Loading
Tried to show that six months of hormone therapy with radiotherapy is enough for locally advanced prostate cancer. It is not: three years works better.
EORTC 22961 registered 1,113 men with locally advanced prostate cancer who had already received external beam radiotherapy and 6 months of androgen suppression, and randomised 970 of them to stop (483) or to continue a luteinising hormone-releasing hormone agonist for a further 2.5 years (487). Short-term suppression would have been declared non-inferior if the hazard ratio for overall survival stayed below 1.35.
At a median 6.4 years, 132 men in the short arm and 98 in the long arm had died, 47 and 29 of them from prostate cancer. Five-year overall mortality was 19.0 percent with short suppression and 15.2 percent with long, and the observed hazard ratio was 1.42 (upper 95.71 percent confidence limit 1.79). Non-inferiority failed (p=0.65). An interim analysis had already shown futility.
The trial is the reason three years, not six months, is the standard duration of androgen deprivation alongside radiotherapy for locally advanced disease, and the reason a man in that position is asked to accept three years of hot flushes, fatigue, loss of libido and bone loss. Adverse events in both arms included fatigue, diminished sexual function and hot flushes.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
970 randomised.
Upper 95.71 percent confidence limit 1.79.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall mortality at 5 yearsprimary | Short suppression, 6 months | 483 | 19% | 1.42 | 0.65 for non-inferiority | link |
| Long suppression, 3 years | 487 | 15.2% |
Shares EORTC 22863, DART 01/05 GICOR, Curative intent vs palliative intent, Androgen deprivation therapy (ADT).
Shares EORTC 22863, Curative intent vs palliative intent, Hormone therapy, Androgen deprivation therapy (ADT).
Shares RTOG 92-02, Curative intent vs palliative intent, Hormone therapy, Androgen deprivation therapy (ADT).
Shares What androgen deprivation costs: the side of hormone therapy the survival curves do not show, Hormone therapy, Quality of life and patient-reported outcomes (QoL, PRO), Androgen deprivation therapy (ADT).
Shares What androgen deprivation costs: the side of hormone therapy the survival curves do not show, Hormone therapy, Quality of life and patient-reported outcomes (QoL, PRO), Androgen deprivation therapy (ADT).
Shares Curative intent vs palliative intent, Androgen deprivation therapy (ADT), Localised prostate cancer, high and very high risk, Androgen deprivation & AR pathway inhibitors.
Shares Curative intent vs palliative intent, Androgen deprivation therapy (ADT), Localised prostate cancer, high and very high risk, Androgen deprivation & AR pathway inhibitors.
Shares What androgen deprivation costs: the side of hormone therapy the survival curves do not show, Hormone therapy, Androgen deprivation therapy (ADT), Localised prostate cancer, high and very high risk.