Abstract
4104 Background: Neuroendocrine tumors (NETs) are a rare and heterogeneous class of neoplasms. They frequently metastasize to the liver and have a unique hypervascular appearance, making this class of tumors an interesting target for angiogenesis inhibition. Methods: Patients (pts) with biopsy proven metastatic or unresectable neuroendocrine tumors received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 850 mg/m2 twice daily by mouth on days 1-14 on a 21-day cycle. Pts with stable disease (SD) or partial response (PR) were allowed to continue therapy with bevacizumab with or without capecitabine. Primary endpoints were progression free survival (PFS) and toxicity; secondary endpoints were overall survival (OS) and response rate by RECIST. Results: Between December 2006 and October 2009, 40 pts enrolled, 31 pts are available for response assessment, 6 patients came off study prior to their first tumor assessment, and 3 others are not yet evaluable for response. At a median follow-up of 11.4 months, 11 pts are still on study. Baseline characteristics were: M:F = 22:18, median age = 55 (range 32-76), primary site = pancreas (20), small intestine (5) and unknown/other (15). Pathology was reviewed on 37 pt samples; Ki67 > 20% (n = 7) and 0-20% (n = 30). PRs were observed in 7 pts (23%), SD in 22 pts (71%), and progressive disease (PD) in 2 pts (6%). Of the pts who achieved a PR, 6 had pancreatic NETs and one had an unknown primary with liver involvement. The 1-year PFS is 52% and median PFS is 13.7 months. The treatment was well-tolerated. A discovery panel of 15 biomarkers was evaluated at baseline and cycle 4 in 22 patients. Serum levels of CHI3L1 (YKL-40) drawn at baseline correlated with PFS and OS (HR 1.64 and 1.98 respectively; p < 0.05 [not adjusted for multiple comparisons]). VEGF levels increased on average 1.5 fold over 4 cycles of therapy (0.5-9.7 fold ± 2.4). Conclusions: The combination of capecitabine, oxaliplatin and bevacizumab in metastatic or unresectable neuroendocrine tumors is well tolerated and shows promising efficacy. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech/Roche, sanofi-aventis
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call