Final results of a phase II study of bevacizumab, cisplatin and pemetrexed as first-line therapy for patients with advanced non squamous non small cell lung cancer.

e19036 Background: Both pemetrexed-cisplatin and bevacizumab-based therapy are treatment options for patients with advanced non-squamous NSCLC. The objective of this study was to explore efficacy and safety of first-line pemetrexed-cisplatin plus bevacizumab followed by maintenance bevacizumab in a sample of Spanish patients, and also study the K-Ras and VEGF status. Methods: Patients (N = 31) with previously untreated advanced non-squamous NSCLC were enrolled. PFS and OS were assessed by Kaplan-Meier curves and analyzed using the log-rank test and Cox proportional hazards model. K-RAS mutational status was determined at the beginning of the study. VEGF levels were assessed before 1st cycle and every 2 cycles thereafter until progression. Patients received bevacizumab 7.5 mg/kg, cisplatin 75 mg/m2 and pemetrexed 500 mg/ m2, given on day 1 each 21-days up to 6 cycles followed by maintenance bevacizumab. Results: By March 2012, 31 patients were enrolled. Median age was 59 years (range: 42–74); 67.7% were men and 32.3% women; ECOG status was 0 in 16.1% and 1 in 83.9%. All patients had metastatic disease (most common sites were lung: 64.5%, bone: 51.8% and liver: 41.9%). 58.06% patients were KRAS wild type, 22.58% KRAS positive, and 19.35% had an unknown result. Median PFS was 7.2 months and median OS was 11.3 months. Partial response was achieved by 48.4% of patients and a further 25.8% had stable disease (disease control rate was 74.2%). Twenty four patients (77.4%) experienced at least a grade 3-4 AE. The most common grade ≥ 3 bevacizumab-related AEs were: Hypertension 9.7%, pulmonary embolism (9.7%) and deep vein thrombosis (9.7%). Conclusions: In this trial, patients treated in first-line with pemetrexed-cisplatin plus bevacizumab shown and acceptable benefit in PFS and OS. Also good disease control rate was achieved in high percentage of patients despite a poor prognosis population (high percentage of patients with liver and bone metastases).The safety profile of the treatment was consistent with the known toxicities of each of the three agents. Clinical trial information: 2008-006145-13.