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Composite Endpoints — SCE Medical Oncology MCQ

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ModerateClinical Trials & StatisticsComposite EndpointsSCE Medical Oncology

A clinical trial uses a composite primary endpoint of 'event-free survival (EFS)' in early breast cancer. EFS includes: invasive ipsilateral recurrence, regional recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast cancer and death from any cause. What is the advantage and limitation of composite endpoints?

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Correct answer: E — Composite endpoints increase event rates (improving statistical power and feasibility) but may dilute clinically meaningful signals if components have different importance — interpretation requires understanding which component events drive the result

Composite endpoints (EFS, DFS, IDFS) combine multiple event types to increase event rates, enabling smaller trials or shorter follow-up to reach statistical significance. However, not all components may be equally clinically relevant (e.g. contralateral breast cancer or second primary may be less treatment-related than ipsilateral recurrence). Trial reporting should present: overall composite result, individual component event rates, and sensitivity analyses excluding less relevant components. The STEEP criteria standardise endpoint definitions in early breast cancer trials.

Reference: JRCPTB Curriculum; STEEP criteria Hudis et al JCO 2007; FDA Endpoints Guidance