RTOG 94-06

Is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity?

Richard K Valicenti, Kathryn Winter, James D. Cox, Howard M. Sandler, Walter Bosch, Srinivasan Vijayakumar, Jeff Michalski, James Purdy

Research output: Contribution to journalArticle

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Abstract

Purpose: This study determines the effect on toxicity of adding neoadjuvant hormonal therapy (NHT) to three-dimensional conformal radiation therapy (3D-CRT) in RTOG 94-06. Methods: Between August 1994 and February 2000, 583 eligible prostate cancer patients enrolled on the first 3 dose levels of RTOG 94-06, a Phase I/II dose escalation 3D-CRT trial. Two hundred and seven men initiated hormonal therapy (HT) between 2 to 3 months before 3D-CRT, and completed all HT no longer than 3 months after radiotherapy. Thirty-three patients receiving longer-duration HT were excluded. The 547 patients were treated at dose level I (68.4 Gy), level II (73.8 Gy), or level III (79.2 Gy). All dose prescriptions were to the minimum isodose surface encompassing the planning target volume (dose levels I and II) or the clinical target volume (dose level III). Men were stratified into three risk groups according to their relative risk of seminal vesicle invasion: <15% (Group 1) vs. >15% (Group 2), or to T stage (T1, 2 vs. T3 tumors [Group 3]). In Group 2 patients, there was a clinical target volume reduction to treat only the prostate after delivery of 55.8 Gy to a planning target volume including the seminal vesicles. All HT consisted of a luteinizing hormone-releasing hormone agonist with or without a nonsteroidal anti-androgen. Results: On univariate analysis, NHT significantly increased the likelihood of Grade 2 acute genitourinary (GU) complications (22% to 32%, p = 0.009). Hormonal therapy did not have a significant univariate effect on any other acute or late toxicity. On multivariate analysis, the percent of the bladder (≤30% vs. >30%) receiving ≥ the reference dose (68.4 Gy, 73.8 Gy, or 79.2 Gy) (p = 0.0009, relative risk = 2.07, confidence interval: 1.88-2.28) was a significant predictor of acute GU effects. Although NHT was not significant in itself, in the multivariate analysis its interaction with baseline urinary status was an important factor (p = 0.011, relative risk = 4.31, confidence interval: 1.68-5.29). Conclusion: Neoadjuvant HT did not show an independent effect on the risk of side effects after 3D-CRT in patients treated on RTOG 94-06. However, this combined modality therapy significantly increased the risk of acute GU effects compared to 3D-CRT alone in men with poor baseline urinary function.

Original languageEnglish (US)
Pages (from-to)614-620
Number of pages7
JournalInternational Journal of Radiation Oncology Biology Physics
Volume57
Issue number3
DOIs
StatePublished - Nov 1 2003
Externally publishedYes

Fingerprint

Neoadjuvant Therapy
toxicity
radiation therapy
therapy
Prostatic Neoplasms
Radiotherapy
cancer
dosage
Seminal Vesicles
Therapeutics
Nonsteroidal Anti-Androgens
Multivariate Analysis
Confidence Intervals
hormones
Combined Modality Therapy
planning
confidence
Gonadotropin-Releasing Hormone
Prescriptions
Prostate

Keywords

  • 3D conformal radiation therapy
  • Hormonal therapy
  • Prostate cancer
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation

Cite this

RTOG 94-06 : Is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity? / Valicenti, Richard K; Winter, Kathryn; Cox, James D.; Sandler, Howard M.; Bosch, Walter; Vijayakumar, Srinivasan; Michalski, Jeff; Purdy, James.

In: International Journal of Radiation Oncology Biology Physics, Vol. 57, No. 3, 01.11.2003, p. 614-620.

Research output: Contribution to journalArticle

Valicenti, Richard K ; Winter, Kathryn ; Cox, James D. ; Sandler, Howard M. ; Bosch, Walter ; Vijayakumar, Srinivasan ; Michalski, Jeff ; Purdy, James. / RTOG 94-06 : Is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity?. In: International Journal of Radiation Oncology Biology Physics. 2003 ; Vol. 57, No. 3. pp. 614-620.
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abstract = "Purpose: This study determines the effect on toxicity of adding neoadjuvant hormonal therapy (NHT) to three-dimensional conformal radiation therapy (3D-CRT) in RTOG 94-06. Methods: Between August 1994 and February 2000, 583 eligible prostate cancer patients enrolled on the first 3 dose levels of RTOG 94-06, a Phase I/II dose escalation 3D-CRT trial. Two hundred and seven men initiated hormonal therapy (HT) between 2 to 3 months before 3D-CRT, and completed all HT no longer than 3 months after radiotherapy. Thirty-three patients receiving longer-duration HT were excluded. The 547 patients were treated at dose level I (68.4 Gy), level II (73.8 Gy), or level III (79.2 Gy). All dose prescriptions were to the minimum isodose surface encompassing the planning target volume (dose levels I and II) or the clinical target volume (dose level III). Men were stratified into three risk groups according to their relative risk of seminal vesicle invasion: <15{\%} (Group 1) vs. >15{\%} (Group 2), or to T stage (T1, 2 vs. T3 tumors [Group 3]). In Group 2 patients, there was a clinical target volume reduction to treat only the prostate after delivery of 55.8 Gy to a planning target volume including the seminal vesicles. All HT consisted of a luteinizing hormone-releasing hormone agonist with or without a nonsteroidal anti-androgen. Results: On univariate analysis, NHT significantly increased the likelihood of Grade 2 acute genitourinary (GU) complications (22{\%} to 32{\%}, p = 0.009). Hormonal therapy did not have a significant univariate effect on any other acute or late toxicity. On multivariate analysis, the percent of the bladder (≤30{\%} vs. >30{\%}) receiving ≥ the reference dose (68.4 Gy, 73.8 Gy, or 79.2 Gy) (p = 0.0009, relative risk = 2.07, confidence interval: 1.88-2.28) was a significant predictor of acute GU effects. Although NHT was not significant in itself, in the multivariate analysis its interaction with baseline urinary status was an important factor (p = 0.011, relative risk = 4.31, confidence interval: 1.68-5.29). Conclusion: Neoadjuvant HT did not show an independent effect on the risk of side effects after 3D-CRT in patients treated on RTOG 94-06. However, this combined modality therapy significantly increased the risk of acute GU effects compared to 3D-CRT alone in men with poor baseline urinary function.",
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T2 - Is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity?

AU - Valicenti, Richard K

AU - Winter, Kathryn

AU - Cox, James D.

AU - Sandler, Howard M.

AU - Bosch, Walter

AU - Vijayakumar, Srinivasan

AU - Michalski, Jeff

AU - Purdy, James

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N2 - Purpose: This study determines the effect on toxicity of adding neoadjuvant hormonal therapy (NHT) to three-dimensional conformal radiation therapy (3D-CRT) in RTOG 94-06. Methods: Between August 1994 and February 2000, 583 eligible prostate cancer patients enrolled on the first 3 dose levels of RTOG 94-06, a Phase I/II dose escalation 3D-CRT trial. Two hundred and seven men initiated hormonal therapy (HT) between 2 to 3 months before 3D-CRT, and completed all HT no longer than 3 months after radiotherapy. Thirty-three patients receiving longer-duration HT were excluded. The 547 patients were treated at dose level I (68.4 Gy), level II (73.8 Gy), or level III (79.2 Gy). All dose prescriptions were to the minimum isodose surface encompassing the planning target volume (dose levels I and II) or the clinical target volume (dose level III). Men were stratified into three risk groups according to their relative risk of seminal vesicle invasion: <15% (Group 1) vs. >15% (Group 2), or to T stage (T1, 2 vs. T3 tumors [Group 3]). In Group 2 patients, there was a clinical target volume reduction to treat only the prostate after delivery of 55.8 Gy to a planning target volume including the seminal vesicles. All HT consisted of a luteinizing hormone-releasing hormone agonist with or without a nonsteroidal anti-androgen. Results: On univariate analysis, NHT significantly increased the likelihood of Grade 2 acute genitourinary (GU) complications (22% to 32%, p = 0.009). Hormonal therapy did not have a significant univariate effect on any other acute or late toxicity. On multivariate analysis, the percent of the bladder (≤30% vs. >30%) receiving ≥ the reference dose (68.4 Gy, 73.8 Gy, or 79.2 Gy) (p = 0.0009, relative risk = 2.07, confidence interval: 1.88-2.28) was a significant predictor of acute GU effects. Although NHT was not significant in itself, in the multivariate analysis its interaction with baseline urinary status was an important factor (p = 0.011, relative risk = 4.31, confidence interval: 1.68-5.29). Conclusion: Neoadjuvant HT did not show an independent effect on the risk of side effects after 3D-CRT in patients treated on RTOG 94-06. However, this combined modality therapy significantly increased the risk of acute GU effects compared to 3D-CRT alone in men with poor baseline urinary function.

AB - Purpose: This study determines the effect on toxicity of adding neoadjuvant hormonal therapy (NHT) to three-dimensional conformal radiation therapy (3D-CRT) in RTOG 94-06. Methods: Between August 1994 and February 2000, 583 eligible prostate cancer patients enrolled on the first 3 dose levels of RTOG 94-06, a Phase I/II dose escalation 3D-CRT trial. Two hundred and seven men initiated hormonal therapy (HT) between 2 to 3 months before 3D-CRT, and completed all HT no longer than 3 months after radiotherapy. Thirty-three patients receiving longer-duration HT were excluded. The 547 patients were treated at dose level I (68.4 Gy), level II (73.8 Gy), or level III (79.2 Gy). All dose prescriptions were to the minimum isodose surface encompassing the planning target volume (dose levels I and II) or the clinical target volume (dose level III). Men were stratified into three risk groups according to their relative risk of seminal vesicle invasion: <15% (Group 1) vs. >15% (Group 2), or to T stage (T1, 2 vs. T3 tumors [Group 3]). In Group 2 patients, there was a clinical target volume reduction to treat only the prostate after delivery of 55.8 Gy to a planning target volume including the seminal vesicles. All HT consisted of a luteinizing hormone-releasing hormone agonist with or without a nonsteroidal anti-androgen. Results: On univariate analysis, NHT significantly increased the likelihood of Grade 2 acute genitourinary (GU) complications (22% to 32%, p = 0.009). Hormonal therapy did not have a significant univariate effect on any other acute or late toxicity. On multivariate analysis, the percent of the bladder (≤30% vs. >30%) receiving ≥ the reference dose (68.4 Gy, 73.8 Gy, or 79.2 Gy) (p = 0.0009, relative risk = 2.07, confidence interval: 1.88-2.28) was a significant predictor of acute GU effects. Although NHT was not significant in itself, in the multivariate analysis its interaction with baseline urinary status was an important factor (p = 0.011, relative risk = 4.31, confidence interval: 1.68-5.29). Conclusion: Neoadjuvant HT did not show an independent effect on the risk of side effects after 3D-CRT in patients treated on RTOG 94-06. However, this combined modality therapy significantly increased the risk of acute GU effects compared to 3D-CRT alone in men with poor baseline urinary function.

KW - 3D conformal radiation therapy

KW - Hormonal therapy

KW - Prostate cancer

KW - Toxicity

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