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1

artículo

Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis...

Publicado por
Regan, MM, Walley, BA, Francis, PA, Fleming, GF, Láng, I, Gómez, HL, Colleoni, M, Tondini, C, Pinotti, G, Salim, M, Spazzapan, S, Parmar, V, Ruhstaller, T, Abdi, EA, Gelber, RD, Coates, AS, Goldhirsch, A, Pagani, O

Publicado 2017

Enlace

Background: Recent breast cancer treatment guidelines recommend that higher-risk premenopausal patients should receive ovarian function suppression (OFS) as part of adjuvant endocrine therapy. If chemotherapy is also given, it is uncertain whether to select concurrent or sequential OFS initiation. Design and methods: We analyzed 1872 patients enrolled in the randomized phase III TEXT and SOFT trials who received adjuvant chemotherapy for hormone receptor-positive, HER2-negative breast cancer and upon randomization to an OFS-containing adjuvant endocrine therapy, initiated gonadotropin-releasing-hormone-agonist triptorelin. Breast cancer-free interval (BCFI) was compared between patients who received OFS concurrently with chemotherapy in TEXT (n = 1242) versus sequentially post-chemotherapy in SOFT (n = 630). Because timing of trial enrollment relative to adjuvant chemotherapy differed, w...

2

artículo

Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials

Publicado por
Saha, P, Regan, MM, Pagani, O, Francis, PA, Walley, BA, Ribi, K, Bernhard, J, Luo, W, Gómez, HL, Burstein, HJ, Parmar, V, Torres, R, Stewart, J, Bellet, M, Perelló, A, Dane, F, Moreira, A, Vorobiof, D, Nottage, M, Price, KN, Coates, AS, Goldhirsch, A, Gelber, RD, Colleoni, M, Fleming, GF, SOFT TEXT Investigators, International Breast Cancer Study Group

Publicado 2017

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Purpose To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receivin...

3

objeto de conferencia

Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials

Publicado por
Pagani, O, Walley, BA, Fleming, G.F, Colleoni M, Láng I, Gomez H.L, Tondini C, Burstein H.J, Goetz M.P, Ciruelos E.M, Stearns V, Bonnefoi H.R, Martino S, Geyer C.E, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer E.P, Ruepp B, Loi S, Coates A.S, Gelber R.D, Goldhirsch A, Regan M.M, Francis P.A.

Publicado 2023

Enlace

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The combined analysis of SOFT-TEXT compared outcomes in 4,690 premenopausal women with estrogen/progesterone receptor-positive (ER/PgR+) early breast cancer randomly assigned to 5 years of exemestane + ovarian function suppression (OFS) versus tamoxifen + OFS. After a median follow-up of 9 years, exemestane + OFS significantly improved disease-free survival (DFS) and distant recurrence-free interval (DRFI), but not overall survival, compared with tamoxifen + OFS. We now rep...

4

artículo

Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer

Publicado por
Francis, PA, Pagani, O, Fleming, GF, Walley, BA, Colleoni, M, Láng, I, Gómez, HL, Tondini, C, Ciruelos, E, Burstein, HJ, Bonnefoi, HR, Bellet, M, Martino, S, Geyer, CE, Goetz, MP, Stearns, V, Pinotti, G, Puglisi, F, Spazzapan, S, Climent, MA, Pavesi, L, Ruhstaller, T, Davidson, NE, Coleman, R, Debled, M, Buchholz, S, Ingle, JN, Winer, EP, Maibach, R, Rabaglio-Poretti, M, Ruepp, B, Di Leo, A, Coates, AS, Gelber, RD, Goldhirsch, A, Regan, MM, SOFT and TEXT Investigators and the International Breast Cancer Study Group.

Publicado 2018

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Background: In the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), the 5-year rates of recurrence of breast cancer were significantly lower among premenopausal women who received the aromatase inhibitor exemestane plus ovarian suppression than among those who received tamoxifen plus ovarian suppression. The addition of ovarian suppression to tamoxifen did not result in significantly lower recurrence rates than those with tamoxifen alone. Here, we report the updated results from the two trials. Methods: Premenopausal women were randomly assigned to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT and to receive tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Randomization was stratified according to the receipt of chemotherapy. Results: In SOFT, th...