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

Journal article
Authors Fredrik Bergh Thorén
H. Anderson
Örjan Strannegård
Published in Cancer Immunology Immunotherapy
Volume 62
Issue 10
Pages 1547-1551
ISSN 0340-7004
Publication year 2013
Published at Sahlgrenska Cancer Center
Institute of Biomedicine, Department of Infectious Medicine
Pages 1547-1551
Language en
Links dx.doi.org/10.1007/s00262-013-1458-...
Keywords Immunotherapy, Survival analysis, Kaplan-Meier, Treatment outcome, Late divergence, Statistical, RESISTANT PROSTATE-CANCER, RANDOMIZED PHASE-III, METASTATIC MELANOMA, CUTANEOUS MELANOMA, LOGRANK TEST, END-POINTS, FOLLOW-UP, VACCINE, VITESPEN, BLOCKADE
Subject categories Clinical Medicine

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.

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