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Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | 김건민 | - |
dc.contributor.author | 김민환 | - |
dc.contributor.author | 김승일 | - |
dc.contributor.author | 김지예 | - |
dc.contributor.author | 김지형 | - |
dc.contributor.author | 박세호 | - |
dc.contributor.author | 박형석 | - |
dc.contributor.author | 배숭준 | - |
dc.contributor.author | 손주혁 | - |
dc.contributor.author | 안성귀 | - |
dc.contributor.author | 정준 | - |
dc.contributor.author | 정희철 | - |
dc.date.accessioned | 2021-09-29T00:50:03Z | - |
dc.date.available | 2021-09-29T00:50:03Z | - |
dc.date.issued | 2021-06 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/184060 | - |
dc.description.abstract | Background: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Frontiers Research Foundation | - |
dc.relation.isPartOf | FRONTIERS IN ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Soong June Bae | - |
dc.contributor.googleauthor | Jee Hung Kim | - |
dc.contributor.googleauthor | Sung Gwe Ahn | - |
dc.contributor.googleauthor | Hei-Cheul Jeung | - |
dc.contributor.googleauthor | Joohyuk Sohn | - |
dc.contributor.googleauthor | Gun Min Kim | - |
dc.contributor.googleauthor | Min Hwan Kim | - |
dc.contributor.googleauthor | Seung Il Kim | - |
dc.contributor.googleauthor | Seho Park | - |
dc.contributor.googleauthor | Hyung Seok Park | - |
dc.contributor.googleauthor | Ji Ye Kim | - |
dc.contributor.googleauthor | Joon Jeong | - |
dc.identifier.doi | 10.3389/fonc.2021.689587 | - |
dc.contributor.localId | A00287 | - |
dc.contributor.localId | A00482 | - |
dc.contributor.localId | A00658 | - |
dc.contributor.localId | A00984 | - |
dc.contributor.localId | A00999 | - |
dc.contributor.localId | A01524 | - |
dc.contributor.localId | A01753 | - |
dc.contributor.localId | A05345 | - |
dc.contributor.localId | A01995 | - |
dc.contributor.localId | A02231 | - |
dc.contributor.localId | A03727 | - |
dc.contributor.localId | A03794 | - |
dc.relation.journalcode | J03512 | - |
dc.identifier.eissn | 2234-943X | - |
dc.identifier.pmid | 34150658 | - |
dc.subject.keyword | CT-P6 | - |
dc.subject.keyword | HER2-positive breast cancer | - |
dc.subject.keyword | biosimilar | - |
dc.subject.keyword | early breast cancer (EBC) | - |
dc.subject.keyword | metastatic breast cancer (mbc) | - |
dc.subject.keyword | trastuzumab | - |
dc.contributor.alternativeName | Kim, Gun Min | - |
dc.contributor.affiliatedAuthor | 김건민 | - |
dc.contributor.affiliatedAuthor | 김민환 | - |
dc.contributor.affiliatedAuthor | 김승일 | - |
dc.contributor.affiliatedAuthor | 김지예 | - |
dc.contributor.affiliatedAuthor | 김지형 | - |
dc.contributor.affiliatedAuthor | 박세호 | - |
dc.contributor.affiliatedAuthor | 박형석 | - |
dc.contributor.affiliatedAuthor | 배숭준 | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.contributor.affiliatedAuthor | 안성귀 | - |
dc.contributor.affiliatedAuthor | 정준 | - |
dc.contributor.affiliatedAuthor | 정희철 | - |
dc.citation.volume | 11 | - |
dc.citation.startPage | 689587 | - |
dc.identifier.bibliographicCitation | FRONTIERS IN ONCOLOGY, Vol.11 : 689587, 2021-06 | - |
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