Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG

Donato Nitti, J. Wils, J. Guimaraes Dos Santos, G. Fountzilas, P. F. Conte, C. Sava, A. Tres, R. C. Coombes, D. Crivellari, A. Marchet, E. Sanchez, J. M. Bliss, J. Homewood, M. L. Couvreur, E. Hall, B. Baron, E. Woods, M. Emson, E. Van Cutsem, M. Lise

Research output: Contribution to journalArticlepeer-review

Abstract

Background: In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil + adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm. Patients and methods: This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan- Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial. Results: In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P = 0.87) or OS (hazards ratio: 0.98, P = 0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively. Conclusion: Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.

Original languageEnglish
Pages (from-to)262-269
Number of pages8
JournalAnnals of Oncology
Volume17
Issue number2
DOIs
Publication statusPublished - Feb 2006

Keywords

  • Adjuvant chemotherapy
  • FAMTX
  • FEMTX
  • Gastric cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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