Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: An intergroup study

Charles W. Taylor, Stephanie Green, William S. Dalton, Silvana Martino, Dorothy Rector, James N. Ingle, Nicholas J. Robert, G. Thomas Budd, Jorge C. Paradelo, Ronald B. Natale, James D. Bearden, James A. Mailliard, C. Kent Osborne

Research output: Contribution to journalArticle

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Abstract

Purpose: To compare failure-free survival (FFS) and overall survival (OS) far patients with metastatic breast cancer treated with the gonadotropin-releasing hormone (GN-RH) agonist, goserelin versus surgical ovariectomy. Patients and Methods: Between August 1, 1987 and July 15, 1995 138 (136 eligible) premenopausal patients with estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive metastatic breast cancer were entered by the Southwest Oncology Group (SWOG), North Central Cancer Treatment Group (NCCTG), and Eastern Cooperative Oncology Group (ECOG). Prior chemotherapy or hormone therapy far metastatic disease was not allowed. Patients were randomly assigned to goserelin (3.6 mg subcutaneously every 4 weeks; (n = 69) versus surgical ovariectomy (n = 67). The study was initially designed as on equivalence trial with 80% power to rule out a 50% improvement in survival due to ovariectomy. However, accrual was slow and the study was terminated early, which resulted in a final power of 60% for the alternative hypothesis of equal survival distributions. Results: FFS and OS were similar for goserelin and ovariectomy. The goserelin/ovariectomy death hazards ratio was .80 and the associated 95% confidence interval (CI) was .53 to 1.20. The test of 50% improvement in survival due to ovariectomy was rejected at P = .006. Goserelin lowered serum estradiol to postmenopausal levels. Hot flashes (75% v 46%) and tumor flare (16% v 3%) were more common with goserelin. Conclusion: Goserelin and ovariectomy resulted in similar FFS and OS. We can rule out o moderate advantage for ovariectomy. Goserelin was safe and well tolerated.

Original languageEnglish (US)
Pages (from-to)994-999
Number of pages6
JournalJournal of Clinical Oncology
Volume16
Issue number3
StatePublished - Mar 1998
Externally publishedYes

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Goserelin
Ovariectomy
Randomized Controlled Trials
Breast Neoplasms
Survival
Hot Flashes
Progesterone Receptors
Gonadotropin-Releasing Hormone
Estrogen Receptors
Estradiol
Neoplasms
Hormones
Confidence Intervals

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer : An intergroup study. / Taylor, Charles W.; Green, Stephanie; Dalton, William S.; Martino, Silvana; Rector, Dorothy; Ingle, James N.; Robert, Nicholas J.; Budd, G. Thomas; Paradelo, Jorge C.; Natale, Ronald B.; Bearden, James D.; Mailliard, James A.; Osborne, C. Kent.

In: Journal of Clinical Oncology, Vol. 16, No. 3, 03.1998, p. 994-999.

Research output: Contribution to journalArticle

Taylor, CW, Green, S, Dalton, WS, Martino, S, Rector, D, Ingle, JN, Robert, NJ, Budd, GT, Paradelo, JC, Natale, RB, Bearden, JD, Mailliard, JA & Osborne, CK 1998, 'Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: An intergroup study', Journal of Clinical Oncology, vol. 16, no. 3, pp. 994-999.
Taylor, Charles W. ; Green, Stephanie ; Dalton, William S. ; Martino, Silvana ; Rector, Dorothy ; Ingle, James N. ; Robert, Nicholas J. ; Budd, G. Thomas ; Paradelo, Jorge C. ; Natale, Ronald B. ; Bearden, James D. ; Mailliard, James A. ; Osborne, C. Kent. / Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer : An intergroup study. In: Journal of Clinical Oncology. 1998 ; Vol. 16, No. 3. pp. 994-999.
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title = "Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: An intergroup study",
abstract = "Purpose: To compare failure-free survival (FFS) and overall survival (OS) far patients with metastatic breast cancer treated with the gonadotropin-releasing hormone (GN-RH) agonist, goserelin versus surgical ovariectomy. Patients and Methods: Between August 1, 1987 and July 15, 1995 138 (136 eligible) premenopausal patients with estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive metastatic breast cancer were entered by the Southwest Oncology Group (SWOG), North Central Cancer Treatment Group (NCCTG), and Eastern Cooperative Oncology Group (ECOG). Prior chemotherapy or hormone therapy far metastatic disease was not allowed. Patients were randomly assigned to goserelin (3.6 mg subcutaneously every 4 weeks; (n = 69) versus surgical ovariectomy (n = 67). The study was initially designed as on equivalence trial with 80{\%} power to rule out a 50{\%} improvement in survival due to ovariectomy. However, accrual was slow and the study was terminated early, which resulted in a final power of 60{\%} for the alternative hypothesis of equal survival distributions. Results: FFS and OS were similar for goserelin and ovariectomy. The goserelin/ovariectomy death hazards ratio was .80 and the associated 95{\%} confidence interval (CI) was .53 to 1.20. The test of 50{\%} improvement in survival due to ovariectomy was rejected at P = .006. Goserelin lowered serum estradiol to postmenopausal levels. Hot flashes (75{\%} v 46{\%}) and tumor flare (16{\%} v 3{\%}) were more common with goserelin. Conclusion: Goserelin and ovariectomy resulted in similar FFS and OS. We can rule out o moderate advantage for ovariectomy. Goserelin was safe and well tolerated.",
author = "Taylor, {Charles W.} and Stephanie Green and Dalton, {William S.} and Silvana Martino and Dorothy Rector and Ingle, {James N.} and Robert, {Nicholas J.} and Budd, {G. Thomas} and Paradelo, {Jorge C.} and Natale, {Ronald B.} and Bearden, {James D.} and Mailliard, {James A.} and Osborne, {C. Kent}",
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T1 - Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer

T2 - An intergroup study

AU - Taylor, Charles W.

AU - Green, Stephanie

AU - Dalton, William S.

AU - Martino, Silvana

AU - Rector, Dorothy

AU - Ingle, James N.

AU - Robert, Nicholas J.

AU - Budd, G. Thomas

AU - Paradelo, Jorge C.

AU - Natale, Ronald B.

AU - Bearden, James D.

AU - Mailliard, James A.

AU - Osborne, C. Kent

PY - 1998/3

Y1 - 1998/3

N2 - Purpose: To compare failure-free survival (FFS) and overall survival (OS) far patients with metastatic breast cancer treated with the gonadotropin-releasing hormone (GN-RH) agonist, goserelin versus surgical ovariectomy. Patients and Methods: Between August 1, 1987 and July 15, 1995 138 (136 eligible) premenopausal patients with estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive metastatic breast cancer were entered by the Southwest Oncology Group (SWOG), North Central Cancer Treatment Group (NCCTG), and Eastern Cooperative Oncology Group (ECOG). Prior chemotherapy or hormone therapy far metastatic disease was not allowed. Patients were randomly assigned to goserelin (3.6 mg subcutaneously every 4 weeks; (n = 69) versus surgical ovariectomy (n = 67). The study was initially designed as on equivalence trial with 80% power to rule out a 50% improvement in survival due to ovariectomy. However, accrual was slow and the study was terminated early, which resulted in a final power of 60% for the alternative hypothesis of equal survival distributions. Results: FFS and OS were similar for goserelin and ovariectomy. The goserelin/ovariectomy death hazards ratio was .80 and the associated 95% confidence interval (CI) was .53 to 1.20. The test of 50% improvement in survival due to ovariectomy was rejected at P = .006. Goserelin lowered serum estradiol to postmenopausal levels. Hot flashes (75% v 46%) and tumor flare (16% v 3%) were more common with goserelin. Conclusion: Goserelin and ovariectomy resulted in similar FFS and OS. We can rule out o moderate advantage for ovariectomy. Goserelin was safe and well tolerated.

AB - Purpose: To compare failure-free survival (FFS) and overall survival (OS) far patients with metastatic breast cancer treated with the gonadotropin-releasing hormone (GN-RH) agonist, goserelin versus surgical ovariectomy. Patients and Methods: Between August 1, 1987 and July 15, 1995 138 (136 eligible) premenopausal patients with estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive metastatic breast cancer were entered by the Southwest Oncology Group (SWOG), North Central Cancer Treatment Group (NCCTG), and Eastern Cooperative Oncology Group (ECOG). Prior chemotherapy or hormone therapy far metastatic disease was not allowed. Patients were randomly assigned to goserelin (3.6 mg subcutaneously every 4 weeks; (n = 69) versus surgical ovariectomy (n = 67). The study was initially designed as on equivalence trial with 80% power to rule out a 50% improvement in survival due to ovariectomy. However, accrual was slow and the study was terminated early, which resulted in a final power of 60% for the alternative hypothesis of equal survival distributions. Results: FFS and OS were similar for goserelin and ovariectomy. The goserelin/ovariectomy death hazards ratio was .80 and the associated 95% confidence interval (CI) was .53 to 1.20. The test of 50% improvement in survival due to ovariectomy was rejected at P = .006. Goserelin lowered serum estradiol to postmenopausal levels. Hot flashes (75% v 46%) and tumor flare (16% v 3%) were more common with goserelin. Conclusion: Goserelin and ovariectomy resulted in similar FFS and OS. We can rule out o moderate advantage for ovariectomy. Goserelin was safe and well tolerated.

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