{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T04:57:02Z","timestamp":1788325022066,"version":"build-2803163510"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T00:00:00Z","timestamp":1750809600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003478","name":"Ministry of Health, Labour and Welfare","doi-asserted-by":"publisher","award":["16lk0103005h0005"],"award-info":[{"award-number":["16lk0103005h0005"]}],"id":[{"id":"10.13039\/501100003478","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["19lk0201074h0003"],"award-info":[{"award-number":["19lk0201074h0003"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,10,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Backgrounds<\/jats:title>\n                  <jats:p>Standard systemic chemotherapy remains unestablished for recurrent or metastatic (RM) salivary gland cancer (SGC) due to its rarity. A single institute phase II trial of trastuzumab and docetaxel previously showed efficacy with human epidermal growth factor receptor 2 (HER2)-positive SGC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a multicenter, single-arm, open-label phase II trial of trastuzumab and docetaxel for HER2-positive RM SGC. Patients received trastuzumab 6\u00a0mg\/kg (loading dose 8\u00a0mg\/kg) and docetaxel 70\u00a0mg\/m2 every 3\u00a0weeks up to eight\u00a0cycles. The primary endpoint was the objective response rate (ORR) by a blinded independent review committee. Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. Forty-eight patients were screened for HER2 status; 23 were HER2-positive.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Eighteen patients were enrolled, with 16 receiving the protocol treatment. Fourteen patients were diagnosed with salivary duct carcinoma. The ORR was 60.0% (95% confidence interval [CI], 32.3 to 83.7). The median PFS was 8.5\u00a0months (95% CI, 6.0 to 12.7), the median OS, 33.8\u00a0months (95% CI, 16.9 to not estimable), and the DCR, 93.3% (95% CI, 68.1 to 99.8). The most frequent grade\u00a0\u22653 treatment-emerged adverse events were neutropenia (100%), leukopenia (93.8%), lymphopenia (18.8%), and febrile neutropenia (12.5%). One treatment-related death occurred (6.3%) due to hypoalbuminemia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>These results demonstrate the significant efficacy and predictable toxicities of trastuzumab and docetaxel in patients with HER2-positive RM SGC, leading to the simultaneous approval of trastuzumab and HER2 companion diagnostics assay for this setting in Japan.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyaf106","type":"journal-article","created":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T15:47:15Z","timestamp":1750866435000},"page":"1131-1140","source":"Crossref","is-referenced-by-count":11,"title":["Multicenter phase II trial of trastuzumab and docetaxel for HER2-positive salivary gland cancer"],"prefix":"10.1093","volume":"55","author":[{"given":"Satoshi","family":"Kano","sequence":"first","affiliation":[{"name":"Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University , N15, W7, Kita-ku, Sapporo , 060-8638,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi","family":"Kiyota","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology and Hematology, Kobe University Hospital , 7-5-2 Kusunoki-ku, Kobe , 650-0017,","place":["Japan"]},{"name":"Kobe University Hospital Cancer Center , 7-5-2 Kusunoki-ku, Kobe , 650-0017,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ichiro","family":"Kinoshita","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichiro","family":"Tada","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Oncology and Surgery, International University of Health and Welfare, Mita Hospital , 1-4-3 Mita, Minato-ku, Tokyo , 108-8329,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kei","family":"Ijichi","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology- Head and Neck Surgery, Nagoya City University Graduate School of Medicine , 1 Kawasumi, Mizuhomachi, Mizuho-ku, Nagoya , 467-8601,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoko","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Division of Head and Neck Cancer Oncology, Miyagi Cancer Center , 47-1 Nodayama, Aza-Shiote, Aijima, Natori, 981-1293,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Hatanaka","sequence":"additional","affiliation":[{"name":"Center for Development of Advanced Diagnostics, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitoshi","family":"Tsuda","sequence":"additional","affiliation":[{"name":"Department of Basic Pathology, National Defense Medical College , 3-2 Namiki, Tokorozawa , 359-8513,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shojiroh","family":"Morinaga","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Pathology, Hino Municipal Hospital , 3-1, 4-chome, Tamadaira, Hino , 191-0062,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Matsuno","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoichi M","family":"Ito","sequence":"additional","affiliation":[{"name":"Data Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Nishimoto","sequence":"additional","affiliation":[{"name":"Clinical Research and Medical Innovation Center, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiko","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Clinical Research and Medical Innovation Center, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiyuki","family":"Isoe","sequence":"additional","affiliation":[{"name":"Clinical Research and Medical Innovation Center, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuro","family":"Noguchi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiro","family":"Homma","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University , N15, W7, Kita-ku, Sapporo , 060-8638,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotoshi","family":"Dosaka-Akita","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hokkaido University Hospital , N14, W5, Kita-ku, Sapporo , 060-8648,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,6,25]]},"reference":[{"key":"2025100708164901000_ref1","doi-asserted-by":"publisher","first-page":"134","DOI":"10.1016\/j.critrevonc.2009.10.004","article-title":"Major and minor salivary gland tumors","volume":"74","author":"Guzzo","year":"2010","journal-title":"Crit Rev Oncol Hematol"},{"key":"2025100708164901000_ref2","doi-asserted-by":"publisher","first-page":"209","DOI":"10.3322\/caac.21660","article-title":"Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 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