Open AccessAdjusting for treatment crossover in the MAVORIC trial: survival in advanced mycosis fungoides and Sézary syndrome
Author(s) -
Neil Hawkins,
Noemi Muszbek,
Rachel Evans,
Pascale Dequen-O’Byrne,
Tarsha Jones,
L.K. McNamara
Publication year - 2022
Publication title -
journal of comparative effectiveness research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.567
H-Index - 23
eISSN - 2042-6313
pISSN - 2042-6305
DOI - 10.2217/cer-2022-0070
Subject(s) - vorinostat , medicine , mycosis fungoides , hazard ratio , oncology , crossover study , overall survival , clinical trial , randomized controlled trial , dermatology , lymphoma , confidence interval , pathology , biochemistry , chemistry , alternative medicine , histone deacetylase , gene , histone , placebo
Background: Relative overall survival (OS) estimates reported in the MAVORIC trial are potentially confounded by a high proportion of patients randomized to vorinostat switching to mogamulizumab; furthermore, vorinostat is not used in clinical practice in the UK. Methods: Three methods were considered for crossover adjustment. Survival post-crossover adjustment was compared with data from the Hospital Episode Statistics (HES) to contextualize estimates. Results: Following adjustment, the OS hazard ratio for mogamulizumab versus vorinostat was 0.42 (95% CI: 0.18, 0.98) using the method considered most appropriate based on an assessment of assumptions and comparison with HES. Conclusions: OS of mogamulizumab relative to vorinostat may be underestimated in MAVORIC due to the presence of crossover. The HES database was used to validate this adjustment.