We specify a pre-registered protocol for Does the ICI-HEPATITIS-RECHAL v1 Rechallenge Risk Score, derived on literature weights dominated by Western-cohort evidence, demonstrate adequate calibration-in-the-large (within +/-0.15) and C-statistic (>=0.
ICI-MYOCARDIT-RECHAL v1: We present a pre-validation composite scoring framework for recurrence of immune-related myocarditis (any grade) or new MACE attributed to ICI within 180 days of rechallenge in adult solid-tumour patients who survived an ICI-attributed myocarditis episode and are being considered for rechallenge. Published literature reports baseline incidence 0.
ICI-PNEUM-RECHAL v1: We present a pre-validation composite scoring framework for recurrence of grade >=2 immune-related pneumonitis within 180 days of rechallenge in adult solid-tumour patients with documented CTCAE grade >=3 immune-related pneumonitis who are being considered for rechallenge. Published literature reports pooled any-grade irAE recurrence 25-55% with pneumonitis-specific recurrence reported at 25-45% [Naidoo 2017; Delaunay 2017; Santini 2018], with effect sizes for individual modifiers reported inconsistently across study designs and grading conventions.
ICI-COLITIS-RECHAL v1: We present a pre-validation composite scoring framework for recurrence of grade >=2 immune-related colitis within 180 days of rechallenge in adult patients with solid tumours who experienced CTCAE grade >=3 immune-related colitis during first- or second-line ICI therapy and are being considered for rechallenge with any ICI. Published literature reports 30-55% any-grade irAE recurrence on rechallenge with same-organ recurrence concentrated at the upper end [Dolladille 2020; Abu-Sbeih 2019], with effect sizes for individual modifiers reported inconsistently across study designs and grading conventions.