Moving beyond conventional stratified analysis to assess the treatment effect in a comparative oncology study

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.

Automated summary

In a comparative oncology study, stratified analyses based on patients' baseline characteristics may not be valid or interpretable, especially in immunotherapy studies. This article presents alternative approaches using data from KEYNOTE-189 trial to address the limitations of conventional stratified analyses.