• Meritxell Bellet, Kathryn P Gray, Prudence A Francis, István Láng, Eva Ciruelos, Ana Lluch, Miguel Angel Climent, Gustavo Catalán, Antoni Avella, Uriel Bohn, Antonio González-Martin, Roser Ferrer, Roberto Catalán, Analía Azaro, Agnita Rajasekaran, Josefa Morales, Josep Vázquez, Gini F Fleming, Karen N Price, and Meredith M Regan.
• Meritxell Bellet and Analía Azaro, Vall d'Hebron Institute of Oncology; Meritxell Bellet, Roser Ferrer, Roberto Catalán, and Analía Azaro, Vall d'Hebron University Hospital; Meritxell Bellet, Universitat Autònoma de Barcelona; Meritxell Bellet, Eva Ciruelos, Ana Lluch, Miguel Angel Climent, Gustavo Catalán, Antoni Avella, Uriel Bohn, Antonio González-Martin, Josefa Morales, and Josep Vázquez, SOLTI Group, Barcelona; Eva Ciruelos, University Hospital 12 de Octubre; Antonio González-Martin, MD Anderson Cancer Center Madrid, Madrid; Ana Lluch, Hospital Clinico Universitario de Valencia/Incliva Biomedical Research Institute; Miguel Angel Climent, Instituto Valenciano de Oncologia, Valencia; Gustavo Catalán, Hospital Son Llàtzer; Antoni Avella, Hospital Universitario Son Espases, Palma de Mallorca; Uriel Bohn, Hospital Dr Negrín de Gran Canaria, Canary Islands, Spain; Kathryn P. Gray and Meredith M. Regan, Dana-Farber Cancer Institute; Kathryn P. Gray, Harvard T.H. Chan School of Public Health; Kathryn P. Gray, Karen N. Price, and Meredith M. Regan, International Breast Cancer Study Group Statistical Center; Karen N. Price, Frontier Science and Technology Research Foundation; Meredith M. Regan, Harvard Medical School, Boston, MA; Agnita Rajasekaran, inVentiv Health Clinical Laboratory, Princeton, NJ; Gini F. Fleming, The University of Chicago Medical Center and Alliance for Clinical Trials in Oncology, Chicago, IL; Prudence A. Francis, Peter MacCallum Cancer Center, St Vincent's Hospital, University of Melbourne, and International Breast Cancer Study Group, Melbourne, Victoria, Australia; and István Láng, National Institute of Oncology and International Breast Cancer Study Group, Budapest, Hungary. mbellet@vhio.net.
• J. Clin. Oncol. 2016 May 10; 34 (14): 1584-93.

PurposeTo describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin.Patients And MethodsPremenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sensitive and specific assay. This preplanned 12-month analysis evaluated E2, E1, E1S, follicle-stimulating hormone, and luteinizing hormone levels in all patients and the proportion of patients with E2 levels greater than 2.72 pg/mL at any time point during treatment with exemestane plus triptorelin.ResultsOne hundred sixteen patients (exemestane, n = 86; tamoxifen, n = 30; median age, 44 years; median E2, 51 pg/mL; 55% prior chemotherapy) started triptorelin and had one or more samples drawn. With exemestane plus triptorelin, median reductions from baseline E2, E1, and E1S levels were consistently ≥ 95%, resulting in significantly lower levels than with tamoxifen plus triptorelin at all time points. Among patients on exemestane plus triptorelin, 25%, 24%, and 17% had an E2 level greater than 2.72 pg/mL at 3, 6, and 12 months, respectively. Baseline factors related to on-treatment E2 level greater than 2.72 pg/mL were no prior chemotherapy (P = .06), higher body mass index (P = .05), and lower follicle-stimulating hormone and luteinizing hormone (each P < .01).ConclusionDuring the first year, most patients on exemestane plus triptorelin had E2 levels below the defined threshold of 2.72 pg/mL, consistent with levels reported in postmenopausal patients on aromatase inhibitors, but at each time point, at least 17% of patients had levels greater than the threshold.© 2016 by American Society of Clinical Oncology.

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