NEW YORK (Reuters Health) - New data support the use of high-dose external beam radiotherapy (EBRT) combined with risk-adapted androgen deprivation in men with unfavorable prostate cancer.
Final data from the DART 01/05 trial show a benefit of high-dose EBRT with 28 months of androgen deprivation for high-risk disease and the absence of benefit of prolonging androgen deprivation beyond six months for intermediate-risk disease.
The optimal duration of androgen deprivation combined with high-dose radiotherapy in prostate cancer remains controversial, Dr. Almudena Zapatero with Princess University Hospital in Madrid and colleagues note in The Lancet Oncology.
The DART 01/05 was an open-label, randomized controlled trial conducted at 10 hospitals in Spain.
The trial compared high-dose EBRT plus either short-term androgen deprivation (STAD) given for four months or long-term androgen deprivation (LTAD) given for 28 months in 354 men with intermediate-risk and high-risk prostate cancer.
The five-year results showed that LTAD combined with high-dose radiotherapy significantly improved overall survival, especially in patients with high-risk disease.
"At 10 years, the results of the updated analysis could not support the previously reported statistically significant survival improvement with LTAD versus STAD, although the magnitude of the benefit was clinically relevant in the high-risk population," the study team reports.
In the high-risk population, LTAD gave an absolute benefit of nearly 12 percentage points in biochemical disease-free, metastasis-free, and overall survival, whereas intermediate-risk patients did not benefit from LTAD.
The author of a comment published with the study says the findings "support the continued use of LTAD combined with dose-escalated EBRT in high-risk prostate cancer."
"Similarly important is the absence of benefit seen with LTAD in the intermediate-risk group. These findings support the recommendation for limiting androgen deprivation to four to six months for intermediate-risk patients," writes Dr. Juanita Crook of the University of British Columbia, in Vancouver, Canada.
Funding for the study was provided by the Radiation Oncology Research Group and the Spanish Society of Radiotherapy Oncology, the National Health Investigation Fund and AstraZeneca.
SOURCE: https://bit.ly/3xZXv8L and https://bit.ly/3rHRGZs The Lancet Oncology, online April 12, 2022.
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