Prospective Study
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World J Gastroenterol. Nov 14, 2014; 20(42): 15820-15829
Published online Nov 14, 2014. doi: 10.3748/wjg.v20.i42.15820
Adjuvant therapy sparing in rectal cancer achieving complete response after chemoradiation
Xabier García-Albéniz, Rosa Gallego, Ralf Dieter Hofheinz, Gloria Fernández-Esparrach, Juan Ramón Ayuso-Colella, Josep Antoni Bombí, Carles Conill, Miriam Cuatrecasas, Salvadora Delgado, Angels Ginés, Rosa Miquel, Mario Pagés, Estela Pineda, Verónica Pereira, Aarón Sosa, Oscar Reig, Iván Victoria, Luis Feliz, Antonio María de Lacy, Antoni Castells, Iris Burkholder, Andreas Hochhaus, Joan Maurel
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States
Rosa Gallego, Estela Pineda, Verónica Pereira, Aarón Sosa, Oscar Reig, Iván Victoria, Luis Feliz, Joan Maurel, Department of Medical Oncology, Hospital Clínic, ICMHO, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona 08007, Spain
Ralf Dieter Hofheinz, Interdisciplinary Tumor Center Mannheim and III Medical Clinic, University Hospital Mannheim, University of Heidelberg, Mannheim 69117, Germany
Gloria Fernández-Esparrach, Angels Ginés, Department of Gastroenterology, Endoscopy Unit, Hospital Clínic, ICMDiM, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona 08007, Spain
Juan Ramón Ayuso-Colella, Mario Pagés, Department of Radiology, Hospital Clínic, CDI, IDIBAPS, University of Barcelona, Barcelona 08007, Spain
Josep Antoni Bombí, Miriam Cuatrecasas, Rosa Miquel, Department of Pathology, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona 08007, Spain
Carles Conill, Department of Radiation Oncology, Hospital Clínic, ICMHO, University of Barcelona, Barcelona 08007, Spain
Salvadora Delgado, Antonio María de Lacy, Department of Gastrointestinal Surgery, Hospital Clínic, ICMDiM, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona 08007, Spain
Antoni Castells, Department of Gastroenterology, Hospital Clínic, ICMDiM, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona 08007, Spain
Iris Burkholder, Department of Nursing and Health, University of Applied Sciences of the Saarland, Saarbruecken, Germany
Andreas Hochhaus, Department for Hematology and Oncology, Clinic for Internal Medicine II, Jena University Hospital, Jena 07743, Germany
Author contributions: Maurel J and Castells A designed the research; García-Albéniz X, Gallego R and Maurel J performed the research; Hofheinz RD, Ayuso-Colella JR, Bombí JA, Conill C, Cuatrecasas M, Delgado S, Ginés A, Miquel R, Pagés M, María de Lacy A, Castells A, Burkholder I, Hochhaus A and Maurel J contributed new reagents or analytic tools; García-Albéniz X analyzed the data; García-Albéniz X and Maurel J wrote the paper; all the authors critically reviewed the manuscript drafts and approved the final manuscript.
Supported by “Ajut Josep Font” (Hospital Clinic, Barcelona) and an ASISA fellowship to Xabier García-Albéniz
Correspondence to: Xabier García-Albéniz, MD, ScM, Department of Epidemiology, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115, United States. xabi@post.harvard.edu
Telephone: +1-617-4321539 Fax: +1-617-4321539
Received: December 24, 2013
Revised: February 27, 2014
Accepted: July 15, 2014
Published online: November 14, 2014
Processing time: 328 Days and 0.2 Hours
Abstract

AIM: To evaluate the long-term results of conventional chemoradiotherapy and laparoscopic mesorectal excision in rectal adenocarcinoma patients without adjuvant therapy.

METHODS: Patients with biopsy-proven adenocarcinoma of the rectum staged cT3-T4 by endoscopic ultrasound or magnetic resonance imaging received neoadjuvant continuous infusion of 5-fluorouracil for five weeks and concomitant radiotherapy. Laparoscopic surgery was planned after 5-8 wk. Patients diagnosed with ypT0N0 stage cancer were not treated with adjuvant therapy according to the protocol. Patients with ypT1-2N0 or ypT3-4 or N+ were offered 5-fluorouracil-based adjuvant treatment on an individual basis. An external cohort was used as a reference for the findings.

RESULTS: One hundred and seventy six patients were treated with induction chemoradiotherapy and 170 underwent total mesorectal excision. Cancer staging of ypT0N0 was achieved in 26/170 (15.3%) patients. After a median follow-up of 58.3 mo, patients with ypT0N0 had five-year disease-free and overall survival rates of 96% (95%CI: 77-99) and 100%, respectively. We provide evidence about the natural history of patients with localized rectal cancer achieving a complete response after preoperative chemoradiation. The inherent good prognosis of these patients will have implications for clinical trial design and care of patients.

CONCLUSION: Withholding adjuvant chemotherapy after complete response following standard neoadjuvant chemoradiotherapy and laparoscopic mesorectal excision might be safe within an experienced multidisciplinary team.

Keywords: Exercise; Follow-up; Gastrointestinal diseases; Irritable bowel syndrome; Physical activity

Core tip: This study shows that patients with localized rectal cancer can achieve a complete response after preoperative chemoradiation. The inherent good prognosis of these patients will have implications for clinical trial design and care of patients. Withholding adjuvant chemotherapy after complete response following standard neoadjuvant chemoradiotherapy and laparoscopic mesorectal excision might be safe within an experienced multidisciplinary team.