Gemcitabine safety overview.

Abstract

The novel nucleoside analog, gemcitabine, appears to be exceptionally well tolerated. To examine gemcitabine's toxicity profile in detail, an analysis of safety data from 18 single-agent gemcitabine studies has been performed. The studies were across a range of tumor types, but all used a dose regimen of 800 to 1,250 mg/ m2 once a week for 3 weeks followed by a week of rest. Seven hundred ninety patients were included in the analysis. Myelosuppression was found to be mild and short-lived: World Health Organization grades 3 and 4, respectively, were recorded in 6.4% and 0.9% of patients for hemoglobin, in 8.1% and 0.5% for leukocytes, in 18.7% and 5.7% for neutrophils, and in 3.7% and 1.0% for platelets. There was little associated infection or hemorrhage. Mild transaminase increases were common but were rarely dose limiting. In general, renal toxicity was mild, but a few cases of renal failure of uncertain etiology were reported. There was little symptomatic toxicity, with low incidences of the gastrointestinal and hair toxicities normally associated with cytotoxic drugs. However, there was a higher incidence than expected of flu-like symptoms and edema, although these were rarely serious. When the safety data from non-small cell lung cancer studies were analyzed separately, the toxicity findings were similar. Therefore, these analyses in large numbers of patients confirm gemcitabine's favorable safety profile.