Phase III trial of androgen suppression using goserelin in unfavorable- prognosis carcinoma of the prostate treated with definitive radiotherapy: Report of Radiation Therapy Oncology Group protocol 85-31

M. V. Pilepich, R. Caplan, R. W. Byhardt, C. A. Lawton, M. J. Gallagher, J. B. Mesic, G. E. Hanks, C. T. Coughlin, A. Porter, W. U. Shipley, David Grignon

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Abstract

Purpose: Although androgen suppression results in a tumor response/remission in the majority of patients with carcinoma of the prostate, its potential value as an adjuvant has not been substantiated. Materials and Methods: In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate. A total of 977 patients had been accessioned to the study. Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm. Results: Actuarial projections show that at 5 years, 84% of patients on the adjuvant goserelin arm and 71% on the observation arm remain without evidence of local recurrence (P <.0001). The corresponding figures for freedom from distant metastases and disease-free survival are 83% versus 70% (P <.001) and 60% and 44% (P <.0001). If prostate-specific antigen (PSA) level greater than 1.5 ng is included as a failure (after ≤ 1 year), the 5- year disease-free survival rate on the adjuvant goserelin arm is 53% versus 20% on the observation arm (P <.0001). The 5-year survival rate (for the entire population) is 75% on the adjuvant arm versus 71% an the observation arm (P = .52). However, in patients with centrally reviewed tumors with a Gleason score of 8 to 10, the difference in actuarial 5-year survival (66% on the adjuvant goserelin arm v 55% on the observation arm) reaches statistical significance (P = .03). Conclusion: Application of androgen suppression as an adjuvant to definitive radiotherapy has been associated with a highly significant improvement in local control and freedom from disease progression. At this point, with a median follow-up time of 4.5 years, a significant improvement in survival has been observed only in patients with centrally reviewed tumors with a Gleason score of 8 to 10.

Original languageEnglish (US)
Pages (from-to)1013-1021
Number of pages9
JournalJournal of Clinical Oncology
Volume15
Issue number3
StatePublished - Mar 1997
Externally publishedYes

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Goserelin
Radiation Oncology
Androgens
Prostate
Radiotherapy
Carcinoma
Observation
Neoplasm Grading
Disease-Free Survival
Survival Rate
Neoplasms
Survival
Prostate-Specific Antigen
Disease Progression
Neoplasm Metastasis
Recurrence
Population

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III trial of androgen suppression using goserelin in unfavorable- prognosis carcinoma of the prostate treated with definitive radiotherapy : Report of Radiation Therapy Oncology Group protocol 85-31. / Pilepich, M. V.; Caplan, R.; Byhardt, R. W.; Lawton, C. A.; Gallagher, M. J.; Mesic, J. B.; Hanks, G. E.; Coughlin, C. T.; Porter, A.; Shipley, W. U.; Grignon, David.

In: Journal of Clinical Oncology, Vol. 15, No. 3, 03.1997, p. 1013-1021.

Research output: Contribution to journalArticle

Pilepich, MV, Caplan, R, Byhardt, RW, Lawton, CA, Gallagher, MJ, Mesic, JB, Hanks, GE, Coughlin, CT, Porter, A, Shipley, WU & Grignon, D 1997, 'Phase III trial of androgen suppression using goserelin in unfavorable- prognosis carcinoma of the prostate treated with definitive radiotherapy: Report of Radiation Therapy Oncology Group protocol 85-31', Journal of Clinical Oncology, vol. 15, no. 3, pp. 1013-1021.
Pilepich, M. V. ; Caplan, R. ; Byhardt, R. W. ; Lawton, C. A. ; Gallagher, M. J. ; Mesic, J. B. ; Hanks, G. E. ; Coughlin, C. T. ; Porter, A. ; Shipley, W. U. ; Grignon, David. / Phase III trial of androgen suppression using goserelin in unfavorable- prognosis carcinoma of the prostate treated with definitive radiotherapy : Report of Radiation Therapy Oncology Group protocol 85-31. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 3. pp. 1013-1021.
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abstract = "Purpose: Although androgen suppression results in a tumor response/remission in the majority of patients with carcinoma of the prostate, its potential value as an adjuvant has not been substantiated. Materials and Methods: In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate. A total of 977 patients had been accessioned to the study. Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm. Results: Actuarial projections show that at 5 years, 84{\%} of patients on the adjuvant goserelin arm and 71{\%} on the observation arm remain without evidence of local recurrence (P <.0001). The corresponding figures for freedom from distant metastases and disease-free survival are 83{\%} versus 70{\%} (P <.001) and 60{\%} and 44{\%} (P <.0001). If prostate-specific antigen (PSA) level greater than 1.5 ng is included as a failure (after ≤ 1 year), the 5- year disease-free survival rate on the adjuvant goserelin arm is 53{\%} versus 20{\%} on the observation arm (P <.0001). The 5-year survival rate (for the entire population) is 75{\%} on the adjuvant arm versus 71{\%} an the observation arm (P = .52). However, in patients with centrally reviewed tumors with a Gleason score of 8 to 10, the difference in actuarial 5-year survival (66{\%} on the adjuvant goserelin arm v 55{\%} on the observation arm) reaches statistical significance (P = .03). Conclusion: Application of androgen suppression as an adjuvant to definitive radiotherapy has been associated with a highly significant improvement in local control and freedom from disease progression. At this point, with a median follow-up time of 4.5 years, a significant improvement in survival has been observed only in patients with centrally reviewed tumors with a Gleason score of 8 to 10.",
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T1 - Phase III trial of androgen suppression using goserelin in unfavorable- prognosis carcinoma of the prostate treated with definitive radiotherapy

T2 - Report of Radiation Therapy Oncology Group protocol 85-31

AU - Pilepich, M. V.

AU - Caplan, R.

AU - Byhardt, R. W.

AU - Lawton, C. A.

AU - Gallagher, M. J.

AU - Mesic, J. B.

AU - Hanks, G. E.

AU - Coughlin, C. T.

AU - Porter, A.

AU - Shipley, W. U.

AU - Grignon, David

PY - 1997/3

Y1 - 1997/3

N2 - Purpose: Although androgen suppression results in a tumor response/remission in the majority of patients with carcinoma of the prostate, its potential value as an adjuvant has not been substantiated. Materials and Methods: In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate. A total of 977 patients had been accessioned to the study. Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm. Results: Actuarial projections show that at 5 years, 84% of patients on the adjuvant goserelin arm and 71% on the observation arm remain without evidence of local recurrence (P <.0001). The corresponding figures for freedom from distant metastases and disease-free survival are 83% versus 70% (P <.001) and 60% and 44% (P <.0001). If prostate-specific antigen (PSA) level greater than 1.5 ng is included as a failure (after ≤ 1 year), the 5- year disease-free survival rate on the adjuvant goserelin arm is 53% versus 20% on the observation arm (P <.0001). The 5-year survival rate (for the entire population) is 75% on the adjuvant arm versus 71% an the observation arm (P = .52). However, in patients with centrally reviewed tumors with a Gleason score of 8 to 10, the difference in actuarial 5-year survival (66% on the adjuvant goserelin arm v 55% on the observation arm) reaches statistical significance (P = .03). Conclusion: Application of androgen suppression as an adjuvant to definitive radiotherapy has been associated with a highly significant improvement in local control and freedom from disease progression. At this point, with a median follow-up time of 4.5 years, a significant improvement in survival has been observed only in patients with centrally reviewed tumors with a Gleason score of 8 to 10.

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