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J Clin Oncol. 2017 Nov 10;35(32):3671-3677. doi: 10.1200/JCO.2017.74.2130. Epub 2017 Oct 4.

Adjuvant Chemoradiotherapy With Epirubicin, Cisplatin, and Fluorouracil Compared With Adjuvant Chemoradiotherapy With Fluorouracil and Leucovorin After Curative Resection of Gastric Cancer: Results From CALGB 80101 (Alliance).

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Charles S. Fuchs, Yale Cancer Center, Smilow Cancer Hospital, New Haven, CT; Charles S. Fuchs, Peter C. Enzinger, Jeffrey Meyerhardt, and Robert J. Mayer, Dana-Farber/Partners CancerCare; Harvey J. Mamon and Richard S. Swanson, Brigham and Women's Hospital, Boston, MA; Donna Niedzwiecki and Xing Ye, Alliance Statistics and Data Center, Duke University; Christopher G. Willett, Duke Cancer Institute, Duke University Medical Center, Durham; Joel E. Tepper, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC; Daniel G. Haller, University of Pennsylvania, Philadelphia, PA; Tomislav Dragovich, Banner MD Anderson Cancer Center, Gilbert; Leonard L. Gunderson, Mayo Clinic, Scottsdale, AZ; Steven R. Alberts, Mayo Clinic, Rochester, MN; Georg A. Bjarnason, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada; Richard M. Goldberg and Kristen Ciombor, Ohio State University, James Cancer Hospital, Columbus, OH; Alan P. Venook, University of California at San Francisco, San Francisco, CA; David Ilson and Eileen O'Reilly, Memorial Sloan Kettering Cancer Center, New York, NY; and David J. Berg, University of Iowa/Holden Comprehensive Cancer Center, Iowa City, IA.


Purpose After curative resection of gastric or gastroesophageal junction adenocarcinoma, Intergroup Trial 0116 (Phase III trial of postoperative adjuvant radiochemotherapy for high risk gastric and gastroesophageal junction adenocarcinoma: Demonstrated superior survival for patients who received postoperative chemoradiotherapy with bolus fluorouracil (FU) and leucovorin (LV) compared with surgery alone. CALGB 80101 (Alliance; Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma) assessed whether a postoperative chemoradiotherapy regimen that replaced FU plus LV with a potentially more active systemic therapy could further improve overall survival. Patients and Methods Between April 2002 and May 2009, 546 patients who had undergone a curative resection of stage IB through IV (M0) gastric or gastroesophageal junction adenocarcinoma were randomly assigned to receive either postoperative FU plus LV before and after combined FU and radiotherapy (FU plus LV arm) or postoperative epirubicin, cisplatin, and infusional FU (ECF) before and after combined FU and radiotherapy (ECF arm). Results With a median follow-up duration of 6.5 years, 5-year overall survival rates were 44% in the FU plus LV arm and 44% in the ECF arm ( Plogrank = .69; multivariable hazard ratio, 0.98; 95% CI, 0.78 to 1.24 comparing ECF with FU plus LV). Five-year disease-free survival rates were 39% in the FU plus LV arm and 37% in the ECF arm ( Plogrank = .94; multivariable hazard ratio, 0.96; 95% CI, 0.77 to 1.20). In post hoc analyses, the effect of treatment seemed to be similar across all examined patient subgroups. Conclusion After a curative resection of gastric or gastroesophageal junction adenocarcinoma, postoperative chemoradiotherapy using a multiagent regimen of ECF before and after radiotherapy does not improve survival compared with standard FU and LV before and after radiotherapy.

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