A phase II multicentre study, performed by the Hellenic Oncology Research Group, shows a combination of paclitaxel and bevacizumab is feasible and active in poor prognosis population of heavily pre-treated patients with advanced, chemo-resistant small-cell lung cancer (SCLC). The results merit further evaluation according to Dr Giannis Mountzios of the Medical Oncology Department, Airforce General Hopsital, Athens, Greece, who presented results in a general poster session at the 4th European Lung Cancer Conference (26-29 March 2014, Geneva, Switzerland). Other researchers involved in the study are from Department of Medical Oncology, University of Crete School of Medicine, Heraklion, Greece.
Therapeutic options for patients with relapsed, chemo-resistant SCLC are limited. Since paclitaxel has demonstrated a single-agent activity in the second-line setting of SCLC and angiogenesis seems to play an important role in the pathogenesis of the disease, this phase II trial was conducted to evaluate the efficacy and tolerance of paclitaxel/bevacizumab combination therapy in patients with relapsed, chemo-resistant disease.
Phase II study in chemoresistant patients
Patient eligibility required performance status (PS) 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG). Furthermore, the patients were eligible for enrolment if they had experienced relapse within three months after completion of first-line chemotherapy for SCLC.
All 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.
In total, 30 patients were enrolled; 27 men and 3 women. Median age was 64 years. There were two patients with ECOG PS 0, 25 with PS 1, and three with PS 2. At least two lines of prior treatment were delivered in 19 patients (63.3%), 17 (56.7%) patients had undergone prior radiotherapy and nine patients (30%) had brain metastases at the time of entry into study.
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 months), the median progression-free survival 2.7 months (range: 0.5 – 9.2 months) and the median overall survival 6.3 months (range: 0.5 – 17.9 months).
Grade 3 and 4 toxicities were limited to neutropenia, diarrhoea and fatigue. There was one case of non-fatal pulmonary embolism.
The authors concluded that the combination of paclitaxel and bevacizumab is feasible and active and merits further evaluation.
Other researchers involved in the study are from the Department of Medical Oncology, University of Crete School of Medicine, Heraklion, Greece.
Abstract 68p: 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.
All authors have declared no conflicts of interest.
The European Lung Cancer Conference (ELCC) is organised by the European Society for Medical Oncology (ESMO) and the International Association for the Study of Lung Cancer (IASLC). During the four-day programme, attendees benefit from educational and scientific updates provided by thoracic oncology specialists on different multidisciplinary topics important for research and clinical practice in the field of lung cancer.