Phase II trial of weekly docetaxel in second-line therapy for nonsmall cell lung carcinoma.

Background: The authors conducted a Phase II study to evaluate the activity and toxicity of weekly docetaxel in second-line therapy for nonsmall cell lung carcinoma (NSCLC).

Methods: Patients with documented recurrent or refractory NSCLC, previously treated with no more than one chemotherapy regimen, were eligible if they had a performance status (PS) of 0-2, measurable or evaluable disease, and adequate organ function. Patients were treated with docetaxel 36 mg/m(2)/week for 6 consecutive weeks, administered intravenously with dexamethasone premedication. Cycles were repeated every 8 weeks.

Results: Thirty-one patients were enrolled. One patient was ineligible because of uncontrolled brain metastases. Hematologic toxicity was minimal. Nonhematologic toxicities were modest except for diarrhea and cumulative fatigue. There were no treatment-related deaths. The overall response rate was 10% (95% confidence interval [CI], 1.6-29%). The median survival time (MST) was 8.0 months. and the 1-year survival rate was 31% (95% CI, 17- 58%). Patients with PS 0-1 had a MST of 11.9 months with 1-year survival of 42%.

Conclusions: Weekly docetaxel is very well tolerated as second-line therapy for NSCLC. The activity of this regimen appears to be comparable to the standard 3-week schedule. This regimen offers new opportunities for combination regimens, both as first- and second-line therapy for NSCLC.