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)

Charles S. Fuchs, Donna Niedzwiecki, Harvey J. Mamon, Joel E. Tepper, Xing Ye, Richard S. Swanson, Peter C. Enzinger, Daniel G. Haller, Tomislav Dragovich, Steven R. Alberts, Georg A. Bjarnason, Christopher G. Willett, Leonard L. Gunderson, Steven Robert Alberts, Alan P. Venook, David Ilson, Eileen O'Reilly, Kristen Ciombor, David J. Berg, Jeffrey MeyerhardtRobert J. Mayer

Research output: Contribution to journalArticle

31 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)3671-3677
Number of pages7
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume35
Issue number32
DOIs
StatePublished - Nov 10 2017

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Adjuvant Chemoradiotherapy
Epirubicin
Leucovorin
Fluorouracil
Cisplatin
Stomach Neoplasms
Esophagogastric Junction
Stomach
Adenocarcinoma
Chemoradiotherapy
Radiotherapy
Survival
Survival Rate
Disease-Free Survival

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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). / Fuchs, Charles S.; Niedzwiecki, Donna; Mamon, Harvey J.; Tepper, Joel E.; Ye, Xing; Swanson, Richard S.; Enzinger, Peter C.; Haller, Daniel G.; Dragovich, Tomislav; Alberts, Steven R.; Bjarnason, Georg A.; Willett, Christopher G.; Gunderson, Leonard L.; Alberts, Steven Robert; Venook, Alan P.; Ilson, David; O'Reilly, Eileen; Ciombor, Kristen; Berg, David J.; Meyerhardt, Jeffrey; Mayer, Robert J.

In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 35, No. 32, 10.11.2017, p. 3671-3677.

Research output: Contribution to journalArticle

Fuchs, CS, Niedzwiecki, D, Mamon, HJ, Tepper, JE, Ye, X, Swanson, RS, Enzinger, PC, Haller, DG, Dragovich, T, Alberts, SR, Bjarnason, GA, Willett, CG, Gunderson, LL, Alberts, SR, Venook, AP, Ilson, D, O'Reilly, E, Ciombor, K, Berg, DJ, Meyerhardt, J & Mayer, RJ 2017, '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)', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 35, no. 32, pp. 3671-3677. https://doi.org/10.1200/JCO.2017.74.2130
Fuchs, Charles S. ; Niedzwiecki, Donna ; Mamon, Harvey J. ; Tepper, Joel E. ; Ye, Xing ; Swanson, Richard S. ; Enzinger, Peter C. ; Haller, Daniel G. ; Dragovich, Tomislav ; Alberts, Steven R. ; Bjarnason, Georg A. ; Willett, Christopher G. ; Gunderson, Leonard L. ; Alberts, Steven Robert ; Venook, Alan P. ; Ilson, David ; O'Reilly, Eileen ; Ciombor, Kristen ; Berg, David J. ; Meyerhardt, Jeffrey ; Mayer, Robert J. / 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). In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2017 ; Vol. 35, No. 32. pp. 3671-3677.
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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 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.",
author = "Fuchs, {Charles S.} and Donna Niedzwiecki and Mamon, {Harvey J.} and Tepper, {Joel E.} and Xing Ye and Swanson, {Richard S.} and Enzinger, {Peter C.} and Haller, {Daniel G.} and Tomislav Dragovich and Alberts, {Steven R.} and Bjarnason, {Georg A.} and Willett, {Christopher G.} and Gunderson, {Leonard L.} and Alberts, {Steven Robert} and Venook, {Alan P.} and David Ilson and Eileen O'Reilly and Kristen Ciombor and Berg, {David J.} and Jeffrey Meyerhardt and Mayer, {Robert J.}",
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TY - JOUR

T1 - Adjuvant Chemoradiotherapy With Epirubicin, Cisplatin, and Fluorouracil Compared With Adjuvant Chemoradiotherapy With Fluorouracil and Leucovorin After Curative Resection of Gastric Cancer

T2 - Results From CALGB 80101 (Alliance)

AU - Fuchs, Charles S.

AU - Niedzwiecki, Donna

AU - Mamon, Harvey J.

AU - Tepper, Joel E.

AU - Ye, Xing

AU - Swanson, Richard S.

AU - Enzinger, Peter C.

AU - Haller, Daniel G.

AU - Dragovich, Tomislav

AU - Alberts, Steven R.

AU - Bjarnason, Georg A.

AU - Willett, Christopher G.

AU - Gunderson, Leonard L.

AU - Alberts, Steven Robert

AU - Venook, Alan P.

AU - Ilson, David

AU - O'Reilly, Eileen

AU - Ciombor, Kristen

AU - Berg, David J.

AU - Meyerhardt, Jeffrey

AU - Mayer, Robert J.

PY - 2017/11/10

Y1 - 2017/11/10

N2 - 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.

AB - 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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U2 - 10.1200/JCO.2017.74.2130

DO - 10.1200/JCO.2017.74.2130

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JO - Journal of Clinical Oncology

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