Gemcitabine and protracted 5-FU for advanced pancreatic cancer. A phase II study
Kurtz, J.E.; Kohser, F.; Négrier, S.; Trillet-Lenoir, V.; Walter, S.; Limacher, J.M.; Untereiner, M.; Kayitalire, L.; Jaeck, D.; Dufour, P.
Hepato-Gastroenterology 47(35): 1450-1453
2000
ISSN/ISBN: 0172-6390 PMID: 11100374 Document Number: 514682
Background/Aims: Although chemotherapy in advanced pancreatic cancer procures dismal results, both 5-fluorouracil and gemcitabine have shown a modest activity. We report a phase II study of gemcitabine combined with protracted 5- fluorouracil. Methodology: Gemcitabine was given at 1000mg/m2/week intravenously, in combination with concomitant 5-fluorouracil 200mg/m2/day as a protracted venous infusion, both 3 out of 4 weeks in patients with locally advanced or metastatic pancreatic adenocarcinoma. Twenty-nine patients were enrolled, among whom 27 were metastatic. Response rate, overall and progression-free survival were endpoints, as well as tolerance and clinical benefit. Results: We observed 3 (10%) partial responses, and 12 (42%) stabilizations within which the median disease control was 5.6 months. The median progression-free and overall survivals were 2.8 and 4 months, respectively. A clinical benefit was observed in 39% of patients. Myelosuppression was the main toxicity, but no grade 4 was observed. Other toxicities were mild. Conclusions: This combination chemotherapy was well tolerated in advanced pancreatic cancer patients.
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