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.
Original language | English (US) |
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Article number | e003323 |
Journal | Journal for immunotherapy of cancer |
Volume | 9 |
Issue number | 11 |
DOIs | |
State | Published - Nov 19 2021 |
Externally published | Yes |
Keywords
- biostatistics
- clinical trials as topic
- immunotherapy
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Molecular Medicine
- Oncology
- Pharmacology
- Cancer Research
MD Anderson CCSG core facilities
- Biostatistics Resource Group