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Randomized Clinical Trial of Adjuvant Mitomycin Plus Tegafur in Patients With Resected Stage III Gastric Cancer

Address reprint requests to Lluis Cirera, MD, Medical Oncology Unit, Hospital Mútua de Terrassa-Universitat de Barcelona, Plaça Dr Robert 5, 08221 Terrassa, Barcelona, Spain

PURPOSE: The efficacy of adjuvant chemotherapy in gastric cancer is controversial. We conducted a phase III, randomized, multicentric clinical trial with the goal of assessing the efficacy of the combination of mitomycin plus tegafur in prolonging the disease-free survival and overall survival of patients with resected stage III gastric cancer.

PATIENTS AND METHODS: Patients with resected stage III gastric adenocarcinoma were randomly assigned, using sealed envelopes, to receive either chemotherapy or no further treatment. Chemotherapy was started within 28 days after surgery according to the following schedule: mitomycin 20 mg/m² intravenously (bolus) at day 1 of chemotherapy; 30 days later, oral tegafur at 400 mg bid daily for 3 months. Disease-free survival and overall survival were estimated using the Kaplan-Meier analysis and the Cox proportional hazards model.

RESULTS: Between January 1988 and September 1994, 148 patients from 10 hospitals in Catalonia, Spain, were included in the study. The median follow-up period was 37 months. The tolerability of the treatment was excellent. The overall survival and disease-free survival were higher in the group of patients treated with chemotherapy (P = .04 for survival and P = .01 for disease-free survival in the log-rank test). The overall 5-year survival rate and the 5-year disease-free survival rate were, respectively, 56% and 51% in the treatment group and 36% and 31% in the control group.

CONCLUSION: Our positive results are consistent with the results of recent studies; which conclude that there is a potential benefit from adjuvant chemotherapy in resected gastric cancer.

Grupo Cooperativo para el estudio del Cáncer Gástrico de los Hospitales Comarcales de Catalunya (The Catalan County Hospitals Cooperative Group on Gastric Cancer).

Medical Oncology Units of: Hospital Mútua de Terrassa, Terrassa; Hospital Arnau de Vilanova, Lleida; Hospital General de Vic, Vic; Hospital del Mar, Barcelona; Consorci Hospitalari de Mataró, Mataró; Hospital de Terrassa, Terrassa; Hospital General de Granollers, Granollers; Corporació Sanitària Parc Taulí, Sabadell; Hospital General de Manresa, Manresa; Hospital-Residència Sant Camil, Sant Pere de Ribes, Spain.

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