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- Title
Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with FOLFOX and Bevacizumab for First-Line Metastatic Colorectal Cancer.
- Authors
García‐Carbonero, Rocío; van Cutsem, Eric; Rivera, Fernando; Jassem, Jacek; Gore, Ira; Tebbutt, Niall; Braiteh, Fadi; Argiles, Guillem; Wainberg, Zev A.; Funke, Roel; Anderson, Maria; McCall, Bruce; Stroh, Mark; Wakshull, Eric; Hegde, Priti; Ye, Weilan; Chen, Daniel; Chang, Ilsung; Rhee, Ina; Hurwitz, Herbert
- Abstract
Background. EGFL7 (epidermal growth factor-like domain 7) is a tumor-enriched vascular extracellular matrix protein that supports endothelial cell survival. This phase II trial evaluated the efficacy of parsatuzumab (also known as MEGF0444A), a humanized anti-EGFL7 IgG1 monoclonal antibody, in combination with modified FOLFOX6 (mFOLFOX6) (folinic acid, 5-fluorouracil, and oxaliplatin) bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC). Methods. One-hundred twenty-seven patients were randomly assigned to parsatuzumab, 400 mg, or placebo, in combination with mFOLFOX6 plus bevacizumab, 5 mg/kg. Treatment cycles were repeated every 2 weeks until disease progression or unacceptable toxicity for a maximum of 24 months, with the exception of oxaliplatin, which was administered for up to 8 cycles. Results. The progression-free survival (PFS) hazard ratio was 1.17 (95% confidence interval [CI], 0.71-1.93; p=.548). The median PFS was 12 months for the experimental arm versus 11.9months for the control arm.The hazard ratio for overall survival was 0.97 (95% CI, 0.46-2.1; p=.943). The overall response rate was 59% in the parsatuzumab arm and 64% in the placebo arm.The adverse event profile was similar in both arms. Conclusions. There was no evidence of efficacy for the addition of parsatuzumab to the combination of bevacizumab and chemotherapy for first-line mCRC.
- Subjects
CANCER chemotherapy; COMBINATION drug therapy; CLINICAL trials; COLON tumors; CONFIDENCE intervals; METASTASIS; MONOCLONAL antibodies; NEOVASCULARIZATION inhibitors; PLACEBOS; RECTUM tumors; RESEARCH; RANDOMIZED controlled trials; PROPORTIONAL hazards models; DATA analysis software; DESCRIPTIVE statistics; KAPLAN-Meier estimator
- Publication
Oncologist, 2017, Vol 22, Issue 4, p375
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2016-0133