A three-arm trial of vinorelbine (Navelbine) plus cisplatin, vindesine plus cisplatin, and single-agent vinorelbine in the treatment of non-small cell lung cancer: an expanded analysis.

Phase II studies have demonstrated that vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) alone or in combination with cisplatin has promising activity against non-small cell lung cancer (NSCLC). On the basis of these preliminary trials, a phase III study was designed to compare intravenous vinorelbine (30 mg/m2 weekly) plus cisplatin (120 mg/m2 on day 1 and day 29 and then every 6 weeks) with vindesine (3 mg/m2 weekly for 6 weeks and then every 2 weeks) plus cisplatin, and to evaluate whether the best of these regimens afforded a survival benefit compared with intravenous vinorelbine alone, an outpatient regimen. This report presents an expanded analysis of data from this previously published study. Six hundred twelve patients were enrolled in this trial: 206 in the vinorelbine plus cisplatin arm, 200 in the vindesine plus cisplatin group, and 206 in the single-agent vinorelbine arm. The vinorelbine plus cisplatin regimen was superior to the other two arms of the study in objective response rate (30% v 19% for vindesine plus cisplatin [P = .02] and 14% for vinorelbine alone [P = .001]), median survival duration (40 weeks v 32 weeks for vindesine plus cisplatin and 31 weeks for vinorelbine alone), and 1-year survival rate (35% v 27% for vindesine plus cisplatin and 30% for vinorelbine alone). An adjusted log-rank test provided a significant advantage for vinorelbine plus cisplatin when compared with vindesine plus cisplatin (P = .04) and with vinorelbine alone (P = .02). The major difference in survival between the two cisplatin-containing regimens occurred in patients with metastatic (stage IV) NSCLC. The incidence of granulocytopenia was significantly higher in the vinorelbine plus cisplatin arm compared with the other two treatment groups, but neurotoxicity was significantly more frequent in the vindesine plus cisplatin group. The results of this study indicate that the combination of vinorelbine plus cisplatin is a viable treatment option for patients with NSCLC and may provide advantages compared with other commonly used regimens.