In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 17, No. 10 ( 1999-10), p. 3195-3200
Abstract:
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/m 2 for VRB on days 1 and 8 and 4 mg/m 2 for MMC on day 1, with a fixed dose of P 80 mg/m 2 on day 1 every 4 weeks. MMC was increased to 6 mg/m 2 at dose level 2 and subsequently to 8 mg/m 2 at dose level 4. At dose level 3, VRB was increased to 25 mg/m 2 . 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/m 2 on days 1 and 8 and MMC 8 mg/m 2 and P 80 mg/m 2 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.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.1999.17.10.3195
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
1999
detail.hit.zdb_id:
2005181-5
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