Open AccessA Systematic Review and Meta-Analysis of Bevacizumab in First-Line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises
Author(s) -
Spencer Phillips Hey,
Bishal Gyawali,
Elvira D’Andrea,
Manoj Kanagaraj,
Jessica M. Franklin,
Aaron S. Kesselheim
Publication year - 2019
Publication title -
journal of the national cancer institute
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.797
H-Index - 356
eISSN - 1460-2105
pISSN - 0027-8874
DOI - 10.1093/jnci/djz211
Subject(s) - bevacizumab , medicine , hazard ratio , oncology , metastatic breast cancer , meta analysis , proportional hazards model , clinical trial , breast cancer , progression free survival , cancer , confidence interval , overall survival , chemotherapy
The US Food and Drug Administration's accelerated approval and later withdrawal of bevacizumab in patients with metastatic breast cancer (mBC) is a seminal case for ongoing debates about the validity of using progression-free survival (PFS) as a surrogate measure for overall survival (OS) in cancer drug approvals. We systematically reviewed and meta-analyzed the evidence around bevacizumab's regulatory approval and withdrawal in mBC.