Adjuvant chemoradiotlherapy with epirubicin, cisplatin, and fluorouracil compared with adjuvant chemoradiotherapy with fluorouracil and leucovorin after curative resection of gastric cancer: Results from CALGB 80101 (Alliance) Journal Article


Authors: Fuchs, C. S.; Niedzwiecki, D.; Mamon, H. J.; Tepper, J. E.; Ye, X.; Swanson, R. S.; Enzinger, P. C.; Haller, D. G.; Dragovich, T.; Alberts, S. R.; Bjarnason, G. A.; Willett, C. G.; Gunderson, L. L.; Goldberg, R. M.; Venook, A. P.; Ilson, D.; O'Reilly, E.; Ciombor, K.; Berg, D. J.; Meyerhardt, J.; Mayer, R. J.
Article Title: Adjuvant chemoradiotlherapy with epirubicin, cisplatin, and fluorouracil compared with adjuvant chemoradiotherapy with fluorouracil and leucovorin after curative resection of gastric cancer: Results from CALGB 80101 (Alliance)
Abstract: 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 FUand radiotherapy (FUplus LV arm) or postoperative epirubicin, cisplatin, and infusional FU (ECF) before and after combined FU and radiotherapy (ECF arm). Results With amedian follow-up duration of 6.5 years, 5-year overall survival rateswere 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 amultiagent regimen of ECF before and after radiotherapy does not improve survival compared with standard FU and LV before and after radiotherapy. © 2017 by American Society of Clinical Oncology.
Keywords: adult; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; cisplatin; fluorouracil; multimodality cancer therapy; united states; combined modality therapy; cancer staging; antineoplastic agent; neoplasm staging; adenocarcinoma; neoplasm recurrence, local; randomized controlled trial; antineoplastic combined chemotherapy protocols; risk factors; pathology; risk factor; tumor recurrence; folinic acid; epirubicin; leucovorin; stomach neoplasms; esophagogastric junction; gastroesophageal junction; adjuvant chemoradiotherapy; chemoradiotherapy, adjuvant; very elderly; humans; human; male; female
Journal Title: Journal of Clinical Oncology
Volume: 35
Issue: 32
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2017-11-10
Start Page: 3671
End Page: 3677
Language: English
DOI: 10.1200/jco.2017.74.2130
PUBMED: 28976791
PROVIDER: scopus
PMCID: PMC5678342
DOI/URL:
Notes: Article -- Export Date: 4 December 2017 -- Source: Scopus
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MSK Authors
  1. David H Ilson
    269 Ilson
  2. Eileen O'Reilly
    316 O'Reilly