Single-agent vinorelbine in the treatment of non-small cell lung cancer.

Vinorelbine, a vinca alkaloid, was the first drug in over 20 years to be approved by the Food and Drug Administration for treatment of advanced non-small cell lung cancer (NSCLC). The drug's nonhematologic toxicities are usually mild; its dose-limiting toxicity is neutropenia. Vinorelbine has been studied in many phase II trials. As a single agent it has produced objective response rates of 8% to 37% and median survivals ranging from 33 to 40.1+ weeks. Several phase III trials have included single-agent vinorelbine as one of the study arms. In a trial that compared vinorelbine with 5-fluorouracil and leucovorin, the vinorelbine recipients had better responses, median and 1-year survival rates, and improvement in cancer-related symptoms. In a large multicenter European trial single-agent vinorelbine was compared with vinorelbine/cisplatin and vindesine/cisplatin. Although the vinorelbine/cisplatin combination was superior to the other treatment arms with regard to response rate and median survival, single-agent vinorelbine was equivalent to the European standard of cisplatin and vindesine and was much less toxic. Vinorelbine is a reasonable alternative for patients not suited for cisplatin-containing regimens. Because of its favorable toxicity profile, vinorelbine has been investigated as a treatment for elderly patients with advanced NSCLC. In a multicenter randomized trial vinorelbine was compared with best supportive care in this particular patient group. Treated patients had a better survival and a trend toward improved quality of life. Single-agent vinorelbine has been used as second-line treatment for NSCLC but has not been particularly effective. Future directions for vinorelbine in the treatment of NSCLC include novel combinations with other agents as well as with radiation therapy in the treatment of locally advanced disease.