Academic Journal
Hormonal factors predictive of fertility in patients with breast cancer interrupting adjuvant endocrine therapy to attempt pregnancy in POSITIVE trial.
| Τίτλος: | Hormonal factors predictive of fertility in patients with breast cancer interrupting adjuvant endocrine therapy to attempt pregnancy in POSITIVE trial. |
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| Συγγραφείς: | Demeestere I; Research Laboratory on Human Reproduction, Université Libre de Bruxelles (ULB), Brussels, Belgium; Gynecology and Obstetrics Department, Fertility Clinic, H.U.B Erasme Hospital, Brussels, Belgium. Electronic address: Isabelle.demeestere@ulb.be., Niman SM; International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Department of Data Science, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA, USA., Partridge AH; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA., Diego DS; Division of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA, USA., Kammler R; Translational Research Coordination, International Breast Cancer Study Group, a Division of ETOP IBCSG Partners Foundation, Bern, Switzerland., Ruggeri M; Program for Young Patients, International Breast Cancer Study Group, a Division of ETOP IBCSG Partners Foundation, Bern, Switzerland., Colleoni M; Division of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy., Shimizu C; Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo, Japan., Saura C; Vall D'Hebron University Hospital, Vall D'Hebron Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain., Gelmon KA; BC Cancer Vancouver Centre, University of British Columbia, Vancouver, BC, Canada., Saetersdal AB; Breast Cancer Unit, Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway., Kroep JR; Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands; Dutch Breast Cancer Research Group (BOOG), the Netherlands., Mailliez A; Department of Medical Oncology, Breast Cancer Unit, Centre Oscar Lambret, Lille, France., Amant F; Department of Oncology, KU Leuven and Leuven Cancer Institute, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Antoni van Leeuwenhoek-Netherlands Cancer Institute, Amsterdam, the Netherlands., Ruız-Borrego M; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Virgen Del Rocio Sevilla, Sevilla, Spain., Lee JE; Breast Division, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; Department of Clinical Research and Evaluation, SAIHST, Sungkyunkwan University, Seoul, South Korea., Kataoka A; Breast Oncology Center, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan., Walshe JM; Cancer Trials Ireland, Dublin, Ireland; Department of Medical Oncology, St. Vincent's University Hospital, Dublin, Ireland., Takei J; St Luke's International Hospital, Breast Center, Tokyo, Japan., Borstnar S; Division of Medical Oncology, Institute of Oncology, Ljubljana, Slovenia., Borges VF; Division of Medical Oncology, Department of Medicine, University of Colorado Cancer Center, Aurora, CO, USA., Saunders C; Department of Surgery, University of Melbourne, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia., Susnjar S; Department of Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia., Bjelic-Radisic V; Breast Unit, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany; Austrian Breast and Colorectal Study Group (ABCSG), Austria., Cardoso F; Breast Unit, Champalimaud Foundation and Advanced Breast Cancer (ABC) Global Alliance, Lisbon, Portugal., Meisel JL; Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA., Kawwass JF; Division of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA, USA., Spanic T; Europa Donna, Ljubljana, Slovenia and Europa Donna - The European Breast Cancer Coalition, Milan, Italy., El-Abed S; Breast International Group, Brussels, Belgium., Piccart M; Breast International Group, Brussels, Belgium; Institut Jules Bordet and Université Libre de Bruxelles, Brussels, Belgium., Korde LA; Breast and Melanoma Therapeutics, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA., Goldhirsch A; International Breast Cancer Study Group, Division of ETOP IBCSG Partners Foundation, Bern, Switzerland; IEO, European Institute of Oncology, IRCCS, Milan, Italy., Gelber RD; International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Department of Data Science, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA, USA; Frontier Science Foundation, Boston, MA, USA; Harvard TH Chan School of Public Health, Boston, MA, USA., Pagani O; Geneva University Hospitals, Geneva, Switzerland; Lugano University, Lugano, Switzerland; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland., Azim HA Jr; Cairo Cure Oncology Center, Cairo, Egypt., Peccatori FA; Fertility and Procreation Unit, Gynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy. |
| Συλλογικό Έργο: | International Breast Cancer Study Group and the POSITIVE Trial Collaborators |
| Πηγή: | Breast (Edinburgh, Scotland) [Breast] 2025 Oct; Vol. 83, pp. 104547. Date of Electronic Publication: 2025 Jul 26. |
| Τύπος έκδοσης: | Journal Article; Multicenter Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 9213011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-3080 (Electronic) Linking ISSN: 09609776 NLM ISO Abbreviation: Breast Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2002- : Amsterdam : Elsevier Original Publication: Edinburgh ; New York : Churchill Livingstone, c1992- |
| Ιατρικοί όροι (MeSH): | Breast Neoplasms*/drug therapy , Breast Neoplasms*/blood , Ovarian Reserve*/physiology , Primary Ovarian Insufficiency*/blood , Antineoplastic Agents, Hormonal*, Anti-Mullerian Hormone/blood ; Fertility Preservation/methods ; Follicle Stimulating Hormone/blood ; Progesterone/blood ; Prolactin/blood ; Thyrotropin/blood ; Adult ; Female ; Humans ; Pregnancy ; Chemotherapy, Adjuvant ; Fertility ; Premenopause |
| Περίληψη: | Purpose: The POSITIVE trial showed that premenopausal women with breast cancer (BC) can safely pause adjuvant endocrine treatment (ET) to attempt conception. 74 % of patients conceived spontaneously or through assisted reproductive technology (ART); Investigating hormonal factors that predict fertility was a key secondary endpoint. Methods: Hormonal factors were assessed in non-pregnant women at months 3, 6, and 12 after ET interruption. The frequency of low ovarian reserve, defined as anti-Mullerian hormone (AMH) < 0.5 ng/mL at month 3, and of premature ovarian insufficiency (POI), defined as follicle stimulating hormone (FSH) > 25 IU/L at month 12, were primary measures. Secondary analyses to predict pregnancy included AMH, FSH, thyroid stimulating hormone (TSH), prolactin and ovulatory status (defined as progesterone >3 ng/mL at month 6), considering covariates such as age, treatment, and ART use. Results: Of 518 women enrolled in POSITIVE, 438 were eligible for low ovarian reserve analysis. Low ovarian reserve was observed in 209 women (47.7 %), more frequently among older women and those with prior chemotherapy, but not in relation to ET type or duration. Overall, low ovarian reserve was associated with reduced odds of pregnancy (OR:0.52; 95 % CI:0.31-0.87). Of 142 patients evaluated for POI, 16.7 % of those who received prior chemotherapy experienced POI. FSH at month 3 was associated with POI, but only modestly with spontaneous pregnancy (OR:0.96; 95 %CI: 0.93-1.00); other factors were not predictive of pregnancy. Conclusion: Hormonal factors are associated with pregnancy in BC patients pausing adjuvant ET to conceive, and their assessment may help to optimize fertility counseling. Trial Registration: ClinicalTrials.gov number NCT02308085. (Copyright © 2025 The Authors. Published by Elsevier Ltd.. All rights reserved.) |
| Competing Interests: | Declaration of competing interest I.Demeestere reported invited speaker honoraria from Ferring and support for attending congress from Theramex, Organon; Research Grant from ROCHE diagnosis, Ferring, Theramex (Inst.). A.H.Partridge reported Royalties for authorship of UpToDate: Wolters Kluwer; and non-Financial Interests as co-Chair of Breast Committee: Alliance for Clinical Trials, National Cancer Institute; and Chief Scientific Advisor: Susan G. Komen Foundation. M.Colleoni: reported Research Funding from Roche (Inst), and non-financial interest as Co-Chair of the International Breast Cancer Study Group Scientific Committee. C. Shimizu reported honoraria from AstraZeneca, Kyowa Hakko Kirin, Chugai Pharma, Taiho Pharmaceutical, Pfizer, Daiichi Sankyo/UCB Japan, MSD; and research grant from Lilly. C. Saura reported Consulting or Advisory Role for AstraZeneca, Daiichi Sankyo, Eisai, MediTech, Novartis, Pfizer, Philips Healthcare, Pierre Fabre, Puma Biotechnology, Roche, SeaGen, Gilead Sciences, Pint Pharma, Synthon, Zymeworks, PharmaLex; Speakers' Bureau for AstraZeneca, Daiichi Sankyo/Astra Zeneca, Pfizer, Pierre Fabre, Puma Biotechnology, Seagen, Exeter Pharmaceuticals, Lilly; Research Funding from Puma Biotechnology (Inst), Roche (Inst), AstraZeneca (Inst), Bayer (Inst), Boehringer Ingelheim (Inst), Bristol Myers Squibb (BMS) (Inst), CytomX Therapeutics (Inst), Daiichi Sakyo (Inst), Roche (Inst), Genentech (Inst), GlaxoSmithKline (Inst), InnoUp (Inst), Lilly (Inst), MacroGenics (Inst), Menarini (Inst), Merus (Inst), Novartis (Inst), Pfizer (Inst), Sanofi/Aventis (Inst), Seagen (Inst); Travel, Accommodations, expenses from Pfizer, Novartis, Roche, AstraZeneca, Puma Biotechnology, Daiichi Sankyo, Eisai Europe and other Relationship: Research funding in the form of third-party medical writing support, furnished by Eleanor Porteous, MSc, of Nucleus Global, an Inizio Company, was provided by F. Hoffmann-La Roche Ltd; K.A. Gelmon reported honoraria from AstraZeneca, Pfizer, Lilly, Novartis, Merck, Gilead, Seagen, City of Hope, Celcuity; AstraZeneca, Pfizer, BMS. A.B. Saetersdal reported Consulting or Advisory Role: Takeda Science Foundation. Judith R. Kroep reported the following institutional research grants from: KWF, AstraZeneca, Novartis, and Philips; receiving consulting fees from AstraZeneca, Daiichi, Eisa, GSK, Lilly, MSD, and Novartis; receiving support for attending meetings and/or travel from: Daiichi; participating on a data safety monitoring board or advisory board for: Alison and TEIPP trials; and serves in a leadership or fiduciary role (in other board, society, committtee, or advocacy group, paid or unpaid) for EORTC-GCG. A. Mailliez reported honoraria as invited speaker or advisory role from Astra Zeneca, MSD oncology, Novartis, Roche; Menarini, Oseus, Seagen, Pfizer, Daiichi Sankyo; and Expert Testimony for GSK. F. Amant reported honoraria from ROCHE and Advisory role for MiMARK Diagnostics; unrestricted research grant from Estée Lauder; M. Ruiz-Borrego reported Honoraria from Roche/Genentech, Pfizer, Novartis and Consulting or Advisory Role for Roche, Puma Biotechnology. J.E.Lee: reported receiving consulting fees from: MSD; receiving payment or honoraria (for lectures, presentations, speakers bureaus, manuscript writing or educational events) from: ExactScience and Takeda Korea; and serving in a leadership or fiduciary role (in other board, society, committee, or advocacy group, paid or unpaid) for: the Korean Breast Cancer Society. Janice M. Walshe reported Honoraria from Novartis, Consulting or Advisory Role from Gilead Sciences; Travel, Accommodations, Expenses: Novartis. Junko Takei reported Speakers' Bureau role for AstraZeneca. S. Borstnar reported honoraria from AstraZeneca, Lilly, Pfizer, Novartis, Roche, MSD Oncology, Sandoz, Gilead Sciences, Consulting or Advisory Role: Novartis, AstraZeneca, Roche, Pfizer, MSD, Oncology, Lilly. V. F. Borges reported Stock and Other Ownership Interests: Perla Therapeutics, Consulting or Advisory Role for Seagen, AstraZeneca, Gilead Sciences, Research Funding: Seagen (Inst), Olema Oncology (Inst), AstraZeneca (Inst). C Saunders: reports serving in a leadership or fiduciary role (in other board, society, committee, or advocacy group, paid or unpaid) for PathWest Laboratory Medicine and Breast Cancer Trials. S. Susnjar reported Consulting or Advisory Role for AstraZeneca, Lilly, Novartis, Roche, Pfizer; Speakers’ Bureau role for Amicus Therapeutics, Novartis, Pfizer, Research Funding: Roche (Inst); Travel, Accommodations, Expenses from Amicus Therapeutics, Roche. V. Bjelic-Radisic reported consulting fees (to the institution) from: Pfizer, Roche, and Lilly; receiving payment or honoraria (to the institution, for lectures, presentations, speakers bureaus, manuscript writing or educational events) from: Pfizer and Lilly; receiving support for attending meetings and/or travel from: Pfizer; participating on a data safety monitoring board or advisory board for Pfizer; and serving in a leadership or fiduciary role (in other board, society, committee, or advocacy group, paid or unpaid) for AWOgyn. F. Cardoso: reported consulting fees from: Amgen, Astellas/Medivation, AstraZeneca, Bayer, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, Gilead, GlaxoSmithKline, Iqvia, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, prIME Oncology, Roche, Sanofi, Samsung, Bioepis, Seagen, Teva, and Touchime; receiving payment or honoraria (for lectures, presentations, speakers bureaus, manuscript writing or educational events) from: Pfizer, Roche, Gilead, AstraZeneca, Novartis, and Merck; receiving support for attending meetings and/or travel from: Pfizer, Roche, Gilead, AstraZeneca, and Novartis; and serving in a leadership or fiduciary role (in other board, society, committee, or advocacy group, paid or unpaid) for ABC Global Alliance (President), ABC Consensus Conference and Guidelines (Chair), European Academy of Cancer Sciences (Fellow), and ESMO, ESO, ASCO, AACR, ECO, AORTIC, UICC, EORTC, IBCSG, SOLTI, EACR, SIS, ASPIC, SPO, and Evita (member/committee member). T. Spanic: reported honoraria from Pfizer, MSD, Roche; Conseling and advisory role for Roche, Invited Speaker for Regional Meeting by Astra Zeneca; Other, Podcast Guest: Novartis; Unrestricted Grant to Europa Donna Slovenija: Novartis, Roche, MSD, AstraZeneca, Lenis; and Non-Financial Interests as member of Board of Directors, Starting Jan 2025: ABC Global Alliance. S. El-Abed: reported the following institutional research grants from: AstraZeneca, Sanofi, Roche, Genentech, GlaxoSmithKline, Pfizer, and Novartis. M. Piccart: reported the following institutional research grants from: AstraZeneca, Lilly, Menarini, MSD, Novartis, Pfizer, Roche-Genentech, Servier, and Gilead; receiving consulting fees from: AstraZeneca, Gilead, Lilly, Menarini, Mersana, MSD, Novartis, Pfizer, Roche-Genentech, Seattle Genetics, Seagen, NBE Therapeutics, and SummitTherapeutics; receiving payment or honoraria (for lectures, presentations, speakers bureaus, manuscript writing or educational events) from: AstraZeneca, Gilead, Lilly, Menarini, Mersana, MSD, Novartis, Pfizer, Roche-Genentech, Seagen, NBE Therapeutics, and Summit Therapeutics; and participating on a data safety monitoring board or advisory board for Oncolytics. R.D. Gelber: reported research funding from AstraZeneca, Roche, Merck. O. Pagani: reported counsulting or advisory role for Debiopharm. H.A. Azim: reported honoraria from Pierre Fabre, emergence therapeutics, Diaccurate, PEP Therapy, Linkinvax; Invited Speaker and travel accommodation expense from Astra Zeneca, Novartis Stocks/Shares: Innate Pharma; Fatima Cardoso and Karen Gelmon are Editor-in-Chief and Deputy Editor in The Breast, respectively, and have no involvement in the peer-review of this article and no access to information regarding its peer review. Ann Partridge, Fedro Alessandro Peccatori and Hatem A Azim Jr are part of the Editorial Board of The Breast and were not involved in the editorial review or the decision to publish this article. No other conflict of interest were reported. |
| Σχόλια: | Erratum in: Breast. 2025 Dec;84:104570. doi: 10.1016/j.breast.2025.104570.. (PMID: 40987054) |
| Grant Information: | U10 CA180868 United States CA NCI NIH HHS; UG1 CA189974 United States CA NCI NIH HHS; UG1 CA189828 United States CA NCI NIH HHS; UG1 CA189823 United States CA NCI NIH HHS; U10 CA180863 United States CA NCI NIH HHS; U24 CA196171 United States CA NCI NIH HHS; U10 CA180888 United States CA NCI NIH HHS |
| Contributed Indexing: | Keywords: Assisted reproductive technology; Breast cancer; Ovarian reserve; Pregnancy; Premature ovarian insufficiency |
| Molecular Sequence: | ClinicalTrials.gov NCT02308085 |
| Substance Nomenclature: | 80497-65-0 (Anti-Mullerian Hormone) 0 (Antineoplastic Agents, Hormonal) 9002-68-0 (Follicle Stimulating Hormone) 4G7DS2Q64Y (Progesterone) 9002-62-4 (Prolactin) 9002-71-5 (Thyrotropin) |
| Entry Date(s): | Date Created: 20250731 Date Completed: 20250921 Latest Revision: 20260815 |
| Update Code: | 20260815 |
| PubMed Central ID: | PMC12336806 |
| DOI: | 10.1016/j.breast.2025.104547 |
| PMID: | 40743662 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1532-3080 |
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| DOI: | 10.1016/j.breast.2025.104547 |