1. Moving beyond conventional stratified analysis to assess the treatment effect in a comparative oncology study.
- Author
-
Sun R, McCaw Z, Tian L, Uno H, Hong F, Kim DH, and Wei LJ
- Subjects
- Humans, Clinical Trials as Topic methods, Immunotherapy methods, Medical Oncology methods
- Abstract
In a comparative oncology study with progression-free or overall survival as the endpoint, the primary or key secondary analysis is routinely stratified by patients' baseline characteristics when evaluating the treatment difference. The validity of a conventional strategy such as a stratified HR analysis depends on stringent model assumptions that are unlikely to be met in practice, especially in immunotherapy studies. Thus, the resulting summary is generally neither valid nor interpretable. This article discusses issues with conventional stratified analyses and presents alternatives using data from KEYNOTE-189, a recent immunotherapy trial for treating patients with metastatic, non-squamous, non-small-cell lung cancer., Competing Interests: Competing interests: There are no competing interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2021
- Full Text
- View/download PDF