Paclitaxel (175 mg/m 2 ) plus carboplatin (6 AUC) versus paclitaxel (225 mg/m ) plus carboplatin (6 AUC) in advanced non-small-cell lung cancer (NSCLC): A multicenter randomized trial

Summary Purpose: The combination of paclitaxel and carboplatin has become a widely used regimen in NSCLC due to phase II reports of moderate toxicity, reasonable activity and easy out- patient administration. Purpose of our present prospective study was to evaluate the dose-response relationship of paclitaxel. Patients and methods: Since July 1996, 198 patients with non-operable NSCLC and measurable disease without pre- vious chemotherapy entered the trial. Ninety nine patients (group A) were randomized to receive paclitaxel 175 mg/m 2 in three-hour infusion plus carboplatin dosed to an area under the concentration-time curve of 6 every 3 weeks and 99 (group B) to receive the same regimen with paclitaxel increased to 225 mg/m 2 . Eligibility criteria included WHO performance status 0-2, documented inoperable stage IIIA and IIIB, IV, no brain metastasis, no prior chemotherapy and adequate renal and hepatic function. Patients in both groups were well-matched with baseline disease characteristics.