Bae Soong June, Kim Jee Hung, Ahn Sung Gwe, Jeung Hei-Cheul, Sohn Joohyuk, Kim Gun Min, Kim Min Hwan, Kim Seung Il, Park Seho, Park Hyung Seok, Kim Ji Ye, Jeong Joon
Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Front Oncol. 2021 Jun 4;11:689587. doi: 10.3389/fonc.2021.689587. eCollection 2021.
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.
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.
A similar percentage of EBC patients achieved a pCR with CT-P6 versus RTZ (74.4% [93/125]) vs 69.8% [90/129], =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, =0.976). The ORR, DCR, and cardiac safety profiles did not also show significant difference efficacy outcomes between two groups.
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.
曲妥珠单抗生物类似药CT-P6在人表皮生长因子受体2（HER2）阳性早期乳腺癌（EBC）的临床试验中已证明与参比曲妥珠单抗（RTZ）具有等效疗效和可比安全性。在此，我们展示了在韩国两家三级医院中，CT-P6与RTZ用于HER2阳性EBC和转移性乳腺癌（MBC）患者新辅助和姑息一线治疗的双HER2靶向治疗的首次真实世界比较。
我们回顾性研究了韩国延世乳腺癌登记处的医疗记录。我们确定了接受RTZ或CT-P6新辅助化疗加帕妥珠单抗、卡铂和多西他赛（TCHP）的HER2阳性EBC患者（n = 254），以及在2014年5月至2019年12月期间接受RTZ或CT-P6姑息一线治疗加帕妥珠单抗和多西他赛（THP）的未经治疗的IV期MBC患者（n = 103）。主要终点是EBC队列中的病理完全缓解（pCR）和MBC队列中的无进展生存期（PFS）。总生存期（OS）、总缓解率（ORR）、疾病控制率（DCR）和心脏安全性为次要终点。
CT-P6组与RTZ组达到pCR的EBC患者百分比相似（74.4% [93/125]对69.8% [90/129]，P = 0.411）。对于MBC患者，CT-P6组和RTZ组的中位随访时间分别为23.0个月和41.0个月；两组之间的中位PFS无显著差异（13.0个月对18.0个月，95%置信区间（CI）0.0 - 26.6对11.3 - 24.7，P = 0.976）。两组之间的ORR、DCR和心脏安全性概况也未显示出显著的疗效差异。
这些真实世界数据表明，生物类似药曲妥珠单抗CT-P6在新辅助或姑息治疗中作为帕妥珠单抗加化疗的双HER2靶向治疗的一部分给药时，在HER2阳性EBC和MBC患者中具有与RTZ相似的有效性和心脏安全性。
