Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer
BackgroundThe 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 ver...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-06-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2021.689587/full |
| _version_ | 1818591880698396672 |
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| author | Soong June Bae Soong June Bae Jee Hung Kim Jee Hung Kim Sung Gwe Ahn Sung Gwe Ahn Hei-Cheul Jeung Hei-Cheul Jeung Joohyuk Sohn Gun Min Kim Min Hwan Kim Seung Il Kim Seho Park Hyung Seok Park Ji Ye Kim Joon Jeong Joon Jeong |
| author_facet | Soong June Bae Soong June Bae Jee Hung Kim Jee Hung Kim Sung Gwe Ahn Sung Gwe Ahn Hei-Cheul Jeung Hei-Cheul Jeung Joohyuk Sohn Gun Min Kim Min Hwan Kim Seung Il Kim Seho Park Hyung Seok Park Ji Ye Kim Joon Jeong Joon Jeong |
| author_sort | Soong June Bae |
| collection | DOAJ |
| description | BackgroundThe 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.MethodsWe 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.ResultsA 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.ConclusionsThese 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. |
| first_indexed | 2024-12-16T10:19:28Z |
| format | Article |
| id | doaj.art-86d989b5422542cc9641d9f35700f3dc |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-12-16T10:19:28Z |
| publishDate | 2021-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-86d989b5422542cc9641d9f35700f3dc2022-12-21T22:35:21ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2021-06-011110.3389/fonc.2021.689587689587Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast CancerSoong June Bae0Soong June Bae1Jee Hung Kim2Jee Hung Kim3Sung Gwe Ahn4Sung Gwe Ahn5Hei-Cheul Jeung6Hei-Cheul Jeung7Joohyuk Sohn8Gun Min Kim9Min Hwan Kim10Seung Il Kim11Seho Park12Hyung Seok Park13Ji Ye Kim14Joon Jeong15Joon Jeong16Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South KoreaInstitute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South KoreaInstitute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South KoreaDivision of Medical Oncology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South KoreaDepartment of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South KoreaInstitute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South KoreaInstitute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South KoreaDivision of Medical Oncology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South KoreaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South KoreaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South KoreaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South KoreaDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South KoreaDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South KoreaDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South KoreaDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South KoreaDepartment of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South KoreaInstitute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South KoreaBackgroundThe 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.MethodsWe 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.ResultsA 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.ConclusionsThese 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.https://www.frontiersin.org/articles/10.3389/fonc.2021.689587/fullbiosimilarHER2-positive breast cancertrastuzumabCT-P6early breast cancer (EBC)metastatic breast cancer (mbc) |
| spellingShingle | Soong June Bae Soong June Bae Jee Hung Kim Jee Hung Kim Sung Gwe Ahn Sung Gwe Ahn Hei-Cheul Jeung Hei-Cheul Jeung Joohyuk Sohn Gun Min Kim Min Hwan Kim Seung Il Kim Seho Park Hyung Seok Park Ji Ye Kim Joon Jeong Joon Jeong Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer Frontiers in Oncology biosimilar HER2-positive breast cancer trastuzumab CT-P6 early breast cancer (EBC) metastatic breast cancer (mbc) |
| title | Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer |
| title_full | Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer |
| title_fullStr | Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer |
| title_full_unstemmed | Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer |
| title_short | Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer |
| title_sort | real world clinical outcomes of biosimilar trastuzumab ct p6 in her2 positive early stage and metastatic breast cancer |
| topic | biosimilar HER2-positive breast cancer trastuzumab CT-P6 early breast cancer (EBC) metastatic breast cancer (mbc) |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2021.689587/full |
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