Abstract
The Italian Tamoxifen Prevention Study includes 5408 healthy hysterectomized women aged 35-70 years who have been randomized to 20 mg/day of tamoxifen or placebo for 5 years. After 46 months median follow-up, an increased risk of venous vascular events (38 women on tamoxifen vs. 18 women on placebo, P = 0.0053), mainly consisting of superficial phlebitis, has been observed and 41 breast cancers have occurred (19 on tamoxifen vs. 22 on placebo, P = 0.64). However, subgroup analyses indicated a borderline significant reduction of breast cancer among women continuously on estrogen replacement therapy (ERT, mostly transdermal) and receiving tamoxifen, with 8 cases of breast cancer among 390 ERT users on placebo versus 1 case among 362 ERT users on tamoxifen (RR = 0.13, 95% CI = 0.02-1.02). Withdrawal rate (mainly due to menopausal symptoms) differed according to ERT use, with compliance being 78% and 75% at 3 and 5 years, respectively, for women who never took ERT, and 92% and 88% at 3 and 5 years, respectively, for women not on ERT at baseline, but who took ERT at some time during the trial. Pharmacokinetic and pharmacodynamic (surrogate end point biomarkers) studies showed that a lower dose of tamoxifen (such as 5 mg/day) does not affect the drug's activity on several biomarkers of both cardiovascular and breast cancer risk. We are therefore planning a multicenter placebo-controlled phase III trial in postmenopausal healthy women on hormone replacement therapy (HRT) to test whether the combination of HRT and low-dose tamoxifen retains the benefits while reducing the risks of either agent maintaining a high compliance rate.
| Original language | English |
|---|---|
| Pages (from-to) | 113-122 |
| Number of pages | 10 |
| Journal | Annals of the New York Academy of Sciences |
| Volume | 949 |
| Publication status | Published - 2001 |
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Keywords
- Breast cancer prevention
- Estrogen replacement therapy (ERT)
- Selective estrogen receptor modulator (SERM)
- Tamoxifen
ASJC Scopus subject areas
- Biochemistry, Genetics and Molecular Biology(all)
Cite this
The Italian breast cancer prevention trial with tamoxifen : Findings and new perspectives. / Guerrieri-Gonzaga, Aliana; Galli, Arianna; Rotmensz, Nicole; Decensi, Andrea.
In: Annals of the New York Academy of Sciences, Vol. 949, 2001, p. 113-122.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The Italian breast cancer prevention trial with tamoxifen
T2 - Findings and new perspectives
AU - Guerrieri-Gonzaga, Aliana
AU - Galli, Arianna
AU - Rotmensz, Nicole
AU - Decensi, Andrea
PY - 2001
Y1 - 2001
N2 - The Italian Tamoxifen Prevention Study includes 5408 healthy hysterectomized women aged 35-70 years who have been randomized to 20 mg/day of tamoxifen or placebo for 5 years. After 46 months median follow-up, an increased risk of venous vascular events (38 women on tamoxifen vs. 18 women on placebo, P = 0.0053), mainly consisting of superficial phlebitis, has been observed and 41 breast cancers have occurred (19 on tamoxifen vs. 22 on placebo, P = 0.64). However, subgroup analyses indicated a borderline significant reduction of breast cancer among women continuously on estrogen replacement therapy (ERT, mostly transdermal) and receiving tamoxifen, with 8 cases of breast cancer among 390 ERT users on placebo versus 1 case among 362 ERT users on tamoxifen (RR = 0.13, 95% CI = 0.02-1.02). Withdrawal rate (mainly due to menopausal symptoms) differed according to ERT use, with compliance being 78% and 75% at 3 and 5 years, respectively, for women who never took ERT, and 92% and 88% at 3 and 5 years, respectively, for women not on ERT at baseline, but who took ERT at some time during the trial. Pharmacokinetic and pharmacodynamic (surrogate end point biomarkers) studies showed that a lower dose of tamoxifen (such as 5 mg/day) does not affect the drug's activity on several biomarkers of both cardiovascular and breast cancer risk. We are therefore planning a multicenter placebo-controlled phase III trial in postmenopausal healthy women on hormone replacement therapy (HRT) to test whether the combination of HRT and low-dose tamoxifen retains the benefits while reducing the risks of either agent maintaining a high compliance rate.
AB - The Italian Tamoxifen Prevention Study includes 5408 healthy hysterectomized women aged 35-70 years who have been randomized to 20 mg/day of tamoxifen or placebo for 5 years. After 46 months median follow-up, an increased risk of venous vascular events (38 women on tamoxifen vs. 18 women on placebo, P = 0.0053), mainly consisting of superficial phlebitis, has been observed and 41 breast cancers have occurred (19 on tamoxifen vs. 22 on placebo, P = 0.64). However, subgroup analyses indicated a borderline significant reduction of breast cancer among women continuously on estrogen replacement therapy (ERT, mostly transdermal) and receiving tamoxifen, with 8 cases of breast cancer among 390 ERT users on placebo versus 1 case among 362 ERT users on tamoxifen (RR = 0.13, 95% CI = 0.02-1.02). Withdrawal rate (mainly due to menopausal symptoms) differed according to ERT use, with compliance being 78% and 75% at 3 and 5 years, respectively, for women who never took ERT, and 92% and 88% at 3 and 5 years, respectively, for women not on ERT at baseline, but who took ERT at some time during the trial. Pharmacokinetic and pharmacodynamic (surrogate end point biomarkers) studies showed that a lower dose of tamoxifen (such as 5 mg/day) does not affect the drug's activity on several biomarkers of both cardiovascular and breast cancer risk. We are therefore planning a multicenter placebo-controlled phase III trial in postmenopausal healthy women on hormone replacement therapy (HRT) to test whether the combination of HRT and low-dose tamoxifen retains the benefits while reducing the risks of either agent maintaining a high compliance rate.
KW - Breast cancer prevention
KW - Estrogen replacement therapy (ERT)
KW - Selective estrogen receptor modulator (SERM)
KW - Tamoxifen
UR - http://www.scopus.com/inward/record.url?scp=0035684089&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0035684089&partnerID=8YFLogxK
M3 - Article
C2 - 11795343
AN - SCOPUS:0035684089
VL - 949
SP - 113
EP - 122
JO - Annals of the New York Academy of Sciences
JF - Annals of the New York Academy of Sciences
SN - 0077-8923
ER -