The development of docetaxel (Taxotere) in non-small cell lung cancer--docetaxel in new combinations and new schedules: an overview of ongoing and future developments.

Non-small cell lung cancer is the most common cause of cancer death in the western world. Non-small cell lung cancer is modestly sensitive to chemotherapy with a small survival benefit in locally advanced and metastatic disease. Newer agents such as docetaxel are yielding encouraging response rates both as single agents and in combination. A phase I/II study is in progress in our institution to determine the maximum tolerated dose and noncomparative efficacy of the combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France), ifosfamide, and cisplatin, with mesna and lenograstim support, in the treatment of patients with advanced non-small cell lung cancer. To date, nine patients have received 37 cycles of treatment at increasing dose levels (no intrapatient dose escalation). Treatment was administered to patients on an inpatient basis every 3 weeks, with lenograstim on days 3 to 10. Dose-limiting toxicity has not occurred at levels I to III (dose level III: docetaxel 75 mg/m2, cisplatin 75 mg/m2, and ifosfamide 3 g/m2). These preliminary results suggest that the combination of docetaxel, ifosfamide, and cisplatin, with lenograstim support, is well tolerated in the doses evaluated. Preliminary efficacy results show a response rate of 67% (six of nine patients). The study continues to determine the maximum tolerated dose of this regimen in preparation for a phase II evaluation.