【研究】他莫昔芬＋卵巢功能抑制对比他莫昔芬单药辅助治疗绝经前早期乳腺癌女性：卵巢功能抑制试验（SOFT）患者报告结局

　　2016年3月28日，美国临床肿瘤学会（ASCO）官方期刊《临床肿瘤学杂志》（JCO）在线发表国际多中心临床研究报告《他莫昔芬＋卵巢功能抑制对比他莫昔芬单药辅助治疗绝经前早期乳腺癌女性：卵巢功能抑制试验（SOFT）患者报告结局》。

J Clin Oncol. 2016 Mar 28. [Epub ahead of print]

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.

Karin Ribi, Aron Goldhirsch, Jürg Bernhard, International Breast Cancer Study Group Coordinating Center; Jürg Bernhard, Bern University Hospital, Inselspital, Bern; Thomas Ruhstaller, Breast Center St Gallen, Swiss Group for Clinical Cancer Research, International Breast Cancer Study Group, St Gallen, Switzerland; Weixiu Luo, Karen N. Price, Richard D. Gelber, Meredith M. Regan, International Breast Cancer Study Group Statistical Center; Weixiu Luo, Harold J. Burstein, Richard D. Gelber, Meredith M. Regan, Dana-Farber Cancer Institute; Harold J. Burstein, Alliance for Clinical Trials in Oncology; Karen N. Price, Richard D. Gelber, Frontier Science, Technology Research Foundation; Richard D. Gelber, Meredith M. Regan, Harvard Medical School, Boston, MA; Gini F. Fleming, The University of Chicago Medical Center, Alliance for Clinical Trials in Oncology, Chicago, IL; Prudence A. Francis, International Breast Cancer Study Group, Peter MacCallum Cancer Center, St Vincent’s Hospital, University of Melbourne, Melbourne, Victoria; Australia, New Zealand Breast Cancer Trials Group, University of Newcastle, Newcastle; Alan S. Coates, International Breast Cancer Study Group, University of Sydney, Sydney, New South Wales, Australia; Eva Ciruelos, University Hospital 12 de Octubre, SOLTI Group, Madrid; Meritxell Bellet, Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, SOLTI Group, Universitat Autònoma de Barcelona, Barcelona; Ana Lluch, Hospital Clinico Universitario de Valencia, Incliva Biomedical Research Institute, University of Valencia, SOLTI Group, Valencia; Antonia Perelló, Hospital Universitari Son Espases, SOLTI Group, Palma de Mallorca, Spain; Lorenzo Pavesi, Salvatore Maugeri Foundation, International Breast Cancer Study Group, Pavia; Marilena Visini, Ospedale Civile di Lecco, International Breast Cancer Study Group, Lecco; Carlo Tondini, Ospedale Papa Giovanni XXIII, International Breast Cancer Study Group, Bergamo; Davide Lombardi, Centro di Riferimento Oncologico, International Breast Cancer Study Group, Aviano; Fabio Puglisi, University Hospital of Udine, University of Udine, International Breast Cancer Study Group, Udine; Marco Colleoni, Aron Goldhirsch, European Institute of Oncology, International Breast Cancer Study Group, Milan, Italy; Vani Parmar, Breast Services, Tata Memorial Hospital, International Breast Cancer Study Group, Mumbai, India; Pierre Kerbrat, Centre Eugène Marquis, Université de Rennes 1, Rennes, France; Pierre Kerbrat, Patrick Neven, European Organisation for Research, Treatment of Cancer, Brussels; Patrick Neven, UZ Gasthuisberg, Leuven, Belgium; Roberto Torres, Instituto Nacional del Cancer, Chilean Cooperative Group for Oncologic Research Group, International Breast Cancer Study Group, Santiago, Chile; Per Karlsson, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, International Breast Cancer Study Group, Gothenburg, Sweden.

PURPOSE: The 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 METHODS: The 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.

RESULTS: Patients on tamoxifen plus OFS were more affected than patients on tamoxifen alone by hot flushes at 6 and 24 months, by loss of sexual interest and sleep disturbance at 6 months, and by vaginal dryness up to 60 months. Without prior chemotherapy, patients on tamoxifen alone reported more vaginal discharge over the 5 years than patients on tamoxifen plus OFS. Symptom-specific treatment differences at 6 months were less pronounced in patients with prior chemotherapy. Changes in global QoL indicators from baseline were small and similar between treatments over the whole treatment period.

CONCLUSION: 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. Short-term differences in symptom-specific QoL, treatment burden, and coping effort between treatment groups were less pronounced for patients with prior chemotherapy, the cohort that benefited most from OFS in terms of disease control.

DOI: 10.1200/JCO.2015.64.8675