A phase II study of single-agent docetaxel chemotherapy for nonsmall cell lung cancer

Background: Docetaxel is an active agent used in the treatment of non-small cell lung cancer (NSCLC). Methods: A phase II trial of single-agent docetaxel chemotherapy was conduc ted in Chinese patients with NSCLC, as either a first- or second-line treat ment, to assess response and toxicity. The treatment scheme was docetaxel 7 5 mg/m(2) intravenous infusion for 1 h every 3 weeks for up to nine cycles. Dexamethasone was routinely given for 3 days, beginning I day before chemo therapy. Results: From August 1996 to December 1997, 48 patients were enrolled, incl uding 34 chemo-naive patients and 14 patients previously treated with one c hemotherapeutic regimen, All patients were evaluable for toxicity profiles and 47 patients were evaluable for response rate. As expected, the major to xicity was myelosuppression. Grade 3 or 4 neutropenia occurred in 41 of 48 (85.5%) patients during treatment. Twenty patients (41.7%) experienced febr ile neutropenia and accounted for two toxic deaths. Only one patient suffer ed from grade 3 thrombocytopenia and two patients from grade 3 anemia. Mode rate or severe asthenia occurred in 30 patients (62.5%). Moderate fluid ret ention (peripheral edema) was observed in five patients (10.4%) and severe fluid retention in three; all were reversible. No grade 3 or 4 neurosensory toxicity was observed. After two cycles of treatment, 14 of 47 evaluable p atients attained a partial response (29.8%, 95% CI 16.7-42.9%), including 3 0.3% (95% CI 14.6-46%) of those in first-line treatment and 28.6% (95% CI 4 .9-52.3%) of those in second-line treatment. The median time to disease pro gression was 13 weeks in first-fine patients and 19 weeks in second-line pa tients. Median survival time was 7.1 and 11.7 months in first- and second-l ine patients, respectively. Conclusion: Docetaxel is active and has an acceptable toxicity profile, in both first- and second-line treatments, in Chinese patients with inoperable NSCLC.