Docetaxel Plus Cisplatin: An Active Combination Regimen in Non-Small-Cell Lung Cancer

Docetaxel (Taxotere) is a semisynthetic taxoid that possesses significant activity as a single agent in the treatment of patients with non-small-cell lung cancer. In patients with advanced non-small-cell lung cancer who had previously failed cisplatin (Platinol)-based chemotherapy, 100 mg/m² of docetaxel administered as an intravenous infusion over 1 hour, once every 3 weeks, produced a median response rate of 17% (of the intent-to-treat population) and median survival of 9 months. The present report describes the preliminary results from 3 phase II trials performed in the United States, France, and Australia, examining the combination of docetaxel and cisplatin in patients with advanced non-small-cell lung cancer. One trial (Australian) studied docetaxel administered as a 1-hour intravenous infusion followed by a 30-minute infusion of cisplatin on days 1, 22, and then every 3 weeks. The French and US trials administered docetaxel every 3 weeks, but gave cisplatin on days 1, 22, and then every 6 weeks. Major response rates ranged from 30% to 51% and median estimated survival ranged from 9 to 10.5 months. Based on the results of these trials, the recommended dose for future phase II and III trials in patients with advanced non-small-cell lung cancer is either 75 mg/m² of docetaxel and 75 mg/m² of cisplatin, or 65 mg/m² of docetaxel and 100 mg/m² of cisplatin, with docetaxel being administered once every 3 weeks and cisplatin on days 1, 22, and then every 6 weeks.