Clinical Course Of Advanced Non-Small Cell Lung Cancer (Nsclc) Patients (Pts) Experiencing Hypertension (Htn) During Treatment (Tx) With Bevacizumab (B) In Combination With Carboplatin (C) And Paclitaxel (P) On E4599

8042 Background: B is a monoclonal antibody that targets VEGF with demonstrated efficacy in combination with PC for the TX of advanced NSCLC. Administration of B is thought to decrease nitrous oxide synthesis and lead to HTN, one of the known toxicities associated with PCB on E4599. This side effect may be a physiological sign that the VEGF pathway is more actively being blocked and indicate differential outcomes between hypertensive and non-hypertensive pts. Methods: Pts randomized to PCB constituted the cohort. Hypertensive pts (HTN of any grade or TX relation reported via a toxicity form, CTCAE v2) were compared to nonhypertensive pts with respect to baseline pt characteristics, overall survival (OS) and progression-free survival (PFS). Blood pressure (BP) data were also collected at each TX cycle; similar comparisons were made for high BP (>150/100). Results: In E4599, 33/417 (7.9%) eligible pts experienced HTN; 30/33 (90.9%) were grade 3 events. Baseline characteristics of the HTN cohort were similar to those in the non-HTN cohort except for a higher proportion of PS 0 pts (70% vs. 38%, p=0.001) and females (67% vs. 48%, p=0.05). Median follow-up was 54.8 mos. The 6-month cumulative incidence of HTN adjusting for death as a competing risk was 6.2% (95% CI: 3.9–8.6%). Landmark analyses measured from the median time to onset of HTN (1.9 mo) suggested higher OS for the HTN pts (14.0 vs. 11.3 mo) as well as higher PFS (8.0 vs. 4.5 mo) although these comparisons did not reach statistical significance. Proportional hazards models for OS and PFS adjusting for HTN as a time-varying covariate resulted in an OS HR=0.64 (0.43–0.96, p=0.03) and PFS HR=0.83 (0.57–1.20, p=0.32). The same modeling adjusting for high BP (>150/100) as a time-varying covariate resulted in OS HR=0.60 (0.44–0.82, p=0.002) and PFS HR=0.71 (0.54–0.95, p=0.02). Results for high BP remained statistically significant after adjusting for sex, PS, histology, adrenal, liver and bone mets. Conclusions: Data from E4599 suggest that onset of HTN during TX with PCB may be associated with improved OS and PFS. Further studies of the downstream effects of VEGF suppression and HTN are needed. [Table: see text]