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Annals of Oncology Advance Access originally published online on November 17, 2005
Annals of Oncology 2006 17(2):262-269; doi:10.1093/annonc/mdj077
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© 2005 European Society for Medical Oncology

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

D. Nitti1,*, J. Wils2, J. Guimaraes Dos Santos3, G. Fountzilas4, P. F. Conte5, C. Sava6, A. Tres7, R. C. Coombes8, D. Crivellari9, A. Marchet1, E. Sanchez3, J. M. Bliss10, J. Homewood10, M. L. Couvreur11, E. Hall10, B. Baron11, E. Woods8, M. Emson8, E. Van Cutsem12 and M. Lise1

1 Università di Padova, Clinica Chirurgica II, Padova, Italy; 2 Laurentius Hospital, Roermond, The Netherlands; 3 Instituto Portugues de Oncologia, Porto, Portugal; 4 Aristotle University of Thessaloniki, Macedonia, Greece; 5 University Hospital, Modena, Italy; 6 Regional Hospital, Treviso, Italy; 7 Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain; 8 Charing Cross Hospital, and International Collaborative Cancer Group (ICCG), Imperial College London, UK; 9 Centro di Riferimento Oncologico, Aviano, Italy; 10 Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton, UK; 11 European Organization for Research and Treatment of Cancer (EORTC), Data Center, Brussels, Belgium; 12 University Hospital Gasthuisberg, Leuven, Belgium

* Correspondence to: Prof. D. Nitti, Clinica Chirurgica II, Via Giustiniani 2, Padova, I-35128, Italy; Tel: +39-049-8212073/8212055, Fax: +39-049-651891; E-mail: donato.nitti{at}unipd.it

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.

Key words: adjuvant chemotherapy, FAMTX, FEMTX, gastric cancer


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