Bevacizumab has recently been demonstrated to prolong overall survival when added to carboplatin and paclitaxel for chemotherapy−naïve 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−naïve patients with advanced, nonsquamous NSCLC.

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.

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 7.9 months and median overall survival was 16.5 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%.

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. © 2010 American Cancer Society.

PMID: 20225327 [PubMed − as supplied by publisher] Source: National Library of Medicine.