A phase II study of a daily x4 schedule of vinorelbine plus cisplatin for advanced non-small cell lung cancer

Background: Because dose intensity may be important as a determinant respon se to vinorelbine, we explored the possibility of increasing the dose inten sity of vinorelbine on a daily x4 schedule. Methods: Between February 1998 and March 1999, 31 patients with previously untreated advanced non-small cell lung cancer were enrolled. Vinorelbine 15 mg/m(2) and cisplatin 20 mg/m(2) were administered intravenously daily for 4 days and repeated every 21 days. Results: A total 96 cycles were administered (median 3, range 1-6); 42% of vinorelbine and 39% of cisplatin injections were dose-reduced or delayed ow ing to toxicity. The actual dose intensity (DI) of vinorelbine was 17.7 mg/ m(2)/week and that of cisplatin was 24 mg/m(2)/week. These figures represen t 88 and 90% of the theoretical DI, respectively. The overall response rate was 40% (12/30, one CR). The main toxicity was myelosuppression: granulocy topenia WHO grade 3 and 4 in 24 patients (77%) and thrombocytopenia grade 3 in two patients (6%). The non-hematological toxicity was mild and tolerabl e. After a median follow-up of 7.5 months (range 3-21 months), the median p rogression-free survival and overall survival times were 5 months (95% CI, 3.8-6.2) and 8 months (95% CI, 4.5-11.5), respectively. Conclusions: This regimen has a comparable therapeutic activity in patients with advanced lung cancers. However, despite supportive care there were ex cessive hematological toxicities. In view of increased toxicity and similar efficacy, this regimen is not indicated outside a clinical trial.