Phase 2 Study of Carboplatin, Docetaxel, and Bevacizumab as Frontline Treatment for Advanced Nonsmall-Cell Lung Cancer

BACKGROUND: Bevacizumab has recently been demonstrated to prolong overall survival when added to carboplatin and paclitaxel for chemotherapy-naive patients with nonsquamous nonsmall-cell lung cancer (NSCLC) However, the effects of combining bevacizumab with other standard, front-line, platinum-based doublets have not been extensively explored We designed this single treatment arm, phase 2 trial to determine whether the combination of carboplatin, docetaxel, and bevacizumab is tolerable and prolongs progression-free survival of chemotherapy-naive patients with advanced, nonsquamous NSCLC METHODS: Forty patients were treated with up to 6 cycles of carboplatin (AUC 6), docetaxel (75 mg/m(2)), and bevacizumab (15 mg/kg) on Day 1 every 21 days Patients with an objective response or stable disease received maintenance bevacizumab (15 mg/kg) every 21 days until disease progression The primary endpoint was median progression-free survival. Secondary endpoints included safety, response rates, and overall survival RESULTS: The median number of chemotherapy and maintenance bevacizumab cycles/patient was 6 and 2, respectively Grades 3-5 adverse events included febrile granulocytopenia (10%), infections (13%). bleeding (13%), thrombotic events (13%), hypertension (5%), bowel perforation (5%), and proteinuria (3%) Median progression-free survival was 79 months and median overall survival was 165 months Partial responses were observed in 21 patients (53%), and stable disease >= 6 weeks occurred in another 17 patients (43%), for a disease control rate of 95% CONCLUSIONS: Carboplatin, docetaxel, and bevacizumab were feasible and effective for front-line treatment of advanced, nonsquamous NSCLC These data provide further evidence that bevacizumab may be used in combination with multiple standard, platinum-based doublets in this setting Cancer 2010;116.2401-8. (C) 2010 American Cancer Society