Combination of vinorelbine, cisplatin, and etoposide in advanced non-small cell lung carcinoma: a pilot study.

The combination of vinorelbine (VNR), cisplatin (CDDP) and etoposide (VP16) was reported to obtain major responses in more than 40% of patients with advanced non-small cell lung carcinoma (NSCLC). However, optimal dosages and schedule of the three drugs has remained unsettled. This trial was carried out to further assess the activity and toxicity of this regimen. We treated 19 patients (all males) affected by NSCLC, with a median age of 62 years and a median ECOG performance status of 1. Eleven of them had locally advanced disease and 8 showed distant metastases. The dose of CDDP was 30 mg/m2 i.v., while VP16 was given at 80 mg/m2 i.v. Both drugs were administered for 3 consecutive days every 3 weeks. The first 7 patients also received VNR 25 mg/m2 i.v. on days 1 and 8, while in the subsequent 12 cases VNR was administered at 30 mg/m2 i.v. on day 1. An overall activity of 42% (95% confidence limits, 20%-66%) was observed among treated patients, with no significant differences related to stage or histology. The dose limiting toxicity was essentially a grade 3-4 neutropenia occurring during treatment in 50% of patients, regardless of schedule employed. The actual median dose intensity of VNR was 13 mg/m2/wk (78% of the planned one) in the first 7 patients, and 9 mg/m2/wk (90% of the ideal one) in the following 12 patients. Though eight patients are still alive from 18+ to 29+ weeks at the time of this analysis, the overall median survival time was only 25 weeks. Our results support the high activity of this three-drug regimen in advanced NSCLC. However, the actual impact of this treatment on survival of patients should be defined with randomized trials.