iRECIST iUPD — SCE Medical Oncology MCQ

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HardLung CanceriRECIST iUPDSCE Medical Oncology

A randomised immunotherapy trial has crossing progression-free-survival curves and strong evidence against proportional hazards. Which estimand provides a clinically interpretable, model-light summary if it was prespecified?

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Correct answer: D — Report prespecified restricted mean survival-time difference at a fixed horizon

A prespecified restricted mean survival-time difference compares average event-free time up to a fixed horizon and remains interpretable when proportional hazards fails. Report a prespecified weighted log-rank treatment effect at a fixed horizon: a weighted log-rank test gives a hypothesis test rather than the requested clinically interpretable time measure. Report a prespecified milestone-survival difference at a fixed horizon: milestone survival uses one time point and discards survival experience before it. Report a prespecified average hazard ratio over a fixed horizon: an average hazard ratio remains less directly interpretable when hazards cross. Report a prespecified time-varying hazard ratio over a fixed horizon: time-varying hazards describe relative instantaneous effects rather than average survival time gained.

Reference: Moving beyond the hazard ratio in quantifying between-group survival differences (Published July 2014): https://pubmed.ncbi.nlm.nih.gov/24982461/; NICE lung-cancer evidence review using restricted mean survival time under non-proportional hazards (Published with NICE NG122 in 2019): https://www.nice.org.uk/guidance/ng122/documents/evidence-review-3