A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer Journal Article
| Authors: | Rothenberg, M. L.; Moore, M. J.; Cripps, M. C.; Andersen, J. S.; Portenoy, R. K.; Burris, H. A. 3rd; Green, M. R.; Tarassoff, P. G.; Brown, T. D.; Casper, E. S.; Storniolo, A. M.; Von Hoff, D. D. |
| Article Title: | A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer |
| 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. |
| Keywords: | adult; cancer chemotherapy; cancer survival; treatment outcome; aged; middle aged; survival rate; major clinical study; clinical trial; fluorouracil; drug efficacy; skin toxicity; gemcitabine; pancreas cancer; pancreatic neoplasms; chemotherapy; adenocarcinoma; pancreas; quality of life; phase 2 clinical trial; antimetabolites, antineoplastic; blood toxicity; gastrointestinal symptom; mucosa inflammation; peripheral neuropathy; body weight; cancer pain; karnofsky performance status; disease progression; pain measurement; deoxycytidine; alopecia; pain assessment; retreatment; intravenous drug administration; clinical benefit; cancer; humans; human; male; female; priority journal; article |
| Journal Title: | Annals of Oncology |
| Volume: | 7 |
| Issue: | 4 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 1996-04-01 |
| Start Page: | 347 |
| End Page: | 353 |
| Language: | English |
| PUBMED: | 8805925 |
| PROVIDER: | scopus |
| DOI: | 10.1093/oxfordjournals.annonc.a010600 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 22 November 2017 -- Source: Scopus |
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