NEW YORK (Reuters Health) - Docetaxel-based chemotherapy added to androgen deprivation therapy (ADT) improves relapse-free survival in men with high-risk localized prostate cancer, according to results from the GETUG 12 study.
Combined docetaxel and estramustine has been shown to improve survival in men with castration-resistant prostate cancer, but whether it improves outcomes in men with high-risk localized prostate cancer has not been determined.
Dr. Karim Fizazi from Institut Gustave Roussy, University of Paris Sud, in Villejuif, France and colleagues from 26 hospitals in France assessed whether docetaxel and estramustine could improve relapse-free survival (RFS) in a phase 3 randomized controlled trial including 413 men with high-risk localized prostate cancer.
During a median follow-up of 8.8 years, 54% (111/206) of men in the ADT-only group experienced relapse or death, compared with 43% (88/207) of men in the ADT plus docetaxel and estramustine group.
At eight years, RFS was significantly higher in the ADT-chemotherapy group than in the ADT only group (62% vs. 50%, p=0.017), the researchers report in The Lancet Oncology, online May 29.
Fifteen percent of patients in the ADT-chemotherapy group developed metastases, compared with 20% of patients in the ADT only group. The combined eight-year overall survival was 83%. (There were not enough events to break down the analysis by treatment group, the researchers say).
The use of chemotherapy was not associated with an increased rate of grade 2 or higher adverse events, regardless of whether or not patients were treated with radiotherapy.
"Longer follow-up will be needed to establish whether this benefit translates into improved metastasis-free survival, and ultimately, overall survival," the researchers conclude.
"Docetaxel is a highly effective systemic agent in men with prostate cancer, and the appropriate timing in the non-metastatic and metastatic settings is rapidly changing based on emerging data," Dr. Andrew J. Armstrong from Duke University's Cancer Institute in Durham, North Carolina, told Reuters Health by email.
"While the present GETUG study should not change practice, other trials such as CHAARTED, STAMPEDE, and RTOG 0521 may lead to recommendations for the earlier use of docetaxel in appropriately high-risk men who are fit for chemotherapy," said Dr. Armstrong, who wrote an accompanying commentary on the findings.
"Guidelines are likely to be updated over the coming months to reflect a changing standard of care where docetaxel will be more commonly used and recommended in men with metastatic hormone-sensitive prostate cancer, particularly those men who present to their doctors with metastatic disease," Dr. Armstrong said.
Sanofi-Aventis and AstraZeneca provided funding for this trial, and Dr. Fizazi reported financial ties to Sanofi-Aventis. Dr. Armstrong's institution has also received grant support from Sanofi-Aventis.
Dr. Fizazi did not respond to a request for comments.
SOURCE: http://bit.ly/1GyBNHn and http://bit.ly/1f6O2QX
Lancet Oncol 2015.
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