Phase III randomized trial of docetaxel in combination with cisplatin or carboplatin or vinorelbine plus cisplatin in advanced non-small cell lung cancer: Interim analysis

In the TAX 326 trial, 1,220 chemotherapy-naive patients with advanced or metastatic non-small cell lung cancer have been randomized to receive one of three regimens: docetaxel 75 mg/m² plus cisplatin 75 mg/m² every 3 weeks; docetaxel 75 mg/m² plus carboplatin to an area under the curve of 6 mg/mL · min every 3 weeks; or a control arm of vinorelbine 25 mg/m² weekly plus cisplatin 100 mg/m² monthly. The treatment and toxicity data presented are based on a planned preliminary analysis conducted after 601 patients had been enrolled. The median age of patients randomized was 60 years and 73% were male. The majority of patients had a Karnofsky score of 80 or greater, two thirds had stage IV disease and 35% had three or more sites of organ involvement. While the relative dose intensity for docetaxel was 0.97 both when combined with cisplatin and when combined with carboplatin, the corresponding figure for vinorelbine was 0.68, reflecting the frequent need for dose reduction when combined with cisplatin on the schedule used. Hematologic toxicities were tolerable and comparable across the three arms of the trial, and the rate of febrile neutropenia was below 5% in all cases. The incidence of nonhematologic toxicities also was similar, although nausea and vomiting appeared to be less frequent among patients assigned to docetaxel plus carboplatin than among patients receiving comparator regimens.