A randomized trial of different docetaxel schedules in non-small cell lung cancer patients who failed previous...

Docetaxel has shown activity in the second-line treatment of non-small cell lung cancer (NSCLC). Phase II studies have suggested that weekly therapy with docetaxel probably has a better toxicity profile than the conventional schedule of once every 3 weeks. Our aim was to evaluate and compare the efficacy of different docetaxel schedules in NSCLC patients who did not respond to previous platinum-based chemotherapy.

National teaching hospital in Taiwan.

Treatment consisted of the following: (1) docetaxel, 35 mg/m(2) IV infusion (D(35)) on days 1, 8, and 15 every 4 weeks; (2) docetaxel, 40 mg/m(2) IV (D(40)) on days 1 and 8 every 3 weeks; and (3) docetaxel, 75 mg/m(2) IV (D(75)) on day 1 every 3 weeks. Patients were randomized at a ratio of 2:2:1, with the D(75) arm as the control arm. From 2002 to 2004, 161 patients were enrolled into the study.

The number of patients enrolled in each arm of the study was as follows: D(35) group, 64 patients; D(40) group, 64 patients; D(75) group, 33 patients. The mean ages of patients were as follows: D(35) group, 65 years of age; D(40) group, 63 years of age; D(75) group, 64 years of age. The median number of cycles of chemotherapy received in each group was as follows: D(35) group, 4; D(40) group, 3; D(75) group, 4. The objective response rates were as follows: D(35) group, 17.2%; D(40) group, 10.9%; D(75) group, 6.1% (p = 0.615). The major toxicity was myelosuppression. Grades 3/4 leukopenia and neutropenia were significantly higher in the D(75) arm of the study (p < 0.001). Drug-induced pneumonitis occurred more frequently in patients on a weekly schedule than in those on a schedule of every 3-weeks (p = 0.05). The median survival times were as follows: D(35) group, 8.4 months; D(40) group, 7.2 months; and D(75) group, 9.5 months (p = 0.855). The 1-year survival rates were 32.8%, 31.9%, and 28.7%, respectively. Lung cancer symptom scores showed no obvious differences among the different treatment arms, except for some minor items.

Weekly docetaxel chemotherapy produces less myelosuppression, and better compliance and response rates than the conventional chemotherapy administered every 3 weeks. These effects were more evident in the D(35) group weekly schedule than in the D(40) weekly schedule. However, physicians should pay more attention to the possibility of a higher frequency of docetaxel-induced pneumonitis in patients receiving treatment on the weekly schedule of treatment.