Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study
DC Field | Value | Language |
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dc.contributor.author | Park, Min Ho | - |
dc.contributor.author | Seo, Jae Hong | - |
dc.contributor.author | Park, Jung Ho | - |
dc.contributor.author | Seong, Min-Ki | - |
dc.contributor.author | Park, Keon Uk | - |
dc.contributor.author | Kim, Min Kyoon | - |
dc.contributor.author | Chang, Myungchul | - |
dc.contributor.author | Koh, Su-Jin | - |
dc.contributor.author | Lee, Moon Hee | - |
dc.contributor.author | Lim, Seung Taek | - |
dc.contributor.author | Yoo, Young Bum | - |
dc.contributor.author | Oh, So Yeon | - |
dc.contributor.author | Kim, Sung Hyun | - |
dc.contributor.author | Ahn, Keum Young | - |
dc.contributor.author | Park, Tae Hong | - |
dc.contributor.author | Ju, Hana | - |
dc.contributor.author | Baek, Eric Hyungseok | - |
dc.contributor.author | Kim, Sinhye | - |
dc.contributor.author | Kim, Nahyun | - |
dc.contributor.author | Lee, Eunkyung | - |
dc.contributor.author | Kim, Tae Hyun | - |
dc.date.accessioned | 2024-05-16T08:00:44Z | - |
dc.date.available | 2024-05-16T08:00:44Z | - |
dc.date.issued | 2024-04 | - |
dc.identifier.issn | 1471-2598 | - |
dc.identifier.issn | 1744-7682 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/73721 | - |
dc.description.abstract | The trastuzumab biosimilar CT-P6 is approved for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC). The objective of this post-marketing surveillance (PMS) study was to evaluate the real-world safety and effectiveness of CT-P6 in patients with HER2-positive cancers. This open-label, observational, prospective, PMS study collected data via investigator surveys from 35 centers in the Republic of Korea (5 October 2018-4 October 2022). Eligible patients with HER2-positive EBC, MBC, or MGC started CT-P6 treatment during routine clinical practice, followed by 1-year observation. Evaluations included adverse events (AEs), adverse drug reactions (ADRs), and effectiveness. Safety was analyzed in 642 patients (494 EBC, 94 MBC, 54 MGC). Overall, 325 (50.6%) patients experienced 1316 AEs, and 550 ADRs occurred in 199 (31.0%) patients. Unexpected ADRs occurred in 62 (9.7%) patients. Unexpected ADRs and ADRs of special interest did not raise any new safety signals. Among trastuzumab-naïve patients, 34/106 (32.1%) with EBC achieved pathological complete response; 30/74 (40.5%) MBC and 24/49 (49.0%) MGC patients achieved complete or partial response. In a real-world setting, CT-P6 demonstrated safety and efficacy findings consistent with previous CT-P6 studies. | - |
dc.format.extent | 8 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | TAYLOR & FRANCIS LTD | - |
dc.title | Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study | - |
dc.type | Article | - |
dc.identifier.doi | 10.1080/14712598.2024.2334386 | - |
dc.identifier.bibliographicCitation | Expert opinion on biological therapy, v.24, no.4, pp 305 - 312 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.wosid | 001209160300001 | - |
dc.identifier.scopusid | 2-s2.0-85191757986 | - |
dc.citation.endPage | 312 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 305 | - |
dc.citation.title | Expert opinion on biological therapy | - |
dc.citation.volume | 24 | - |
dc.type.docType | Article | - |
dc.publisher.location | 영국 | - |
dc.subject.keywordAuthor | Anti-HER2 | - |
dc.subject.keywordAuthor | CT-P6 | - |
dc.subject.keywordAuthor | biosimilar | - |
dc.subject.keywordAuthor | human epidermal growth receptor 2 | - |
dc.subject.keywordAuthor | post-marketing surveillance | - |
dc.subject.keywordAuthor | trastuzumab | - |
dc.relation.journalResearchArea | Biotechnology & Applied Microbiology | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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