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Adjuvant goserelin boosted prostate ca survival.

Administering goserelin acetate as an adjuvant treatment after radiotherapy increases long-term survival in patients with high-risk prostate cancer, according to results of a phase III trial of the Radiation Therapy Oncology Group led by Miljenko Pilepich, M.D., a radiation oncologist at the University of California, Los Angeles.

In all, 977 patients were entered into the trial (RTOG 85-31) between 1987 and 1992 (Int. J. Radiat. Oncol. Biol. Phys. 2005;61:1285-90). Of those, 488 patients were randomized to radiotherapy with goserelin (Zoladex) and 489 were assigned to radiotherapy alone, followed by observation and goserelin if there was a relapse. In the first group, goserelin was started during the last week of radiotherapy and continued indefinitely or until there were signs of progression.

Patients had clinical stage T3 disease, regional lymphatic involvement, or positive margins at prostatectomy. Patients had to have a Karnofsky performance status greater than 60%.

As of July 2003, the median follow-up for all patients was 7.6 years, and for living patients it was 11 years. At 10 years, the absolute survival rate was significantly greater for the group receiving adjuvant therapy (49%) than for the control group (39%). The 10-year local failure rate for the adjuvant group was 23%, compared with 38% for the control arm. At the same time point, 24% of adjuvant patients had distant metastases, compared with 39% of the control group; and disease-specific mortality--death from prostate cancer or treatment--was 16% for the adjuvant arm and 22% for the control arm. Although side effects weren't described in this paper, they will be the subject of a forthcoming analysis, Dr. Pilepich and associates said.

Patients with a high Gleason score (8-10) benefited most from adjuvant goserelin, while those with a score of 2-6 benefited least. A parallel study (RTOG 86-10) has shown that androgen suppression given before and during radiotherapy improved outcome in patients with Gleason 2-6 disease. While neoadjuvant androgen suppression benefits these patients, long-term adjuvant therapy may not be justified.

However, for patients with clinical stage T3 disease or regional lymphatic involvement and high Gleason scores, long-term androgen therapy "could be adopted as the standard of care," the authors concluded. The study was supported by the U.S. Public Health Service and the National Cancer Institute.


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Title Annotation:Urology
Author:Ault, Alicia
Publication:Internal Medicine News
Geographic Code:1USA
Date:Jul 15, 2005
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