{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T07:35:31Z","timestamp":1771054531903,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,11,7]],"date-time":"2018-11-07T00:00:00Z","timestamp":1541548800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl Journal of Cancer"],"published-print":{"date-parts":[[2018,12,15]]},"abstract":"<jats:p>Although the introduction of human epidermal growth factor receptor (HER)2\u2010directed therapy including trastuzumab, pertuzumab, lapatinib and trastuzumab emtansine (T\u2010DM1) in the treatment of HER2\u2010positive metastatic breast cancers (mBCs) favorably changed the natural history of this disease, most cases of HER2\u2010positive mBC will eventually progress. Poziotinib is an oral pan\u2010HER kinase inhibitor showing potent activity through irreversible inhibition of these kinases. This open\u2010label, multicenter phase II study was designed to evaluate the efficacy and safety of poziotinib monotherapy in patients with HER2\u2010positive mBC who had progressed from more than two HER2\u2010directed therapies. Patients received 12 mg poziotinib once daily on a 14\u2010day on\/7\u2010day off schedule. Progression\u2010free survival (PFS) as the primary endpoint, the objective response rate (ORR), overall survival (OS) and safety were evaluated. From April 2015 to February 2016, 106 patients were enrolled in the trial from seven institutes in South Korea. They had a median age of 51 years (range 30\u201376) and had received a median of four prior therapies including two HER2\u2010directed therapies for advanced or metastatic cancers. The median follow\u2010up duration was 12 months. The median PFS was 4.04 months (95% confidence interval [CI], 2.94\u20134.40 months), and median overall survival has not been reached. The most common treatment\u2010related adverse events were (total\/grade \u22653) diarrhea (96.23%\/14.15%), stomatitis (92.45%\/12.26%) and rashes (63.21%\/3.77%). Poziotinib showed meaningful activity in these heavily treated HER2\u2010positive mBCs. Diarrhea and stomatitis were the major toxicities. Biomarker studies analyzed are warranted to support further evaluation of this treatment in such cases.<\/jats:p>","DOI":"10.1002\/ijc.31651","type":"journal-article","created":{"date-parts":[[2018,7,6]],"date-time":"2018-07-06T09:05:17Z","timestamp":1530867917000},"page":"3240-3247","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["A phase II trial of the pan\u2010HER inhibitor poziotinib, in patients with HER2\u2010positive metastatic breast cancer who had received at least two prior HER2\u2010directed regimens: results of the NOV120101\u2010203 trial"],"prefix":"10.1002","volume":"143","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4156-9212","authenticated-orcid":false,"given":"Yeon Hee","family":"Park","sequence":"first","affiliation":[{"name":"Division of Hematology\u2010Oncology, Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyung\u2010Hun","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joo Hyuk","family":"Sohn","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Yonsei Cancer Center  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keun Seok","family":"Lee","sequence":"additional","affiliation":[{"name":"Center for Breast Cancer, National Cancer Center Hospital  Goyang South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyung Hae","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Oncology, Asan Medical Center University of Ulsan College of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jee\u2010Hyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University Bundang Hospital, Seoul National University College of Medicine  Soengnam South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ki Hyeong","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Chungbuk National University Hospital  Cheongju South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin Seok","family":"Ahn","sequence":"additional","affiliation":[{"name":"Division of Hematology\u2010Oncology, Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tae\u2010Yong","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gun Min","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Yonsei Cancer Center  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"In Hae","family":"Park","sequence":"additional","affiliation":[{"name":"Center for Breast Cancer, National Cancer Center Hospital  Goyang South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sung\u2010Bae","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Oncology, Asan Medical Center University of Ulsan College of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Se Hyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University Bundang Hospital, Seoul National University College of Medicine  Soengnam South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hye Sook","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Chungbuk National University Hospital  Cheongju South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Young\u2010Hyuck","family":"Im","sequence":"additional","affiliation":[{"name":"Division of Hematology\u2010Oncology, Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin\u2010Hee","family":"Ahn","sequence":"additional","affiliation":[{"name":"Department of Oncology, Asan Medical Center University of Ulsan College of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jung\u2010Yong","family":"Kim","sequence":"additional","affiliation":[{"name":"Clinical Development Division National OncoVenture  Goyang South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jahoon","family":"Kang","sequence":"additional","affiliation":[{"name":"Clinical Research and Development Hanmi Pharmaceutical Co., Ltd.  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5396-6533","authenticated-orcid":false,"given":"Seock\u2010Ah","family":"Im","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,11,7]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1125951"},{"key":"e_1_2_6_3_1","first-page":"4332","article-title":"HER\u20102\/neu amplification predicts poor survival in node\u2010positive breast cancer","volume":"50","author":"Borg A","year":"1990","journal-title":"Cancer Res"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.09.2775"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrclinonc.2011.177"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI57152"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/emboj\/19.13.3159"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrc2656"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.canlet.2011.01.010"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.26276"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/CAD.0b013e32834e7d9b"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.4143\/crt.2017.303"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)70178-0"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32616-2"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1349-7006.2010.01711.x"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa064320"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-07-0701"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)00551-3"}],"container-title":["International Journal of Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fijc.31651","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ijc.31651","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T04:07:04Z","timestamp":1694318824000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ijc.31651"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11,7]]},"references-count":17,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2018,12,15]]}},"alternative-id":["10.1002\/ijc.31651"],"URL":"https:\/\/doi.org\/10.1002\/ijc.31651","archive":["Portico"],"relation":{},"ISSN":["0020-7136","1097-0215"],"issn-type":[{"value":"0020-7136","type":"print"},{"value":"1097-0215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11,7]]},"assertion":[{"value":"2018-01-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-04-10","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-07","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}