Phase II study of a fixed dose-rate infusion of gemcitabine associated to cisplatin and UFT in advanced carcinoma of the pancreas, an ONCOPAZ study

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4099 Background. The efficacy of gemcitabine can be improved by using a fixed dose-rate infusion. Our objective was to evaluate the efficacy and toxicity of a fixed dose-rate infusion of gemcitabine associated to cisplatin and UFT in patients with advanced adenocarcinoma of the pancreas. Patients and method. From May 2002 to September 2003, 46 chemotherapy-naïve patients were included, median age 57 years (range 27–77), male/female 30/16. Eleven patients (24%) had locally advanced disease and thirty-five (76%) distant metastases. The Karnofsky score was 80–100 in 34 (74%) and 60–70 in 12 (26%). Treatment consisted of gemcitabine 1200 mg/m2 given as a 120-minute infusion weekly for three consecutive weeks, cisplatin 50 mg/m2 on day 1 and oral UFT 400 mg/m2/day (in 2–3 daily doses) on days 1 to 21. Cycles were given every 28 days. Results. A total of 170 cycles of chemotherapy were delivered with a median of four per patient (range 1–11). There were fourteen partial responses (30%, 95%CI:19–48%), 17patients had stable disease (37%), and fifteen had a progression (33%). The median time to progression was five months and the median overall survival was nine months. Among 33 patients evaluable for clinical benefit, eighteen (55%) experienced a clinical benefit response. Grade 3–4 WHO toxicities per patient were as follows: neutropenia in twenty-six patients (57%), thrombocytopenia in fifteen (33%), anaemia in six (13%), diarrhoea in five (11%), nausea/vomiting in 6 (13%) and asthenia in two (4%). There were no toxic deaths. Conclusion. A fixed dose-rate infusion of gemcitabine associated to cisplatin and UFT is active in patients with advanced carcinoma of the pancreas, although at the cost of considerable toxicity. No significant financial relationships to disclose.