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, Michelle DeSilvio, Mack Roach, Valery Uhl, Robert Kirsch, Michael Seider, Marvin Rotman, Christopher Jones, Sucha Asbell, Richard K Valicenti, Stephen Hahn, Charles R. Thomas

Research output: Contribution to journalArticle

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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 ≥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.

Original languageEnglish (US)
Pages (from-to)646-655
Number of pages10
JournalInternational Journal of Radiation Oncology Biology Physics
Volume69
Issue number3
DOIs
StatePublished - Nov 1 2007
Externally publishedYes

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hormones
Neoadjuvant Therapy
Androgens
Prostate
radiation therapy
therapy
Radiotherapy
retarding
Hormones
Radiation
radiation
Disease-Free Survival
interactions
progressions
Survival
Biological Phenomena
Therapeutics
Adjuvant Radiotherapy
Radiation Oncology
Prostate-Specific Antigen

Keywords

  • Hormonal therapy
  • Prostate cancer
  • Radiotherapy

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation

Cite this

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. / Lawton, Colleen A.; DeSilvio, Michelle; Roach, Mack; Uhl, Valery; Kirsch, Robert; Seider, Michael; Rotman, Marvin; Jones, Christopher; Asbell, Sucha; Valicenti, Richard K; Hahn, Stephen; Thomas, Charles R.

In: International Journal of Radiation Oncology Biology Physics, Vol. 69, No. 3, 01.11.2007, p. 646-655.

Research output: Contribution to journalArticle

Lawton, Colleen A. ; DeSilvio, Michelle ; Roach, Mack ; Uhl, Valery ; Kirsch, Robert ; Seider, Michael ; Rotman, Marvin ; Jones, Christopher ; Asbell, Sucha ; Valicenti, Richard K ; Hahn, Stephen ; Thomas, Charles R. / 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. In: International Journal of Radiation Oncology Biology Physics. 2007 ; Vol. 69, No. 3. pp. 646-655.
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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 ≥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.",
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AU - DeSilvio, Michelle

AU - Roach, Mack

AU - Uhl, Valery

AU - Kirsch, Robert

AU - Seider, Michael

AU - Rotman, Marvin

AU - Jones, Christopher

AU - Asbell, Sucha

AU - Valicenti, Richard K

AU - Hahn, Stephen

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