Originally published as JCO Early Release 10.1200/JCO.2008.17.4052 on March 23 2009

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Impact of the Duration of Adjuvant Hormonal Therapy in Patients With Locally Advanced Prostate Cancer Treated With Radiotherapy: A Secondary Analysis of RTOG 85-31

From the McGill University Health Center, Montreal, Quebec, Canada; Radiation Therapy Oncology Group, Philadelphia, PA; University of California Medical Center, Los Angeles, CA; and University of Michigan, Ann Arbor, MI.

Corresponding author: Luis Souhami, MD, Montreal General Hospital, 1650 Cedar Ave, Montreal, Quebec H3G 1A4, Canada; e-mail: luis.souhami{at}muhc.mcgill.ca.

Purpose Radiation Therapy Oncology Group 85-31 was a randomized trial of androgen suppression for life for patients with locally advanced prostate cancer. However, not all patients continued on the protocol-mandated long-term hormonal therapy despite no evidence of recurrence. We correlated duration of adjuvant hormonal therapy and outcomes among patients who prematurely discontinued hormonal therapy.

Patients and Methods The protocol mandated pelvic radiotherapy followed by goserelin given indefinitely or until disease progression. There were 189 analyzable patients. Patients were divided in groups based on the tertile of hormonal therapy duration (HTD) as follows: 1 year, more than 1 year and 5 years, and more than 5 years. Overall survival (OS), disease-free survival (DFS), cause-specific mortality, local failure (LF), and distant metastasis (DM) were studied. Kaplan-Meier estimation and Cox proportional hazards regression model were used for OS and DFS, and Fine and Gray's regression model was used for the other outcomes.

Results The median follow-up for surviving patients is 9.6 years. The median duration of adjuvant hormonal therapy was 2.2 years. The HTD more than 5 years group is significantly associated with an improved survival and DFS and fewer DMs than other HTD groups. After adjustment for age, radical prostatectomy, nodal status, Gleason score, and stage variables, the HTD more than 5 years group remains significantly associated with better OS and DFS than other HTD groups.

Conclusion In this hypothesis-generating analysis, prolonged HTD of more than 5 years seems significantly associated with improvements in most outcomes. Given these data, decreasing HTD to 5 years may have a detrimental effect on patients with locally advanced prostate cancer. Only a randomized trial will conclusively clarify this issue.

Supported by National Cancer Institute Grants No. Radiation Therapy Oncology Group U10 CA21661, Community Clinical Oncology Program U10 CA37422, and Stat U10 CA32115.

Presented at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

The contents of this article are the sole responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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This article has been cited by other articles:

				L. Collette and U. E. Studer Selection Bias Is Not a Good Reason for Advising More Than 5 Years of Adjuvant Hormonal Therapy for All Patients With Locally Advanced Prostate Cancer Treated With Radiotherapy J. Clin. Oncol., November 20, 2009; 27(33): e201 - e202. [Full Text] [PDF]

				L. Souhami, K. Bae, and H. Sandler Reply to L. Collette et al and C.M. Tangen et al J. Clin. Oncol., November 20, 2009; 27(33): e204 - e204. [Full Text] [PDF]

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