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, Anna Maria Storniolo, D. D. Von Hoff

Research output: Contribution to journalArticle

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Abstract

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
Volume7
Issue number4
StatePublished - Apr 1996
Externally publishedYes

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gemcitabine
Pancreatic Neoplasms
Fluorouracil
Pain
Proxy
Multicenter Studies
Analgesics
Therapeutics
Outcome Assessment (Health Care)
Survival
Incidence

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Rothenberg, M. L., Moore, M. J., Cripps, M. C., Andersen, J. S., Portenoy, R. K., Burris, H. A., ... 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.

A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. / 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, Anna Maria; Von Hoff, D. D.

In: Annals of Oncology, Vol. 7, No. 4, 04.1996, p. 347-353.

Research output: Contribution to journalArticle

Rothenberg, ML, Moore, MJ, Cripps, MC, Andersen, JS, Portenoy, RK, Burris, HA, Green, MR, Tarassoff, PG, Brown, TD, Casper, ES, Storniolo, AM & Von Hoff, DD 1996, 'A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer', Annals of Oncology, vol. 7, no. 4, pp. 347-353.
Rothenberg ML, Moore MJ, Cripps MC, Andersen JS, Portenoy RK, Burris HA et al. A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. Annals of Oncology. 1996 Apr;7(4):347-353.
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, Anna Maria ; Von Hoff, D. D. / A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. In: Annals of Oncology. 1996 ; Vol. 7, No. 4. pp. 347-353.
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abstract = "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.",
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