Paclitaxel plus bevacizumab in patients with chemoresistant relapsed small cell lung cancer as salvage treatment: A phase II multicenter study of the Hellenic Oncology Research Group

Introduction Therapeutic options for patients with relapsed, chemo-resistant small-cell lung cancer (SCLC) are limited. Since paclitaxel has demonstrated single-agent activity in the second-line setting of SCLC and angiogenesis seems to play an important role in the pathogenesis of the disease, a phase II trial was conducted in order to evaluate the efficacy and the tolerance of their combination in patients with relapsed, chemo-resistant SCLC. Patients and methods Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2 who experienced relapse within 3 months after completion of 1st line chemotherapy for SCLC were eligible. Patients were treated with paclitaxel (90 mg/m2, days 1, 8 and 15) along with bevacizumab (10 mg per kg of body weight, days 1 and 15) in cycles of 28 days. Results Thirty patients (male/female: 27/3) with a median age of 64 years and ECOG performance status 0/1/2: 2/25/3 were enrolled. Nineteen patients (63.3%) had received at least two lines of prior treatment, 17 (56.7%) had undergone prior radiotherapy and nine (30%) had brain metastases at the time of study entry. The overall objective response rate was 20% (95% CI: 5.69–34.31%), including one complete remission, whereas the disease control rate was 36.7%. The median duration of response was 2.5 months (range, 1.5–5.7), the median progression-free survival 2.7 months (range, 0.5–9.2) and the median overall survival 6.3 months (range, 0.5–17.9). Grades 3 and 4 toxicities were limited in neutropenia, diarrhea and fatigue. There was one case of non-fatal pulmonary embolism. Conclusions The combination of paclitaxel with bevacizumab was feasible and active in this poor prognosis and heavily pretreated population of patients with advanced, chemoresistant SCLC, representing a valid therapeutic alternative which merits further evaluation.