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Defining Endpoints for Recurrence in Randomised Controlled Trials of Systemic Therapy for Early Breast Cancer: A Call fo

Recurrence-related endpoints. . Four most used recurrence endpoints in early breast cancer:Disease Free Survival (DFS)Recurrence Free Survival (RFS)Event Free Survival (EFS)Time to Recurrence (TTR)Usually composites of two or more of the following events:Local Recurrence (LR)Distant Recurrence (DR)Contralateral breast cancer (CLB)Non breast second primary (NBSP)Breast cancer death (BC death)Death - any cause.

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Defining Endpoints for Recurrence in Randomised Controlled Trials of Systemic Therapy for Early Breast Cancer: A Call fo

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    1. Defining Endpoints for Recurrence in Randomised Controlled Trials of Systemic Therapy for Early Breast Cancer: A Call for Standardisation Lucy S Kilburn Clinical Trials & Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK

    2. Recurrence-related endpoints

    3. Why does endpoint definition matter?

    4. Why does endpoint definition matter?

    5. Systematic review Systematic review of RCTs of systemic therapy for early breast cancer (EBC) Review had two stages: 1st stage � broad search criteria: �breast cancer� limiting to 2003-2004 and RCTs 2nd stage � narrowing of inclusion criteria to EBC, systemic therapy and time to event analysis

    6. Extracting definitions

    7. Results - starting points

    8. Results � event types

    9. Recent proposals for standard definitions

    10. Results � event types

    12. Non-invasive events Should only invasive events be included or is there any merit in including non-invasive events e.g. DCIS?

    13. Non-breast second primaries Should non breast second primaries be included as events or censored?

    14. All second primary cancers Should all second primary cancers be included or only those where a change in systemic treatment is required?

    15. Deaths from unknown cause How should deaths from unknown cause be treated?

    16. Death from other cancers Is it necessary to distinguish death from other cancers and non-cancer death?

    17. Generalisation to all cancer types Should any proposed definitions be general to all cancer types?

    18. Specific populations Can proposed definitions be changed to reflect specific populations e.g. older populations? e.g. ACTION Trial � Primary endpoint = relapse free interval. Includes disease related events, BC death and non BC death for the first four months post treatment completion.

    19. Conclusions and recommendations Variation still exists in names and what events are included Further debate and resolution is required Maybe a role for the newly formed UK Breast Intergroup

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