Phase II trial of docetaxel in Asian patients with inoperable stage III non-small cell lung cancer

Docetaxel has a response rate of greater than 30% in first-line treatment o f Western patients with advanced non-small cell lung cancer (NSCLC). The go al of this open-label, phase II study was to evaluate the activity and safe ty profile of docetaxel in Asian patients with inoperable untreated stage I II NSCLC. Docetaxel was given at 100 mg/m(2) as a l-h infusion every 3 week s. Prophylactic dexamethasone was given to reduce hypersensitivity reaction s and edema. Thirty-five patients were enrolled in the study. The response rate was 34% (95% CII 19%-50%,) according to intent-to-treat analysis. No c omplete response was observed. Twenty-four patients (69%) had grade 3 or 4 neutropenia in cycle 1, and febrile neutropenia was seen in 12 patients. Si x patients (17%) experienced mild fluid retention. Docetaxel is an active a gent in first-line treatment of Asian patients with locally advanced NSCLC, with the main toxicity being neutropenia. Fluid retention was a minor prob lem in this study.