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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.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2006 Feb; Vol. 17 (2), pp. 262-9. Date of Electronic Publication: 2005 Nov 17. - Publication Year :
- 2006
-
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.<br />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.<br />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.<br />Conclusion: Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.
- Subjects :
- 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 surgery
Survival Analysis
Adenocarcinoma drug therapy
Stomach Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0923-7534
- Volume :
- 17
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 16293676
- Full Text :
- https://doi.org/10.1093/annonc/mdj077