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Adjuvant chemotherapy improves survival for men with high-risk localized prostate cancer
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CHICAGO — The addition of docetaxel chemotherapy to standard hormone and radiation therapy reduced the risk for death in men with high-risk localized prostate cancer, according to findings from a phase 3 study presented at the ASCO Annual Meeting.
“This is the first study that shows there is a potential survival benefit to using chemotherapy in this high-risk patient subset,” Howard M. Sandler, MD, MS, FASTRO, chair of the department of radiation oncology at Cedars-Sinai Medical Center, Los Angeles, said during a press conference. “For the right patient and the right physician there will be justification based on these results for adding adjuvant docetaxel, a relatively familiar and well-tolerated systemic chemotherapy regimen.”
Prostate cancer currently does not have an established adjuvant regimen, according to researchers. Sandler and colleagues, thus, sought to determine if adjuvant docetaxel and prednisone added to standard, long-term (24 months) androgen suppression and radiotherapy would improve OS.
The analysis included 562 evaluable men with high-risk, locally advanced prostate cancer. Researchers randomly assigned patients to treatment with standard therapy alone or standard therapy followed by docetaxel 1 month after radiation therapy for 18 weeks.
The primary endpoint was OS.
After a mean follow-up of 5.5 years, 52 deaths occurred in the standard therapy arm compared with 36 deaths in the docetaxel arm. The 4-year OS in the standard therapy group was 89% (95% CI, 84-92) compared with 93% (95% CI, 90-96) in the docetaxel group (HR = 0.68; 95% CI, 0.44-1.03).
Docetaxel also reduced the risk for relapse. Five-year DFS was 73% in the docetaxel arm compared with 66% in the standard therapy arm (HR = 0.76; 95% CI, 0.57-1).
There was one grade 5 adverse event in the standard therapy arm that was likely unrelated to treatment whereas there were two grade 5 adverse events in the docetaxel arm that were considered possibly or probably related to the treatment.
Follow-up will continue as researchers assess the long-term benefit of adjuvant chemotherapy in this setting. A quality of life data analysis also is planned.
“These findings could improve outcomes for thousands of men,” Sandler said. “But how widely it becomes adopted remains to be seen. If anything, the worst and most aggressive cancers would be the best candidates for this. In the intermediate- and low-risk subsets, I wouldn’t recommend chemotherapy.” – by Anthony SanFilippo
Reference:
Sandler HM, et al. Abstract LBA5002. Presented at: ASCO Annual Meeting; May 29-June 2, 2015; Chicago.
Disclosure: The study was funded by the AstraZeneca, NIH and Sanofi. Sandler reports consultant/advisory roles with, research funding from and other financial relationships with Astellas, AstraZeneca, Bayer, Caribou Publishing, Eviti, Janssen, Medivation, Myriad Genetics and Sanofi. Please the abstract for a list of all other researchers’ relevant financial disclosures.
Perspective
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Charles J. Ryan, MD
This is the first positive adjuvant study for chemotherapy in prostate cancer ever, which is an important aspect when looking at it. This is a powerful new use for a long-established therapy, especially for patients with high-risk prostate cancer. The follow-up time of 4 years is relatively short for a patient with prostate cancer who is being treated with curative intent. A reduction in early deaths is quite a significant outcome. Should this apply to intermediate-risk patients as well? These data included a high-risk cohort. We will still have to wait for the data looking at patients with a Gleason score below 8 and a PSA below 20.
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