Italian randomized trial among women with hysterectomy

Tamoxifen and hormone-dependent breast cancer in high-risk women

Umberto Veronesi, Patrick Maisonneuve, Nicole Rotmensz, Alberto Costa, Virgilio Sachhini, Roberto Travaglini, Giuseppe D'Aiuto, Francesco Lovison, Giacomo Gucciardo, Maria Grazia Muraca, Maria Antonietta Pizzichetta, Serafino Conforti, Andrea Decensi, Chris Robertson, Peter Boyle

Research output: Contribution to journalArticle

134 Citations (Scopus)

Abstract

Tamoxifen improves outcome in women with breast cancer and reduces the incidence of estrogen receptor-positive (ER+) breast tumors in prevention trials. Tamoxifen use is associated with an increased risk of potentially serious adverse events, principally endometrial cancer and venous thromboembolic events and, therefore, detailed knowledge of the effects of tamoxifen is important. With more cases of breast cancer being found as the follow-up time increases, it is now possible to perform more detailed analysis of the Italian Randomized Trial of Tamoxifen. Women with hysterectomy (N = 5408) were randomly assigned to receive 20 mg tamoxifen per day (N = 2700) or placebo (N = 2708). After a median of 81.2 months of follow-up, 79 case subjects (34 in the tamoxifen arm and 45 in the placebo arm) were diagnosed with breast cancer. We were able to identify a group of women at increased risk of ER+ breast cancers (high-risk group) on the basis of baseline as well as reproductive and hormonal characteristics (height, age at menarche, parity, age at first birth, and oophorectomy). Tamoxifen administered to women in the high-risk group showed statistically significantly reduced incidence of breast cancer (tamoxifen, 3 and placebo, 15; P = .003), but no such effect was seen in the low-risk group (tamoxifen, 31 and placebo, 30; P = .89). The positive effect of tamoxifen on breast cancer among high-risk women is most marked for ER+ tumors (tamoxifen, 1 and placebo, 11; P = .002). Chemoprevention of breast cancer with tamoxifen appears to be effective in women at high risk of ER+ tumors but not among women at low risk, who may well be protected naturally by late age at menarche or early first pregnancy, or artificially by removal of the ovaries. Tamoxifen could be offered as a preventive agent to women identified at high-risk of breast cancer because of hormone-related risk factors. Such a strategy would greatly reduce the numbers of women who would need to take tamoxifen to obtain the same absolute reduction in breast cancer. These findings are exploratory and need to be confirmed in other randomized trials.

Original languageEnglish
Pages (from-to)160-165
Number of pages6
JournalJournal of the National Cancer Institute
Volume95
Issue number2
Publication statusPublished - Jan 15 2003

Fingerprint

Tamoxifen
Hysterectomy
Hormones
Breast Neoplasms
Placebos
Menarche
Birth Order
Incidence
Chemoprevention
Ovariectomy
Endometrial Neoplasms
Parity
Estrogen Receptors
Ovary
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Italian randomized trial among women with hysterectomy : Tamoxifen and hormone-dependent breast cancer in high-risk women. / Veronesi, Umberto; Maisonneuve, Patrick; Rotmensz, Nicole; Costa, Alberto; Sachhini, Virgilio; Travaglini, Roberto; D'Aiuto, Giuseppe; Lovison, Francesco; Gucciardo, Giacomo; Muraca, Maria Grazia; Pizzichetta, Maria Antonietta; Conforti, Serafino; Decensi, Andrea; Robertson, Chris; Boyle, Peter.

In: Journal of the National Cancer Institute, Vol. 95, No. 2, 15.01.2003, p. 160-165.

Research output: Contribution to journalArticle

Veronesi, U, Maisonneuve, P, Rotmensz, N, Costa, A, Sachhini, V, Travaglini, R, D'Aiuto, G, Lovison, F, Gucciardo, G, Muraca, MG, Pizzichetta, MA, Conforti, S, Decensi, A, Robertson, C & Boyle, P 2003, 'Italian randomized trial among women with hysterectomy: Tamoxifen and hormone-dependent breast cancer in high-risk women', Journal of the National Cancer Institute, vol. 95, no. 2, pp. 160-165.
Veronesi, Umberto ; Maisonneuve, Patrick ; Rotmensz, Nicole ; Costa, Alberto ; Sachhini, Virgilio ; Travaglini, Roberto ; D'Aiuto, Giuseppe ; Lovison, Francesco ; Gucciardo, Giacomo ; Muraca, Maria Grazia ; Pizzichetta, Maria Antonietta ; Conforti, Serafino ; Decensi, Andrea ; Robertson, Chris ; Boyle, Peter. / Italian randomized trial among women with hysterectomy : Tamoxifen and hormone-dependent breast cancer in high-risk women. In: Journal of the National Cancer Institute. 2003 ; Vol. 95, No. 2. pp. 160-165.
@article{416129feac5c4fcbbf96ddbb285c5033,
title = "Italian randomized trial among women with hysterectomy: Tamoxifen and hormone-dependent breast cancer in high-risk women",
abstract = "Tamoxifen improves outcome in women with breast cancer and reduces the incidence of estrogen receptor-positive (ER+) breast tumors in prevention trials. Tamoxifen use is associated with an increased risk of potentially serious adverse events, principally endometrial cancer and venous thromboembolic events and, therefore, detailed knowledge of the effects of tamoxifen is important. With more cases of breast cancer being found as the follow-up time increases, it is now possible to perform more detailed analysis of the Italian Randomized Trial of Tamoxifen. Women with hysterectomy (N = 5408) were randomly assigned to receive 20 mg tamoxifen per day (N = 2700) or placebo (N = 2708). After a median of 81.2 months of follow-up, 79 case subjects (34 in the tamoxifen arm and 45 in the placebo arm) were diagnosed with breast cancer. We were able to identify a group of women at increased risk of ER+ breast cancers (high-risk group) on the basis of baseline as well as reproductive and hormonal characteristics (height, age at menarche, parity, age at first birth, and oophorectomy). Tamoxifen administered to women in the high-risk group showed statistically significantly reduced incidence of breast cancer (tamoxifen, 3 and placebo, 15; P = .003), but no such effect was seen in the low-risk group (tamoxifen, 31 and placebo, 30; P = .89). The positive effect of tamoxifen on breast cancer among high-risk women is most marked for ER+ tumors (tamoxifen, 1 and placebo, 11; P = .002). Chemoprevention of breast cancer with tamoxifen appears to be effective in women at high risk of ER+ tumors but not among women at low risk, who may well be protected naturally by late age at menarche or early first pregnancy, or artificially by removal of the ovaries. Tamoxifen could be offered as a preventive agent to women identified at high-risk of breast cancer because of hormone-related risk factors. Such a strategy would greatly reduce the numbers of women who would need to take tamoxifen to obtain the same absolute reduction in breast cancer. These findings are exploratory and need to be confirmed in other randomized trials.",
author = "Umberto Veronesi and Patrick Maisonneuve and Nicole Rotmensz and Alberto Costa and Virgilio Sachhini and Roberto Travaglini and Giuseppe D'Aiuto and Francesco Lovison and Giacomo Gucciardo and Muraca, {Maria Grazia} and Pizzichetta, {Maria Antonietta} and Serafino Conforti and Andrea Decensi and Chris Robertson and Peter Boyle",
year = "2003",
month = "1",
day = "15",
language = "English",
volume = "95",
pages = "160--165",
journal = "Journal of the National Cancer Institute",
issn = "0027-8874",
publisher = "Oxford University Press",
number = "2",

}

TY - JOUR

T1 - Italian randomized trial among women with hysterectomy

T2 - Tamoxifen and hormone-dependent breast cancer in high-risk women

AU - Veronesi, Umberto

AU - Maisonneuve, Patrick

AU - Rotmensz, Nicole

AU - Costa, Alberto

AU - Sachhini, Virgilio

AU - Travaglini, Roberto

AU - D'Aiuto, Giuseppe

AU - Lovison, Francesco

AU - Gucciardo, Giacomo

AU - Muraca, Maria Grazia

AU - Pizzichetta, Maria Antonietta

AU - Conforti, Serafino

AU - Decensi, Andrea

AU - Robertson, Chris

AU - Boyle, Peter

PY - 2003/1/15

Y1 - 2003/1/15

N2 - Tamoxifen improves outcome in women with breast cancer and reduces the incidence of estrogen receptor-positive (ER+) breast tumors in prevention trials. Tamoxifen use is associated with an increased risk of potentially serious adverse events, principally endometrial cancer and venous thromboembolic events and, therefore, detailed knowledge of the effects of tamoxifen is important. With more cases of breast cancer being found as the follow-up time increases, it is now possible to perform more detailed analysis of the Italian Randomized Trial of Tamoxifen. Women with hysterectomy (N = 5408) were randomly assigned to receive 20 mg tamoxifen per day (N = 2700) or placebo (N = 2708). After a median of 81.2 months of follow-up, 79 case subjects (34 in the tamoxifen arm and 45 in the placebo arm) were diagnosed with breast cancer. We were able to identify a group of women at increased risk of ER+ breast cancers (high-risk group) on the basis of baseline as well as reproductive and hormonal characteristics (height, age at menarche, parity, age at first birth, and oophorectomy). Tamoxifen administered to women in the high-risk group showed statistically significantly reduced incidence of breast cancer (tamoxifen, 3 and placebo, 15; P = .003), but no such effect was seen in the low-risk group (tamoxifen, 31 and placebo, 30; P = .89). The positive effect of tamoxifen on breast cancer among high-risk women is most marked for ER+ tumors (tamoxifen, 1 and placebo, 11; P = .002). Chemoprevention of breast cancer with tamoxifen appears to be effective in women at high risk of ER+ tumors but not among women at low risk, who may well be protected naturally by late age at menarche or early first pregnancy, or artificially by removal of the ovaries. Tamoxifen could be offered as a preventive agent to women identified at high-risk of breast cancer because of hormone-related risk factors. Such a strategy would greatly reduce the numbers of women who would need to take tamoxifen to obtain the same absolute reduction in breast cancer. These findings are exploratory and need to be confirmed in other randomized trials.

AB - Tamoxifen improves outcome in women with breast cancer and reduces the incidence of estrogen receptor-positive (ER+) breast tumors in prevention trials. Tamoxifen use is associated with an increased risk of potentially serious adverse events, principally endometrial cancer and venous thromboembolic events and, therefore, detailed knowledge of the effects of tamoxifen is important. With more cases of breast cancer being found as the follow-up time increases, it is now possible to perform more detailed analysis of the Italian Randomized Trial of Tamoxifen. Women with hysterectomy (N = 5408) were randomly assigned to receive 20 mg tamoxifen per day (N = 2700) or placebo (N = 2708). After a median of 81.2 months of follow-up, 79 case subjects (34 in the tamoxifen arm and 45 in the placebo arm) were diagnosed with breast cancer. We were able to identify a group of women at increased risk of ER+ breast cancers (high-risk group) on the basis of baseline as well as reproductive and hormonal characteristics (height, age at menarche, parity, age at first birth, and oophorectomy). Tamoxifen administered to women in the high-risk group showed statistically significantly reduced incidence of breast cancer (tamoxifen, 3 and placebo, 15; P = .003), but no such effect was seen in the low-risk group (tamoxifen, 31 and placebo, 30; P = .89). The positive effect of tamoxifen on breast cancer among high-risk women is most marked for ER+ tumors (tamoxifen, 1 and placebo, 11; P = .002). Chemoprevention of breast cancer with tamoxifen appears to be effective in women at high risk of ER+ tumors but not among women at low risk, who may well be protected naturally by late age at menarche or early first pregnancy, or artificially by removal of the ovaries. Tamoxifen could be offered as a preventive agent to women identified at high-risk of breast cancer because of hormone-related risk factors. Such a strategy would greatly reduce the numbers of women who would need to take tamoxifen to obtain the same absolute reduction in breast cancer. These findings are exploratory and need to be confirmed in other randomized trials.

UR - http://www.scopus.com/inward/record.url?scp=20244363902&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=20244363902&partnerID=8YFLogxK

M3 - Article

VL - 95

SP - 160

EP - 165

JO - Journal of the National Cancer Institute

JF - Journal of the National Cancer Institute

SN - 0027-8874

IS - 2

ER -