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Annals of Oncology Advance Access published online on June 6, 2005
Annals of Oncology, doi:10.1093/annonc/mdi270
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© 2005 European Society for Medical Oncology
Received March 12, 2005
Revised April 18, 2005
Accepted April 19, 2005

Original article

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. Bouché 1*, M. Ychou 2, P. Burtin 3, L. Bedenne 4, M. Ducreux 5, G. Lebreton 6, J. Baulieux 7, B. Nordlinger 8, C. Martin 9, J. F. Seitz 10, J. M. Tigaud 11, E. Echinard 12, N. Stremsdoerfer 13, C. Milan 14, P. Rougier 15, and On behalf of the Fédération Francophone de Cancérologie Digestive Group

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

* To whom correspondence should be addressed.
O. Bouché, E-mail: obouche{at}chu-reims.fr


  Abstract

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.

Keywords: adjuvant chemotherapy; cisplatin; gastric cancer; lymph nodes ratio; prognostic factor; randomized controlled trial.
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