Annals of Oncology 7:347-353, 1996
© 1996 European Society for Medical Oncology
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A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer*
1The University of Texas Health Science Center at San Antonio
2Cancer Therapy and Research Center San Antonio, TX, U.S.A.
3Princess Margaret Hospital Toronto
4Ottawa Regional Cancer Center Ottawa, Ontario, Canada
5Lilly Research Laboratories Indianapolis, IN
6Memorial Sloan-Kettering Cancer Center New York, NY
7Brooke Army Medical Center Ft. Sam Houston, TX
8University of California, San Diego Cancer Center San Diego, CA
9Duke University Medical Center Durham, NC, U.S.A.
Correspondence to: Mace L. Rothenberg, MD, FACP Division of Medical Oncology University of Texas Health Science Center 7703 Floyd Curl Drive San Antonio, TX 78284-7884 U.S.A.
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 
50% reduction in pain intensity, 50% reduction in daily analgesic consumption, or 20 point improvement in KPS that was sustained for 4 consecutive weeks.
RESULTS:: Seventeen of 63 pts (27.0%) attained a Clinical Benefit Response (95% CI: 16.0% 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 out comes 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.
chemotherapy, clinical benefit, gemcitabine, pancreas cancer, quality of life
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