VINORELBINE - A NEW ANTINEOPLASTIC DRUG FOR THE TREATMENT OF NON-SMALL-CELL LUNG-CANCER

OBJECTIVE: To review the chemistry, pharmacology, pharmacokinetics, cl inical activity, adverse effects, and dosage and administration guidel ines for vinorelbine in the treatment of non-small-cell lung cancer (N SCLC). DATA SOURCES: A MEDLINE search (1989-1995) using the terms vino relbine and Navelbine was conducted. Additional unpublished data were provided by Glare Wellcome Drug information. STUDY SELECTION AND DATA EXTRACTION: The articles chosen for inclusion all appeared in peer-rev iewed journals. Pertinent abstracts, as judged by the authors, were al so included. DATA SYNTHESIS: Vinorelbine is a new semisynthetic vinca alkaloid approved by the Food and Drug Administration for the first-li ne treatment of patients with advanced NSCLC. The drug demonstrated a broad spectrum of antitumor activity in preclinical studies and produc ed dose-limiting neutropenia in Phase I trials. In Phase ii studies, a n overall response rate of approximately 30% was reported with single- agent vinorelbine. Furthermore, in large, multicenter, randomized Phas e III trials, treatment with vinorelbine alone and in combination with cisplatin resulted in improved survival compared with controls. The d rug was well tolerated, with granulocytopenia being the most commonly reported adverse effect. However, the incidence of fever and hospitali zation associated with this granulocytopenia was exceptionally low. Th e recommended dose is 30 mg/m(2) weekly administered by intravenous in jection or infusion. CONCLUSIONS: As no specific chemotherapy regimen has previously been regarded as standard therapy for advanced NSCLC, v inorelbine is a promising new treatment for this patient population. I t has been shown in several randomized, controlled trials to increase survival without compromising quality of life.