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
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
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