Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the suppression of ovarian function trial (SOFT): The SOFT-EST substudy

Meritxell Bellet, Kathryn P. Gray, Prudence A. Francis, I. Láng, Eva Ciruelos, Ana Lluch, Miguel Angel Climent, Gustavo Catalán, Antoni Avella, Uriel Bohn, Antonio González-Martin, Roser Ferrer, Roberto Catalán, Analía Azaro, Agnita Rajasekaran, Josefa Morales, Josep Vázquez, Gini F. Fleming, Karen N. Price, Meredith M. Regan

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Abstract

Purpose To describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin. Patients and Methods Premenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sensitive and specific assay. This preplanned 12-month analysis evaluated E2, E1, E1S, follicle-stimulating hormone, and luteinizing hormone levels in all patients and the proportion of patients with E2 levels greater than 2.72 pg/mL at any time point during treatment with exemestane plus triptorelin. Results One hundred sixteen patients (exemestane, n = 86; tamoxifen, n = 30; median age, 44 years; median E2, 51 pg/mL; 55% prior chemotherapy) started triptorelin and had one or more samples drawn. With exemestane plus triptorelin, median reductions from baseline E2, E1, and E1S levels were consistently$95%, resulting in significantly lower levels than with tamoxifen plus triptorelin at all time points. Among patients on exemestane plus triptorelin, 25%, 24%, and 17% had an E2 level greater than 2.72 pg/mL at 3, 6, and 12 months, respectively. Baseline factors related to ontreatment E2 level greater than 2.72 pg/mL were no prior chemotherapy (P =.06), higher body mass index (P =.05), and lower follicle-stimulating hormone and luteinizing hormone (each P

Original languageEnglish
Pages (from-to)1584-1593
Number of pages10
JournalJournal of Clinical Oncology
Volume34
Issue number14
DOIs
Publication statusPublished - May 10 2016

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exemestane
Triptorelin Pamoate
Tamoxifen
Estrogens
Hormones
Breast Neoplasms
Follicle Stimulating Hormone
Luteinizing Hormone
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the suppression of ovarian function trial (SOFT) : The SOFT-EST substudy. / Bellet, Meritxell; Gray, Kathryn P.; Francis, Prudence A.; Láng, I.; Ciruelos, Eva; Lluch, Ana; Climent, Miguel Angel; Catalán, Gustavo; Avella, Antoni; Bohn, Uriel; González-Martin, Antonio; Ferrer, Roser; Catalán, Roberto; Azaro, Analía; Rajasekaran, Agnita; Morales, Josefa; Vázquez, Josep; Fleming, Gini F.; Price, Karen N.; Regan, Meredith M.

In: Journal of Clinical Oncology, Vol. 34, No. 14, 10.05.2016, p. 1584-1593.

Research output: Contribution to journalArticle

Bellet, M, Gray, KP, Francis, PA, Láng, I, Ciruelos, E, Lluch, A, Climent, MA, Catalán, G, Avella, A, Bohn, U, González-Martin, A, Ferrer, R, Catalán, R, Azaro, A, Rajasekaran, A, Morales, J, Vázquez, J, Fleming, GF, Price, KN & Regan, MM 2016, 'Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the suppression of ovarian function trial (SOFT): The SOFT-EST substudy', Journal of Clinical Oncology, vol. 34, no. 14, pp. 1584-1593. https://doi.org/10.1200/JCO.2015.61.2259
Bellet, Meritxell ; Gray, Kathryn P. ; Francis, Prudence A. ; Láng, I. ; Ciruelos, Eva ; Lluch, Ana ; Climent, Miguel Angel ; Catalán, Gustavo ; Avella, Antoni ; Bohn, Uriel ; González-Martin, Antonio ; Ferrer, Roser ; Catalán, Roberto ; Azaro, Analía ; Rajasekaran, Agnita ; Morales, Josefa ; Vázquez, Josep ; Fleming, Gini F. ; Price, Karen N. ; Regan, Meredith M. / Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the suppression of ovarian function trial (SOFT) : The SOFT-EST substudy. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 14. pp. 1584-1593.
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abstract = "Purpose To describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin. Patients and Methods Premenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sensitive and specific assay. This preplanned 12-month analysis evaluated E2, E1, E1S, follicle-stimulating hormone, and luteinizing hormone levels in all patients and the proportion of patients with E2 levels greater than 2.72 pg/mL at any time point during treatment with exemestane plus triptorelin. Results One hundred sixteen patients (exemestane, n = 86; tamoxifen, n = 30; median age, 44 years; median E2, 51 pg/mL; 55{\%} prior chemotherapy) started triptorelin and had one or more samples drawn. With exemestane plus triptorelin, median reductions from baseline E2, E1, and E1S levels were consistently$95{\%}, resulting in significantly lower levels than with tamoxifen plus triptorelin at all time points. Among patients on exemestane plus triptorelin, 25{\%}, 24{\%}, and 17{\%} had an E2 level greater than 2.72 pg/mL at 3, 6, and 12 months, respectively. Baseline factors related to ontreatment E2 level greater than 2.72 pg/mL were no prior chemotherapy (P =.06), higher body mass index (P =.05), and lower follicle-stimulating hormone and luteinizing hormone (each P",
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T1 - Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the suppression of ovarian function trial (SOFT)

T2 - The SOFT-EST substudy

AU - Bellet, Meritxell

AU - Gray, Kathryn P.

AU - Francis, Prudence A.

AU - Láng, I.

AU - Ciruelos, Eva

AU - Lluch, Ana

AU - Climent, Miguel Angel

AU - Catalán, Gustavo

AU - Avella, Antoni

AU - Bohn, Uriel

AU - González-Martin, Antonio

AU - Ferrer, Roser

AU - Catalán, Roberto

AU - Azaro, Analía

AU - Rajasekaran, Agnita

AU - Morales, Josefa

AU - Vázquez, Josep

AU - Fleming, Gini F.

AU - Price, Karen N.

AU - Regan, Meredith M.

PY - 2016/5/10

Y1 - 2016/5/10

N2 - Purpose To describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin. Patients and Methods Premenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sensitive and specific assay. This preplanned 12-month analysis evaluated E2, E1, E1S, follicle-stimulating hormone, and luteinizing hormone levels in all patients and the proportion of patients with E2 levels greater than 2.72 pg/mL at any time point during treatment with exemestane plus triptorelin. Results One hundred sixteen patients (exemestane, n = 86; tamoxifen, n = 30; median age, 44 years; median E2, 51 pg/mL; 55% prior chemotherapy) started triptorelin and had one or more samples drawn. With exemestane plus triptorelin, median reductions from baseline E2, E1, and E1S levels were consistently$95%, resulting in significantly lower levels than with tamoxifen plus triptorelin at all time points. Among patients on exemestane plus triptorelin, 25%, 24%, and 17% had an E2 level greater than 2.72 pg/mL at 3, 6, and 12 months, respectively. Baseline factors related to ontreatment E2 level greater than 2.72 pg/mL were no prior chemotherapy (P =.06), higher body mass index (P =.05), and lower follicle-stimulating hormone and luteinizing hormone (each P

AB - Purpose To describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin. Patients and Methods Premenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sensitive and specific assay. This preplanned 12-month analysis evaluated E2, E1, E1S, follicle-stimulating hormone, and luteinizing hormone levels in all patients and the proportion of patients with E2 levels greater than 2.72 pg/mL at any time point during treatment with exemestane plus triptorelin. Results One hundred sixteen patients (exemestane, n = 86; tamoxifen, n = 30; median age, 44 years; median E2, 51 pg/mL; 55% prior chemotherapy) started triptorelin and had one or more samples drawn. With exemestane plus triptorelin, median reductions from baseline E2, E1, and E1S levels were consistently$95%, resulting in significantly lower levels than with tamoxifen plus triptorelin at all time points. Among patients on exemestane plus triptorelin, 25%, 24%, and 17% had an E2 level greater than 2.72 pg/mL at 3, 6, and 12 months, respectively. Baseline factors related to ontreatment E2 level greater than 2.72 pg/mL were no prior chemotherapy (P =.06), higher body mass index (P =.05), and lower follicle-stimulating hormone and luteinizing hormone (each P

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