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| |  Hormonal Therapy Plus Radiation Beats Radiation Alone in Prostate Cancer: Presented at ASCO-GU By Fred Gebhart SAN FRANCISCO -- March 6, 2010 -- Short-term hormonal therapy offers survival advantages to men who are undergoing radiation therapy for intermediate risk, early-stage prostate cancer, according to a study presented here at the 2010 Genitourinary Cancers Symposium (ASCO-GU). “We found that neoadjuvant hormonal therapy plus radiation offers advantages compared with radiation alone,” said lead author David McGowan, MD, Cross Cancer Institute, Edmonton, Alberta, on March 5. “We used the standard of care as it was back in 1994.” The Radiation Therapy Oncology Group (RTOG) trial began in 1994 and was the largest-ever randomised trial of hormonal therapy plus radiation versus radiation alone. The researchers followed 1,979 men who were randomised to hormonal therapy plus radiation (n = 987) or radiation therapy alone (n = 992). Men who received combination therapy started a 4-month course of total androgen suppression 2 months before starting radiation. Hormones continued for 2 months after the start of radiation. The control group received radiation alone. Both groups received what are relatively low doses of radiation by current treatment standards. The primary endpoint of the study was overall survival. After 12 years of follow-up, overall survival in the hormone group was 51% compared with 46% in the radiation-only group (P = .03). Median follow-up was 8.4 years in the hormone group and 8.1 years in the radiation-only group. Death from noncancer causes was similar in both groups, Dr. McGowan said. The survival benefit appeared to be the greatest for men with intermediate risk, those with a Gleason score of 7 or a Gleason score of 6 plus either a prostate-specific antigen (PSA) between 10 and 20 or clinical T2b disease. This intermediate-risk group made up 54% of the total study population. Men with low-risk disease did not show any survival advantage or other benefit from hormone therapy. Of the original group, 843 men were given a repeat biopsy 2 years following treatment. In the hormone group, 439 of 987 men were rebiopsied; 78% of biopsies showed no evidence of cancer. In the radiation-only group, 404 of 992 men were rebiopsied; 60% were cancer free. Acute and late radiation toxicity was similar in both groups, Dr. McGowan reported. Hormonal toxicity was primarily liver and was grade 3 or grade 4 in less than 5% of patients. Cardiovascular toxicity in the hormonal group was minor, grade 1 or grade 2 in just 1% of patients. “There doesn’t seem to be any disadvantage to the addition of hormonal treatment to radiation,” Dr. McGowan concluded. “We can recommend the use of hormonal therapy with radiation in high risk and intermediate risk patients, but not for low risk patients.” The conference is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO). [Presentation title: Effect of Short-Term Endocrine Therapy Prior to and During Radiation Therapy on Overall Survival in Patients With T1b-T2b Adenocarcinoma of the Prostate and PSA Equal to or Less Than 20: Initial Results of RTOG 94-08. Abstract 6]
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