An Update of the Phase III Trial Comparing Whole Pelvic to Prostate Only Radiotherapy and Neoadjuvant to Adjuvant Total Androgen Suppression: Updated Analysis of RTOG 94-13, With Emphasis on Unexpected Hormone/Radiation Interactions

Journal Article · Thu Nov 01 04:00:00 UTC 2007 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2007.04.003· OSTI ID:21039564

DeSilvio, Michelle ^[1]; Roach, Mack ^[2]; Uhl, Valery ^[3]; Kirsch, Robert ^[4]; Seider, Michael ^[5]; Rotman, Marvin ^[6]; Jones, Christopher ^[7]; Asbell, Sucha ^[8]; Valicenti, Richard ^[9]; Hahn, Stephen ^[10]; Thomas, Charles R ^[11]

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1. Statistical Headquarters Radiation Therapy Oncology Group, Philadelphia, PA (United States)
2. Department of Radiation Oncology, University of California, San Francisco, Comprehensive Cancer Center, San Francisco, CA (United States)
3. Department of Radiation Oncology, Summit Medical Center, Oakland, CA (United States)
4. University of Pennsylvania, Philadelphia, PA (United States)
5. Radiation Therapy, Akron City Hospital, Akron, OH (United States)
6. Department of Radiation Oncology, State University of New York Downstate Medical Center, Brooklyn, NY (United States)
7. Radiological Associates of Sacramento, Sacramento, CA (United States)
8. Department of Radiation Oncology, Albert Einstein Medical Center, Philadelphia, PA (United States)
9. Department of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, PA (United States)
10. Wayne State University, Detroit, MI (United States)
11. Department of Radiation Medicine, Oregon Health and Science University, Portland, OR (United States)

Purpose: This trial was designed to test the hypothesis that total androgen suppression and whole pelvic radiotherapy (WPRT) followed by a prostate boost improves progression-free survival (PFS) by {>=}10% compared with total androgen suppression and prostate only RT (PORT). This trial was also designed to test the hypothesis that neoadjuvant hormonal therapy (NHT) followed by concurrent total androgen suppression and RT improves PFS compared with RT followed by adjuvant hormonal therapy (AHT) by {>=}10%. Methods and Materials: Patients eligible for the study included those with clinically localized adenocarcinoma of the prostate and an elevated prostate-specific antigen level of <100 ng/mL. Patients were stratified by T stage, prostate-specific antigen level, and Gleason score and were required to have an estimated risk of lymph node involvement of >15%. Results: The difference in overall survival for the four arms was statistically significant (p = 0.027). However, no statistically significant differences were found in PFS or overall survival between NHT vs. AHT and WPRT compared with PORT. A trend towards a difference was found in PFS (p = 0.065) in favor of the WPRT + NHT arm compared with the PORT + NHT and WPRT + AHT arms. Conclusions: Unexpected interactions appear to exist between the timing of hormonal therapy and radiation field size for this patient population. Four Phase III trials have demonstrated better outcomes when NHT was combined with RT compared with RT alone. The Radiation Therapy Oncology Group 9413 trial results have demonstrated that when NHT is used in conjunction with RT, WPRT yields a better PFS than does PORT. It also showed that when NHT + WPRT results in better overall survival than does WPRT + short-term AHT. Additional studies are warranted to determine whether the failure to demonstrate an advantage for NHT + WPRT compared with PORT + AHT is chance or, more likely, reflects a previously unrecognized biologic phenomenon.

• OSTI ID: 21039564
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 3 Vol. 69; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
ANDROGENS
ANTIGENS
CARCINOMAS
FAILURES
HEALTH HAZARDS
HYPOTHESIS
INHIBITION
LYMPH NODES
PATIENTS
PROSTATE
RADIOTHERAPY