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Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer

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dc.contributor.author김건민-
dc.contributor.author김민환-
dc.contributor.author김승일-
dc.contributor.author김지예-
dc.contributor.author김지형-
dc.contributor.author박세호-
dc.contributor.author박형석-
dc.contributor.author배숭준-
dc.contributor.author손주혁-
dc.contributor.author안성귀-
dc.contributor.author정준-
dc.contributor.author정희철-
dc.date.accessioned2021-09-29T00:50:03Z-
dc.date.available2021-09-29T00:50:03Z-
dc.date.issued2021-06-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/184060-
dc.description.abstractBackground: The trastuzumab biosimilar CT-P6 has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC). Here, we present the first real-world comparison of CT-P6 versus RTZ with dual HER2-targeted therapy for the neoadjuvant and palliative first-line treatment with HER2-positive EBC and metastatic breast cancer (MBC) patients in two tertiary hospitals in Korea. Methods: We retrospectively investigated medical records in the Severance Breast Cancer Registry in Korea. We identified patients with HER2-positive EBC (n=254) who had received neoadjuvant chemotherapy with RTZ or CT-P6, plus pertuzumab, carboplatin and docetaxel (TCHP) and untreated stage IV MBC (n=103) who had received palliative first-line treatment with RTZ or CT-P6, plus pertuzumab and docetaxel (THP) between May 2014 and December 2019. The primary endpoints were pathologic complete response (pCR) in the EBC and progression-free survival (PFS) in the MBC cohort. Overall survival (OS), overall response rate (ORR), disease control rate (DCR), and cardiac safety were secondary endpoints. Results: A similar percentage of EBC patients achieved a pCR with CT-P6 versus RTZ (74.4% [93/125]) vs 69.8% [90/129], p=0.411). For patients with MBC, median follow-up duration was 23.0 and 41.0 months for CT-P6 and RTZ groups, respectively; median PFS did not differ significantly between two groups (13.0 vs 18.0 months, 95% confidence intervals (CIs) 0.0-26.6 vs 11.3-24.7, p=0.976). The ORR, DCR, and cardiac safety profiles did not also show significant difference efficacy outcomes between two groups. Conclusions: These real-world data suggest that biosimilar trastuzumab CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherFrontiers Research Foundation-
dc.relation.isPartOfFRONTIERS IN ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleReal-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorSoong June Bae-
dc.contributor.googleauthorJee Hung Kim-
dc.contributor.googleauthorSung Gwe Ahn-
dc.contributor.googleauthorHei-Cheul Jeung-
dc.contributor.googleauthorJoohyuk Sohn-
dc.contributor.googleauthorGun Min Kim-
dc.contributor.googleauthorMin Hwan Kim-
dc.contributor.googleauthorSeung Il Kim-
dc.contributor.googleauthorSeho Park-
dc.contributor.googleauthorHyung Seok Park-
dc.contributor.googleauthorJi Ye Kim-
dc.contributor.googleauthorJoon Jeong-
dc.identifier.doi10.3389/fonc.2021.689587-
dc.contributor.localIdA00287-
dc.contributor.localIdA00482-
dc.contributor.localIdA00658-
dc.contributor.localIdA00984-
dc.contributor.localIdA00999-
dc.contributor.localIdA01524-
dc.contributor.localIdA01753-
dc.contributor.localIdA05345-
dc.contributor.localIdA01995-
dc.contributor.localIdA02231-
dc.contributor.localIdA03727-
dc.contributor.localIdA03794-
dc.relation.journalcodeJ03512-
dc.identifier.eissn2234-943X-
dc.identifier.pmid34150658-
dc.subject.keywordCT-P6-
dc.subject.keywordHER2-positive breast cancer-
dc.subject.keywordbiosimilar-
dc.subject.keywordearly breast cancer (EBC)-
dc.subject.keywordmetastatic breast cancer (mbc)-
dc.subject.keywordtrastuzumab-
dc.contributor.alternativeNameKim, Gun Min-
dc.contributor.affiliatedAuthor김건민-
dc.contributor.affiliatedAuthor김민환-
dc.contributor.affiliatedAuthor김승일-
dc.contributor.affiliatedAuthor김지예-
dc.contributor.affiliatedAuthor김지형-
dc.contributor.affiliatedAuthor박세호-
dc.contributor.affiliatedAuthor박형석-
dc.contributor.affiliatedAuthor배숭준-
dc.contributor.affiliatedAuthor손주혁-
dc.contributor.affiliatedAuthor안성귀-
dc.contributor.affiliatedAuthor정준-
dc.contributor.affiliatedAuthor정희철-
dc.citation.volume11-
dc.citation.startPage689587-
dc.identifier.bibliographicCitationFRONTIERS IN ONCOLOGY, Vol.11 : 689587, 2021-06-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers

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