Baseline (BL) radiographic characteristics and severe pulmonary hemorrhage (SPH) in bevacizumab (BV)-treated non-small cell lung cancer (NSCLC) patients (pt): Results from ARIES, an observational cohort study (OCS).

Abstract

7619 Background: BV prolongs progression free and overall survival in advanced NSCLC pts. ARIES, a prospective OCS, evaluates BV clinical outcomes in a real world setting. Post hoc analyses from randomized controlled trials suggest location and cavitation as potential risk factors for SPH, a serious and often fatal adverse event (AE). ARIES presents a unique opportunity to independently evaluate BL tumor characteristics and correlate with SPH. Methods: Pts with advanced nonsquamous NSCLC on first-line chemotherapy and BV enrolled. No doses, regimens or assessments were prespecified. Data were collected electronically at BL and quarterly. SPH were reported expeditiously. BL CT scans were requested for all pts and reviewed by an independent review facility (IRF). Results: NSCLC enrollment completed 06/2009. As of 09/2009, 1,970 pts had median follow-up of 9.6 mo. The IRF reviewed BL scans of 1,881 pts; 1,470 (78%) had ≥ 1 BL measurable (meas) tumor (≥ 0.5cm) and 49% (718) were central; 67% had largest tumor size ≥ 3 cm; 14% had cavities and 10% had > 1 cavity. BL tumor characteristics were generally similar across subpopulations (age ≥ 70, PS ≥ 2, pts with CNS mets). Pts with a history (Hx) of hemoptysis (n = 105) had more centrally located tumors, fewer numbers of meas tumor, and larger cavity size. There are 15 (0.8%) reported SPH events to date; 2 pts had no BL CT scan submitted and 2 pts with BL scans had no meas tumor (1 had Hx of hemoptysis). Of the remaining 11 pts with SPH: 8 had central tumors; 1 had cavitation (1.2 cm); 0 were on anticoagulants at BL; largest tumor size ranged from 1.8-11.6cm. There was 1 SPH in pts with ≥ 1 cavity (0.5%) and 8 in pts with central tumors (1.1%). Conclusions: ARIES has the largest series of independently reviewed BL scans from advanced NSCLC pts, providing an opportunity to correlate radiographic factors with outcomes in BV treated pts. Although limited by small numbers, the data suggest that cavitation is not predictive of SPH. Correlation of BL radiographic characteristics with outcomes and risk factor analysis will be presented. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech, Infinity Pharma AstraZeneca, BIPI, Genentech, Merck Infinity Pharma, Roche Genentech