Docetaxel/Gemcitabine Effective in Advanced NSCLC

ORLANDO—Weekly docetaxel (Taxotere) combined with gemcitabine (Gemzar) is a useful doublet in circumstances in which a platinum-containing doublet is not desirable in the treatment of advanced non-small-cell lung cancer (NSCLC), according to the ACORN 9901 multicenter trial. Ravindrath Patel, MD, of the Comprehensive Blood and Cancer Institute, Bakersfield, California, presented the data at a poster session of the 38th Annual Meeting of the American Society of Clinical Oncology (abstract 1276).

The results apply to the subpopulation of patients unable to tolerate standard cisplatin (Platinol)-based chemotherapy. In this study, the docetaxel/gemcitabine doublet was compared with paclitaxel (Taxol)/gemcitabine, and offered an improved toxicity profile.

The randomized phase III study included 113 patients with advanced NSCLC, 94 of whom were evaluable. Two thirds of patients had stage IIIB disease, and one third had stage IV; two thirds were performance status (PS) 0-1 and one third were PS2. A greater than 5% weight loss was seen in 27%.

Patients were randomized to receive either docetaxel 40 mg/m² and gem-citabine 1,200 mg/m² on days 1 and 8 every 3 weeks or paclitaxel 120 mg/m² plus gemcitabine 1,200 mg/m² on days 1 and 8 every 3 weeks. The median number of cycles delivered was three in each treatment arm.

The docetaxel/gemcitabine arm proved more favorable in all response parameters, although the differences did not reach statistical significance. Objective responses were seen in 15 of 43 patients in the docetaxel/gemcitabine arm (30%) and 11 of 45 patients (23%) in the paclitaxel/gemcitabine arm. This included one complete response (2%) with docetaxel/gemcitabine and none in the other treatment arm, Dr. Patel reported.

He noted that more patients in the docetaxel/gemcitabine arm also had stable disease: 16 (32%) vs 12 (27%) with the paclitaxel/gemcitabine combination.

Patients taking paclitaxel had more frequent grade 4 neutropenia and grade 3-4 neurotoxicity. Toxicity grade 2 or greater was also more frequently seen with paclitaxel in terms of diarrhea, anemia, and stomatitis.

The study concluded that for patients in whom non-platinum-based chemotherapy is preferred, docetaxel plus gem-citabine is a good option. This regimen produced a higher response rate, higher percentage of patients with stable disease, and a better toxicity profile than paclitaxel plus gemcitabine because of its lower frequency of neuropathy, anemia, neutropenia, diarrhea, and stomatitis, Dr. Patel concluded.