Effect of Long-Term Hormonal Therapy (vs Short-Term Hormonal Therapy): A Secondary Analysis of Intermediate-Risk Prostate Cancer Patients Treated on NRG Oncology RTOG 9202
NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival...
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Published in | International journal of radiation oncology, biology, physics Vol. 97; no. 3; pp. 511 - 515 |
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Main Authors | , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
Elsevier Inc
01.03.2017
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ISSN | 0360-3016 1879-355X 1879-355X |
DOI | 10.1016/j.ijrobp.2016.11.002 |
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Abstract | NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) <20 ng/mL, with benefit observed mostly among intermediate-risk patients. It was still unknown whether intermediate-risk patients would experience an additional survival benefit with LTAD; thus, we performed a secondary analysis to explore whether LTAD had any incremental benefit beyond STAD among the intermediate-risk subset of RTOG 9202. The study endpoints were OS, disease-specific survival (DSS), and PSA failure (PSAF).
An analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA<10 ng/mL, and Gleason score = 7 or cT2 disease, PSA 10-20 ng/mL, and Gleason score <7). This review yielded 133 patients: 74 (STAD) and 59 (LTAD). The Kaplan-Meier method was used to estimate OS; the cumulative incidence approach was used to estimate DSS and PSAF. A 2-sided test was used, with significance level defined to be .05.
With over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P=.53), DSS (10-year DSS, 96% vs 97%; P=.72), or PSAF (10-year PSAF, 53% vs 55%; P=.99) between groups.
LTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer hormonal therapy is worth testing in the intermediate-risk prostate cancer subset. |
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AbstractList | NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) <20 ng/mL, with benefit observed mostly among intermediate-risk patients. It was still unknown whether intermediate-risk patients would experience an additional survival benefit with LTAD; thus, we performed a secondary analysis to explore whether LTAD had any incremental benefit beyond STAD among the intermediate-risk subset of RTOG 9202. The study endpoints were OS, disease-specific survival (DSS), and PSA failure (PSAF).
An analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA<10 ng/mL, and Gleason score = 7 or cT2 disease, PSA 10-20 ng/mL, and Gleason score <7). This review yielded 133 patients: 74 (STAD) and 59 (LTAD). The Kaplan-Meier method was used to estimate OS; the cumulative incidence approach was used to estimate DSS and PSAF. A 2-sided test was used, with significance level defined to be .05.
With over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P=.53), DSS (10-year DSS, 96% vs 97%; P=.72), or PSAF (10-year PSAF, 53% vs 55%; P=.99) between groups.
LTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer hormonal therapy is worth testing in the intermediate-risk prostate cancer subset. Purpose NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) <20 ng/mL, with benefit observed mostly among intermediate-risk patients. It was still unknown whether intermediate-risk patients would experience an additional survival benefit with LTAD; thus, we performed a secondary analysis to explore whether LTAD had any incremental benefit beyond STAD among the intermediate-risk subset of RTOG 9202. The study endpoints were OS, disease-specific survival (DSS), and PSA failure (PSAF). Methods and Materials An analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA<10 ng/mL, and Gleason score = 7 or cT2 disease, PSA 10-20 ng/mL, and Gleason score <7). This review yielded 133 patients: 74 (STAD) and 59 (LTAD). The Kaplan-Meier method was used to estimate OS; the cumulative incidence approach was used to estimate DSS and PSAF. A 2-sided test was used, with significance level defined to be .05. Results With over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P =.53), DSS (10-year DSS, 96% vs 97%; P =.72), or PSAF (10-year PSAF, 53% vs 55%; P =.99) between groups. Conclusion LTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer hormonal therapy is worth testing in the intermediate-risk prostate cancer subset. NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) <20 ng/mL, with benefit observed mostly among intermediate-risk patients. It was still unknown whether intermediate-risk patients would experience an additional survival benefit with LTAD; thus, we performed a secondary analysis to explore whether LTAD had any incremental benefit beyond STAD among the intermediate-risk subset of RTOG 9202. The study endpoints were OS, disease-specific survival (DSS), and PSA failure (PSAF).PURPOSENRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) <20 ng/mL, with benefit observed mostly among intermediate-risk patients. It was still unknown whether intermediate-risk patients would experience an additional survival benefit with LTAD; thus, we performed a secondary analysis to explore whether LTAD had any incremental benefit beyond STAD among the intermediate-risk subset of RTOG 9202. The study endpoints were OS, disease-specific survival (DSS), and PSA failure (PSAF).An analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA<10 ng/mL, and Gleason score = 7 or cT2 disease, PSA 10-20 ng/mL, and Gleason score <7). This review yielded 133 patients: 74 (STAD) and 59 (LTAD). The Kaplan-Meier method was used to estimate OS; the cumulative incidence approach was used to estimate DSS and PSAF. A 2-sided test was used, with significance level defined to be .05.METHODS AND MATERIALSAn analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA<10 ng/mL, and Gleason score = 7 or cT2 disease, PSA 10-20 ng/mL, and Gleason score <7). This review yielded 133 patients: 74 (STAD) and 59 (LTAD). The Kaplan-Meier method was used to estimate OS; the cumulative incidence approach was used to estimate DSS and PSAF. A 2-sided test was used, with significance level defined to be .05.With over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P=.53), DSS (10-year DSS, 96% vs 97%; P=.72), or PSAF (10-year PSAF, 53% vs 55%; P=.99) between groups.RESULTSWith over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P=.53), DSS (10-year DSS, 96% vs 97%; P=.72), or PSAF (10-year PSAF, 53% vs 55%; P=.99) between groups.LTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer hormonal therapy is worth testing in the intermediate-risk prostate cancer subset.CONCLUSIONLTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer hormonal therapy is worth testing in the intermediate-risk prostate cancer subset. |
Author | Parliament, Matthew B. Zeitzer, Kenneth Zhang, Qiang Grignon, David J. Peters, Christopher A. Reznik, Robert S. Mirhadi, Amin J. Hanks, Gerald E. Rosenthal, Seth A. Radwan, John S. Lawton, Colleen Lepor, Herbert Sandler, Howard M. |
AuthorAffiliation | Fox Chase Cancer Center, Philadelphia, Pennsylvania Indiana University, Indianapolis, Indiana Northeast Radiation Oncology Center, Dunmore, Pennsylvania NYU Medical Center, New York, New York Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada Cedars-Sinai Medical Center, Los Angeles, California London Regional Cancer Program, London, Ontario, Canada NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania Medical College of Wisconsin, Milwaukee, Wisconsin Sutter General Hospital, Sacramento, California Albert Einstein Medical Center, Philadelphia, Pennsylvania |
AuthorAffiliation_xml | – name: NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania – name: Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada – name: Albert Einstein Medical Center, Philadelphia, Pennsylvania – name: NYU Medical Center, New York, New York – name: Fox Chase Cancer Center, Philadelphia, Pennsylvania – name: Sutter General Hospital, Sacramento, California – name: Medical College of Wisconsin, Milwaukee, Wisconsin – name: Cedars-Sinai Medical Center, Los Angeles, California – name: Indiana University, Indianapolis, Indiana – name: Northeast Radiation Oncology Center, Dunmore, Pennsylvania – name: London Regional Cancer Program, London, Ontario, Canada |
Author_xml | – sequence: 1 givenname: Amin J. surname: Mirhadi fullname: Mirhadi, Amin J. email: amin.mirhadi@cshs.org organization: Cedars-Sinai Medical Center, Los Angeles, California – sequence: 2 givenname: Qiang surname: Zhang fullname: Zhang, Qiang organization: NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania – sequence: 3 givenname: Gerald E. surname: Hanks fullname: Hanks, Gerald E. organization: Fox Chase Cancer Center, Philadelphia, Pennsylvania – sequence: 4 givenname: Herbert surname: Lepor fullname: Lepor, Herbert organization: NYU Medical Center, New York, New York – sequence: 5 givenname: David J. surname: Grignon fullname: Grignon, David J. organization: Indiana University, Indianapolis, Indiana – sequence: 6 givenname: Christopher A. surname: Peters fullname: Peters, Christopher A. organization: Northeast Radiation Oncology Center, Dunmore, Pennsylvania – sequence: 7 givenname: Seth A. surname: Rosenthal fullname: Rosenthal, Seth A. organization: Sutter General Hospital, Sacramento, California – sequence: 8 givenname: Kenneth surname: Zeitzer fullname: Zeitzer, Kenneth organization: Albert Einstein Medical Center, Philadelphia, Pennsylvania – sequence: 9 givenname: John S. surname: Radwan fullname: Radwan, John S. organization: London Regional Cancer Program, London, Ontario, Canada – sequence: 10 givenname: Colleen surname: Lawton fullname: Lawton, Colleen organization: Medical College of Wisconsin, Milwaukee, Wisconsin – sequence: 11 givenname: Matthew B. surname: Parliament fullname: Parliament, Matthew B. organization: Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada – sequence: 12 givenname: Robert S. surname: Reznik fullname: Reznik, Robert S. organization: Cedars-Sinai Medical Center, Los Angeles, California – sequence: 13 givenname: Howard M. surname: Sandler fullname: Sandler, Howard M. organization: Cedars-Sinai Medical Center, Los Angeles, California |
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Snippet | NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with... Purpose NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD)... |
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SubjectTerms | Adenocarcinoma Aged Aged, 80 and over Androgen Antagonists - therapeutic use Antineoplastic Agents, Hormonal - therapeutic use Combined Modality Therapy - methods Disease-Free Survival Drug Administration Schedule Hematology, Oncology and Palliative Medicine Humans Kaplan-Meier Estimate Male Middle Aged Neoplasm Grading Prostate-Specific Antigen - blood Prostatic Neoplasms - blood Prostatic Neoplasms - drug therapy Prostatic Neoplasms - mortality Prostatic Neoplasms - radiotherapy Radiology Radiotherapy, Conformal Retrospective Studies Risk Survival Rate Time Factors Treatment Outcome |
Title | Effect of Long-Term Hormonal Therapy (vs Short-Term Hormonal Therapy): A Secondary Analysis of Intermediate-Risk Prostate Cancer Patients Treated on NRG Oncology RTOG 9202 |
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