JCO Early Release, published online ahead of print Apr 14 2008
Journal of Clinical Oncology, 10.1200/JCO.2007.14.9021
Received October 19, 2007
Accepted February 4, 2008
Ten-Year Follow-Up of Radiation Therapy Oncology Group Protocol 92-02: A Phase III Trial of the Duration of Elective Androgen Deprivation in Locally Advanced Prostate Cancer
Eric M. Horwitz,* Kyounghwa Bae, Gerald E. Hanks, Arthur Porter, David J. Grignon, Harmar D. Brereton, Varagur Venkatesan, Colleen A. Lawton, Seth A. Rosenthal, Howard M. Sandler, and William U. Shipley
From the Department of Radiation Oncology, Fox Chase Cancer Center; Department of Biostatistics, Radiation Therapy Oncology Group, Philadelphia; Northeast Radiation Oncology Center, Scranton, PA; Department of Radiation Oncology, McGill University, Montréal, Québec; Department of Radiation Oncology, University of Western Ontario, London, Ontario, Canada; Department of Pathology, Indiana University, Indianapolis, IN; Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI; Department of Radiation Oncology, Radiological Associates of Sacramento, Sacramento, CA; Department of Radiation Oncology, University of Michigan, Ann Arbor, MI; and the Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.
* To whom correspondence should be addressed. E-mail: eric.horwitz{at}fccc.edu
Purpose: To determine whether adding 2 years of androgen-deprivation therapy (ADT) improved outcome for patients electively treated with ADT before and during radiation therapy (RT).
Patients and Methods: Prostate cancer patients with T2c-T4 prostate cancer with no extra pelvic lymph node involvement and prostate-specific antigen (PSA) less than 150 ng/mL were included. All patients received 4 months of goserelin and flutamide before and during RT. They were randomized to no further ADT (short-term ADT [STAD] + RT) or 24 months of goserelin (long-term ADT [LTAD] + RT). A total of 1,554 patients were entered. RT was 45 Gy to the pelvic nodes and 65 to 70 Gy to the prostate. Median follow-up of all survival patients is 11.31 and 11.27 years for the two arms.
Results: At 10 years, the LTAD + RT group showed significant improvement over the STAD + RT group for all end points except overall survival: disease-free survival (13.2% v 22.5%; P < .0001), disease-specific survival (83.9% v 88.7%; P = .0042), local progression (22.2% v 12.3%; P < .0001), distant metastasis (22.8% v 14.8%; P < .0001), biochemical failure (68.1% v 51.9%; P  .0001), and overall survival (51.6% v 53.9%, P = .36). One subgroup analyzed consisted of all cancers with a Gleason score of 8 to 10 cancers. An overall survival difference was observed (31.9% v 45.1%; P = .0061), as well as in all other end points herein.
Conclusion: LTAD as delivered in this study for the treatment of locally advanced prostate cancer is superior to STAD for all end points except survival. A survival advantage for LTAD + RT in the treatment of locally advanced tumors with a Gleason score of 8 to 10 suggests that this should be the standard of treatment for these high-risk patients.
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