Amye J Tevaarwerk1, Molin Wang2, Fengmin Zhao2, John H Fetting2, David Cella2, Lynne I Wagner2, Silvana Martino2, James N Ingle2, Joseph A Sparano2, Lawrence J Solin2, William C Wood2, Nicholas J Robert2. 1. Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Molin Wang, Harvard University; Fengmin Zhao, Dana-Farber Cancer Institute, Boston, MA; John H. Fetting, Johns Hopkins University, Baltimore, MD; David Cella and Lynne I. Wagner, Northwestern University, Chicago, IL; Silvana Martino, Angeles Clinic and Research Institute, Santa Monica, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Joseph A. Sparano, Montefiore Medical Center, Bronx, NY; Lawrence J. Solin, Albert Einstein Medical Center, Philadelphia, PA; William C. Wood, Emory University, Atlanta, GA; and Nicholas J. Robert, Virginia Cancer Specialists, Fairfax, VA. at4@medicine.wisc.edu. 2. Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Molin Wang, Harvard University; Fengmin Zhao, Dana-Farber Cancer Institute, Boston, MA; John H. Fetting, Johns Hopkins University, Baltimore, MD; David Cella and Lynne I. Wagner, Northwestern University, Chicago, IL; Silvana Martino, Angeles Clinic and Research Institute, Santa Monica, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Joseph A. Sparano, Montefiore Medical Center, Bronx, NY; Lawrence J. Solin, Albert Einstein Medical Center, Philadelphia, PA; William C. Wood, Emory University, Atlanta, GA; and Nicholas J. Robert, Virginia Cancer Specialists, Fairfax, VA.
Abstract
PURPOSE: The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS. PATIENTS AND METHODS: Premenopausal women with axillary node-negative, hormone receptor-positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration. RESULTS: In all, 345 premenopausal women were enrolled: 171 ontamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up. CONCLUSION: When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.
RCT Entities:
PURPOSE: The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS. PATIENTS AND METHODS: Premenopausal women with axillary node-negative, hormone receptor-positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration. RESULTS: In all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up. CONCLUSION: When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.
Authors: W Jonat; M Kaufmann; W Sauerbrei; R Blamey; J Cuzick; M Namer; I Fogelman; J C de Haes; A de Matteis; A Stewart; W Eiermann; I Szakolczai; M Palmer; M Schumacher; M Geberth; B Lisboa Journal: J Clin Oncol Date: 2002-12-15 Impact factor: 44.544
Authors: Nancy E Davidson; Anne M O'Neill; Allen M Vukov; C Kent Osborne; Silvana Martino; Douglas R White; Martin D Abeloff Journal: J Clin Oncol Date: 2005-08-08 Impact factor: 44.544
Authors: Michael Gnant; Brigitte Mlineritsch; Herbert Stoeger; Gero Luschin-Ebengreuth; Dietmar Heck; Christian Menzel; Raimund Jakesz; Michael Seifert; Michael Hubalek; Gunda Pristauz; Thomas Bauernhofer; Holger Eidtmann; Wolfgang Eiermann; Guenther Steger; Werner Kwasny; Peter Dubsky; Gerhard Hochreiner; Ernst-Pius Forsthuber; Christian Fesl; Richard Greil Journal: Lancet Oncol Date: 2011-06-05 Impact factor: 41.316
Authors: F Boccardo; A Rubagotti; D Amoroso; M Mesiti; D Romeo; P Sismondi; M Giai; F Genta; P Pacini; V Distante; A Bolognesi; D Aldrighetti; A Farris Journal: J Clin Oncol Date: 2000-07 Impact factor: 44.544
Authors: Olivia Pagani; Meredith M Regan; Barbara A Walley; Gini F Fleming; Marco Colleoni; István Láng; Henry L Gomez; Carlo Tondini; Harold J Burstein; Edith A Perez; Eva Ciruelos; Vered Stearns; Hervé R 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 Journal: N Engl J Med Date: 2014-06-01 Impact factor: 91.245
Authors: Allan Hackshaw; Michael Baum; Tommy Fornander; Bo Nordenskjold; Antonio Nicolucci; Kathryn Monson; Sharon Forsyth; Krystyna Reczko; Ulla Johansson; Helena Fohlin; Miriam Valentini; Richard Sainsbury Journal: J Natl Cancer Inst Date: 2009-02-24 Impact factor: 13.506
Authors: Tessa G Steenbruggen; Mette S van Ramshorst; Marleen Kok; Sabine C Linn; Carolien H Smorenburg; Gabe S Sonke Journal: Drugs Date: 2017-08 Impact factor: 9.546
Authors: A S Coates; E P Winer; A Goldhirsch; R D Gelber; M Gnant; M Piccart-Gebhart; B Thürlimann; H-J Senn Journal: Ann Oncol Date: 2015-05-04 Impact factor: 32.976
Authors: Courtney L Andersen; Matthew J Sikora; Michelle M Boisen; Tianzhou Ma; Alec Christie; George Tseng; Yongseok Park; Soumya Luthra; Uma Chandran; Paul Haluska; Gina M Mantia-Smaldone; Kunle Odunsi; Karen McLean; Adrian V Lee; Esther Elishaev; Robert P Edwards; Steffi Oesterreich Journal: Clin Cancer Res Date: 2017-01-10 Impact factor: 12.531
Authors: Herman A Perroud; Carlos M Alasino; Maria J Rico; Francisco Queralt; Stella M Pezzotto; Viviana R Rozados; O Graciela Scharovsky Journal: Future Oncol Date: 2016-03-07 Impact factor: 3.404