survival to their counterparts who undergo surgical resection, and also have a better quality of life, fewer complications, and potentially avoid a stoma. The dogma of surgery as regional curative intent therapy has been challenged by similar recurrence rates among those treated with total mesorectal excision (TME) and those treated with watch and wait. Furthermore, those who develop local recurrence in the watch and wait groups are equally salvageable, either by surgery, brachytherapy, or chemotherapy. While watch and wait is not appropriate in all patients, this manuscript highlights the benefits and drawbacks of both therapeutic modalities.
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Affiliation(s)
- Ayaa Ali
- Department of Surgery, Loma Linda University Health, Loma Linda, CA, USA
| | - Wang Fai Lee
- Department of Surgery, University of California Irvine, Irvine, CA, USA
| | - Michael P O'Leary
- Department of Surgery, Loma Linda University Health, Loma Linda, CA, USA
| | - Matthew Whealon
- Department of Surgery, University of California Irvine, Irvine, CA, USA
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6
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Hadizadeh A, Kazemi-Khaledi H, Fazeli MS, Ahmadi-Tafti SM, Keshvari A, Akbari-Asbagh R, Keramati MR, Kazemeini A, Fazeli AR, Behboudi B, Parsaei M. Predictive value of flexible proctosigmoidoscopy and laboratory findings for complete clinical responses after neoadjuvant chemoradiotherapy in patients with locally advanced primary rectal cancer: a retrospective cohort study. Int J Colorectal Dis 2024; 39:124. [PMID: 39096339 PMCID: PMC11297812 DOI: 10.1007/s00384-024-04696-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 07/22/2024] [Indexed: 08/05/2024]
Abstract
PURPOSE Colorectal cancer is the second leading cause of cancer death worldwide. Standard treatments for locally advanced rectal cancer include neoadjuvant chemoradiotherapy and total mesorectal excision (TME), which are associated with significant morbidity. After neoadjuvant therapy, one-third of patients achieve a pathological complete response (pCR) and are eligible for a watch-and-wait approach without TME. The purpose of this study was to determine the potential predictors of pCR before surgery. METHODS The demographic, clinical, and endoscopic data of 119 patients with primary locally advanced rectal cancer without distant metastasis who underwent restaging endoscopy and TME 6-8 weeks after the end of neoadjuvant therapy were collected. The absence of tumor cells in the histological examination of the TME specimen after neoadjuvant therapy was considered pCR. Binary logistic regression and receiver operating characteristic curves were utilized for analysis. RESULTS According to the multivariate logistic regression analysis, flattening of marginal tumor swelling (p value < 0.001, odds ratio = 100.605) emerged as an independent predictor of pCR in rectal cancer patients. Additionally, receiver operating characteristic curve analysis revealed that lower preoperative carcinoembryonic antigen and erythrocyte sedimentation rate levels predict pCR, with cutoffs of 2.15 ng/ml and 19.0 mm/h, respectively. CONCLUSION Carcinoembryonic antigen and erythrocyte sedimentation rate, along with the presence of flattening of marginal tumor swelling, can predict pCR after neoadjuvant chemoradiotherapy in patients with primary rectal cancer. These factors offer a potential method for selecting candidates for conservative treatment based on endoscopic and laboratory findings.
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Affiliation(s)
- Alireza Hadizadeh
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
| | - Hamed Kazemi-Khaledi
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran
| | - Mohammad-Sadegh Fazeli
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran
| | - Seyed-Mohsen Ahmadi-Tafti
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran
| | - Amir Keshvari
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran
| | - Reza Akbari-Asbagh
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran
- Research Center for Advanced Technologies in Cardiovascular Medicine, Cardiovascular Research Institute, Tehran University of Medical Sciences, Tehran, Iran
| | - Mohammad-Reza Keramati
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran
| | - Alireza Kazemeini
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran
| | - Amir-Reza Fazeli
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran.
| | - Behnam Behboudi
- Colorectal Research Center, Imam Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehan, 1419733141, Iran.
| | - Mohammadamin Parsaei
- Maternal, Fetal & Neonatal Research Center, Family Health Research Institute, Tehran University of Medical Sciences, Tehran, Iran
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Custers PA, Beets GL, Bach SP, Blomqvist LK, Figueiredo N, Gollub MJ, Martling A, Melenhorst J, Ortega CD, Perez RO, Smith JJ, Lambregts DMJ, Beets-Tan RGH, Maas M. An International Expert-Based Consensus on the Definition of a Clinical Near-Complete Response After Neoadjuvant (Chemo)radiotherapy for Rectal Cancer. Dis Colon Rectum 2024; 67:782-795. [PMID: 38701503 DOI: 10.1097/dcr.0000000000003209] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/05/2024]
Abstract
BACKGROUND A variety of definitions for a clinical near-complete response after neoadjuvant (chemo) radiotherapy for rectal cancer are currently used. This variety leads to inconsistency in clinical practice, long-term outcome, and trial enrollment. OBJECTIVE The aim of this study was to reach expert-based consensus on the definition of a clinical near-complete response after (chemo) radiotherapy. DESIGN A modified Delphi process, including a systematic review, 3 surveys, and 2 meetings, was performed with an international expert panel consisting of 7 surgeons and 4 radiologists. The surveys consisted of individual features, statements, and feature combinations (endoscopy, T2-weighted MRI, and diffusion-weighted MRI). SETTING The modified Delphi process was performed in an online setting; all 3 surveys were completed online by the expert panel, and both meetings were hosted online. MAIN OUTCOME MEASURES The main outcome was to reach consensus (80% or more agreement). RESULTS The expert panel reached consensus on a 3-tier categorization of the near-complete response category based on the likelihood of the response to evolve into a clinical complete response after a longer waiting interval. The panelists agreed that a near-complete response is a temporary entity only to be used in the first 6 months after (chemo)radiotherapy. Furthermore, consensus was reached that the lymph node status should be considered when deciding on a near-complete response and that biopsies are not always needed when a near-complete response is found. No consensus was reached on whether primary staging characteristics have to be taken into account when deciding on a near-complete response. LIMITATIONS This 3-tier subcategorization is expert-based; therefore, there is no supporting evidence for this subcategorization. Also, it is unclear whether this subcategorization can be generalized into clinical practice. CONCLUSIONS Consensus was reached on the use of a 3-tier categorization of a near-complete response, which can be helpful in daily practice as guidance for treatment and to inform patients with a near-complete response on the likelihood of successful organ preservation. See Video Abstract. UN CONSENSO INTERNACIONAL BASADO EN EXPERTOS ACERCA DE LA DEFINICIN DE UNA RESPUESTA CLNICA CASI COMPLETA DESPUS DE QUIMIORADIOTERAPIA NEOADYUVANTE CONTRA EL CNCER DE RECTO ANTECEDENTES:Actualmente, se utilizan una variedad de definiciones para una respuesta clínica casi completa después de quimioradioterapia neoadyuvante contra el cáncer de recto. Esta variedad resulta en inconsistencia en la práctica clínica, los resultados a largo plazo y la inscripción en ensayos.OBJETIVO:El objetivo de este estudio fue llegar a un consenso de expertos sobre la definición de una respuesta clínica casi completa después de quimioradioterapia.DISEÑO:Se realizó un proceso Delphi modificado que incluyó una revisión sistemática, 3 encuestas y 2 reuniones con un panel internacional de expertos compuesto por siete cirujanos y 4 radiólogos. Las encuestas consistieron en características individuales, declaraciones y combinaciones de características (endoscopía, T2W-MRI y DWI).AJUSTE:El proceso Delphi modificado se realizó en un entorno en línea; el panel de expertos completó las tres encuestas en línea y ambas reuniones se realizaron en línea.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue llegar a un consenso (≥80% de acuerdo).RESULTADOS:El panel de expertos llegó a un consenso sobre una categorización de tres niveles de la categoría de respuesta casi completa basada en la probabilidad de que la respuesta evolucione hacia una respuesta clínica completa después de un intervalo de espera más largo. Los panelistas coincidieron en que una respuesta casi completa es una entidad temporal que sólo debe utilizarse en los primeros 6 meses después de la quimioradioterapia. Además, se llegó a un consenso en que se debe considerar el estado de los nódulos linfáticos al decidir sobre una respuesta casi completa y que no siempre se necesitan biopsias cuando se encuentra una respuesta casi completa. No se llegó a un consenso sobre si se deben tener en cuenta las características primarias de estadificación al decidir una respuesta casi completa.LIMITACIONES:Esta subcategorización de 3 niveles está basada en expertos; por lo tanto, no hay evidencia que respalde esta subcategorización. Además, no está claro si esta subcategorización puede generalizarse a la práctica clínica.CONCLUSIONES:Se alcanzó consenso sobre el uso de una categorización de 3 niveles de una respuesta casi completa que puede ser útil en la práctica diaria como guía para el tratamiento y para informar a los pacientes con una respuesta casi completa sobre la probabilidad de una preservación exitosa del órgano. (Traducción - Dr. Aurian Garcia Gonzalez).
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Affiliation(s)
- Petra A Custers
- Department of Surgery, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, the Netherlands
- GROW School for Oncology and Developmental Reproduction, Maastricht University, Maastricht, the Netherlands
| | - Geerard L Beets
- Department of Surgery, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, the Netherlands
- GROW School for Oncology and Developmental Reproduction, Maastricht University, Maastricht, the Netherlands
| | - Simon P Bach
- Department of Surgery, Queen Elizabeth Hospital, Birmingham, United Kingdom
| | - Lennart K Blomqvist
- Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden
- Department of Radiation Physics and Nuclear Medicine, Karolinska University Hospital, Stockholm, Sweden
| | - Nuno Figueiredo
- Department of Surgery, Hospital Lusiadas Lisboa, Lisbon, Portugal
| | - Marc J Gollub
- Department of Radiology, Memorial Sloan Kettering Cancer Center, New York
| | - Anna Martling
- Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden
- Department of Pelvic Cancer, Division of Coloproctology, Karolinska University Hospital, Stockholm, Sweden
| | - Jarno Melenhorst
- GROW School for Oncology and Developmental Reproduction, Maastricht University, Maastricht, the Netherlands
- Department of Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands
| | - Cinthia D Ortega
- Department of Radiology, University of São Paulo School of Medicine, São Paulo, Brazil
- Department of Radiology and Diagnostic Imaging, Hospital Israelita Albert Einstein, São Paulo, Brazil
| | - Rodrigo O Perez
- Division of Colorectal Surgery, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
| | - J Joshua Smith
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York
| | - Doenja M J Lambregts
- GROW School for Oncology and Developmental Reproduction, Maastricht University, Maastricht, the Netherlands
- Department of Radiology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, the Netherlands
| | - Regina G H Beets-Tan
- GROW School for Oncology and Developmental Reproduction, Maastricht University, Maastricht, the Netherlands
- Department of Radiology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, the Netherlands
| | - Monique Maas
- GROW School for Oncology and Developmental Reproduction, Maastricht University, Maastricht, the Netherlands
- Department of Radiology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, the Netherlands
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8
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Safont MJ, García-Figueiras R, Hernando-Requejo O, Jimenez-Rodriguez R, Lopez-Vicente J, Machado I, Ayuso JR, Bustamante-Balén M, De Torres-Olombrada MV, Domínguez Tristancho JL, Fernández-Aceñero MJ, Suarez J, Vera R. Interdisciplinary Spanish consensus on a watch-and-wait approach for rectal cancer. Clin Transl Oncol 2024; 26:825-835. [PMID: 37787973 DOI: 10.1007/s12094-023-03322-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2023] [Accepted: 09/07/2023] [Indexed: 10/04/2023]
Abstract
Watch-and-wait has emerged as a new strategy for the management of rectal cancer when a complete clinical response is achieved after neoadjuvant therapy. In an attempt to standardize this new clinical approach, initiated by the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD), and with the participation of the Spanish Association of Coloproctology (AECP), the Spanish Society of Pathology (SEAP), the Spanish Society of Gastrointestinal Endoscopy (SEED), the Spanish Society of Radiation Oncology (SEOR), and the Spanish Society of Medical Radiology (SERAM), we present herein a consensus on a watch-and-wait approach for the management of rectal cancer. We have focused on patient selection, the treatment schemes evaluated, the optimal timing for evaluating the clinical complete response, the oncologic outcomes after the implementation of this strategy, and a protocol for surveillance of these patients.
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Affiliation(s)
- Maria Jose Safont
- Oncology Department, Consorcio Hospital General Universitario de Valencia. Valencia University, Av. de les Tres Creus, 2, 46014, València, Spain.
| | - Roberto García-Figueiras
- Radiology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain
| | | | | | - Jorge Lopez-Vicente
- Gastroenterology Department, Hospital Universitario de Mostoles, Mósteles, Spain
| | - Isidro Machado
- Instituto Valenciano de Oncología, Valencia, Spain
- Pathology Department, Patologika Laboratory QuironSalud, Valencia, Spain
- Pathology Department, University of Valencia, Valencia, Spain
| | | | - Marco Bustamante-Balén
- Gastrointestinal Endoscopy Unit, Hospital Universitari i Politècnic La Fe, Valencia, Spain
| | | | | | - Mª Jesús Fernández-Aceñero
- Surgical Pathology Department, Hospital Clínico San Carlos, IdiSSC, Universidad Complutense de Madrid, Madrid, Spain
| | - Javier Suarez
- General Surgery Department, Hospital Universitario de Navarra, Pamplona, Spain
| | - Ruth Vera
- Medical Oncology Department, Hospital Universitario de Navarra, Instituto de Investigación (Idisna), Pamplona, Spain
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Williams H, Thompson HM, Lin ST, Verheij FS, Omer DM, Qin LX, Garcia-Aguilar J. Endoscopic Predictors of Residual Tumor After Total Neoadjuvant Therapy: A Post Hoc Analysis From the Organ Preservation in Rectal Adenocarcinoma Trial. Dis Colon Rectum 2024; 67:369-376. [PMID: 38039292 PMCID: PMC10922113 DOI: 10.1097/dcr.0000000000003096] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/03/2023]
Abstract
BACKGROUND Restaging endoscopy plays a critical role in selecting patients with locally advanced rectal cancer who respond to neoadjuvant therapy for nonoperative management. OBJECTIVE This study evaluated the restaging endoscopic features that best predict the presence of residual tumor in the bowel wall. DESIGN This was a post hoc analysis of a prospective randomized trial. SETTINGS The Organ Preservation in Rectal Adenocarcinoma Trial randomly assigned patients across 18 institutions with stage II/III rectal adenocarcinoma to receive either induction or consolidation total neoadjuvant therapy. Surgeons completed a restaging tumor assessment form, which stratified patients across 3 tiers of clinical response. PATIENTS Patients enrolled in the Organ Preservation in Rectal Adenocarcinoma Trial with a completed tumor assessment form were included. MAIN OUTCOME MEASURES The main outcome was residual tumor, which was defined as either an incomplete clinical response or local tumor regrowth within 2 years of restaging. Independent predictors of residual tumor were identified using backward-selected multivariable logistic regression analysis. Subgroup analyses for complete and near complete clinical responders were performed. RESULTS Surgeons completed restaging forms for 263 patients at a median of 7.7 weeks after neoadjuvant therapy; 128 patients (48.7%) had a residual tumor. On multivariable regression analysis, several characteristics of a near complete response, including ulcer (OR 6.66; 95% CI, 2.54-19.9), irregular mucosa (OR 3.66; 95% CI, 1.61-8.68), and nodularity (OR 2.96; 95% CI, 1.36-6.58), remained independent predictors of residual tumor. A flat scar was associated with lower odds of harboring residual disease (OR 0.32; 95% CI, 0.11-0.93) for patients categorized as clinical complete responders. LIMITATIONS Limitations include analysis of endoscopic features at a single time point and ambiguities in tumor assessment form response criteria. CONCLUSIONS Patients with ulcer, nodularity, or irregular mucosa, on restaging endoscopy have higher odds of residual tumor. Recognizing negative prognostic implications of these features will help surgeons better select candidates for nonoperative management and suggests that patients with high-risk characteristics would benefit from close interval surveillance. See Video Abstract . PREDICTORES ENDOSCPICOS DE TUMOR RESIDUAL DESPUS DE TERAPIA NEOADYUVANTE TOTAL UN ANLISIS POST HOC DEL ENSAYO DE PRESERVACIN DE RGANOS EN ADENOCARCINOMA RECTAL ANTECEDENTES:La reestadificación por endoscopia juega un papel crítico en la selección de pacientes con cáncer de recto localmente avanzado que responden a la terapia neoadyuvante para el manejo no quirúrgico.OBJETIVO:Este estudio evaluó las características endoscópicas de reestadificación que mejor predicen la presencia de tumor residual en la pared intestinal.DISEÑO:Este fue un análisis post hoc de un ensayo prospectivo aleatorizado.ESCENARIO:El ensayo Organ Preservation in Rectal Adenocarcinoma aleatorizó a pacientes de 18 instituciones con adenocarcinoma de recto en estadio II/III para recibir terapia neoadyuvante total de inducción o consolidación. Los cirujanos completaron un formulario de reestadificación de evaluación del tumor, que estratificó a los pacientes en tres niveles de respuesta clínica.PACIENTES:Se incluyeron pacientes inscritos en el ensayo de preservación de órganos en adenocarcinoma rectal con un formulario de evaluación del tumor completado.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue presencia de tumor residual, que se definió como una respuesta clínica incompleta o un nuevo crecimiento local del tumor dentro de los dos años posteriores a la reestadificación. Los predictores independientes de tumor residual se identificaron mediante un análisis de regresión logística multivariable seleccionado hacia atrás. Se realizaron análisis de subgrupos para pacientes con respuesta clínica completa y casi completa.RESULTADOS:Los cirujanos completaron formularios de reestadificación para 263 pacientes en una mediana de 7.7 semanas después de la terapia neoadyuvante; 128 (48.7%) tenían tumor residual. En el análisis de regresión multivariable, varias características de una respuesta casi completa, incluyendo úlcera (OR 6.66; IC 95% 2.54-19.9), mucosa irregular (OR 3.66; IC 95% 1.61-8.68) y nodularidad (OR 2.96; IC 95% 1.36 -6.58) siguieron siendo predictores independientes de tumor residual. Una cicatriz plana se asoció con menores probabilidades de albergar enfermedad residual (OR 0.32; IC del 95 %: 0.11-0.93) para los pacientes clasificados como respondedores clínicos completos.LIMITACIONES:Las limitaciones de este estudio incluyen el análisis de las características endoscópicas en un solo momento y las ambigüedades en los criterios de respuesta.en la forma de evaluación del tumorCONCLUSIONES:Los pacientes con úlcera, nodularidad o mucosa irregular en la endoscopia de reestadificación tienen mayores probabilidades de tumor residual. El reconocer las implicaciones pronósticas negativas de estas características ayudará a los cirujanos a seleccionar mejor a los candidatos para el tratamiento no quirúrgico y sugiere que los pacientes con características de alto riesgo se beneficiarían de una vigilancia a intervalos estrechos. (Traducción-Dr. Jorge Silva Velazco ).
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Affiliation(s)
- Hannah Williams
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Hannah M. Thompson
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Sabrina T. Lin
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Floris S. Verheij
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Dana M. Omer
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Li-Xuan Qin
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Julio Garcia-Aguilar
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York
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Langenfeld SJ, Davis BR, Vogel JD, Davids JS, Temple LKF, Cologne KG, Hendren S, Hunt S, Garcia Aguilar J, Feingold DL, Lightner AL, Paquette IM. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Rectal Cancer 2023 Supplement. Dis Colon Rectum 2024; 67:18-31. [PMID: 37647138 DOI: 10.1097/dcr.0000000000003057] [Citation(s) in RCA: 7] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/01/2023]
Affiliation(s)
- Sean J Langenfeld
- Department of Surgery, University of Nebraska Medical Center, Omaha, Nebraska
| | - Bradley R Davis
- Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina
| | - Jon D Vogel
- Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado
| | | | - Larissa K F Temple
- Colorectal Surgery Division, Department of Surgery, University of Rochester Medical Center, Rochester, New York
| | - Kyle G Cologne
- Department of Surgery, Division of Colorectal Surgery, University of Southern California, Los Angeles, California
| | - Samantha Hendren
- Division of Colon and Rectal Surgery, Department of Surgery, University of Michigan, Michigan Medicine, Ann Arbor, Michigan
| | - Steven Hunt
- Department of Surgery, Section of Colon and Rectal Surgery, Washington University School of Medicine, St. Louis, Missouri
| | - Julio Garcia Aguilar
- Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Daniel L Feingold
- Department of Surgery, Rutgers University, New Brunswick, New Jersey
| | - Amy L Lightner
- Department of Colon and Rectal Surgery, Cleveland Clinic, Cleveland, Ohio
| | - Ian M Paquette
- Department of Surgery, Division of Colon and Rectal Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio
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11
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Stefanou AJ, Dessureault S, Sanchez J, Felder S. Clinical Tools for Rectal Cancer Response Assessment following Neoadjuvant Treatment in the Era of Organ Preservation. Cancers (Basel) 2023; 15:5535. [PMID: 38067239 PMCID: PMC10705332 DOI: 10.3390/cancers15235535] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2023] [Revised: 11/04/2023] [Accepted: 11/10/2023] [Indexed: 09/16/2024] Open
Abstract
Local tumor response evaluation following neoadjuvant treatment(s) in rectal adenocarcinoma requires a multi-modality approach including physical and endoscopic evaluations, rectal protocoled MRI, and cross-sectional imaging. Clinical tumor response exists on a spectrum from complete clinical response (cCR), defined as the absence of clinical evidence of residual tumor, to near-complete response (nCR), which assumes a significant reduction in tumor burden but with increased uncertainty of residual microscopic disease, to incomplete clinical response (iCR), which incorporates all responses less than nCR that is not progressive disease. This article aims to review the clinical tools currently routinely available to evaluate treatment response and offers a potential management approach based on the extent of local tumor response.
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Affiliation(s)
| | | | | | - Seth Felder
- Clinical and Pathologic Response to Therapy in Gastrointestinal Oncology, Moffitt Cancer Center, 12902 Magnolia Dr., Tampa, FL 33612, USA; (A.J.S.); (S.D.); (J.S.)
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12
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Xiao B, Yu J, Ding PR. Nonoperative Management of dMMR/MSI-H Colorectal Cancer following Neoadjuvant Immunotherapy: A Narrative Review. Clin Colon Rectal Surg 2023; 36:378-384. [PMID: 37795463 PMCID: PMC10547541 DOI: 10.1055/s-0043-1767703] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/06/2023]
Abstract
Immunotherapy with PD-1 blockade has achieved a great success in colorectal cancers (CRCs) with high microsatellite instability (MSI-H) and deficient mismatch repair (dMMR), and has become the first-line therapy in metastatic setting. Studies of neoadjuvant immunotherapy also report exciting results, showing high rates of clinical complete response (cCR) and pathological complete response. The high efficacy and long duration of response of immunotherapy has prompt attempts to adopt watch-and-wait strategy for patients achieving cCR following the treatment. Thankfully, the watch-and-wait approach has been proposed for nearly 20 years for patients undergoing chemoradiotherapy and has gained ground among patients as well as clinicians. In this narrative review, we combed through the available information on immunotherapy for CRC and on the watch-and-wait strategy in chemoradiotherapy, and looked forward to a future where neoadjuvant immunotherapy as a curative therapy would play a big part in the treatment of MSI-H/dMMR CRC.
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Affiliation(s)
- Binyi Xiao
- Department of Colorectal Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, P. R. China
| | - Jiehai Yu
- Department of Colorectal Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, P. R. China
| | - Pei-Rong Ding
- Department of Colorectal Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, P. R. China
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13
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Wang A, Zhou J, Wang G, Zhang B, Xin H, Zhou H. Deep learning of endoscopic features for the assessment of neoadjuvant therapy response in locally advanced rectal cancer. Asian J Surg 2023; 46:3568-3574. [PMID: 37062601 DOI: 10.1016/j.asjsur.2023.03.165] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/06/2022] [Revised: 03/28/2023] [Accepted: 03/30/2023] [Indexed: 04/18/2023] Open
Abstract
BACKGROUND For locally advanced rectal cancer (LARC), accurate response evaluation is necessary to select complete responders after neoadjuvant therapy (NAT) for a watch-and-wait (W&W) strategy. Algorithms based on deep learning have shown great value in medical image analyses. Here we used deep learning algorithms of endoscopic images for the assessment of NAT response in LARC. METHOD 214 LARC patients were retrospectively included in the study. After NAT, these patients underwent total mesorectal excision (TME) surgery. Among them, 51 (23.8%) of the patients achieved a pathological complete response (pCR). 160 patients from Shanghai Changzheng Hospital were regarded as primary dataset, and the other 54 patients from Zhejiang Cancer Hospital were regarded as validation dataset. ResNet-18 and DenseNet-121 were applied to train the models based on endoscopic images after NAT. Deep learning models were valid in the validation dataset and compared to manual method. RESULTS The performances were comparable in AUC between deep learning models and manual method. For mean metrics, sensitivity (0.750 vs. 0.417) and AUC (0.716 vs. 0.601) in ResNet-18 deep learning model were higher than those in the manual method. The deep learning models were able to identify the endoscopic features associated with NAT response by the heatmaps. A diagnostic flow diagram which integrated the deep learning model to assist the clinicians in making decisions for W&W strategy was constructed. CONCLUSIONS We created deep learning models using endoscopic features for assessment of NAT in LARC. The deep learning models achieved modest accuracies and performed comparably to manual method.
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Affiliation(s)
- Anqi Wang
- Department of Colorectal Surgery, Changzheng Hospital, Navy Medical University, China
| | - Jieli Zhou
- UM-SJTU Joint Institute, Shanghai Jiao Tong University, China
| | - Gang Wang
- Department of Colorectal Surgery, Zhejiang Cancer Hospital, China
| | - Beibei Zhang
- Department of Dermatology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, China.
| | - Hongyi Xin
- UM-SJTU Joint Institute, Shanghai Jiao Tong University, China.
| | - Haiyang Zhou
- Department of Colorectal Surgery, Changzheng Hospital, Navy Medical University, China.
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14
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Kimura C, Crowder SE, Kin C. Is It Really Gone? Assessing Response to Neoadjuvant Therapy in Rectal Cancer. J Gastrointest Cancer 2023; 54:703-711. [PMID: 36417142 DOI: 10.1007/s12029-022-00889-x] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/13/2022] [Indexed: 11/25/2022]
Abstract
PURPOSE Non-operative management of rectal cancer is a feasible and appealing treatment option for patients who develop a complete response after neoadjuvant therapy. However, identifying patients who are complete responders is often a challenge. This review aims to present and discuss current evidence and recommendations regarding the assessment of treatment response in rectal cancer. METHODS A review of the current literature on rectal cancer restaging was performed. Studies included in this review explored the optimal interval between the end of neoadjuvant therapy and restaging, as well as modalities of assessment and their diagnostic performance. RESULTS The current standard for restaging rectal cancer is a multimodal assessment with the digital rectal examination, endoscopy, and T2-weighted MRI with diffusion-weighted imaging. Other diagnostic procedures under investigation are PET/MRI, radiomics, confocal laser endomicroscopy, artificial intelligence-assisted endoscopy, cell-free DNA, and prediction models incorporating one or more of the above-mentioned exams. CONCLUSION Non-operative management of rectal cancer requires a multidisciplinary approach. Understanding of the robustness and limitations of each exam is critical to inform patient selection for that treatment strategy.
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Affiliation(s)
- Cintia Kimura
- Department of Surgery, Division of General Surgery, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA, H3680K94305, USA
| | - Sarah Elizabeth Crowder
- Department of Surgery, Division of General Surgery, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA, H3680K94305, USA
- Brigham Young University, Provo, UT, USA
| | - Cindy Kin
- Department of Surgery, Division of General Surgery, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA, H3680K94305, USA.
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15
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Beets GL. Near-complete response following neoadjuvant therapy in rectal cancer: wait a bit longer? Br J Surg 2023:znad165. [PMID: 37364285 DOI: 10.1093/bjs/znad165] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2023] [Accepted: 05/12/2023] [Indexed: 06/28/2023]
Affiliation(s)
- Geerard L Beets
- Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands
- GROW School for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands
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16
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Temmink SJD, Peeters KCMJ, Bahadoer RR, Kranenbarg EMK, Roodvoets AGH, Melenhorst J, Burger JWA, Wolthuis A, Renehan AG, Figueiredo NL, Pares O, Martling A, Perez RO, Beets GL, van de Velde CJH, Nilsson PJ. Watch and wait after neoadjuvant treatment in rectal cancer: comparison of outcomes in patients with and without a complete response at first reassessment in the International Watch & Wait Database (IWWD). Br J Surg 2023; 110:676-684. [PMID: 36972213 PMCID: PMC10364523 DOI: 10.1093/bjs/znad051] [Citation(s) in RCA: 29] [Impact Index Per Article: 14.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2022] [Revised: 01/13/2023] [Accepted: 02/05/2023] [Indexed: 03/29/2023]
Abstract
BACKGROUND In rectal cancer, watch and wait for patients with a cCR after neoadjuvant treatment has an established evidence base. However, there is a lack of consensus on the definition and management of a near-cCR. This study aimed to compare outcomes in patients who achieved a cCR at first reassessment versus later reassessment. METHODS This registry study included patients from the International Watch & Wait Database. Patients were categorized as having a cCR at first reassessment or at later reassessment (that is near-cCR at first reassessment) based on MRI and endoscopy. Organ preservation, distant metastasis-free survival, and overall survival rates were calculated. Subgroup analyses were done for near-cCR groups based on the response evaluation according to modality. RESULTS A total of 1010 patients were identified. At first reassessment, 608 patients had a cCR; 402 had a cCR at later reassessment. Median follow-up was 2.6 years for patients with a cCR at first reassessment and 2.9 years for those with a cCR at later reassessment. The 2-year organ preservation rate was 77.8 (95 per cent c.i. 74.2 to 81.5) and 79.3 (75.1 to 83.7) per cent respectively (P = 0.499). Similarly, no differences were found between groups in distant metastasis-free survival or overall survival rate. Subgroup analyses showed a higher organ preservation rate in the group with a near-cCR categorized exclusively by MRI. CONCLUSION Oncological outcomes for patients with a cCR at later reassessment are no worse than those of patients with a cCR at first reassessment.
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Affiliation(s)
- Sofieke J D Temmink
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
| | - Koen C M J Peeters
- Department of Surgery, Leiden University Medical Centre, Leiden, the Netherlands
| | - Renu R Bahadoer
- Department of Surgery, Leiden University Medical Centre, Leiden, the Netherlands
| | | | - Annet G H Roodvoets
- Department of Surgery, Leiden University Medical Centre, Leiden, the Netherlands
| | - Jarno Melenhorst
- Department of Surgery, Maastricht Universitair Medisch Centrum+, Maastricht, the Netherlands
| | | | - Albert Wolthuis
- Department of Abdominal Surgery, University Hospitals Leuven, Leuven, Belgium
| | - Andrew G Renehan
- Manchester Cancer Research Centre, National Institute for Health Research Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK
- Colorectal and Peritoneal Oncology Centre, Christie National Health Service Foundation Trust, Manchester, UK
| | | | - Oriol Pares
- Department of Radiation Oncology, Champalimaud Foundation, Lisbon, Portugal
| | - Anna Martling
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
| | - Rodrigo O Perez
- Department of Colorectal Surgery, Angelita and Joaquim Gama Institute, São Paulo, Brazil
- Department of Surgical Oncology, Hospital Beneficencia Portuguesa, São Paulo, Brazil
- Colorectal Surgery Division, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
- Ludwig Institute for Cancer Research, São Paulo Branch, São Paulo, Brazil
| | - Geerard L Beets
- Department of Surgery, Netherlands Cancer Institute—Antoni van Leeuwenhoek, Amsterdam, the Netherlands
- GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands
| | | | - Per J Nilsson
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
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17
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Cuicchi D, Castagna G, Cardelli S, Larotonda C, Petrello B, Poggioli G. Restaging rectal cancer following neoadjuvant chemoradiotherapy. World J Gastrointest Oncol 2023; 15:700-712. [PMID: 37275455 PMCID: PMC10237020 DOI: 10.4251/wjgo.v15.i5.700] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2022] [Revised: 03/01/2023] [Accepted: 03/29/2023] [Indexed: 05/12/2023] Open
Abstract
Correct tumour restaging is pivotal for identifying the most personalised surgical treatment for patients with locally advanced rectal cancer undergoing neoadjuvant therapy, and works to avoid both poor oncological outcome and overtreatment. Digital rectal examination, endoscopy, and pelvic magnetic resonance imaging are the recommended modalities for local tumour restaging, while chest and abdominal computed tomography are utilised for the assessment of distant disease. The optimal length of time between neoadjuvant treatment and restaging, in terms of both oncological safety and clinical effectiveness of treatment, remains unclear, especially for patients receiving prolonged total neoadjuvant therapy. The timely identification of patients who are radioresistant and at risk of disease progression remains challenging.
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Affiliation(s)
- Dajana Cuicchi
- Department of Medical and Surgical Sciences, Surgery of the Alimentary Tract, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy
| | - Giovanni Castagna
- Department of Medical and Surgical Sciences, Surgery of the Alimentary Tract, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy
| | - Stefano Cardelli
- Department of Medical and Surgical Sciences, Surgery of the Alimentary Tract, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy
| | - Cristina Larotonda
- Department of Medical and Surgical Sciences, Surgery of the Alimentary Tract, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy
| | - Benedetta Petrello
- Department of Medical and Surgical Sciences, Surgery of the Alimentary Tract, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy
| | - Gilberto Poggioli
- Department of Medical and Surgical Sciences, Surgery of the Alimentary Tract, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy
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18
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Thompson HM, Kim JK, Jimenez-Rodriguez RM, Garcia-Aguilar J, Veeraraghavan H. Deep Learning-Based Model for Identifying Tumors in Endoscopic Images From Patients With Locally Advanced Rectal Cancer Treated With Total Neoadjuvant Therapy. Dis Colon Rectum 2023; 66:383-391. [PMID: 35358109 PMCID: PMC10185333 DOI: 10.1097/dcr.0000000000002295] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Abstract
BACKGROUND A barrier to the widespread adoption of watch-and-wait management for locally advanced rectal cancer is the inaccuracy and variability of identifying tumor response endoscopically in patients who have completed total neoadjuvant therapy (chemoradiotherapy and systemic chemotherapy). OBJECTIVE This study aimed to develop a novel method of identifying the presence or absence of a tumor in endoscopic images using deep convolutional neural network-based automatic classification and to assess the accuracy of the method. DESIGN In this prospective pilot study, endoscopic images obtained before, during, and after total neoadjuvant therapy were grouped on the basis of tumor presence. A convolutional neural network was modified for probabilistic classification of tumor versus no tumor and trained with an endoscopic image set. After training, a testing endoscopic imaging set was applied to the network. SETTINGS The study was conducted at a comprehensive cancer center. PATIENTS Images were analyzed from 109 patients who were diagnosed with locally advanced rectal cancer between December 2012 and July 2017 and who underwent total neoadjuvant therapy. MAIN OUTCOME MEASURES The main outcomes were accuracy of identifying tumor presence or absence in endoscopic images measured as area under the receiver operating characteristic for the training and testing image sets. RESULTS A total of 1392 images were included; 1099 images (468 of no tumor and 631 of tumor) were for training and 293 images (151 of no tumor and 142 of tumor) for testing. The area under the receiver operating characteristic for training and testing was 0.83. LIMITATIONS The study had a limited number of images in each set and was conducted at a single institution. CONCLUSIONS The convolutional neural network method is moderately accurate in distinguishing tumor from no tumor. Further research should focus on validating the convolutional neural network on a large image set. See Video Abstract at http://links.lww.com/DCR/B959 . MODELO BASADO EN APRENDIZAJE PROFUNDO PARA IDENTIFICAR TUMORES EN IMGENES ENDOSCPICAS DE PACIENTES CON CNCER DE RECTO LOCALMENTE AVANZADO TRATADOS CON TERAPIA NEOADYUVANTE TOTAL ANTECEDENTES:Una barrera para la aceptación generalizada del tratamiento de Observar y Esperar para el cáncer de recto localmente avanzado, es la imprecisión y la variabilidad en la identificación de la respuesta tumoral endoscópica, en pacientes que completaron la terapia neoadyuvante total (quimiorradioterapia y quimioterapia sistémica).OBJETIVO:Desarrollar un método novedoso para identificar la presencia o ausencia de un tumor en imágenes endoscópicas utilizando una clasificación automática basada en redes neuronales convolucionales profundas y evaluar la precisión del método.DISEÑO:Las imágenes endoscópicas obtenidas antes, durante y después de la terapia neoadyuvante total se agruparon en base de la presencia del tumor. Se modificó una red neuronal convolucional para la clasificación probabilística de tumor versus no tumor y se entrenó con un conjunto de imágenes endoscópicas. Después del entrenamiento, se aplicó a la red un conjunto de imágenes endoscópicas de prueba.ENTORNO CLINICO:El estudio se realizó en un centro oncológico integral.PACIENTES:Analizamos imágenes de 109 pacientes que fueron diagnosticados de cáncer de recto localmente avanzado entre diciembre de 2012 y julio de 2017 y que se sometieron a terapia neoadyuvante total.PRINCIPALES MEDIDAS DE VALORACION:La precisión en la identificación de la presencia o ausencia de tumores en imágenes endoscópicas medidas como el área bajo la curva de funcionamiento del receptor para los conjuntos de imágenes de entrenamiento y prueba.RESULTADOS:Se incluyeron mil trescientas noventa y dos imágenes: 1099 (468 sin tumor y 631 con tumor) para entrenamiento y 293 (151 sin tumor y 142 con tumor) para prueba. El área bajo la curva operativa del receptor para entrenamiento y prueba fue de 0,83.LIMITACIONES:El estudio tuvo un número limitado de imágenes en cada conjunto y se realizó en una sola institución.CONCLUSIÓN:El método de la red neuronal convolucional es moderadamente preciso para distinguir el tumor de ningún tumor. La investigación adicional debería centrarse en validar la red neuronal convolucional en un conjunto de imágenes mayor. Consulte Video Resumen en http://links.lww.com/DCR/B959 . (Traducción -Dr. Fidel Ruiz Healy ).
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Affiliation(s)
- Hannah M Thompson
- Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Jin K Kim
- Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York
| | | | - Julio Garcia-Aguilar
- Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Harini Veeraraghavan
- Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York
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Predictive value of modified MRI-based split scar sign (mrSSS) score for pathological complete response after neoadjuvant chemoradiotherapy for patients with rectal cancer. Int J Colorectal Dis 2023; 38:40. [PMID: 36790595 DOI: 10.1007/s00384-023-04330-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 02/04/2023] [Indexed: 02/16/2023]
Abstract
PURPOSE To measure the diagnostic performance of modified MRI-based split scar sign (mrSSS) score for the prediction of pathological complete response (pCR) after neoadjuvant chemoradiotherapy (nCRT) for patients with rectal cancer. METHODS The modified MRI-based split scar sign (mrSSS) score, which consists of T2-weighted images (T2WI)-based score and diffusion-weighted images (DWI)-based score. The sensitivity, specificity, and accuracy of modified mrSSS score, endoscopic gross type, and MRI-based tumor regression grading (mrTRG) score, in the prediction of pCR, were compared. The prognostic value of the modified mrSSS score was also studied. RESULTS A total of 189 patients were included in the study. The Kendall's coefficient of interobserver concordance of modified mrSSS score, T2WI -based score, and DWI-based score were 0.899, 0.890, and 0.789 respectively. And the maximum and minimum k value of the modified mrSSS score was 0.797 (0.742-0.853) and 0.562 (0.490-0.634). The sensitivity, specificity, and accuracy of prediction of pCR were 0.66, 0.97, and 0.90 for modified mrSSS score; 0.37, 0.89, and 0.78 for endoscopic gross type (scar); and 0.24, 0.92, and 0.77 for mrTRG score (mrTRG = 1). The modified mrSSS score had significantly higher sensitivity than the endoscopic gross type and the mrTRG score in predicting pCR. Patients with lower modified mrSSS scores had significantly longer disease-free survival (P < 0.05). CONCLUSION The modified mrSSS score showed satisfactory interobserver agreement and higher sensitivity in predicting pCR after nCRT in patients with rectal cancer. The modified mrSSS score is also a predictor of disease-free survival.
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20
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Features on Endoscopy and MRI after Treatment with Contact X-ray Brachytherapy for Rectal Cancer: Explorative Results. Cancers (Basel) 2022; 14:cancers14225565. [PMID: 36428659 PMCID: PMC9688812 DOI: 10.3390/cancers14225565] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2022] [Revised: 11/06/2022] [Accepted: 11/08/2022] [Indexed: 11/16/2022] Open
Abstract
After neoadjuvant (chemo)radiotherapy for rectal cancer, contact X-ray brachytherapy (CXB) can be applied aiming at organ preservation. This explorative study describes the early features on endoscopy and MRI after CXB. Patients treated with CXB following (chemo)radiotherapy and a follow-up of ≥12 months were selected. Endoscopy and MRI were performed every 3 months. Expert readers scored all the images according to structured reporting templates. Thirty-six patients were included, 15 of whom obtained a cCR. On endoscopy, the most frequently observed feature early in follow-up was an ulcer, regardless of whether patients developed a cCR. A flat, white scar and tumor mass were common at 6 months. Focal tumor signal on T2W-MRI and mass-like high signal on DWI were generally absent in patients with a cCR. An ulceration on T2W-MRI and "reactive" mucosal signal on DWI were observed early in follow-up regardless of the final tumor response. The distinction between a cCR and a residual tumor generally can be made at 6 months. Features associated with a residual tumor are tumor mass on endoscopy, focal tumor signal on T2W-MRI, and mass-like high signal on DWI. Early recognition of these features is necessary to identify patients who will not develop a cCR as early as possible.
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21
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Rojas MA, Cataneo J, Gagnon-Konamna M, Borsuk DJ, Jarzabek AJ, Marecik SJ, Park JJ, Kochar K. Correlation of Tumor Response Between Flexible Sigmoidoscopy and Magnetic Resonance Imaging in Patients Undergoing Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Retrospective Review. Am Surg 2022:31348221105575. [PMID: 35617529 DOI: 10.1177/00031348221105575] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
BACKGROUND The National Accreditation Program for Rectal Cancer recommends a pelvic MRI to assess the response to neoadjuvant therapy for advanced rectal cancers. However, there is no single restaging modality that can identify all patients with complete tumor response. At our institution, we perform both a pelvic MRI and a flexible sigmoidoscopy (FS) after neoadjuvant therapy prior to surgical resection. OBJECTIVE The objective is to elucidate the correlation of tumor response between FS and MRI in patients undergoing neoadjuvant therapy for locally advanced rectal cancer. DESIGN Single institution from 2010 to 2019. Retrospective cohort study comparing local tumor response on FS to MRI utilizing final pathology as the gold standard for comparison. PATIENTS Patients with confirmed locally advanced rectal adenocarcinoma (stage II or III) who underwent neoadjuvant therapy prior to surgical intervention and underwent flexible endoscopy and a standardized rectal cancer protocol MRI to evaluate tumor response. RESULTS A total of 48 patients were evaluated. Seven (14%) patients had a complete pathological response. MRI adequately reported 1 (14%), while FS found 4 (57.14%) out of the 7 complete responders. Nevertheless, this did not reach statistical significance (P = .06). On logistic regression analysis, flexible sigmoidoscopy had a 5.5 higher likelihood to report an accurate complete response (OR 5.5, 95% CI: 1.02-29.64; P = .047). CONCLUSIONS Flexible sigmoidoscopy should be used in conjunction with MRI in the work up of patients who have received neoadjuvant therapy for advanced rectal cancer prior to surgical resection.
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Affiliation(s)
- Maria A Rojas
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Jose Cataneo
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Marianne Gagnon-Konamna
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Daniel J Borsuk
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA.,Division of Colon and Rectal Surgery, University of Illinois at Chicago, Chicago, IL, USA.,Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA
| | - Angela J Jarzabek
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Slawomir J Marecik
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA.,Division of Colon and Rectal Surgery, University of Illinois at Chicago, Chicago, IL, USA
| | - John J Park
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA.,Division of Colon and Rectal Surgery, University of Illinois at Chicago, Chicago, IL, USA
| | - Kunal Kochar
- Division of Colon and Rectal Surgery, 21886Advocate Lutheran General Hospital, Park Ridge, IL, USA.,Division of Colon and Rectal Surgery, University of Illinois at Chicago, Chicago, IL, USA
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22
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Chen X, Chen J, He X, Xu L, Liu W, Lin D, Luo Y, Feng Y, Lian L, Hu J, Lan P. Endoscopy-Based Deep Convolutional Neural Network Predicts Response to Neoadjuvant Treatment for Locally Advanced Rectal Cancer. Front Physiol 2022; 13:880981. [PMID: 35574447 PMCID: PMC9091815 DOI: 10.3389/fphys.2022.880981] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2022] [Accepted: 03/11/2022] [Indexed: 11/13/2022] Open
Abstract
Background and Aims: Although the wait and watch (W&W) strategy is a treatment choice for locally advanced rectal cancer (LARC) patients who achieve clinical complete response (cCR) after neoadjuvant therapy (NT), the issue on consistency between cCR and pathological CR (pCR) remains unsettled. Herein, we aimed to develop a deep convolutional neural network (DCNN) model using endoscopic images of LARC patients after NT to distinguish tumor regression grade (TRG) 0 from non-TRG0, thus providing strength in identifying surgery candidates. Methods: A total of 1000 LARC patients (6,939 endoscopic images) who underwent radical surgery after NT from April 2013 to April 2021 at the Sixth Affiliated Hospital, Sun Yat-sen University were retrospectively included in our study. Patients were divided into three cohorts in chronological order: the training set for constructing the model, the validation set, and the independent test set for validating its predictive capability. Besides, we compared the model's performance with that of three endoscopists on a class-balanced, randomly selected subset of 20 patients' LARC images (10 TRG0 patients with 70 images and 10 non-TRG0 patients with 72 images). The measures used to evaluate the efficacy for identifying TRG0 included overall accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUROC). Results: There were 219 (21.9%) cases of TRG0 in the included patients. The constructed DCNN model in the training set obtained an excellent performance with good accuracy of 94.21%, specificity of 94.39%, NPV of 98.11%, and AUROC of 0.94. The validation set showed accuracy, specificity, NPV, and AUROC of 92.13%, 93.04%, 96.69%, and 0.95, respectively; the corresponding values in the independent set were 87.14%, 92.98%, 91.37%, and 0.77, respectively. In the reader study, the model outperformed the three experienced endoscopists with an AUROC of 0.85. Conclusions: The proposed DCNN model achieved high specificity and NPV in detecting TRG0 LARC tumors after NT, with a better performance than experienced endoscopists. As a supplement to radiological images, this model may serve as a useful tool for identifying surgery candidates in LARC patients after NT.
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Affiliation(s)
- Xijie Chen
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Junguo Chen
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Xiaosheng He
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Liang Xu
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Pathology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Wei Liu
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Endoscopic Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Dezheng Lin
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Endoscopic Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Yuxuan Luo
- Tianjin Economic-Technological Development Area, Yujin Digestive Health Industry Research Institute, Tianjin, China
| | - Yue Feng
- Tianjin Economic-Technological Development Area, Yujin Digestive Health Industry Research Institute, Tianjin, China
| | - Lei Lian
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Jiancong Hu
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Endoscopic Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Network Management, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Ping Lan
- Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
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23
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Kim JK, Thompson H, Jimenez-Rodriguez RM, Wu F, Sanchez-Vega F, Nash GM, Guillem JG, Paty PB, Wei IH, Pappou EP, Widmar M, Weiser MR, Smith JJ, Garcia-Aguilar J. Adoption of Organ Preservation and Surgeon Variability for Patients with Rectal Cancer Does Not Correlate with Worse Survival. Ann Surg Oncol 2022; 29:1172-1179. [PMID: 34601641 PMCID: PMC8727510 DOI: 10.1245/s10434-021-10877-3] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/05/2021] [Accepted: 09/04/2021] [Indexed: 02/03/2023]
Abstract
BACKGROUND AND OBJECTIVES Watch-and-wait is variably adopted by surgeons and the impact of this on outcomes is unknown. We compared the disease-free survival and organ preservation rates of locally advanced rectal cancer patients treated by expert colorectal surgeons at a comprehensive cancer center. METHODS This study included retrospective data on patients diagnosed with stage II/III rectal adenocarcinoma from January 2013 to June 2017 who initiated neoadjuvant therapy (either with chemoradiation, chemotherapy, or a combination of both) and were treated by an expert colorectal surgeon. RESULTS Overall, 444 locally advanced rectal cancer patients managed by five surgeons were included. Tumor distance from the anal verge, type of neoadjuvant therapy, and organ preservation rates varied by treating surgeon. There was no difference in disease-free survival after stratifying by the treating surgeon (p = 0.2). On multivariable analysis, neither the type of neoadjuvant therapy nor the treating surgeon was associated with disease-free survival. CONCLUSIONS While neoadjuvant therapy type and organ preservation rates varied among surgeons, there were no meaningful differences in disease-free survival. These data suggest that among expert colorectal surgeons, differing thresholds for selecting patients for watch-and-wait do not affect survival.
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Affiliation(s)
- Jin K Kim
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Hannah Thompson
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Rosa M Jimenez-Rodriguez
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Fan Wu
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Francisco Sanchez-Vega
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Garrett M Nash
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Jose G Guillem
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Philip B Paty
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Iris H Wei
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Emmanouil P Pappou
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Maria Widmar
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Martin R Weiser
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - J Joshua Smith
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Julio Garcia-Aguilar
- Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
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24
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Predicting pathologic complete response in locally advanced rectal cancer patients after neoadjuvant therapy: a machine learning model using XGBoost. Int J Colorectal Dis 2022; 37:1621-1634. [PMID: 35704090 PMCID: PMC9262764 DOI: 10.1007/s00384-022-04157-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/17/2022] [Indexed: 02/04/2023]
Abstract
PURPOSE Watch and wait strategy is a safe and effective alternative to surgery in patients with locally advanced rectal cancer (LARC) who have achieved pathological complete response (pCR) after neoadjuvant therapy (NAT); present restaging methods do not meet clinical needs. This study aimed to construct a machine learning (ML) model to predict pCR preoperatively. METHODS LARC patients who received NAT were included to generate an extreme gradient boosting-based ML model to predict pCR. The group was divided into a training set and a tuning set at a 7:3 ratio. The SHapley Additive exPlanations value was used to quantify feature importance. The ML model was compared with a nomogram model developed using independent risk factors identified by conventional multivariate logistic regression analysis. RESULTS Compared with the nomogram model, our ML model improved the area under the receiver operating characteristics from 0.72 to 0.95, sensitivity from 43 to 82.2%, and specificity from 87.1 to 91.6% in the training set, the same trend applied to the tuning set. Neoadjuvant radiotherapy, preoperative carbohydrate antigen 125 (CA125), CA199, carcinoembryonic antigen level, and depth of tumor invasion were significant in predicting pCR in both models. CONCLUSION Our ML model is a potential alternative to the existing assessment tools to conduct triage treatment for patients and provides reference for clinicians in tailoring individual treatment: the watch and wait strategy is used to avoid surgical trauma in pCR patients, and non-pCR patients receive surgical treatment to avoid missing the optimal operation time window.
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25
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Park IJ. Watch and wait strategies for rectal cancer A systematic review. PRECISION AND FUTURE MEDICINE 2021. [DOI: 10.23838/pfm.2021.00177] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
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26
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Haak HE, Gao X, Maas M, Waktola S, Benson S, Beets-Tan RGH, Beets GL, van Leerdam M, Melenhorst J. The use of deep learning on endoscopic images to assess the response of rectal cancer after chemoradiation. Surg Endosc 2021; 36:3592-3600. [PMID: 34642794 PMCID: PMC9001548 DOI: 10.1007/s00464-021-08685-7] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/17/2020] [Accepted: 08/07/2021] [Indexed: 12/30/2022]
Abstract
Background Accurate response evaluation is necessary to select complete responders (CRs) for a watch-and-wait approach. Deep learning may aid in this process, but so far has never been evaluated for this purpose. The aim was to evaluate the accuracy to assess response with deep learning methods based on endoscopic images in rectal cancer patients after neoadjuvant therapy. Methods Rectal cancer patients diagnosed between January 2012 and December 2015 and treated with neoadjuvant (chemo)radiotherapy were retrospectively selected from a single institute. All patients underwent flexible endoscopy for response evaluation. Diagnostic performance (accuracy, area under the receiver operator characteristics curve (AUC), positive- and negative predictive values, sensitivities and specificities) of different open accessible deep learning networks was calculated. Reference standard was histology after surgery, or long-term outcome (>2 years of follow-up) in a watch-and-wait policy. Results 226 patients were included for the study (117(52%) were non-CRs; 109(48%) were CRs). The accuracy, AUC, positive- and negative predictive values, sensitivity and specificity of the different models varied from 0.67–0.75%, 0.76–0.83%, 67–74%, 70–78%, 68–79% to 66–75%, respectively. Overall, EfficientNet-B2 was the most successful model with the highest diagnostic performance. Conclusions This pilot study shows that deep learning has a modest accuracy (AUCs 0.76-0.83). This is not accurate enough for clinical decision making, and lower than what is generally reported by experienced endoscopists. Deep learning models can however be further improved and may become useful to assist endoscopists in evaluating the response. More well-designed prospective studies are required. Supplementary Information The online version contains supplementary material available at 10.1007/s00464-021-08685-7.
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Affiliation(s)
- Hester E Haak
- Department of Surgery, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands.,GROW School for Oncology and Developmental Biology-Maastricht University, Maastricht, The Netherlands
| | - Xinpei Gao
- Department of Radiology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands
| | - Monique Maas
- Department of Radiology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands
| | - Selam Waktola
- Department of Radiology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands
| | - Sean Benson
- Department of Radiology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands
| | - Regina G H Beets-Tan
- GROW School for Oncology and Developmental Biology-Maastricht University, Maastricht, The Netherlands.,Department of Radiology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands
| | - Geerard L Beets
- Department of Surgery, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands.,GROW School for Oncology and Developmental Biology-Maastricht University, Maastricht, The Netherlands
| | - Monique van Leerdam
- Department of Gastroenterology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek, Amsterdam, The Netherlands
| | - Jarno Melenhorst
- GROW School for Oncology and Developmental Biology-Maastricht University, Maastricht, The Netherlands. .,Department of Surgery, Maastricht University Medical Centre, Postbox 5800, 6202 AZ, Maastricht, The Netherlands.
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27
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Verweij ME, Hoendervangers S, Couwenberg AM, Burbach JPM, Berbee M, Buijsen J, Roodhart J, Reerink O, Pronk A, Consten ECJ, Smits AB, Heikens JT, van Grevenstein WMU, Intven MPW, Verkooijen HM. Impact of dose-escalated chemoradiation on quality of life in patients with locally advanced rectal cancer: two year follow-up of the randomized RECTAL-BOOST trial. Int J Radiat Oncol Biol Phys 2021; 112:694-703. [PMID: 34634436 DOI: 10.1016/j.ijrobp.2021.09.052] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2021] [Revised: 09/28/2021] [Accepted: 09/30/2021] [Indexed: 11/26/2022]
Abstract
BACKGROUND Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer (LARC) did not result in higher complete response rates, but initiated more tumor regression in the randomized XXXXX trial (Clinicaltrials.gov XXXXX). This study compared patient reported outcomes (PROs) between patients who received dose-escalated CRT (5 × 3Gy boost + CRT) or standard CRT for two years following randomization. METHODS Patients with LARC, participating in the XXXXX trial, filled out EORTC QLQ-C30 and CR29 questionnaires on quality of life (QoL) and symptoms at baseline, 3, 6, 12, 18 and 24 months following start of treatment. Between-group differences in functional QoL domains were estimated using a linear mixed-effects model and expressed as effect size (ES). Symptom scores were compared using Mann-Whitney U test. RESULTS Patients treated with dose-escalated CRT (boost group, n=51) experienced a significantly stronger decline in global health at 3 and 6 months (ES -0,4 and ES -0,4), physical functioning at 6 months (ES -1,1), role functioning at 3 and 6 months (ES -0,8 and ES -0,6) and social functioning at 6 months (ES -0,6) compared to patients treated with standard CRT (control group, n=64). The boost group reported significantly more fatigue at 3 and 6 months (83% vs. 66% resp. 89% vs. 76%), pain at 3 and 6 months (67% vs. 36% resp. 80% vs. 44%) and diarrhea at 3 months (45% vs. 29%) compared to the control group. From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood/mucus in stool in the boost group. CONCLUSION In patients with LARC, dose-escalated CRT resulted in a transient deterioration in global health, physical, role, and social functioning and more pain, fatigue and diarrhea at 3 and 6 months following start of treatment compared to standard CRT. From 12 months onwards, the impact of dose-escalated CRT on QoL largely resolved.
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Affiliation(s)
- M E Verweij
- Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands.
| | - S Hoendervangers
- Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands
| | - A M Couwenberg
- Department of Radiation Oncology, Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, the Netherlands
| | - J P M Burbach
- Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands
| | - M Berbee
- Department of Radiation Oncology (Maastro), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands
| | - J Buijsen
- Department of Radiation Oncology (Maastro), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands
| | - J Roodhart
- Department of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - O Reerink
- Department of Radiation Oncology, Isala Clinic, Zwolle, The Netherlands
| | - A Pronk
- Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands
| | - E C J Consten
- Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands; Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands
| | - A B Smits
- Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands
| | - J T Heikens
- Department of Surgery, Hospital Rivierenland, Tiel, The Netherlands
| | | | - M P W Intven
- Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - H M Verkooijen
- Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands
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28
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Felder SI, Feuerlein S, Parsee A, Imanirad I, Sanchez J, Dessureault S, Kim R, Hoffe S, Frakes J, Costello J. Endoscopic and MRI response evaluation following neoadjuvant treatment for rectal cancer: a pictorial review with matched MRI, endoscopic, and pathologic examples. Abdom Radiol (NY) 2021; 46:1783-1804. [PMID: 33111189 DOI: 10.1007/s00261-020-02827-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2020] [Revised: 10/05/2020] [Accepted: 10/10/2020] [Indexed: 10/23/2022]
Abstract
A nonoperative management strategy, or Watch-and-Wait, following neoadjuvant therapies of locally advanced rectal adenocarcinoma is increasingly considered for select patients. Yet, standardized tumor response assessment to best select and surveil suitable patients remains an unmet clinical challenge. Endoscopic and MRI currently provide the most reliable tumor response estimations. However, resources illustrating variable tumor responses to neoadjuvant therapies remain limited. This pictorial review aims to provide detailed and annotated examples of common endoscopic and MRI findings of rectal cancer treatment response, while also emphasizing their respective diagnostic shortcomings and consequently, the necessity for a multidisciplinary approach to optimally manage these patients.
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29
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Anker CJ, Akselrod D, Ades S, Bianchi NA, Lester-Coll NH, Cataldo PA. Non-operative Management (NOM) of Rectal Cancer: Literature Review and Translation of Evidence into Practice. CURRENT COLORECTAL CANCER REPORTS 2021. [DOI: 10.1007/s11888-020-00463-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/24/2022]
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30
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Felder SI, Garcia-Aguilar J. ASO Author Reflections: Endoscopic Rectal Cancer Response to Neoadjuvant Therapy: Qualitative or Quantitative Interpretation? Ann Surg Oncol 2021; 28:5224-5225. [PMID: 33796996 DOI: 10.1245/s10434-021-09895-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2021] [Accepted: 03/11/2021] [Indexed: 11/18/2022]
Affiliation(s)
- Seth I Felder
- Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, FL, USA.
| | - Julio Garcia-Aguilar
- Department of Surgery, Colorectal Service, Benno C. Schmidt Chair in Surgical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA
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López-Campos F, Martín-Martín M, Fornell-Pérez R, García-Pérez JC, Die-Trill J, Fuentes-Mateos R, López-Durán S, Domínguez-Rullán J, Ferreiro R, Riquelme-Oliveira A, Hervás-Morón A, Couñago F. Watch and wait approach in rectal cancer: Current controversies and future directions. World J Gastroenterol 2020; 26:4218-4239. [PMID: 32848330 PMCID: PMC7422545 DOI: 10.3748/wjg.v26.i29.4218] [Citation(s) in RCA: 77] [Impact Index Per Article: 15.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2020] [Revised: 04/25/2020] [Accepted: 07/22/2020] [Indexed: 02/06/2023] Open
Abstract
According to the main international clinical guidelines, the recommended treatment for locally-advanced rectal cancer is neoadjuvant chemoradiotherapy followed by surgery. However, doubts have been raised about the appropriate definition of clinical complete response (cCR) after neoadjuvant therapy and the role of surgery in patients who achieve a cCR. Surgical resection is associated with significant morbidity and decreased quality of life (QoL), which is especially relevant given the favourable prognosis in this patient subset. Accordingly, there has been a growing interest in alternative approaches with less morbidity, including the organ-preserving watch and wait strategy, in which surgery is omitted in patients who have achieved a cCR. These patients are managed with a specific follow-up protocol to ensure adequate cancer control, including the early identification of recurrent disease. However, there are several open questions about this strategy, including patient selection, the clinical and radiological criteria to accurately determine cCR, the duration of neoadjuvant treatment, the role of dose intensification (chemotherapy and/or radiotherapy), optimal follow-up protocols, and the future perspectives of this approach. In the present review, we summarize the available evidence on the watch and wait strategy in this clinical scenario, including ongoing clinical trials, QoL in these patients, and the controversies surrounding this treatment approach.
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Affiliation(s)
- Fernando López-Campos
- Department of Radiation Oncology, Hospital Universitario Ramón y Cajal, Madrid 28034, Spain
| | | | - Roberto Fornell-Pérez
- Department of Radiology, Hospital Universitario de Basurto, Bilbao 48013, Vizcaya, Spain
| | | | - Javier Die-Trill
- Department of Surgery, Hospital Universitario Ramón y Cajal, Madrid 28034, Spain
| | - Raquel Fuentes-Mateos
- Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid 28034, Spain
| | - Sergio López-Durán
- Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Madrid 28034, Spain
| | - José Domínguez-Rullán
- Department of Radiation Oncology, Hospital Universitario Ramón y Cajal, Madrid 28034, Spain
| | - Reyes Ferreiro
- Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid 28034, Spain
| | | | - Asunción Hervás-Morón
- Department of Radiation Oncology, Hospital Universitario Ramón y Cajal, Madrid 28034, Spain
| | - Felipe Couñago
- Department of Radiation Oncology, Hospital Universitario Quirónsalud, Madrid 28003, Spain
- Department of Radiation Oncology, Hospital La Luz, Madrid 28003, Spain
- Universidad Europea de Madrid (UEM), Madrid 28223, Spain
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MRI T2-weighted sequences-based texture analysis (TA) as a predictor of response to neoadjuvant chemo-radiotherapy (nCRT) in patients with locally advanced rectal cancer (LARC). Radiol Med 2020; 125:1216-1224. [DOI: 10.1007/s11547-020-01215-w] [Citation(s) in RCA: 39] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2020] [Accepted: 04/27/2020] [Indexed: 12/13/2022]
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