A PHASE-II TRIAL OF GEMCITABINE IN PATIENTS WITH 5-FU-REFRACTORY PANCREAS CANCER

Purpose: To assess the effect of gemcitabine in patients with metastat ic pancreas cancer that had progressed despite prior treatment with 5- FU. Patients and methods: Seventy-four patients were enrolled in this multicenter trial. Alleviation of cancer-related symptoms was the prim ary endpoint. Sixty-three patients completed a pain stabilization peri od and were treated with gemcitabine. Clinical Benefit Response was de fined as a greater than or equal to 50% reduction in pain intensity, g reater than or equal to 50% reduction in daily analgesic consumption, or greater than or equal to 20 point improvement in KPS that was susta ined for greater than or equal to 4 consecutive weeks. Results: Sevent een of 63 pts (27.0%) attained a Clinical Benefit Response (95% CI: 16 .0%-38.0%). The median duration of Clinical Benefit Response was 14 we eks (range: 4-69 weeks). Median survival for patients treated with gem citabine was 3.85 months (range: 0.3-18.0+ months). Therapy was genera lly well-tolerated with a low incidence of grade 3 or 4 toxicities. Co nclusion: Systematic assessment of subjective outcomes can be used to evaluate the clinical impact of new therapies for pancreas cancer, a h ighly symptomatic disease. Our findings suggest that gemcitabine is a useful palliative agent in patients with 5-FU-refractory pancreas canc er.