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

Docetaxel is an active agent used in the treatment of non-small cell lung cancer (NSCLC).

A phase II trial of single-agent docetaxel chemotherapy was conducted in Chinese patients with NSCLC, as either a first- or second-line treatment, to assess response and toxicity. The treatment scheme was docetaxel 75 mg/m2 intravenous infusion for 1 h every 3 weeks for up to nine cycles. Dexamethasone was routinely given for 3 days, beginning 1 day before chemotherapy.

From August 1996 to December 1997, 48 patients were enrolled, including 34 chemo-naive patients and 14 patients previously treated with one chemotherapeutic regimen. All patients were evaluable for toxicity profiles and 47 patients were evaluable for response rate. As expected, the major toxicity was myelosuppression. Grade 3 or 4 neutropenia occurred in 41 of 48 (85.5%) patients during treatment. Twenty patients (41.7%) experienced febrile neutropenia and accounted for two toxic deaths. Only one patient suffered from grade 3 thrombocytopenia and two patients from grade 3 anemia. Moderate or severe asthenia occurred in 30 patients (62.5%). Moderate fluid retention (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 patients attained a partial response (29.8%, 95% CI 16.7-42.9%), including 30.3% (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 progression was 13 weeks in first-line patients and 19 weeks in second-line patients. Median survival time was 7.1 and 11.7 months in first- and second-line patients, respectively.

Docetaxel is active and has an acceptable toxicity profile, in both first- and second-line treatments, in Chinese patients with inoperable NSCLC.