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Phase I/II Study of Vinorelbine, Mitomycin, and Cisplatin for Stage IIIB or IV Non–Small-Cell Lung Cancer

From the Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases; Division of Respiratory Oncology, National Cancer Center Hospital East, Chiba; Department of Respiratory Medicine, Osaka General Hospital, Osaka; Department of Internal Medicine, Prefectural Habikino Hospital, Osaka; and Department of Adult Health and Nursing, Faculty, Faculty of Medicine, University of Tokyo, Tokyo, Japan.

Address reprint requests to Kiyoyuki Furuse, MD, Division of Respiratory Diseases, Health Insurance Union Osaka Central Hospital, 3-3-17, Niwashirodai, Sakai, Osaka 590-0133 Japan; email ha7k-frs{at}asahi-net.or.jp

PURPOSE: To determine the maximum-tolerated doses (MTDs) of vinorelbine (VRB), mitomycin (MMC), and cisplatin (P), given in two courses every 28 days to previously untreated patients with stage IIIB or IV non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: At least three or four patients were entered at each dose level. The starting dose was 20 mg/m² for VRB on days 1 and 8 and 4 mg/m² for MMC on day 1, with a fixed dose of P 80 mg/m² on day 1 every 4 weeks. MMC was increased to 6 mg/m² at dose level 2 and subsequently to 8 mg/m² at dose level 4. At dose level 3, VRB was increased to 25 mg/m². Twenty-five patients were entered onto the phase I study and 19 patients were entered onto phase II study.

RESULTS: Nadir leukocyte and platelet counts decreased at each dose level. At dose levels 1 and 2, the dose-limiting toxicity (DLT) was not seen, but at dose levels 3 and 4, DLT was encountered in two patients. Nearly half the patients at dose level 4 had dose reduction due to grade 4 leukopenia. A mathematic model of all toxicity suggested that dose level 4 (VRB 25 mg/m² on days 1 and 8 and MMC 8 mg/m² and P 80 mg/m² on day 1, every 4 weeks) would be the recommended dose for phase II study at which grade 4 toxicity is expected in 25% of patients over two courses. Of the 25 assessable patients in the phase I study, 13 achieved a partial response and one had a complete response for a response rate of 56.0%. Of the 19 assessable patients in the phase II study, 12 had a partial response (63.2%; 95% confidence interval, 38.4% to 83.7%). Grade 3 and 4 leukopenia was observed in 19 (100%), and grade 3 thrombocytopenia was seen in seven (36.8%). Median survival time was 10.7 months and the 1-year survival rate was 43.2% in the 44 assessable patients.

CONCLUSION: The VRB/MMC/P regimen is effective against NSCLC, and its efficacy should be confirmed through a randomized study.

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