ABSTRACT
BACKGROUND: Vinorelbine and docetaxel are active single agents in the treatment of nonsmall cell lung carcinoma (NSCLC) and may provide enhanced activity when combined in a dose-dense fashion. The efficacy and safety of this combination was assessed when it was administered every 14 days with Filgrastim support in a community practice setting. METHODS: This open-label study was conducted at 12 community oncology practices in the United States. Sixty-one chemotherapy-naive patients with Stage IIIB/IV NSCLC received vinorelbine 45 mg/m2 followed by docetaxel 60 mg/m2 on Day 1 and Filgrastim 5 mcg/kg beginning on Day 2, with cycles repeated every 14 days. RESULTS: Among 61 enrolled patients, 44% of patients had either a complete or partial response as their best response, and 27% of patients had confirmed complete or partial responses. The median time to confirmed response was 1.9 months (95% confidence interval [95% CI], 0.9-2.3 mos), and the median duration of confirmed response was 6.0 months (95% CI, 3.1-14.4 mos). The median time to disease progression was 4.9 months (95% CI, 3.8-5.8 mos). With a median follow-up of 14.3 months, the median survival was 12.9 months (95% CI, 8.1-14.3 mos), and the 1-year survival rate was 56% (95% CI, 43-69%). The relative dose intensity was 94% for vinorelbine and 93% for docetaxel. Febrile neutropenia occurred in 9 patients (15%) and during 9 of 351 cycles (3%). CONCLUSIONS: It was possible to administer dose-dense vinorelbine and docetaxel chemotherapy with Filgrastim support, beginning in the first cycle, to patients with NSCLC who were treated in a community practice setting.
