Low dose carboplatin (AUC 4.5) combined with vinorelbine in the treatment of advanced non-small cell lung cancer: a single institution phase II study.

ABSTRACT

Platinum compounds and vinorelbine (VNB) are active in the treatment of non-small cell lung cancer (NSCLC), but moderate toxicity has been reported. The aims of the present study were to assess activity and tolerability of low dose carboplatin (CBDCA) 4.5 AUC according to Calvert formula on day 1, combined with vinorelbine 25 mg/m2 on days 1 and 8, administered every 4 weeks. Eighty-five advanced NSCLC patients entered the study; all of them were evaluable for toxicity and 83 were evaluable for activity. According to an intent to treat analysis, 26 patients attained a partial response (30.5%; 95% CI 20.5-40.5), 27 (31.7%) obtained a disease stabilization and 30 (35%) progressed. This regimen appeared to be modestly toxic, grade 3-4 leukopenia and thrombocytopenia were observed in less than 5% of cases and grade 2 neuropathy in 10% of cases. Median time to progression and overall survival were 7 and 9 months, respectively. In conclusion, low dose CBDCA (administered following Calvert's formula) and VNB combination is an active and very well tolerated cytotoxic regimen in the treatment of advanced NSCLC. The application of the Calvert formula may have contributed to limit the side effects related to CBDCA.