A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma: efficacy and low toxicity

Autor: S. Skaria, Leslie Samuel, Marianne Nicolson, M. Koruth, Russell D. Petty, T. S. Sinclair
Rok vydání: 2003
Předmět:
Zdroj: Annals of oncology : official journal of the European Society for Medical Oncology. 14(7)
ISSN: 0923-7534
Popis: Background: The effective treatment of unresectable pancreatic carcinoma represents a formidable challenge. There is aeed to develop systemic therapies which combine efficacy with acceptable toxicity. The current ‘gold standard’ gemcitabine gives an objective response rate of the order of 20% and median survival up to 6 months. Here we have evaluated the efficacy and toxicity of mitomycin C, cisplatin and protracted infusional 5-fluorouracil (MCF). Patients and methods: Forty-five patients with locally advanced (13 patients) or metastatic (32 patients) pancreatic carcinoma were treated with mitomycin C 7 mg/m2 6 weekly, cisplatin 60 mg/m2 3 weekly and protracted venous infusion 5-FU 300 mg/m2/day. Patients were evaluated for response after three cycles and received six cycles in total in the absence of progressive disease or poor tolerance. Median age was 62(45–75) years; 41 patients were World Health Organization performance status 0–1. Results: Treatment was well tolerated with 36 (84%) patients completing three or more cycles. Grade 3 or 4 toxicities were uncommon: anaemia in three patients (7%), mucositis in two (5%),ausea and vomiting in three (7%) and diarrhoea in one (1%). An objective response was seen in 21 (46%) patients. There was one complete response. The median survival overall was 7.1 months and 10.5 months in responders. The median duration of response was 4.3 months. One-year survival was 29%, 2-year survival was 18%. Conclusions: MCF combines efficacy with low toxicity in the treatment of advanced pancreatic carcinoma. The efficacy is at least comparable and may be superior to single-agent gemcitabine and MCF may therefore provide a cost-effective alternative.
Databáze: OpenAIRE