Opinion Paper

Cancer Immunology, Immunotherapy

, Volume 62, Issue 10, pp 1547-1551

First online:

Late divergence of survival curves in cancer immunotherapy trials: interpretation and implications

  • Fredrik B. ThorénAffiliated withSahlgrenska Cancer Center, University of GothenburgDepartment of Infectious Diseases, University of Gothenburg Email author 
  • , Harald AndersonAffiliated withDepartment of Cancer Epidemiology, University of Lund
  • , Örjan StrannegårdAffiliated withDepartment of Infectious Diseases, University of Gothenburg

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Abstract

Late divergence of survival curves of treated patients and controls is commonly seen in successful cancer immunotherapy trials. Although late survival curve divergence may be caused by a delayed action of therapy, it may also be related to early effects of the treatment. We suggest that late survival divergence most often reflects a specific benefit of therapy for patients who suffer from a comparatively slow progression of disease. The occurrence of delayed survival curve divergence has important implications for the statistical analysis of immunotherapy trials. Thus, it leads to non-proportional hazard ratios that make commonly used statistical tests, e.g., the logrank test, suboptimal. It is therefore suggested that the statistical analysis of immunotherapy trials primarily should be based on a test that compares the survival curves at or after a prespecified, fixed, late time point.

Keywords

Immunotherapy Survival analysis Kaplan–Meier Treatment outcome Late divergence Statistical models