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Annals of Oncology Advance Access originally published online on June 6, 2005
Annals of Oncology 2005 16(9):1488-1497; doi:10.1093/annonc/mdi270
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© 2005 European Society for Medical Oncology

Adjuvant chemotherapy with 5-fluorouracil and cisplatin compared with surgery alone for gastric cancer: 7-year results of the FFCD randomized phase III trial (8801)

O. Bouché1,*, M. Ychou2, P. Burtin3, L. Bedenne4,5, M. Ducreux6,7, G. Lebreton8, J. Baulieux9, B. Nordlinger10,11, C. Martin12, J. F. Seitz13,14, J. M. Tigaud15, E. Echinard16, N. Stremsdoerfer17, C. Milan5, P. Rougier11 On behalf of the Fédération Francophone de Cancérologie Digestive Group

1 University Hospital, Reims; 2 Centre Val d'Aurelle, Montpellier; 3 University Hospital, Angers; 4 University Hospital, Dijon; 5 Fédération Francophone de Cancérologie Digestive, Faculté Médecine, Equipe Mixte Inserm 106, Dijon; 6 Institut Gustave Roussy, Villejuif; 7 University Hospital Bicêtre AP-HP, Paris; 8 University Hospital, Caen; 9 University Hospital Croix Rousse, Lyon; 10 University Hospital Saint Antoine AP-HP, Paris; 11 University Hospital Ambroise Paré AP-HP, Boulogne; 12 General Hospital, Annecy; 13 Institut Paoli Calmettes, Marseille; 14 University Hospital La Timone, Marseille; 15 General Hospital, Villeneuve Saint Georges; 16 Clinique Saint Etienne, Bayonne; 17 General Hospital, Bourgoin Jallieu; France

* Correspondence to: Dr O. Bouché, Service d'Hépato-Gastroentérologie, CHU Robert Debré, Avenue du Général Koenig, F-51 092 Reims Cedex, France. Tel: +33-3267-87 170; Fax: +33-3267-84 061; Email: obouche{at}chu-reims.fr

Background: The aim of this study was to evaluate the efficacy of adjuvant chemotherapy after resection for gastric cancer in a randomized controlled trial.

Patients and methods: After curative resection, stage II-III-IVM0 gastric cancer patients were randomly assigned to postoperative chemotherapy or surgery alone. 5-Fluorouracil (5-FU) 800 mg/m2 daily (5-day continuous infusion) was initiated before day 14 after resection. One month later, four 5-day cycles of 5-FU (1 g/m2 per day) plus cisplatin (100 mg/m2 on day 2) were administered every 4 weeks.

Results: The study was closed prematurely after enrollment of 260 patients (79.7% N+), owing to poor accrual. At 97.8 months median follow-up, 5- and 7-year overall survival were 41.9% and 34.9% in the control group versus 46.6% and 44.6% in the chemotherapy group (P=0.22). Cox model hazard ratios were 0.74 [95% confidence interval (CI) 0.54–1.02; P=0.063] for death and 0.70 (95% CI 0.51–0.97; P=0.032) for recurrence. An invaded/removed lymph nodes ratio >0.3 was the main independent poor prognostic factor identified by multivariate analysis (P=0.0001). Because of toxicity, only 48.8% of patients received more than 80% of the planned dose.

Conclusion: There was no statistically significant survival benefit with this toxic cisplatin-based adjuvant chemotherapy, but a risk reduction in recurrence was observed.

Key words: adjuvant chemotherapy, cisplatin, gastric cancer, lymph nodes ratio, prognostic factor, randomized controlled trial


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