Phase II study of docetaxel and cisplatin administered as three consecutive weekly infusions for advanced non-small cell lung cancer

Weekly administration of low-dose taxane reduces myelosuppression and increases dose intensity as compared with an every third week schedule. We conducted a phase 11 trial of weekly docetaxel and cisplatin in patients with advanced non-small cell lung cancer (NSCLC) to evaluate safety and efficacy. Thirty-seven patients with chemonaive stage IIIB (n = 15), stage IV (n = 16), or recurrence after operation (n = 6) NSCLC received intravenous infusions of docetaxel at 35 mg/m(2) and cisplatin at 25 mg/m(2) for three consecutive weeks, followed by a week of rest. There were ten partial responses for an objective response rate of 30% (95% confidence interval (CI), 15-46%) in 33 evaluable patients and 27% (95% CI, 13-41%) in the intent-to-treatment population, The median survival was 12.8 months (range 2.5-17.1), and the 1-year survival was 54%. Hematologic toxicities, which were mild, included grade 4 neutropenia in 6%. There were none with febrile neutropenia or severe (grade 3-4) infections, and no septic deaths. The common nonhematologic toxicities included grade 2-3 nausea and vomiting (44%) and grade 2-3 diarrhea (14%). Consecutive weekly administrations of docetaxel and cisplatin for 3 weeks produces minimal myelosuppression and shows activity in the treatment of chemonaive patients with advanced NSCLC. A randomized phase III trial is warranted to compare this 3 consecutive weeks protocol with administration of docetaxel and cisplatin every third week. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.