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

Giannis Mountzios, Christos Emmanouilidis, Nikolaos Vardakis, Emmanouil Kontopodis, Dora Hatzidaki, Evagelos Popis, Niki Karachaliou, Athanassios Kotsakis, Maria Agelidou, Vassilis Georgoulias
Lung Cancer: Journal of the International Association for the Study of Lung Cancer 2012, 77 (1): 146-50

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/m(2), days 1, 8 and 15) along with bevacizumab (10mg 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.

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