A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer

摘要: PURPOSE To assess the effect of gemcitabine in patients with metastatic pancreas cancer that had progressed despite prior treatment 5-FU. PATIENTS AND METHODS Seventy-four were enrolled this multicenter trial. Alleviation cancer-related symptoms was primary endpoint. Sixty-three completed a pain stabilization period and treated gemcitabine. Clinical Benefit Response defined as > or = 50% reduction intensity, daily analgesic consumption, 20 point improvement KPS sustained for 4 consecutive weeks. RESULTS Seventeen 63 pts (27.0%) attained (95% CI: 16.0%-38.0%). The median duration 14 weeks (range: 4-69 weeks). Median survival 3.85 months 0.3-18.0+ months). Therapy generally well-tolerated low incidence grade 3 toxicities. CONCLUSION Systematic assessment subjective outcomes can be used to evaluate clinical impact new therapies cancer, highly symptomatic disease. Our findings suggest is useful palliative agent 5-FU-refractory cancer.