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Clinical Trial
. 2007 Nov 1;69(3):646-55.
doi: 10.1016/j.ijrobp.2007.04.003. Epub 2007 May 24.

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

Colleen A Lawton  1 , Michelle DeSilvio, Mack Roach 3rd, Valery Uhl, Robert Kirsch, Michael Seider, Marvin Rotman, Christopher Jones, Sucha Asbell, Richard Valicenti, Stephen Hahn, Charles R Thomas Jr
Affiliations
Clinical Trial

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

Colleen A Lawton et al. Int J Radiat Oncol Biol Phys. .

Abstract

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 > or =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 > or =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.

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Figures

Figure 1
Figure 1
Figure 1a: Progression Free Survival NHT vs AHT (protocol definition of biochemical failure) Figure 1b: Progression Free Survival NHT vs AHT (nadir + 2 definition of biochemical failure)
Figure 2
Figure 2
Figure 2a: Progression Free Survival WPRT vs PORT (protocol definition of biochemical failure) Figure 2b: Progression Free Survival WPRT vs PORT (nadir + 2 definition of biochemical failure)
Figure 3
Figure 3
Figure 3a: Progression Free Survival by Treatment Arm (protocol definition of biochemical failure) Figure 3b: Progression Free Survival by Treatment Arm (nadir + 2 definition of biochemical failure)
Figure 4
Figure 4
Overall Survival by Treatment Arm
Figure 5
Figure 5
Figure 5a: Biochemical Failure by Treatment Arm (protocol definition) Figure 5b: Biochemical Failure by Treatment Arm (nadir + 2 definition)
Figure 6
Figure 6
Figre 6a: Cause Specific Survival (prostate cancer survival) Figure 6b: Non Prostate Cancer Survival
Figure 7
Figure 7
Progression Free Survival (protocol definition of biochemical failure) Arm 1 vs. Arm 2–4
See this image and copyright information in PMC

Comment in

References

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