{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T22:06:21Z","timestamp":1789596381825,"version":"build-2803163510"},"reference-count":34,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"27","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,9,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Salivary gland carcinoma (SGC), particularly salivary duct carcinoma (SDC), is a rare and aggressive malignancy with no standard systemic treatment. Androgen receptor (AR) expression is frequently detected in SDC, which suggests inhibition of the AR pathway as a therapeutic strategy. We conducted a prospective phase II trial of the efficacy and safety of darolutamide, a second-generation AR signaling inhibitor, as monotherapy or in combination with goserelin, in patients with AR-positive unresectable locally advanced (LA) or recurrent\/metastatic (R\/M) SGC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>DISCOVARY was a multicenter, single-arm, phase II trial conducted in Japan. Patients with unresectable LA or R\/M AR-positive SGC were enrolled into two sequential cohorts, a monotherapy cohort (darolutamide 600 mg orally twice daily) and a combination cohort (darolutamide plus goserelin 3.6 mg subcutaneously once every 28 days). The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival (OS), safety, and health-related quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Fifty-seven patients were enrolled (monotherapy, n = 24; combination, n = 33). In the monotherapy cohort, the confirmed ORR was 8.3% (90% CI, 1.5 to 24.0) and the median PFS was 5.7 months. In the combination cohort, ORR was 45.2% (90% CI, 29.7 to 61.3) and the median PFS was 13.1 months. Twelve-month OS rates were 91.3% and 87.0%, respectively. Most adverse events were grade 1 or 2 in severity, with no treatment-related deaths. Quality of life was preserved. No clear association between AR expression level or Ki-67 index and treatment response was evident in exploratory analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Darolutamide demonstrated antitumor activity in AR-positive SGC, with numerically more favorable outcomes with goserelin. Darolutamide plus goserelin may represent a chemotherapy-sparing option in this rare malignancy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-03028","type":"journal-article","created":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T19:59:15Z","timestamp":1785787155000},"page":"2602-2613","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":0,"title":["Darolutamide Alone and in Combination With Goserelin in Androgen Receptor\u2013Positive Salivary Gland Carcinoma: Results From the Phase II DISCOVARY Trial"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct05694819","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6639-9753","authenticated-orcid":false,"given":"Susumu","family":"Okano","sequence":"first","affiliation":[{"name":"Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9035-3106","authenticated-orcid":false,"given":"Makoto","family":"Tahara","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyoaki","family":"Tsukahara","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3394-0720","authenticated-orcid":false,"given":"Tomoyuki","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4750-5332","authenticated-orcid":false,"given":"Satoshi","family":"Kano","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Hokkaido, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6350-5186","authenticated-orcid":false,"given":"Masato","family":"Nagaoka","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Jikei University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3502-817X","authenticated-orcid":false,"given":"Hideoki","family":"Uryu","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7686-4724","authenticated-orcid":false,"given":"Daisuke","family":"Sano","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Yokohama City University Graduate School of Medicine, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1495-0376","authenticated-orcid":false,"given":"Naoki","family":"Nishio","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Nagoya University Graduate School of Medicine, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6826-799X","authenticated-orcid":false,"given":"Kazuchika","family":"Ono","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0652-7041","authenticated-orcid":false,"given":"Akira","family":"Ohkoshi","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toyoyuki","family":"Hanazawa","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0651-438X","authenticated-orcid":false,"given":"Satoru","family":"Shinoda","sequence":"additional","affiliation":[{"name":"YCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuriko","family":"Takeda","sequence":"additional","affiliation":[{"name":"YCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0696-9659","authenticated-orcid":false,"given":"Kouji","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"YCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8021-6116","authenticated-orcid":false,"given":"Naomi","family":"Kiyota","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology and Hematology, Cancer Center, Kobe University Hospital, Hyogo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_10_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.semradonc.2012.03.009"},{"key":"e_1_3_10_3_2","doi-asserted-by":"publisher","DOI":"10.1186\/s41199-016-0011-z"},{"key":"e_1_3_10_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.21116"},{"key":"e_1_3_10_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.humpath.2017.05.014"},{"key":"e_1_3_10_6_2","doi-asserted-by":"publisher","DOI":"10.7717\/peerj.19626"},{"key":"e_1_3_10_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.33968"},{"key":"e_1_3_10_8_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.05.3025"},{"key":"e_1_3_10_9_2","doi-asserted-by":"publisher","DOI":"10.3390\/curroncol32040232"},{"key":"e_1_3_10_10_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.18.00545"},{"key":"e_1_3_10_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyad181"},{"key":"e_1_3_10_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.humpath.2019.08.007"},{"key":"e_1_3_10_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-025-02785-3"},{"key":"e_1_3_10_14_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.00229"},{"key":"e_1_3_10_15_2","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-24-0455"},{"key":"e_1_3_10_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx771"},{"key":"e_1_3_10_17_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1207506"},{"key":"e_1_3_10_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clgc.2018.07.017"},{"key":"e_1_3_10_19_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO-24-01798"},{"key":"e_1_3_10_20_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001342"},{"key":"e_1_3_10_21_2","doi-asserted-by":"publisher","DOI":"10.1038\/onc.2013.206"},{"key":"e_1_3_10_22_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12955-024-02294-3"},{"key":"e_1_3_10_23_2","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-5-70"},{"key":"e_1_3_10_24_2","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2020.580141"},{"key":"e_1_3_10_25_2","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyaf192"},{"key":"e_1_3_10_26_2","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.annonc.a010684"},{"key":"e_1_3_10_27_2","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19881201)62:11<2313::AID-CNCR2820621110>3.0.CO;2-4"},{"key":"e_1_3_10_28_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12032-021-01581-z"},{"key":"e_1_3_10_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2024.08.2275"},{"key":"e_1_3_10_30_2","first-page":"87","article-title":"Evolution of androgen deprivation therapy (ADT) and its new emerging modalities in prostate cancer: An update for practicing urologists, Clinicians and medical providers","volume":"14","author":"Choi E","year":"2022","unstructured":"Choi E, Buie J, Camacho J, et al: Evolution of androgen deprivation therapy (ADT) and its new emerging modalities in prostate cancer: An update for practicing urologists, Clinicians and medical providers. Res Rep Urol 14:87-108, 2022","journal-title":"Res Rep Urol"},{"key":"e_1_3_10_31_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)70129-9"},{"key":"e_1_3_10_32_2","doi-asserted-by":"publisher","DOI":"10.1530\/ERC-10-0339"},{"key":"e_1_3_10_33_2","doi-asserted-by":"publisher","DOI":"10.2147\/CMAR.S227583"},{"key":"e_1_3_10_34_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-023-01268-w"},{"key":"e_1_3_10_35_2","first-page":"163","article-title":"Estrogenic side effects of androgen deprivation therapy","volume":"9","author":"Guise TA","year":"2007","unstructured":"Guise TA, Oefelein MG, Eastham JA, et al: Estrogenic side effects of androgen deprivation therapy. Rev Urol 9:163-180, 2007","journal-title":"Rev Urol"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO-25-03028","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T22:00:22Z","timestamp":1789596022000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO-25-03028"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,20]]},"references-count":34,"journal-issue":{"issue":"27","published-print":{"date-parts":[[2026,9,20]]}},"alternative-id":["10.1200\/JCO-25-03028"],"URL":"https:\/\/doi.org\/10.1200\/jco-25-03028","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,20]]},"assertion":[{"value":"2026-01-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-20","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}