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.

Background: Efficacy and safety data for cisplatin and pemetrexed plusbevacizumabinnon squamousnon non-small cell lung cancer (NSCLC) are stilllimited. Nevertheless, either bevacizumab plus platinum doublet or pemetrexedplus platinum is approved options for first line therapy. Predictive factorsfor bevacizumab are needed. KRAS isone of the most common oncogenic drivers in lung cancer. Its prognostic andpredictive value in NSCLC is under investigation. Patients and methods: Thistrial evaluates the addition of bevacizumab 7.5 mg/kg to cisplatin 75 mg/m2 plus pemetrexed 500 mg/m2 as first line treatment in stage IVnon-squamous NSCLC patients. Maintenance bevacizumab was received asmonotherapy until progressive disease, unacceptable toxicityor consent with drawal.The primary objective was progression free survival (PFS). Secondary objectivesincluded overall survival (OS), safety, global objective responses and thedetermination of KRAS mutation atbaseline. Results: From March 2009 to March2012, 31 patients were enrolled. Mean age was 59.19(standard deviation (SD) 8.53). From all the patients included in this trial,67.70% were men. KRAS was wild type in 19 patients (58.06%); in 7(22.58%) was mutated and was unknown in 6 patients (19.35%). Median PFS for KRAS mutated patients was 4 months, whereas for the KRAS wild type it was 7.9 months (P = 0.0031). Median OS was 4months for the KRAS population, and16.1 months for the KRAS wild type (P= 0.0032). Twenty four patients (77.42%) experienced at least a grade 3 - 4adverse event. The most common grade 3 - 4 toxicity was asthenia. Conclusions: BothPFS and OS were statistically longer for the KRAS wild type patients compared with the KRAS mutated population (P = 0.0031). Median OS was shorter than the reported in previous trials withbevacizumab. Nevertheless, focussing on the OS for KRAS wild type patients, this achieves a result or 16.1 months.Therefore, this would be a consistent data supporting to qualify this parameteras a predictive factor before starting treatment for NSCLC.