Toremifene and tamoxifen are equally effective for early-stage breast cancer: First results of International Breast Cancer Study Group trials 12-93 and 14-93

O. Pagani, S. Gelber, E. Simoncini, M. Castiglione-Gertsch, K. Price, David Zahrieh, R. Gelber, A. Coates, A. Goldhirsch

Research output: Contribution to journalArticle

74 Citations (Scopus)

Abstract

Background: Toremifene is a chlorinated derivative of tamoxifen, developed to improve its risk-benefit profile. The International Breast Cancer Study Group (IBCSG) conducted two complementary randomized trials for peri- and postmenopausal patients with node-positive breast cancer to compare toremifene versus tamoxifen as the endocrine agent and simultaneously investigate a chemotherapy-oriented question. This is the first report of the endocrine comparison after a median follow-up of 5.5 years. Patients and methods: 1035 patients were available for analysis: 75% had estrogen receptor (ER)-positive primary tumors, the median number of involved axillary lymph nodes was three and 81% received prior adjuvant chemotherapy. Results: Toremifene and tamoxifen yielded similar disease-free (DFS) and overall survival (OS): 5-year DFS rates of 72% and 69%, respectively [risk ratio (RR)=0.95; 95% confidence interval (CI)=0.76-1.18]; 5-year OS rates of 85% and 81%, respectively (RR = 1.03; 95% CI = 0.78-1.36). Similar outcomes were observed in the ER-positive cohort. Toxicities were similar in the two treatment groups with very few women (<1%) experiencing severe thromboembolic or cerebrovascular complications. Quality of life results were also similar. Nine patients developed early stage endometrial cancer (toremifene, six; tamoxifen, three). Conclusions: Toremifene is a valid and safe alternative to tamoxifen in postmenopausal women with endocrine-responsive breast cancer.

Original languageEnglish (US)
Pages (from-to)1749-1758
Number of pages10
JournalAnnals of Oncology
Volume15
Issue number12
DOIs
StatePublished - Dec 1 2004
Externally publishedYes

Fingerprint

Toremifene
Tamoxifen
Breast Neoplasms
Estrogen Receptors
Odds Ratio
Confidence Intervals
Adjuvant Chemotherapy
Endometrial Neoplasms
Survival Rate
Lymph Nodes
Quality of Life
Drug Therapy
Survival
Neoplasms

Keywords

  • Adjuvant therapy
  • Early-stage breast cancer
  • Tamoxifen
  • Toremifene

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Toremifene and tamoxifen are equally effective for early-stage breast cancer : First results of International Breast Cancer Study Group trials 12-93 and 14-93. / Pagani, O.; Gelber, S.; Simoncini, E.; Castiglione-Gertsch, M.; Price, K.; Zahrieh, David; Gelber, R.; Coates, A.; Goldhirsch, A.

In: Annals of Oncology, Vol. 15, No. 12, 01.12.2004, p. 1749-1758.

Research output: Contribution to journalArticle

Pagani, O, Gelber, S, Simoncini, E, Castiglione-Gertsch, M, Price, K, Zahrieh, D, Gelber, R, Coates, A & Goldhirsch, A 2004, 'Toremifene and tamoxifen are equally effective for early-stage breast cancer: First results of International Breast Cancer Study Group trials 12-93 and 14-93', Annals of Oncology, vol. 15, no. 12, pp. 1749-1758. https://doi.org/10.1093/annonc/mdh463
Pagani, O. ; Gelber, S. ; Simoncini, E. ; Castiglione-Gertsch, M. ; Price, K. ; Zahrieh, David ; Gelber, R. ; Coates, A. ; Goldhirsch, A. / Toremifene and tamoxifen are equally effective for early-stage breast cancer : First results of International Breast Cancer Study Group trials 12-93 and 14-93. In: Annals of Oncology. 2004 ; Vol. 15, No. 12. pp. 1749-1758.
@article{3758e58c642e4c13b777c7ca458caa4a,
title = "Toremifene and tamoxifen are equally effective for early-stage breast cancer: First results of International Breast Cancer Study Group trials 12-93 and 14-93",
abstract = "Background: Toremifene is a chlorinated derivative of tamoxifen, developed to improve its risk-benefit profile. The International Breast Cancer Study Group (IBCSG) conducted two complementary randomized trials for peri- and postmenopausal patients with node-positive breast cancer to compare toremifene versus tamoxifen as the endocrine agent and simultaneously investigate a chemotherapy-oriented question. This is the first report of the endocrine comparison after a median follow-up of 5.5 years. Patients and methods: 1035 patients were available for analysis: 75{\%} had estrogen receptor (ER)-positive primary tumors, the median number of involved axillary lymph nodes was three and 81{\%} received prior adjuvant chemotherapy. Results: Toremifene and tamoxifen yielded similar disease-free (DFS) and overall survival (OS): 5-year DFS rates of 72{\%} and 69{\%}, respectively [risk ratio (RR)=0.95; 95{\%} confidence interval (CI)=0.76-1.18]; 5-year OS rates of 85{\%} and 81{\%}, respectively (RR = 1.03; 95{\%} CI = 0.78-1.36). Similar outcomes were observed in the ER-positive cohort. Toxicities were similar in the two treatment groups with very few women (<1{\%}) experiencing severe thromboembolic or cerebrovascular complications. Quality of life results were also similar. Nine patients developed early stage endometrial cancer (toremifene, six; tamoxifen, three). Conclusions: Toremifene is a valid and safe alternative to tamoxifen in postmenopausal women with endocrine-responsive breast cancer.",
keywords = "Adjuvant therapy, Early-stage breast cancer, Tamoxifen, Toremifene",
author = "O. Pagani and S. Gelber and E. Simoncini and M. Castiglione-Gertsch and K. Price and David Zahrieh and R. Gelber and A. Coates and A. Goldhirsch",
year = "2004",
month = "12",
day = "1",
doi = "10.1093/annonc/mdh463",
language = "English (US)",
volume = "15",
pages = "1749--1758",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "12",

}

TY - JOUR

T1 - Toremifene and tamoxifen are equally effective for early-stage breast cancer

T2 - First results of International Breast Cancer Study Group trials 12-93 and 14-93

AU - Pagani, O.

AU - Gelber, S.

AU - Simoncini, E.

AU - Castiglione-Gertsch, M.

AU - Price, K.

AU - Zahrieh, David

AU - Gelber, R.

AU - Coates, A.

AU - Goldhirsch, A.

PY - 2004/12/1

Y1 - 2004/12/1

N2 - Background: Toremifene is a chlorinated derivative of tamoxifen, developed to improve its risk-benefit profile. The International Breast Cancer Study Group (IBCSG) conducted two complementary randomized trials for peri- and postmenopausal patients with node-positive breast cancer to compare toremifene versus tamoxifen as the endocrine agent and simultaneously investigate a chemotherapy-oriented question. This is the first report of the endocrine comparison after a median follow-up of 5.5 years. Patients and methods: 1035 patients were available for analysis: 75% had estrogen receptor (ER)-positive primary tumors, the median number of involved axillary lymph nodes was three and 81% received prior adjuvant chemotherapy. Results: Toremifene and tamoxifen yielded similar disease-free (DFS) and overall survival (OS): 5-year DFS rates of 72% and 69%, respectively [risk ratio (RR)=0.95; 95% confidence interval (CI)=0.76-1.18]; 5-year OS rates of 85% and 81%, respectively (RR = 1.03; 95% CI = 0.78-1.36). Similar outcomes were observed in the ER-positive cohort. Toxicities were similar in the two treatment groups with very few women (<1%) experiencing severe thromboembolic or cerebrovascular complications. Quality of life results were also similar. Nine patients developed early stage endometrial cancer (toremifene, six; tamoxifen, three). Conclusions: Toremifene is a valid and safe alternative to tamoxifen in postmenopausal women with endocrine-responsive breast cancer.

AB - Background: Toremifene is a chlorinated derivative of tamoxifen, developed to improve its risk-benefit profile. The International Breast Cancer Study Group (IBCSG) conducted two complementary randomized trials for peri- and postmenopausal patients with node-positive breast cancer to compare toremifene versus tamoxifen as the endocrine agent and simultaneously investigate a chemotherapy-oriented question. This is the first report of the endocrine comparison after a median follow-up of 5.5 years. Patients and methods: 1035 patients were available for analysis: 75% had estrogen receptor (ER)-positive primary tumors, the median number of involved axillary lymph nodes was three and 81% received prior adjuvant chemotherapy. Results: Toremifene and tamoxifen yielded similar disease-free (DFS) and overall survival (OS): 5-year DFS rates of 72% and 69%, respectively [risk ratio (RR)=0.95; 95% confidence interval (CI)=0.76-1.18]; 5-year OS rates of 85% and 81%, respectively (RR = 1.03; 95% CI = 0.78-1.36). Similar outcomes were observed in the ER-positive cohort. Toxicities were similar in the two treatment groups with very few women (<1%) experiencing severe thromboembolic or cerebrovascular complications. Quality of life results were also similar. Nine patients developed early stage endometrial cancer (toremifene, six; tamoxifen, three). Conclusions: Toremifene is a valid and safe alternative to tamoxifen in postmenopausal women with endocrine-responsive breast cancer.

KW - Adjuvant therapy

KW - Early-stage breast cancer

KW - Tamoxifen

KW - Toremifene

UR - http://www.scopus.com/inward/record.url?scp=10944221233&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=10944221233&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdh463

DO - 10.1093/annonc/mdh463

M3 - Article

C2 - 15550579

AN - SCOPUS:10944221233

VL - 15

SP - 1749

EP - 1758

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 12

ER -