Safety Data From North American Trials of Vinorelbine

ABSTRACT: Data from North American clinical trials have shown that vinorelbine (Navelbine) is well tolerated when used as a single agent for the treatment of non-small-cell lung cancer, advanced breast cancer, or ovarian cancer. Myelosuppression is the primary dose-limiting toxicity. Although the incidence of grade 4 granulocytopenia has been approximately 38%, the rate of related hospitalizations has been acceptable (10%). Moreover, hematologic toxicity is noncumulative and reversible. The rate of septic deaths is low, severe anemia is uncommon, and thrombocytopenia is rare. Most nonhematologic toxicities are of mild or moderate intensity, and severe complications are infrequent. Injection-site reactions are more common with longer infusions, whereas back pain is more likely to occur with shorter infusions; a 6- to 10-minute infusion has therefore been deemed optimal. Nausea and vomiting have occurred in approximately one-half of patients, but these effects have been severe in less than 3%. The incidence of neurotoxicity has been relatively low compared with other Vinca alkaloids. Respiratory reactions have been infrequent and have been similar to those reported with other Vinca alkaloids. Vinorelbine has maintained a favorable safety profile when used in combination with cisplatin (Platinol). [ONCOLOGY 11(Suppl 12):16-19, 1997]

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