Phase II trial of docetaxel with dexamethasone premedication in patients with advanced non-small cell lung cancer: the Canadian experience

We performed a Phase II trial to evaluate the activity and tolerability of docetaxel as a single agent in the treatment of advanced non-small cell lun g cancer (NSCLC). Forty-four patients with metastatic and/or locally advanc ed NSCLC received i.v. docetaxel 100 mg/m(2) every 3 weeks for a median of 4 (range 1-11) cycles. All patients received premedication with oral dexame thasone 8 mg twice daily far 5 days starting the day before chemotherapy. S even partial responses were observed among 35 evaluable patients, and the o verall response rate was 20% (95% CI 8-37). The median response duration wa s 5 months, median survival time was 10 months and the estimated I-year sur vival rate was 42%. Treatment was generally well tolerated. Febrile neutrop enia occurred in 10 patients (23%); neutropenic infection occurred in 4 pat ients, and led to 2 toxic deaths (both patients had borderline exclusion cr iteria). The corticosteroid premedication effectively reduced the overall i ncidence (34%) and severity (4% severe) of fluid retention, and delayed the median time to onset from cycle 4 to cycle 7. This study shows the promisi ng efficacy of docetaxel as monotherapy in advanced NSCLC, and combination chemotherapy regimens incorporating docetaxel are now being evaluated in th is clinical setting.