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.

Details

Serval ID
serval:BIB_A20260C65C6B
Type
Article: article from journal or magazin.
Publication sub-type
Case report (case report): feedback on an observation with a short commentary.
Collection
Publications
Institution
Title
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.
Journal
Annals of Oncology : Official Journal of the European Society For Medical Oncology / Esmo
Author(s)
Nitti D., Wils J., Dos Santos J.G., Fountzilas G., Conte P.F., Sava C., Tres A., Coombes R.C., Crivellari D., Marchet A., Sanchez E., Bliss J.M., Homewood J., Couvreur M.L., Hall E., Baron B., Woods E., Emson M., Van Cutsem E., Lise M., ICCG 
Working group(s)
EORTC GI Group
Contributor(s)
ICCG 
ISSN
0923-7534 (Print)
ISSN-L
0923-7534
Publication state
Published
Issued date
2006
Volume
17
Number
2
Pages
262-269
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Meta-Analysis ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
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.
Keywords
Adenocarcinoma/drug therapy, Adenocarcinoma/surgery, Adult, Aged, Antineoplastic Agents/administration & dosage, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Chemotherapy, Adjuvant, Clinical Trials, Phase III as Topic, Combined Modality Therapy, Disease-Free Survival, Doxorubicin/administration & dosage, Epirubicin/administration & dosage, Female, Fluorouracil/administration & dosage, Humans, Male, Methotrexate/administration & dosage, Middle Aged, Randomized Controlled Trials as Topic, Stomach Neoplasms/drug therapy, Stomach Neoplasms/surgery, Survival Analysis
Pubmed
Web of science
Open Access
Yes
Create date
24/04/2008 16:05
Last modification date
20/08/2019 15:08
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