Safety of bevacizumab-based therapy as first-line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC): MO19390 (SAiL)

Abstract

8085 Background: MO19390 (SAiL) is an open-label single-arm trial evaluating the safety of first-line bevacizumab (Bev) combined with standard chemotherapy regimens, in some 2000 patients (pts) with NSCLC. As baseline brain scans were not required, pts with asymptomatic brain metastases (mets) could be recruited allowing preliminary analysis of Bev safety in pts diagnosed with CNS mets during the course of the study. Methods: The primary endpoint is safety. Eligibility criteria include; untreated, locally advanced, metastatic or recurrent non-squamous NSCLC; performance status (ECOG PS) 0–2. Pts with history of gross hemoptysis or evidence of tumor invading major blood vessels are ineligible. Pts receive a standard first-line chemotherapy regimen for up to 6 cycles combined with Bev, followed by Bev until disease progression. Results: Here we present preliminary data as documented in the EDC system (November 2007). Analyses are based on the safety population (pts who received ≥1 cycle of therapy; n=1065). Patient characteristics are: median age 60 years (range 24–83); male/female (%) 61/39; ECOG PS 0/1/2 (%) 39.9/53.3/6.8; adenocarcinoma/other (%) 83.8/15.7 (no data 26 pts); stage IIIb/IV (%) 20.2/79.8 (no data 4 pts); chemotherapy regimen: carboplatin doublets/cisplatin-doublets/non-platinum doublets/monotherapy (%) 48.2/40.0/1.2/2.7. 396 serious adverse events (SAEs) were reported, 64 (16%) Bev related: 207 in the Bev and chemotherapy phase and 29 in the Bev maintenance phase. 299 of these 396 SAEs (75.5%) have resolved or improved. CNS progression was observed in 12 pts (1.1%). No CNS hemorrhage was observed during treatment. Grade 3–4 hypertension was seen in 29 pts (2.7%). One patient diagnosed with brain mets after cessation of Bev had a CNS hemorrhage 26 weeks after the last dose. Conclusions: Preliminary analyses in >1000 pts confirm the well-characterized safety profile of Bev based therapy in the treatment of NSCLC, using a range of chemotherapy partners in a large patient population. There have been no cases of CNS hemorrhage associated with metastases under therapy to date. Updated results will be discussed. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly, Roche, sanofi-aventis Amgen, AstraZeneca Oncology, Eli Lilly, Roche, sanofi-aventis Roche Amgen, Eli Lilly, Roche, sanofi-aventis