In a large, multinational, randomized phase III trial, 1,220 patients with advanced and/or metastatic non-small cell lung cancer were randomized to receive one of three treatments: docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 every 3 weeks; docetaxel 75 mg/m2 plus carboplatin to an AUC of 6 every 3 weeks; or a standard reference arm of vinorelbine given at 25 mg/m2 on days 1, 8, 15, and 22 plus cisplatin 100 mg/m2 on day 1 every 4 weeks. The choice of treatment and dose was based on a series of four phase II studies that indicated the combination of docetaxel (75 to 100 mg/m2) and cisplatin (75 to 100 mg/m2) was active and feasible; carboplatin may have a more favorable therapeutic index than cisplatin, particularly with regard to nonhematologic toxicities, and had proven activity in combination with docetaxel in phase II study; and randomized studies had shown the combination of vinorelbine plus cisplatin was superior to either vinorelbine alone or cisplatin alone and was considered as a reference study regimen in the clinical setting upon initiation of this phase III study. Preliminary results of the phase III trial showed that the overall survival among patients randomized to receive docetaxel plus cisplatin was significantly better than that among patients treated with vinorelbine/cisplatin and similar between the docetaxel plus carboplatin versus control arm. The three arms were similar for toxicity data, except the use of vinorelbine plus cisplatin was associated with a significantly greater incidence of grade 3/4 anemia and nausea and vomiting than use of docetaxel plus either cisplatin or carboplatin.
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