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

M. L. Rothenberg, M. J. Moore, M. C. Cripps, J. S. Andersen, R. K. Portenoy, H. A. Burris, M. R. Green, P. G. Tarassoff, T. D. Brown, E. S. Casper, A. M. Storniolo, D. D. Von Hoff

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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: 16.00/0-38.0%). 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.

Original languageEnglish (US)
Pages (from-to)347-353
Number of pages7
JournalAnnals of Oncology
Issue number4
StatePublished - Apr 1996
Externally publishedYes


  • Cancer
  • Chemotherapy
  • Clinical benefit
  • Gemcitabine
  • Pancreas
  • Quality of life

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Rothenberg, M. L., Moore, M. J., Cripps, M. C., Andersen, J. S., Portenoy, R. K., Burris, H. A., Green, M. R., Tarassoff, P. G., Brown, T. D., Casper, E. S., Storniolo, A. M., & Von Hoff, D. D. (1996). A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. Annals of Oncology, 7(4), 347-353. https://doi.org/10.1093/oxfordjournals.annonc.a010600