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Annals of Oncology 2:751-754, 1991
© 1991 European Society for Medical Oncology

research-article

Original article: Combination chemotherapy with cisplatin and 5-fluorouracil 5-day infusion in the therapy of advanced gastric cancer: A Phase II trial

A. J. Lacave1,, F. J. Barón1, L. M. Antón2, E. Estrada1, L. M. G. De Sande1, I. Palacio1, E. Esteban1, J. M. Gracia1, J. M. Buesa1, O. A. Fernández2 and M. González Barón3

1Servicio de Oncoiogia Médica, Hospital General de Asturias Oviedo
2Clinica Uniwrsitaria de Navarra Pamplona
3Hospital La Paz Madrid, Spain

Correspondence to: Dr. Angel J. Lacave Servicio de Oncología Médica, Hospital General de Asturias, 33006 Oviedo, Spain

Fifty-six patients with measurable or evaluable advanced gastric cancer were treated with cisplatin, 100 mg/m2 in continuous infusion of 24 hours, and 5-fluorouracil, 1000 mg/nr/day (by continuous 5-day infusion) every 4 weeks. Three patients were found ineligible for the study. A response rate of 41% (22/53) was obtained (95% confidence interval: 28%-54%), with a median duration of remission of 10.2 months and an overall median survival time of 10.6 months. Leukopenia and thrombocytopenia were mild. Nausea and vomiting were common, and 23.5% of the patients had grade 3 stomatitis. Peripheral neuropathy and renal insufficiency increased with the number of cycles, representing the cumulative dose-limiting toxicity. This study indicates that the combination of cisplatin plus 5-fluorouracil is synergistic or at least has additive antitumor activity. We think that thig association of 2 drugs should be considered for further phase III clinical trials.

chemotherapy, cisplatin plus 5-fluorouracil, continuous infusion, gastric cancer, Phase II trial, treatment


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