Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial
Karin Ribi,Weixiu Luo,Jürg Bernhard,Prudence A. Francis,Harold J. Burstein,Eva Ciruelos,Meritxell Bellet,Lorenzo Pavesi,Ana Lluch,Marilena Visini,Vani Parmar,Carlo Tondini,Pierre Kerbrat,Antonia Perelló,Patrick Neven,Roberto Torres,Davide Lombardi,Fabio Puglisi,Per Karlsson,Thomas Ruhstaller,Marco Colleoni,Alan S. Coates,Aron Goldhirsch,Karen N. Price,Richard D. Gelber,Meredith M. Regan,Gini F. Fleming +26 more
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TLDR
Overall, OFS added to tamoxifen resulted in worse endocrine symptoms and sexual functioning during the first 2 years of treatment, with variable magnitudes of treatment differences.Abstract:
PurposeThe Suppression of Ovarian Function trial showed improved disease control for tamoxifen plus ovarian function suppression (OFS) compared with tamoxifen alone for the cohort of premenopausal patients who received prior chemotherapy. We present the patient-reported outcomes.Patients and MethodsThe quality-of-life (QoL) analysis includes 1,722 of 2,045 premenopausal patients with hormone receptor–positive breast cancer randomly assigned to receive adjuvant treatment with 5 years of tamoxifen plus OFS or tamoxifen alone. Chemotherapy use before enrollment was optional. Patients completed a QoL form consisting of global and symptom indicators at baseline, every 6 months for 24 months, and annually during years 3 to 6. Differences in the change of QoL from baseline between the two treatments were tested at 6, 24, and 60 months with mixed models for repeated measures with and without chemotherapy and overall.ResultsPatients on tamoxifen plus OFS were more affected than patients on tamoxifen alone by hot f...read more
Citations
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De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017
Giuseppe Curigliano,Harold J. Burstein,Eric P. Winer,Michael Gnant,Peter Dubsky,Sibylle Loibl,Marco Colleoni,Meredith M. Regan,Martine Piccart-Gebhart,H.-J. Senn,Beat Thürlimann,Fabrice Andre,José Baselga,Jonas Bergh,Hervé Bonnefoi,Sara Y. Brucker,Fatima Cardoso,Lisa A. Carey,Eva Ciruelos,Jack Cuzick,Carsten Denkert,A. Di Leo,Bent Ejlertsen,Prudence A. Francis,Viviana Galimberti,Judy Garber,Bahadir M. Gulluoglu,Pamela J. Goodwin,Nadia Harbeck,Daniel F. Hayes,Chiun-Sheng Huang,Jens Huober,H. Khaled,Jacek Jassem,Zefei Jiang,Per Karlsson,Monica Morrow,Roberto Orecchia,Kent Osborne,Olivia Pagani,Ann H. Partridge,Kathleen I. Pritchard,Jungsil Ro,Emiel J. Th. Rutgers,Felix Sedlmayer,Vladimir Semiglazov,Zhimin Shao,I.E. Smith,Masakazu Toi,Andrew Tutt,Giuseppe Viale,Toshihiro Watanabe,Timothy J. Whelan,Bo Xu +53 more
TL;DR: The 15th St. Gallen International Breast Cancer Conference 2017 in Vienna, Austria reviewed substantial new evidence on loco-regional and systemic therapies for early breast cancer, and recommended bisphosphonate use in postmenopausal women to prevent breast cancer recurrence.
Journal ArticleDOI
Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer.
Prudence A. Francis,Prudence A. Francis,Olivia Pagani,Gini F. Fleming,Barbara Walley,M.A. Colleoni,István Láng,Henry L. Gomez,Carlo Tondini,Eva Ciruelos,Harold J. Burstein,H. Bonnefoi,Meritxell Bellet,Silvana Martino,Charles E. Geyer,Matthew P. Goetz,Vered Stearns,Graziella Pinotti,Fabio Puglisi,S. Spazzapan,Miguel Angel Climent,Lorenzo Pavesi,Thomas Ruhstaller,Nancy E. Davidson,Robert E. Coleman,Marc Debled,Stefan Buchholz,JN Ingle,Eric P. Winer,Rudolf Maibach,Manuela Rabaglio-Poretti,Barbara Ruepp,A. Di Leo,Alan S. Coates,Richard D. Gelber,A. Goldhirsch,Meredith M. Regan +36 more
TL;DR: Among premenopausal women with breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly higher 8‐year rates of both disease‐free and overall survival than tamox ifen alone and the use of exemestane plus ovarian suppression resulted in even higher rates of freedom from recurrence.
Journal ArticleDOI
Gonadotropin-Releasing Hormone Agonists During Chemotherapy for Preservation of Ovarian Function and Fertility in Premenopausal Patients With Early Breast Cancer: A Systematic Review and Meta-Analysis of Individual Patient–Level Data
Matteo Lambertini,Halle C. F. Moore,Robert C. F. Leonard,Sibylle Loibl,Pamela N. Munster,Marco Bruzzone,Luca Boni,Joseph M. Unger,Richard A. Anderson,Keyur Mehta,Susan Minton,Francesca Poggio,Kathy S. Albain,Douglas Adamson,Bernd Gerber,Amy Cripps,Gianfilippo Bertelli,Sabine Seiler,Marcello Ceppi,Ann H. Partridge,Lucia Del Mastro +20 more
TL;DR: Evidence is provided for the efficacy and safety of temporary ovarian suppression with GnRHa during chemotherapy as an available option to reduce the likelihood of chemotherapy-induced POI and potentially improve future fertility in premenopausal patients with early breast cancer.
Journal ArticleDOI
Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression
Harold J. Burstein,Christina Lacchetti,Holly Anderson,Thomas A. Buchholz,Nancy E. Davidson,Karen E. Gelmon,Sharon H. Giordano,Clifford A. Hudis,Alexander J. Solky,Vered Stearns,Eric P. Winer,Jennifer J. Griggs +11 more
TL;DR: The addition of ovarian suppression to standard adjuvant therapy with tamoxifen or with an aromatase inhibitor improved disease-free survival and improved freedom from breast cancer and distant recurrence compared with tamxifen alone among the subset of patients who were at sufficient risk for recurrence such that adjUvant chemotherapy was warranted.
Journal ArticleDOI
Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Early Breast Cancer: TEXT and SOFT Trials
Meredith M. Regan,Prudence A. Francis,Prudence A. Francis,Olivia Pagani,Gini F. Fleming,Barbara Walley,Giuseppe Viale,Marco Colleoni,István Láng,Henry L. Gomez,Carlo Tondini,Graziella Pinotti,Karen N. Price,Alan S. Coates,Aron Goldhirsch,Richard D. Gelber +15 more
TL;DR: Premenopausal women with hormone receptor-positive, HER2-negative disease and high recurrence risk may experience improvement of 10% to 15% in 5-year BCFI with exemestane plus OFS versus tamoxifen alone, and improvement is minimal for those at lowest risk.
References
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Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015
Alan S. Coates,Eric P. Winer,A. Goldhirsch,Richard D. Gelber,Michael Gnant,Martine Piccart-Gebhart,Beat Thürlimann,H.-J. Senn +7 more
TL;DR: The 14th St Gallen International Breast Cancer Conference (2015) reviewed new evidence on locoregional and systemic therapies for early breast cancer and summarizes treatment-oriented classification of subgroups and treatment recommendations.
Journal ArticleDOI
Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
Olivia Pagani,Meredith M. Regan,Barbara Walley,Gini F. Fleming,Marco Colleoni,István Láng,Henry L. Gomez,Carlo Tondini,Harold J. Burstein,Edith A. Perez,Eva Ciruelos,Vered Stearns,Hervé Bonnefoi,Silvana Martino,Charles E. Geyer,Graziella Pinotti,Fabio Puglisi,Diana Crivellari,Thomas Ruhstaller,Eric P. Winer,Manuela Rabaglio-Poretti,Rudolf Maibach,Barbara Ruepp,Anita Giobbie-Hurder,Karen N. Price,Jürg Bernhard,Weixiu Luo,Karin Ribi,Giuseppe Viale,Alan S. Coates,Richard D. Gelber,Aron Goldhirsch,Prudence A. Francis +32 more
TL;DR: In premenopausal women with hormone-receptor-positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppressed, significantly reduced recurrence.
Journal ArticleDOI
Adjuvant ovarian suppression in premenopausal breast cancer
Prudence A. Francis,Prudence A. Francis,Meredith M. Regan,Gini F. Fleming,István Láng,Eva Ciruelos,Meritxell Bellet,Hervé Bonnefoi,Hervé Bonnefoi,Miguel Angel Climent,Gian Antonio Da Prada,Harold J. Burstein,Silvana Martino,Nancy E. Davidson,Charles E. Geyer,Barbara Walley,Robert E. Coleman,Pierre Kerbrat,Stefan Buchholz,James N. Ingle,E. P.Manuela Winer,Manuela Rabaglio-Poretti,Rudolf Maibach,Barbara Ruepp,Anita Giobbie-Hurder,Karen N. Price,Marco Colleoni,Giuseppe Viale,Alan S. Coates,Alan S. Coates,Aron Goldhirsch,Richard D. Gelber +31 more
TL;DR: Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population, but for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes.
Journal ArticleDOI
Health-Related Quality of Life and Tamoxifen in Breast Cancer Prevention: A Report From the National Surgical Adjuvant Breast and Bowel Project P-1 Study
Richard O. Day,Patricia A. Ganz,J. P. Costantino,Walter M. Cronin,D. Lawrence Wickerham,Bernard Fisher +5 more
TL;DR: Women need to be informed of the increased frequency of vasomotor and gynecologic symptoms and problems of sexual functioning associated with tamoxifen use, according to the initial report from the health-related quality of life component of the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial.
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