1353 - Phase II Trial of Bevacizumab Plus Docetaxel in Patients with Previously Treated Non-Squamous Non-Small Cell Lung Cancer

Abstract

ABSTRACT Background The additional effects of bevacizumab (B) as a first line chemotherapy for non-squamous (Nsq) non-small cell lung cancer (NSCLC) have been established. However, its efficacy as a second line or higher chemotherapeutic agent is not sufficiently investigated. Docetaxel (D) is a standard second line therapy for NSCLC, and the synergistic effects of a combination of D and B (D + B) have been demonstrated in preclinical models. Therefore, this phase II study evaluated the efficacy and safety of D + B in patients with previously treated Nsq NSCLC. Methods Patients with histologically or cytologically confirmed Nsq NSCLC (20–74 years) with an Eastern Cooperative Oncology Group performance status (PS) of 0-2 and at least one prior course of chemotherapy were eligible for the study. Patients were treated with D (60 mg/m2) and B (15 mg/kg) on day 1, which was repeated every 3 weeks until progressive disease (PD) or unacceptable toxicity occurred. The primary endpoint was the response rate (RR). Results Between May 2010 and July 2011, 28 patients were enrolled in the study (16 males/12 females; median age, 65 years; PS, 0/1/2: 19/9/0; adeno/other: 22/6; number of prior chemotherapy regimens, 1/2/3/4/5: 16/5/2/1/4). Of these, 28 patients were included in the analysis of toxicities and 27 were evaluated for their response. An objective response was observed in 18 patients (partial response, 18; stable disease, 8; PD, 1). RR and disease control rate were 66.7% and 96%, respectively. After a median follow-up of 15.7 months, the median progression-free survival was 7.2 months and median overall survival was 16.7 months. The main toxicity observed was myelosuppression (grade 3/4 neutropenia, 85.7%; febrile neutropenia, 21%). Mild nonhematological toxicity with minimal bleeding was also observed. Conclusions A combination of D and B was highly active in patients with previously treated Nsq NSCLC; further study is warrented. Disclosure All authors have declared no conflicts of interest.