Author： Moen Marit D. Wellington Keri
Publisher： Adis International
ISSN： 1175-6357
Source： American Journal of Cancer, Vol.4, Iss.5, 2005-01, pp. : 327-333
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Abstract
Gemcitabine has antitumor activity against a range of cancers both alone and in combination with other chemotherapy agents. It is a nucleoside analog prodrug that inhibits DNA synthesis via its active metabolites gemcitabine triphosphate and gemcitabine diphosphate. In a randomized, nonblind, multicenter, phase III study in patients with metastatic breast cancer who had received prior adjuvant or neoadjuvant anthracycline treatment, gemcitabine 1250 mg/m2 plus paclitaxel 175 mg/m2 on day 1 and gemcitabine 1250 mg/m2 on day 8 of a 21-day cycle resulted in a significantly longer median time to disease progression and a significantly higher overall response rate than paclitaxel 175 mg/m2 alone. The median interim overall survival duration was 18.5 months for gemcitabine plus paclitaxel recipients and 15.8 months for paclitaxel recipients. The adjusted overall survival hazard ratio in an interim analysis was 0.74 (95% CI 0.60, 0.92) in favor of gemcitabine plus paclitaxel. Gemcitabine plus paclitaxel was generally well tolerated. The most common grade 3 or 4 adverse event was neutropenia. Fatigue and sensory neuropathy were the most frequent grade 3 or 4 clinical adverse events.
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