RC48-ADC treatment for patients with HER2-expressing locally advanced or metastatic solid tumors: a real-world study

作者全名："Wang, Ping; Xia, Lei"

作者地址："[Wang, Ping; Xia, Lei] Chongqing Med Univ, Affiliated Hosp 2, Dept Canc Ctr, Chongqing 401336, Peoples R China; [Xia, Lei] Chinese Acad Med Sci & Peking Union Med Coll, Inst Radiat Med, Tianjin Key Lab Radiat Med & Mol Nucl Med, Tianjin 300110, Peoples R China; [Xia, Lei] Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Dept Radiat Oncol,Key Lab Canc Prevent & Therapy, Tianjin 300060, Peoples R China"

通信作者："Xia, L (通讯作者)，Chongqing Med Univ, Affiliated Hosp 2, Dept Canc Ctr, Chongqing 401336, Peoples R China.; Xia, L (通讯作者)，Chinese Acad Med Sci & Peking Union Med Coll, Inst Radiat Med, Tianjin Key Lab Radiat Med & Mol Nucl Med, Tianjin 300110, Peoples R China.; Xia, L (通讯作者)，Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc, Dept Radiat Oncol,Key Lab Canc Prevent & Therapy, Tianjin 300060, Peoples R China."

来源：BMC CANCER

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001103140700006

JCR分区：Q2

影响因子：3.4

年份：2023

卷号：23

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：RC48-ADC; HER2; Solid tumors; Disease control rate; Progression-free survival; Safety

摘要："BackgroundRC48-antibody-drug conjugates (ADC) link humanized anti-HER2 immunoglobulin with monomethyl auristatin E (MMAE). Clinical trials suggest promising antitumor activity in HER2-expressing solid tumors. This study probes RC48-ADC's efficacy and safety in patients with HER2-expressing advanced or metastatic solid tumors.MethodData was collected from 23 advanced cancer patients treated with RC48-ADC at our oncology center between July 2021 and December 2022. These patients exhibited at least 1 + expression of HER2 immunohistochemistry, had previously experienced at least one failed systemic chemotherapy, and were treated with RC48-ADC until the occurrence of intolerable adverse reactions or disease progression. The primary endpoint was the disease control rate (DCR), and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety.Results23 of 25 screened patients received RC48 treatment. The ORR was 43.5% (95% CI, 23.2-63.7%) with a median PFS of 6.0 months (95% CI, 4.8-7.4). In the low-to-medium HER2 expression subgroup, ORR was 37.5%, median PFS 5.75 months. In the high HER2 expression subgroup, ORR was 57.1%, median PFS 7 months. For the cohort combining RC48 with PD-1 inhibitors, ORR was 53.8%, median PFS 8 months. In the concurrent local radiation therapy subgroup, ORR was 40.0%, median PFS 6.0 months. Treatment-related adverse events (TRAEs) were anemia (60.8%), leukopenia (56.2%), raised transaminases (52.17%), and neutropenia (43.5%). Five patients (21.7%) experienced Grade 3 symptoms, including anemia (21.7%) and neutropenia (14.0%). No Grade 4 adverse reactions or deaths were reported.ConclusionRC48-ADC shows promising efficacy and manageable safety in HER2-expressing advanced or metastatic solid tumor patients."

基金机构：We are grateful to all patients and their families and all members of the study group.

基金资助正文：We are grateful to all patients and their families and all members of the study group.