📃 Paper Title: Duration of androgen suppression in the treatment of prostate cancer.
🧍 Author: Bolla M
🕒 Year: 2009
📚 Journal: The New England Journal of Medicine (NEJM)
🌎 Country: France
ㅤContext to the study:
Can you tell me about a study that outlines the use of androgen suppression alongside radiotherapy for locally advanced prostate cancer? And the optimal duration?
ㅤ✅ Take-home message of study:
In men with locally advanced prostate cancer ie. Stage T2c and above, radiotherapy + 3 years of androgen suppression is modestly superior to radiotherapy + only 6 month of androgen suppression. No additional clinical side effects were noted in the short-term vs long-term group.
ㅤ Randomised, non-inferiority trial.
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Study participants:
Number of patients: 1113: 970 randomly assigned (483 vs 487; short vs long term).
Recruitment: April 1997-November 2001.
2 arms: radiotherapy and short-term androgen suppression (6 months) (n=483) vs. radiotherapy and long-term androgen suppression (36 months) (n=487).
Inclusion criteria:
Histologically confirmed prostate adenocarcinoma T1c to T2a-b, N1 or N2, M0
Or with clinical tumour stages T2c to T4 N0 to N2, M0
PSA up to 40 times upper limit of normal range.
WHO performance status of 0-2.Other criteria:
HB ≥ 10g/dl
WBC ≥ 2×109 /l
PLT ≥ 100×109 /l
No prior treatment for prostate cancer, and no previous cancer (except treated basal-cell skin cancer).
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Key study outcomes:
Follow-up of patients:
For the first 5 years: 6 monthly clinical assessments, laboratory testing for toxicity and PSA measurements.
After 5 years: annual assessment
Repeated imaging in cases where progression was suspected.
Primary end point: Overall survival
5-year overall mortality was 19.0% for short-term, and 15.2% for long-term suppression; the observed hazard ratio was 1.42 (upper 95.71% confidence limit, 1.79; p=0.65 for non-inferiority).
Secondary end points: survival free of
Clinical progression
Regional and distant metastases,
Biochemical progression.
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Study Limitations:
Results are difficult to generalise to smaller tumours.
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