{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T12:10:31Z","timestamp":1773144631382,"version":"3.50.1"},"reference-count":21,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"5","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2019,2,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> To evaluate endocrine activity in terms of ovarian function suppression (OFS) of degarelix (a gonadotropin-releasing hormone [GnRH] antagonist) versus triptorelin (a GnRH agonist) in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer. <\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p> Premenopausal women with stage cT2 to 4b, any N, M0; estrogen receptor and progesterone receptor greater than 50%; human epidermal growth factor receptor 2\u2013negative breast cancer were randomly assigned to triptorelin 3.75 mg administered intramuscularly on day 1 of every cycle or degarelix 240 mg administered subcutaneously (SC) on day 1 of cycle 1 then 80 mg SC on day 1 of cycles 2 through 6, both with letrozole 2.5 mg\/day for six 28-day cycles. Surgery was performed 2 to 3 weeks after the last injection. Serum was collected at baseline, after 24 and 72 hours, at 7 and 14 days, and then before injections on cycles 2 through 6. The primary end point was time to optimal OFS (time from the first injection to first assessment of centrally assessed estradiol level \u2264 2.72 pg\/mL [\u2264 10 pmol\/L] during neoadjuvant therapy). The trial had 90% power to detect a difference using a log-rank test with a two-sided \u03b1 of .05. Secondary end points included response, tolerability, and patient-reported endocrine symptoms. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> Between February 2014 and January 2017, 51 patients were enrolled (n = 26 received triptorelin plus letrozole; n = 25 received degarelix plus letrozole). Time to optimal OFS was three times faster for patients assigned to degarelix and letrozole than to triptorelin and letrozole (median, 3 v 14 days; hazard ratio, 3.05; 95% CI, 1.65 to 5.65; P &lt; .001). Furthermore, OFS was maintained during subsequent cycles for all patients assigned to receive degarelix and letrozole, whereas 15.4% of patients assigned to receive triptorelin and letrozole had suboptimal OFS after cycle 1 (six events during 127 measurements). Adverse events as a result of both degarelix plus letrozole and triptorelin plus letrozole were as expected. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> In premenopausal women receiving letrozole for neoadjuvant endocrine therapy, OFS was achieved more quickly and maintained more effectively with degarelix than with triptorelin. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.18.00296","type":"journal-article","created":{"date-parts":[[2018,12,27]],"date-time":"2018-12-27T15:59:52Z","timestamp":1545926392000},"page":"386-395","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":26,"title":["Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Who Receive Letrozole for Locally Advanced Endocrine-Responsive Breast Cancer: A Randomized Phase II Trial"],"prefix":"10.1200","volume":"37","author":[{"given":"Silvia","family":"Dellapasqua","sequence":"first","affiliation":[{"name":"IEO, European Institute of Oncology Istituto di Recovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathryn P.","family":"Gray","sequence":"additional","affiliation":[{"name":"Dana-Farber Cancer Institute and Harvard T.H. Chan School of Public Health, Boston, MA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabetta","family":"Munzone","sequence":"additional","affiliation":[{"name":"IEO, European Institute of Oncology Istituto di Recovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela","family":"Rubino","sequence":"additional","affiliation":[{"name":"S Orsola Hospital, Bologna, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lorenzo","family":"Gianni","sequence":"additional","affiliation":[{"name":"Ospedale Infermi di Rimini, Azienda Unita Sanitaria (AUSL) della Romagna, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harriet","family":"Johansson","sequence":"additional","affiliation":[{"name":"IEO, European Institute of Oncology Istituto di Recovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Viale","sequence":"additional","affiliation":[{"name":"IEO, European Institute of Oncology Istituto di Recovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Ribi","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group Coordinating Center, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00fcrg","family":"Bernhard","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group Coordinating Center, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roswitha","family":"Kammler","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group Coordinating Center, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rudolf","family":"Maibach","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group Coordinating Center, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manuela","family":"Rabaglio-Poretti","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group Coordinating Center, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Ruepp","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group Coordinating Center, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelo","family":"Di Leo","sequence":"additional","affiliation":[{"name":"Hospital of Prato\u2013AUSL Toscana Centro, Prato, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan S.","family":"Coates","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group and University of Sydney, Sydney, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard D.","family":"Gelber","sequence":"additional","affiliation":[{"name":"Frontier Science and Technology Research Foundation and Harvard Medical School, Boston, MA"},{"name":"International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meredith M.","family":"Regan","sequence":"additional","affiliation":[{"name":"International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aron","family":"Goldhirsch","sequence":"additional","affiliation":[{"name":"IEO, European Institute of Oncology Istituto di Recovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Colleoni","sequence":"additional","affiliation":[{"name":"IEO, European Institute of Oncology Istituto di Recovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the International Breast Cancer Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)72307-0"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(96)05023-4"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx036"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx308"},{"key":"B5","volume-title":"Proceedings of the 13th World Congress of Gynecology and Obstetrics","author":"Lindner CH","year":"1991"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2017.1363181"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2008.08183.x"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-17-0228"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70373-4"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.05.3694"},{"key":"B12","volume-title":"WHO Handbook for Reporting Results of Cancer Treatment","author":"WHO","year":"1979"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1023\/A:1006263818115"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2012.43"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2008.04.065"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2008.07.033"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1404037"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.65.9573"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.61.2259"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2018.79.2721"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6603947"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410X.2003.04308.x"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.18.00296","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,29]],"date-time":"2022-05-29T03:47:17Z","timestamp":1653796037000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.18.00296"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,2,10]]},"references-count":21,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2019,2,10]]}},"alternative-id":["10.1200\/JCO.18.00296"],"URL":"https:\/\/doi.org\/10.1200\/jco.18.00296","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,2,10]]},"assertion":[{"value":"2018-12-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}