The Absolute Effect / Evidence / EORTC 22961
Prostate Cancer · Radiation · Locally advanced / high-risk
EORTC 22961
Clinical question
Is 6 months of ADT sufficient compared with 3 years when combined with definitive radiotherapy?
Trial context
Population
970 men
Intervention
RT 70 Gy + 6 months complete androgen blockade versus the same first 6 months followed by 30 additional months of triptorelin.
Comparator
36-month ADT
Primary / key evidence
5-y OS 81% vs 84.8%; short-term arm failed non-inferiority. 5-y prostate-cancer mortality 4.7% vs 3.2%.
Absolute Effect
What changes for patients?
5-y OS 81% vs 84.8%; short-term arm failed non-inferiority. 5-y prostate-cancer mortality 4.7% vs 3.2%.
NNT/NNH: Not calculated unless a defensible fixed-time event-rate comparison was available in the cited primary analysis; median-survival differences alone are not converted to NNT.
Clinical interpretation
Six months was not non-inferior to 36 months for overall survival; the study supports longer ADT in appropriately selected locally advanced/high-risk patients.
Limitations / maturity
Interpret the effect in the context of the trial population, endpoint definition, follow-up and treatment era. Subsequent trials and evolving standards may limit direct applicability to contemporary patients.
Primary publication
Bolla M et al. N Engl J Med. 2009;360:2516–2527.