Phase II trial of bevacizumab plus docetaxel in patients with previously treated nonsquamous non-small cell lung cancer.

Abstract

e18004 Background: The additional effects of bevacizumab (B) as first line chemotherapy for non-squamous (Nsq) non-small cell lung cancer (NSCLC) have been established. However, the efficacy of bevacizumab as a second- or more line chemotherapeutic agent has not been well examined. Docetaxel (D) is a standard second line treatment for NSCLC, a synergistic effect of the combination of D and B being shown in preclinical models. Therefore, this phase II study was conducted to evaluate the efficacy and safety of DB in patients with previously treated Nsq NSCLC. Methods: Patients with histologically or cytologically confirmed Nsq NSCLC, 20 to 74 years of age, ECOG performance status 0-2, with at least one prior chemotherapy, were eligible for the study. Patients were treated with D (60 mg/m²) and B (15 mg/kg) on day 1, repeated every 3 weeks until progressive disease (PD)or unacceptable toxicity occurred. The primary endpoint was the response rate (RR), and planned sample size was 28 patients. Results: Between May 2010 and July 2011, 28 patients (16 males/12 females; median age 65 years; PS 0/1/2: 19/9/0; ad/other: 22/6, no. of prior chemotherapy 1/2/3/4/5: 16/5/2/1/4) were enrolled in the study. Among these patients, 28 were included in analysis of toxicities and 27 patients were evaluated for response. Objective response was observed in 18 patients (PR; 18, SD; 8, PD 1), the response rate and disease control rate being 66.7% and 96%, respectively. With a median follow-up of 12.7 months, the median progression free survival was 7.9 months and overall survival did not reach median. Main toxicities of this regimen were myelosuppression (G3/4 neutropenia 85.7% and febrile neutropenia 21%). Mild non-hematological toxicity with no severe bleeding was also observed. Conclusions: The combination of D plus B is a very active regimen in previously treated Nsq NSCLC, warranting further study.