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Xu X, Wang L, Cao Y, Wang J, Yao J, Huo L, Song Y, Ding W, Gu J, Li Q. Long-term follow-up outcomes of intraoperative radiotherapy for breast-conserving treatment in early breast cancer: A retrospective cohort study. Oncol Lett 2025; 30:346. [PMID: 40438870 PMCID: PMC12117530 DOI: 10.3892/ol.2025.15092] [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: 11/01/2024] [Accepted: 04/17/2025] [Indexed: 06/01/2025] Open
Abstract
Intraoperative radiotherapy (IORT) has been used as a novel therapeutic alternative for breast-conserving surgery (BCS) in patients with breast cancer. However, the long-term outcomes and safety of IORT in patients with breast cancer remain incompletely understood. Therefore, the present study aimed to explore the long-term outcomes of IORT following BCS, focusing on the oncological outcomes and cosmetic consequences compared with postoperative RT (PORT) in patients with breast cancer. Patients with early-stage breast cancer who underwent BCS followed by IORT or PORT between January 2016 and October 2020 at the Research Institute of General Surgery, Jinling Hospital, Nanjing Medical University (Nanjing, China), were retrospectively reviewed. After screening, a total of 59 patients were included in the present study and divided into two groups according RT records as follows: The IORT group (n=21) and the PORT group (n=38). The clinical data of all patients, including surgical and RT complications, cosmetic grading and scoring, and other events, were collected and retrospectively analyzed. No significant difference was observed in terms of the mean follow-up time in the IORT (5.89±1.57 years) and PORT (6.09±1.60 years) groups (P>0.05). Compared with PORT, IORT showed non-inferior therapeutic efficacy, with no significant differences in postoperative complications (surgical site infection and chronic pain; P>0.05). Notably, the IORT group achieved superior cosmetic outcomes, with 95.2% (20/21) of patients achieving a rating of excellent/good vs. 44.7% (17/38 patients) in the PORT group (P<0.001), alongside higher median cosmetic scores at all postoperative intervals (P<0.01). IORT also reduced healthcare utilization, shortening hospitalization by 23.8 days (12.1±5.1 vs. 35.9±3.5 days; P<0.001) and lowering costs significantly (33,117.98±6,281.17 vs. 77,789.55±7,000.90 CNY; P<0.001). These findings suggest that IORT offers comparable safety, improved cosmesis and greater cost-effectiveness than PORT, supporting its integration into clinical practice for eligible patients.
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Affiliation(s)
- Xiaofan Xu
- Research Institute of General Surgery, Jinling Hospital, Nanjing Medical University, Nanjing, Jiangsu 210002, P.R. China
- Research Institute of General Surgery, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
| | - Lu Wang
- Research Institute of General Surgery, Jinling Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu 210002, P.R. China
| | - Yuanyuan Cao
- Medical Service Training Center, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
| | - Jingyi Wang
- Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu 211166, P.R. China
| | - Jie Yao
- Research Institute of General Surgery, Jinling Hospital, Nanjing Medical University, Nanjing, Jiangsu 210002, P.R. China
- Research Institute of General Surgery, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
| | - Liqun Huo
- Research Institute of General Surgery, Jinling Hospital, Nanjing Medical University, Nanjing, Jiangsu 210002, P.R. China
- Research Institute of General Surgery, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
| | - Yuqing Song
- Research Institute of General Surgery, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
| | - Wei Ding
- Department of Radiation Oncology, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
| | - Jun Gu
- Research Institute of General Surgery, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
| | - Qiurong Li
- Research Institute of General Surgery, Jinling Hospital, Nanjing Medical University, Nanjing, Jiangsu 210002, P.R. China
- Research Institute of General Surgery, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210002, P.R. China
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Anderson B, Vicini F, Wazer D, Arthur D. Breast brachytherapy: Building a bright future on the foundation of a rich history of advancement in technology, technique, and patient-centered care. Brachytherapy 2023; 22:368-380. [PMID: 36740541 DOI: 10.1016/j.brachy.2022.12.009] [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: 09/20/2022] [Revised: 12/02/2022] [Accepted: 12/23/2022] [Indexed: 02/05/2023]
Abstract
For over 20 years, the concept of accelerated partial breast irradiation (APBI) has received considerable attention. Initially concentrating on the appropriateness of APBI as an alternative treatment to whole breast radiotherapy, investigation and innovation evolved towards dose delivery and technique appropriateness. The purpose of this article is to review the pertinent literature that supports the role brachytherapy serves in delivering APBI and the recognized brachytherapy techniques for dose delivery. Publications establishing techniques utilizing multicatheter brachytherapy, single-entry brachytherapy applicators, permanent breast seed implantation brachytherapy, noninvasive breast brachytherapy and electronic brachytherapy are described. The use of brachytherapy for repeat breast conservation therapy is additionally reviewed. A historical perspective and potential direction of future investigation and innovation are presented.
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Affiliation(s)
- Bethany Anderson
- Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI
| | | | - David Wazer
- Department of Radiation Oncology, Tufts Medical Center, Boston, MA
| | - Douglas Arthur
- Department of Radiation Oncology, Virginia Commonwealth University, Richmond, VA.
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Provenzano D, Rao K, Cifter G, Taunk N, Fischer-Valuck B, Lin A, Sarfaraz M, Aghdam H, Ojong-Ntui M, Loew MH, Goyal S, Rao YJ. Adverse events of after-loading high dose rate brachytherapy reported to the United States Food and Drug Administration (FDA). Brachytherapy 2021; 20:1053-1061. [PMID: 34088594 DOI: 10.1016/j.brachy.2021.04.005] [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: 01/21/2021] [Revised: 04/26/2021] [Accepted: 04/28/2021] [Indexed: 10/21/2022]
Abstract
PURPOSE To provide an assessment of safety regarding high-dose-rate after-loading brachytherapy (HDR-BT) based on adverse events reported to the OpenFDA, an open access database maintained by the United States Food and Drug Administration (FDA). METHODS OpenFDA was queried for HDR-BT events between 1993 and 2019. A brachytherapist categorized adverse events (AEs) based on disease site, applicator, manufacturer, event type, dosimetry impact, and outcomes. Important findings are summarized. RESULTS 372 AEs were reported between 1993 and 2019, with a downwards trend after 2014. Nearly half of AEs (48.9%) were caused by a device malfunction, and 27.4% resulted in patient injury. Breast (49.2%) and Gyn (23.7%) were the most common disease sites of AEs. Applicator breaks cause the majority of AEs (64.2%) and breast balloon implants were the most common applicator to malfunction (38.7%). User error contributed to only 16.7% of events. 11.0% of events required repair of the afterloader. There were no reported staff injuries or patient deaths from an AE, however 24.7% of patients received resultant incorrect radiation dose, 16.4% required additional procedures to rectify the AE, and 3.0% resulted in unintended radiation to staff. CONCLUSION The OpenFDA database has shown a decreasing trend in AEs since 2014 for HDR-BT. Most AEs are not caused by user error and do not cause patient injury or incorrect radiation dose. Investigation into methods to prevent failures and improve applicators such as the breast balloon could improve safety. These results support the continued use of HDR-BT as a safe treatment modality for cancer.
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Affiliation(s)
- Destie Provenzano
- Division of Radiation Oncology, The George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Biomedical Engineering, The George Washington University, Washington, DC
| | - Kevin Rao
- Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD
| | - Gizem Cifter
- Division of Radiation Oncology, The George Washington University School of Medicine and Health Sciences, Washington, DC
| | - Neil Taunk
- Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA
| | | | - Alexander Lin
- Department of Radiation Oncology, Washington University in St. Louis, Saint Louis, MO
| | - Mehrdad Sarfaraz
- Division of Radiation Oncology, The George Washington University School of Medicine and Health Sciences, Washington, DC
| | - Hamid Aghdam
- Division of Radiation Oncology, The George Washington University School of Medicine and Health Sciences, Washington, DC
| | - Martin Ojong-Ntui
- Division of Radiation Oncology, The George Washington University School of Medicine and Health Sciences, Washington, DC
| | - Murray H Loew
- Department of Biomedical Engineering, The George Washington University, Washington, DC
| | - Sharad Goyal
- Division of Radiation Oncology, The George Washington University School of Medicine and Health Sciences, Washington, DC
| | - Yuan James Rao
- Division of Radiation Oncology, The George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Biomedical Engineering, The George Washington University, Washington, DC.
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Fozza A, Giannelli F, Blandino G, Bosetti D, Milanese M, Agostinelli S, Garelli S, Corvò R, Guenzi M. Mono-institutional Italian Experience with a Double-lumen Balloon-brachytherapy Device for Early Breast Cancer: Results at a 5-year Minimum follow-up. TUMORI JOURNAL 2018; 100:163-8. [DOI: 10.1177/030089161410000208] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Aims and Background To report the 5-year minimum follow-up in low-risk breast cancer patients treated with a double-lumen balloon-brachytherapy device in one mono-institutional Italian experience. Local control data and cosmetic outcomes were collected and analyzed. Methods Between October 2004 and December 2007, we treated 30 early stage breast cancer patients who underwent conservative surgery followed by adjuvant accelerated partial breast irradiation with a double-lumen balloon-brachytherapy system. Eligibility criteria for the protocol were based on the indications of the American Brachytherapy Society and the American Society of Breast Surgeons. The device was placed inside the lumpectomy cavity during surgery by open technique in all the patients. Computed tomography images and standard X-ray were used for treatment planning. The total irradiation dose was 34 Gy in 10 fractions of 3.4 Gy (twice daily) over 5 days to the lumpectomy cavity. Results Median follow-up was 80.5 months (range, 60–98). No patient developed local recurrence or distant metastasis. At the end of treatment, there was evidence of a symptomatic seroma in 83% of the total patients, with a yearly decreasing trend. However, the incidence of mild and moderate fibrosis progressively increased. Seventy seven percent of the patients were satisfied with their cosmetic results. Conclusions Our findings reinforce the hypothesis that an accelerated double-lumen balloon-breast brachytherapy catheter in selected low-risk patients is safe, and a favorable cosmetic outcome can be achieved.
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Affiliation(s)
- Alessandra Fozza
- Department of Radiotherapy, and IRCCS AOU San Martino, IST, Genoa, Italy
| | - Flavio Giannelli
- Department of Radiotherapy, and IRCCS AOU San Martino, IST, Genoa, Italy
| | - Gladys Blandino
- Department of Radiotherapy, and IRCCS AOU San Martino, IST, Genoa, Italy
| | - Davide Bosetti
- Department of Radiotherapy, and IRCCS AOU San Martino, IST, Genoa, Italy
| | | | | | - Stefania Garelli
- Department of Medical Physics, IRCCS AOU San Martino, IST, Genoa, Italy
| | - Renzo Corvò
- Department of Radiotherapy, and IRCCS AOU San Martino, IST, Genoa, Italy
| | - Marina Guenzi
- Department of Radiotherapy, and IRCCS AOU San Martino, IST, Genoa, Italy
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The American Brachytherapy Society consensus statement for accelerated partial-breast irradiation. Brachytherapy 2018; 17:154-170. [DOI: 10.1016/j.brachy.2017.09.004] [Citation(s) in RCA: 98] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2017] [Revised: 09/11/2017] [Accepted: 09/18/2017] [Indexed: 12/29/2022]
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Shah S, Holzwanger E, Khwaja R, Fang D, Figueroa-Bodine J, Iannuzzi C, Shi C. A Single-Site Retrospective, Nonrandomized Study of Accelerated Partial Breast Irradiation Brachytherapy for Early-Stage Breast Cancer Treatment to Evaluate Local Tumor Control, Cosmetic Outcome, and Toxicities. Technol Cancer Res Treat 2016. [DOI: 10.1177/1533034615595724] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/24/2023] Open
Abstract
Purpose: To evaluate the efficacy and safety of the accelerated partial breast irradiation brachytherapy with a combination of applicators at a community hospital cancer center. Methods and Materials: Between 2005 and 2009, 120 patients with early-stage breast cancer were being followed after treatment with accelerated partial breast irradiation brachytherapy using MammoSite, single or multilumen balloon, or Contura multilumen balloon. After their lumpectomy surgery, each patient was treated with Ir-192 high-dose rate unit following radiation therapy oncology group 0413 guidelines. The patients had multiple follow-ups at 6 months, 1 year, 2 years, 3 years, or more. Results: Based on the Harvard Breast Cosmesis Scale, 95.00% of patients described their cosmetic evaluation as the treated breast essentially the same as the opposite side (excellent) or minimal but identifiable effects were noticed from radiation (good). After a median follow-up of 36 months, the local recurrence rate was 1.66% and a disease-free survival is 98.3%. Forty-two patients reported 85 adverse events, which were fibrosis: 24.70%, hyperpigmentation: 20.00%, radiation skin reaction: 7.05%, seroma: 7.05%, breast pain: 7.05%, erythema: 5.88%, and other events were less than 5.00%. Of all the adverse events recorded, grade 1 to 3 events are 95.29% (n = 81), 2.35% (n = 2), and 2.35% (n = 2). There was no grade 4 or 5 events recorded. Conclusions: Our study has shown promising results for delivering radiation with MammoSite, single or multilumen balloon, or Contura multilumen balloon and has been successful in achieving local control in patients with early-stage breast cancer.
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Affiliation(s)
- Shalin Shah
- Radiation Oncology, Saint Vincent’s Medical Center, Bridgeport, CT, USA
| | - Erik Holzwanger
- Radiation Oncology, Saint Vincent’s Medical Center, Bridgeport, CT, USA
| | - Radhika Khwaja
- Radiation Oncology, Saint Vincent’s Medical Center, Bridgeport, CT, USA
| | - Deborah Fang
- Radiation Oncology, Saint Vincent’s Medical Center, Bridgeport, CT, USA
| | | | | | - Chengyu Shi
- Radiation Oncology, Saint Vincent’s Medical Center, Bridgeport, CT, USA
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Shah C, Vicini F, Wazer DE, Arthur D, Patel RR. The American Brachytherapy Society consensus statement for accelerated partial breast irradiation. Brachytherapy 2013; 12:267-77. [PMID: 23619524 DOI: 10.1016/j.brachy.2013.02.001] [Citation(s) in RCA: 134] [Impact Index Per Article: 11.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/22/2012] [Revised: 01/21/2013] [Accepted: 02/01/2013] [Indexed: 01/08/2023]
Abstract
PURPOSE To develop clinical guidelines for the quality practice of accelerated partial breast irradiation (APBI) as part of breast-conserving therapy for women with early-stage breast cancer. METHODS AND MATERIALS Members of the American Brachytherapy Society with expertise in breast cancer and breast brachytherapy in particular devised updated guidelines for appropriate patient evaluation and selection based on an extensive literature search and clinical experience. RESULTS Increasing numbers of randomized and single and multi-institution series have been published documenting the efficacy of various APBI modalities. With more than 10-year followup, multiple series have documented excellent clinical outcomes with interstitial APBI. Patient selection for APBI should be based on a review of clinical and pathologic factors by the clinician with particular attention paid to age (≥50 years old), tumor size (≤3cm), histology (all invasive subtypes and ductal carcinoma in situ), surgical margins (negative), lymphovascular space invasion (not present), and nodal status (negative). Consistent dosimetric guidelines should be used to improve target coverage and limit potential for toxicity following treatment. CONCLUSIONS These guidelines have been created to provide clinicians with appropriate patient selection criteria to allow clinicians to use APBI in a manner that will optimize clinical outcomes and patient satisfaction. These guidelines will continue to be evaluated and revised as future publications further stratify optimal patient selection.
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Affiliation(s)
- Chirag Shah
- Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, MO, USA
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Kishi K, Tanino H, Sonomura T, Shirai S, Noda Y, Sato M, Okamura Y. Novel eradicative high-dose rate brachytherapy for internal mammary lymph node metastasis from breast cancer. World J Radiol 2012; 4:443-9. [PMID: 23251722 PMCID: PMC3524510 DOI: 10.4329/wjr.v4.i11.443] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/11/2012] [Revised: 09/18/2012] [Accepted: 09/26/2012] [Indexed: 02/06/2023] Open
Abstract
AIM: To develop a method of delivering an eradicative high radiotherapeutic dose safely preserving the surrounding skin in the treatment of internal mammary lymph node metastasis (IMLNM) of breast cancer.
METHODS: We report a 38-year-old female patient with a solo IMLNM showing no response to 60 Gy in 2.5 Gy fractions of external beam radiotherapy. To eradicate this tumor, a boost brachytherapy plan was created after percutaneous insertion of an applicator needle into the IMLNM lesion avoiding the pleura and vessels under ultrasound monitoring. According to the dose distribution, the required thickness of a spacer between the skin and the tumor was determined, and hyaluronic gel was injected up to this thickness under ultrasound monitoring. We evaluated skin doses, target doses and clinical outcome.
RESULTS: All procedures were performed easily. Sixteen Gy (34.7 Gy equivalent in 2 Gy fractions calculated by the linear quadratic model at α/β = 10: EQD2, α/β = 10, cumulative total was 101.9 Gy EQD10) to 100% of the target volume was irradiated with cumulative maximum skin dose of 70 Gy EQD2, α/β = 3 which was 98.7 Gy EQD2, α/β = 3 without spacer. No procedure related- or late complications and no local recurrence at the treated site were observed for three years until expiration.
CONCLUSION: We consider that this procedure will provide an eradicative high-dose irradiation to IMLNM of breast cancer, preserving skin from overdose complications.
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Brachytherapy in accelerated partial breast irradiation (APBI) - review of treatment methods. J Contemp Brachytherapy 2012; 4:152-64. [PMID: 23346145 PMCID: PMC3551377 DOI: 10.5114/jcb.2012.30682] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/14/2012] [Revised: 09/03/2012] [Accepted: 09/06/2012] [Indexed: 11/17/2022] Open
Abstract
Breast conserving surgery (BCS) with following radiotherapy (EBRT) of the conserved breast became widely accepted in the last decades as the treatment of early invasive breast cancer. In an early stage of breast cancer, research has shown that the area requiring radiation treatment to prevent cancer from local recurrence is the breast tissue that surrounds the area where the initial cancer was removed. Accelerated partial breast irradiation (APBI) is an approach that treats only the lumpectomy bed with 1-2 cm margin, rather than the whole breast and as a result allows accelerated delivery of the radiation dose in four to five days. Published results of APBI are very promising. It is evident that APBI will play a role in the management of a selected group of early breast cancer. We discuss current status, indications, technical aspects and recently published results of APBI using different brachytherapy techniques.
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Dragun AE, Harper JL, Olyejar SE, Zunzunegui RG, Wazer DE. The use of adjuvant high-dose-rate breast brachytherapy in patients with collagen vascular disease: A collaborative experience. Brachytherapy 2011; 10:121-7. [DOI: 10.1016/j.brachy.2010.05.001] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2010] [Revised: 05/06/2010] [Accepted: 05/07/2010] [Indexed: 10/19/2022]
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Ahmed HM, DiPiro PJ, Devlin PM, Nguyen ML, Bellon JR. Mammographic Appearance Following Accelerated Partial Breast Irradiation by Using MammoSite Brachytherapy. Radiology 2010; 255:362-8. [DOI: 10.1148/radiol.10091625] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
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Shah A, Strauss J, Kirk M, Chen S, Dickler A. A dosimetric analysis comparing electron beam with the MammoSite brachytherapy applicator for intact breast boost. Phys Med 2010; 26:80-7. [DOI: 10.1016/j.ejmp.2009.08.004] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2009] [Revised: 06/17/2009] [Accepted: 08/29/2009] [Indexed: 11/25/2022] Open
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Israel PZ, Robbins AB, Shroff P, Haile K, Pope DK. Initial surgical experience evaluating early tolerance and toxicities in patients undergoing accelerated partial breast irradiation using the Contura Multi Lumen Balloon breast brachytherapy catheter. Am Surg 2009; 75:1042-9. [PMID: 19927502 DOI: 10.1177/000313480907501103] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
We reviewed our surgical experience with the Contura Multi Lumen Balloon breast brachytherapy catheter used to deliver accelerated partial breast irradiation and determined short-term treatment efficacy, cosmesis, and toxicity. Forty-six patients undergoing breast conserving therapy, including the use of Contura catheter, were analyzed. Thirty-four Gray were delivered in 10 fractions. Fourteen patients had stage 0, 24 had stage I, and 8 had stage II breast cancer. Catheters were placed with a closed cavity technique. Median minimum skin spacing was 10 mm (range, 2-18 mm). Median maximum skin doses were 99.7 per cent of the prescription dose. Nine patients were treated with a skin spacing < or = 5 mm (2 patients with 2 mm skin spacing). The percentage of patients with excellent/good cosmesis at 6 (n = 26) and 12 (n = 13) months was 100 per cent, respectively. Patient tolerance was assessed on a scale of 0-10 (0 = no pain, 10 = requiring narcotic analgesics). Pain was graded < or = 3 in 98 per cent of patients at catheter insertion and 84 per cent at catheter removal. Four breast infections (8.8%) and one symptomatic seroma developed. Adjuvant accelerated partial breast irradiation using the Contura Multi Lumen Balloon exhibited similar toxicities to standard single lumen, single dwell balloon brachytherapy with improvements in dosimetric capabilities allowing the treatment of patients with skin spacing < or = 5 mm.
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Guenzi M, Giannelli F, Azinwi C, Ricchetti F, Vagge S, Canavese G, Massa T, Garelli S, Carli F, Corvò R. Accelerated Partial Breast Irradiation Via the Mammosite®Catheter: Preliminary Reports of a Single-Institution Experience. Breast J 2009; 15:603-9. [DOI: 10.1111/j.1524-4741.2009.00836.x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
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Phase I/II study evaluating early tolerance in breast cancer patients undergoing accelerated partial breast irradiation treated with the mammosite balloon breast brachytherapy catheter using a 2-day dose schedule. Int J Radiat Oncol Biol Phys 2009; 77:531-6. [PMID: 19775830 DOI: 10.1016/j.ijrobp.2009.05.043] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/20/2009] [Revised: 05/04/2009] [Accepted: 05/05/2009] [Indexed: 11/21/2022]
Abstract
PURPOSE Initial Phase I/II results using balloon brachytherapy to deliver accelerated partial breast irradiation (APBI) in 2 days in patients with early-stage breast cancer are presented. MATERIALS AND METHODS Between March 2004 and August 2007, 45 patients received adjuvant radiation therapy after lumpectomy with balloon brachytherapy in a Phase I/II trial delivering 2800 cGy in four fractions of 700 cGy. Toxicities were evaluated using the National Cancer Institute Common Toxicity Criteria for Adverse Events v3.0 scale and cosmesis was documented at >or=6 months. RESULTS The median age was 66 years (range, 48-83) and median skin spacing was 12 mm (range, 8-24). The median follow-up was 11.4 months (5.4-48 months) with 21 patients (47%) followed >or=1 year, 11 (24%) >or=2 years, and 7 (16%) >or=3 years. At <6 months (n = 45), Grade II toxicity rates were 9% radiation dermatitis, 13% breast pain, 2% edema, and 2% hyperpigmentation. Grade III breast pain was reported in 13% (n = 6). At >or=6 months (n = 43), Grade II toxicity rates were: 2% radiation dermatitis, 2% induration, and 2% hypopigmentation. Grade III breast pain was reported in 2%. Infection was 13% (n = 6) at <6 months and 5% (n = 2) at >or=6 months. Persistent seroma >or=6 months was 30% (n = 13). Fat necrosis developed in 4 cases (2 symptomatic). Rib fractures were seen in 4% (n = 2). Cosmesis was good/excellent in 96% of cases. CONCLUSIONS Treatment with balloon brachytherapy using a 2-day dose schedule resulted acceptable rates of Grade II/III chronic toxicity rates and similar cosmetic results observed with a standard 5-day accelerated partial breast irradiation schedule.
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Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys 2009; 74:987-1001. [PMID: 19545784 DOI: 10.1016/j.ijrobp.2009.02.031] [Citation(s) in RCA: 607] [Impact Index Per Article: 37.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/04/2009] [Accepted: 02/25/2009] [Indexed: 01/05/2023]
Abstract
PURPOSE To present guidance for patients and physicians regarding the use of accelerated partial-breast irradiation (APBI), based on current published evidence complemented by expert opinion. METHODS AND MATERIALS A systematic search of the National Library of Medicine's PubMed database yielded 645 candidate original research articles potentially applicable to APBI. Of these, 4 randomized trials and 38 prospective single-arm studies were identified. A Task Force composed of all authors synthesized the published evidence and, through a series of meetings, reached consensus regarding the recommendations contained herein. RESULTS The Task Force proposed three patient groups: (1) a "suitable" group, for whom APBI outside of a clinical trial is acceptable, (2) a "cautionary" group, for whom caution and concern should be applied when considering APBI outside of a clinical trial, and (3) an "unsuitable" group, for whom APBI outside of a clinical trial is not generally considered warranted. Patients who choose treatment with APBI should be informed that whole-breast irradiation (WBI) is an established treatment with a much longer track record that has documented long-term effectiveness and safety. CONCLUSION Accelerated partial-breast irradiation is a new technology that may ultimately demonstrate long-term effectiveness and safety comparable to that of WBI for selected patients with early breast cancer. This consensus statement is intended to provide guidance regarding the use of APBI outside of a clinical trial and to serve as a framework to promote additional clinical investigations into the optimal role of APBI in the treatment of breast cancer.
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Chen SS, Strauss JB, Shah AP, Rao RD, Bernard DA, Griem KL. Radiation recall reaction with docetaxel administration after accelerated partial breast irradiation with electronic brachytherapy. Brachytherapy 2009; 8:331-4. [PMID: 19446501 DOI: 10.1016/j.brachy.2009.01.001] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/24/2008] [Revised: 01/16/2009] [Accepted: 01/20/2009] [Indexed: 10/20/2022]
Abstract
PURPOSE Accelerated partial breast irradiation (APBI) offers several advantages over whole breast irradiation. Electronic brachytherapy may further reduce barriers to breast conserving therapy by making APBI more available. However, its toxicity profile is not well characterized. METHODS AND MATERIALS A 60-year-old woman was treated with APBI using Axxent (Xoft, Sunnyvale, CA) electronic brachytherapy. One month after APBI, a cycle of docetaxel and cyclophosphamide was given. Within 3 weeks, the patient developed an ulcerative radiation recall reaction in the skin overlying the lumpectomy cavity. To investigate this toxicity, the skin dose from electronic brachytherapy was compared with the dose that would have been delivered by an iridium-192 ((192)Ir) source. Additionally, a dose equivalent was estimated by adjusting for the increased relative biologic effectiveness (RBE) of low energy photons generated by the electronic source. RESULTS Using electronic brachytherapy, the skin dose was 537cGy per fraction compared with 470cGy for an (192)Ir source. Given an RBE for a 40kV source of 1.28 compared with (192)Ir, the equivalent dose at the skin for an electronic source was 687cGy-equivalents, a 46% increase. CONCLUSIONS We present a case of an ulcerative radiation recall reaction in a patient receiving APBI with electronic brachytherapy followed by chemotherapy. Our analysis shows that the use of electronic brachytherapy resulted in the deposition of significantly higher equivalent dose at the skin compared with (192)Ir. These findings suggest that standard guidelines (e.g., surface-to-skin distance) that apply to (192)Ir-based balloon brachytherapy may not be applicable to electronic brachytherapy.
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Affiliation(s)
- Sea S Chen
- Department of Radiation Oncology, Rush University Medical Center, Chicago, IL, USA
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Strauss JB, Dickler A. Accelerated partial breast irradiation utilizing balloon brachytherapy techniques. Radiother Oncol 2009; 91:157-65. [DOI: 10.1016/j.radonc.2008.12.014] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2007] [Revised: 12/20/2008] [Accepted: 12/25/2008] [Indexed: 10/21/2022]
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Current status and perspectives of brachytherapy for breast cancer. Int J Clin Oncol 2009; 14:7-24. [DOI: 10.1007/s10147-008-0867-y] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2008] [Indexed: 10/21/2022]
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Offersen BV, Overgaard M, Kroman N, Overgaard J. Accelerated partial breast irradiation as part of breast conserving therapy of early breast carcinoma: a systematic review. Radiother Oncol 2008; 90:1-13. [PMID: 18783840 DOI: 10.1016/j.radonc.2008.08.005] [Citation(s) in RCA: 151] [Impact Index Per Article: 8.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/05/2008] [Revised: 08/08/2008] [Accepted: 08/13/2008] [Indexed: 12/24/2022]
Abstract
New strategies for adjuvant radiotherapy of early breast cancer are being investigated in several phase III randomised trials at the present time. Accelerated partial breast irradiation (APBI) is a way to offer an early breast cancer patient, who has had breast conservative surgery, an adjuvant radiotherapy of short duration aimed at the tumour bed with a certain margin. The rationale of this strategy is that most local recurrences appear close to the tumorectomy cavity and a wish to spare the patient late radiation morbidity. This review discusses the background for APBI, the different techniques, and we highlight possible pitfalls using these techniques. A systematic overview of all phase I and II studies is provided. Patient selection for this therapy is pivotal and based on evidence from previous studies on patient/tumour characteristics and pattern of local recurrences we propose inclusion criteria for patients in APBI protocols.
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Dragun AE, Harper JL, Jenrette JM, Sinha D, Cole DJ. Predictors of cosmetic outcome following MammoSite breast brachytherapy: a single-institution experience of 100 patients with two years of follow-up. Int J Radiat Oncol Biol Phys 2007; 68:354-8. [PMID: 17383829 DOI: 10.1016/j.ijrobp.2006.12.014] [Citation(s) in RCA: 37] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/21/2006] [Revised: 12/14/2006] [Accepted: 12/15/2006] [Indexed: 11/23/2022]
Abstract
PURPOSE To identify the factors that predict for excellent cosmesis in patients who receive MammoSite breast brachytherapy (MBT). METHODS AND MATERIALS One hundred patients with Stage 0, I, or II adenocarcinoma of the breast underwent adjuvant therapy using MBT. A dose of 34 Gy, delivered in 10 fractions twice daily, was prescribed to 1-cm depth using (192)Ir high-dose-rate brachytherapy. Patients were assessed for acute toxicity on the day of therapy completion, 4 weeks after therapy, and at least every 3 months by radiation, surgical, and/or medical oncologists. All available data were reviewed for documentation of cosmesis and rated using the Harvard Scale. All patients had a minimum follow-up of 6 months (median = 24 months). RESULTS Of 100 patients treated, 90 had adequate data and follow-up. Cosmesis was excellent in 62 (68.9%), good in 19 (21.1%), fair in 8 (8.9%), and poor in 1 (1.1%) patient. Using stepwise logistic regression, the factors that predicted for excellent cosmesis were as follows: the absence vs. presence of infection (p = 0.017), and the absence vs. presence of acute skin toxicity (p = 0.026). There was a statistically significant association between acute skin toxicity (present vs. absent) and balloon-to-skin distance (<8 vs. >8 mm, p = 0.001). Factors that did not predict for cosmesis were age, balloon placement technique, balloon volume, catheter days in situ, subcutaneous toxicity, and chemotherapy or hormonal therapy. CONCLUSIONS The acute and late-term toxicity profiles of MBT have been acceptable. Cosmetic outcome is improved by proper patient selection and infection prevention.
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Affiliation(s)
- Anthony E Dragun
- Department of Radiation Oncology, Bioinformatics and Epidemiology, Hollings Cancer Center, Medical University of South Carolina, Charleston, SC 29425, USA.
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Mamou J, Feleppa EJ. Singular spectrum analysis applied to ultrasonic detection and imaging of brachytherapy seeds. THE JOURNAL OF THE ACOUSTICAL SOCIETY OF AMERICA 2007; 121:1790-801. [PMID: 17407916 PMCID: PMC2692313 DOI: 10.1121/1.2436713] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 05/14/2023]
Abstract
Ultrasound-guided brachytherapy using titanium-shelled radioactive seeds is a popular, effective means of treating prostate cancer. Unfortunately, implantation using needles inserted transperitoneally causes gland movement and distortion, which often results in seed misplacement and dosimetry errors. If actual seed locations could be determined in the operating room, then corrections to dosimetry errors could be made immediately. However, seed specularity, shadowing, and tissue clutter make imaging seeds difficult using conventional ultrasound. Singular spectrum analysis (SSA) shows promise for reliably imaging radioactive seeds implanted in the prostate and enabling additional corrective implantations to be made in the operating room. SSA utilizes eigenvalues derived from the diagonalized correlation matrix of envelope-detected radio-frequency echo signals to yield a P value indicative of the likelihood of a seed-specific repetitive signal. We demonstrated the potential of SSA for seed detection and imaging and illustrated the trade-off considerations for optimization of SSA in clinical applications using simulations assessing performance as a function of different levels of noise and the presence of repetitive signals with various repetition periods; experiments in an ideal scattering environment; and experiments using seeds implanted in beef.
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Affiliation(s)
- Jonathan Mamou
- Frederic L. Lizzi Center for Biomedical Engineering, Riverside Research Institute, 156 William Street, New York, New York 10038, USA.
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Abstract
Breast cancer is the second leading cause of cancer related deaths in the United States. The area of breast interventions has benefited from recent advances in devices and imaging quality. Ultrasound, MRI, and stereotactic guided vacuum assisted and mechanical rotating stick freeze biopsy are the preferred methods for histologic diagnosis of breast lesions. Ablation techniques are available for the treatment of benign and malignant breast disease. The MammoSite balloon catheter can be placed percutaneously for delivering high dose short term brachytherapy. Interventional Radiologists can and should perform all of these procedures to improve the quality of women's health.
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Affiliation(s)
- Kenneth R Tomkovich
- Department of Radiology, CentraState Medical Center, Freehold, NJ 07728, USA.
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