Vinorelbine and carboplatin in inoperable non-small cell lung cancer: a monoinstitutional phase II study.

Chemotherapy regimens for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) provide typically palliation or limited symptom-free survival. We investigated the efficacy, in terms of response rate and time to progression, of a combination chemotherapy containing carboplatin and vinorelbine as a first-line treatment for inoperable NSCLC. Fifty-two consecutive patients with advanced NSCLC were treated with carboplatin AUC 6 according to Calvert's formula on day 1, combined with vinorelbine, 25 mg/m(2) on days 1 and 8. Therapy was given every 3 weeks. The median age was 66 years (range, 40-80); ECOG performance status was 0 in 20, 1 in 25 and 2 in 7 patients. According to an intent-to-treat analysis, response rate (partial and complete responses) in 52 assessable patients was 18/52 (34.6%; 95% confidence interval, 22-47%). In addition, 16 patients (30.8%) had stable disease and 18/52 (34.6%; 95% CI, 22-47%) progressed while on treatment. Median time to progression and overall survival were 7, 5 and 12.3 months, respectively. Grade 3/4 granulocytopenia was observed in 18/8 patients (34.6/15.4%). Grade 3/4 nadirs generally lasted no more than 7 days, and no neutropenic fever was reported. The treatment was generally very well tolerated: grade 1 or 2 nausea and vomiting was observed in 12 and 4 patients, respectively, and grade 2 neuropathy in 5% of cases. Statistical analysis did not highlight any significant differences in clinical benefit (partial and complete responses and stable disease), time to progression, or grade 3-4 hematologic and non-hematological toxicity according to age (<or=65 vs. >65 years). Carboplatin AUC 6 and vinorelbine was found to be an efficacious regimen as a first-line treatment for inoperable lung cancer patients and was also subjectively very well tolerated in aged patients. The regimen warrants further investigation in the emerging subgroup of aged patients in order to draw firm conclusions. Copyright 2003 S. Karger AG, Basel