Dose‐dense vinorelbine and docetaxel with Filgrastim support in patients with advanced nonsmall cell lung carcinoma

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/m 2 followed by docetaxel 60 mg/m 2 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. Cancer 2005. © 2005 American Cancer Society.