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


PURPOSE To assess the effect of gemcitabine in patients with metastatic 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 primary endpoint. Sixty-three patients completed a pain stabilization period and were treated with gemcitabine. Clinical Benefit Response was defined as a > or = 50% reduction in pain intensity, > or = 50% reduction in daily analgesic consumption, or > or = 20 point improvement in KPS that was sustained for > or = 4 consecutive weeks. RESULTS Seventeen 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 weeks (range: 4-69 weeks). Median survival for patients treated with gemcitabine was 3.85 months (range: 0.3-18.0+ months). Therapy was generally well-tolerated with a low incidence of grade 3 or 4 toxicities. CONCLUSION Systematic assessment of subjective outcomes can be used to evaluate the clinical impact of new therapies for pancreas cancer, a highly symptomatic disease. Our findings suggest that gemcitabine is a useful palliative agent in patients with 5-FU-refractory pancreas cancer.

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@article{Rothenberg1996API, title={A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer.}, author={Mace L. Rothenberg and Malcom J. Moore and Martin Cripps and Jakob Steen Andersen and Russell K. Portenoy and Howard A. Burris and Mark R . Green and Peter G. Tarassoff and Thomas D. Brown and Ephraim S. Casper and Anna Maria Storniolo and Daniel D. Von Hoff}, journal={Annals of oncology : official journal of the European Society for Medical Oncology}, year={1996}, volume={7 4}, pages={347-53} }