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Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study

BACKGROUND: Pertuzumab plus trastuzumab combined with chemotherapy has become a standard neoadjuvant therapy option for patients with high-risk human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). There is still not enough evidence for the efficacy and safety of neoadjuvant p...

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Autores principales: Zhou, Meirong, Wang, Shouman, Wan, Nengbin, Yuan, Songlin, Hu, Xiongqiang, Zhou, Wei, Qing, Bohua, Liu, Mingwen, Sun, Weihua, Fan, Peizhi, Wang, Jianguo, Cao, Hong, Xu, Haifan, Dai, Bin, Tang, Peizhi, Qian, Liyuan, Zhao, Xi, Xiao, Jun, Zhou, Huaiying, Hu, Jinhui, Ding, Li, Tripodi, Domenico, Zdenkowski, Nicholas, O’Keefe, Thomas J., Sanchez, Alejandro Martin, Chen, Li, Zhang, Ping, Xu, Feng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AME Publishing Company 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9843401/
https://www.ncbi.nlm.nih.gov/pubmed/36660637
http://dx.doi.org/10.21037/atm-22-6054
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author Zhou, Meirong
Wang, Shouman
Wan, Nengbin
Yuan, Songlin
Hu, Xiongqiang
Zhou, Wei
Qing, Bohua
Liu, Mingwen
Sun, Weihua
Fan, Peizhi
Wang, Jianguo
Cao, Hong
Xu, Haifan
Dai, Bin
Tang, Peizhi
Qian, Liyuan
Zhao, Xi
Xiao, Jun
Zhou, Huaiying
Hu, Jinhui
Ding, Li
Tripodi, Domenico
Zdenkowski, Nicholas
O’Keefe, Thomas J.
Sanchez, Alejandro Martin
Chen, Li
Zhang, Ping
Xu, Feng
author_facet Zhou, Meirong
Wang, Shouman
Wan, Nengbin
Yuan, Songlin
Hu, Xiongqiang
Zhou, Wei
Qing, Bohua
Liu, Mingwen
Sun, Weihua
Fan, Peizhi
Wang, Jianguo
Cao, Hong
Xu, Haifan
Dai, Bin
Tang, Peizhi
Qian, Liyuan
Zhao, Xi
Xiao, Jun
Zhou, Huaiying
Hu, Jinhui
Ding, Li
Tripodi, Domenico
Zdenkowski, Nicholas
O’Keefe, Thomas J.
Sanchez, Alejandro Martin
Chen, Li
Zhang, Ping
Xu, Feng
author_sort Zhou, Meirong
collection PubMed
description BACKGROUND: Pertuzumab plus trastuzumab combined with chemotherapy has become a standard neoadjuvant therapy option for patients with high-risk human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). There is still not enough evidence for the efficacy and safety of neoadjuvant pertuzumab and trastuzumab plus chemotherapy in HER2-positive BC patients in China, both in clinical trials and real-world settings. This study aimed to assess the efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy in Chinese patients with HER2-positive BC in real-world clinical application. METHODS: We retrospectively collected the data from the electronic medical records of HER2-positive patients treated with neoadjuvant trastuzumab and pertuzumab plus chemotherapy from December 2018 to May 2021 at 21 hospitals located in Hunan Province, China, including age, American Joint Committee on Cancer (AJCC) stage, clinical tumor size, clinical lymph node status, pathological characteristics (before neoadjuvant systemic therapy), treatment approach, adverse events to neoadjuvant therapy, and achievement of pathological complete response (pCR). The primary endpoint was the total rate of pCR, and the secondary endpoints were the rate of pCR of each subgroup and the safety of dual anti-HER2 therapy. RESULTS: A total of 188 patients met the inclusion criteria and were included in the analysis. Of the 188 patients, 119 (63.3%) were diagnosed at stage II and 64 (34.0%) at stage III; 163 (86.7%) were cT2-3; 149 patients (79.3%) were ≥ cN1; 84 patients (44.7%) were hormone receptor (HR)-positive. pCR was observed in 88 of 188 patients (46.8%). The pCR rate of HR-negative patients (54.8%) was higher (P=0.014) than that of HR-positive patients (36.9%). Patients with Ki-67 <15% achieved a higher (P=0.033) pCR rate (68.2%) than those with Ki-67 ≥15% (44.0%). Anemia was the most common adverse event (63.4%), and the most common grade 3–4 adverse event was nausea and vomiting (8.5%). CONCLUSIONS: Our study confirmed the benefit of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy on pCR with a tolerable safety profile in routine clinical practice in Chinese patients with HER2-positive BC. HR-negativity and Ki-67 <15% were associated with pCR in these patients.
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spelling pubmed-98434012023-01-18 Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study Zhou, Meirong Wang, Shouman Wan, Nengbin Yuan, Songlin Hu, Xiongqiang Zhou, Wei Qing, Bohua Liu, Mingwen Sun, Weihua Fan, Peizhi Wang, Jianguo Cao, Hong Xu, Haifan Dai, Bin Tang, Peizhi Qian, Liyuan Zhao, Xi Xiao, Jun Zhou, Huaiying Hu, Jinhui Ding, Li Tripodi, Domenico Zdenkowski, Nicholas O’Keefe, Thomas J. Sanchez, Alejandro Martin Chen, Li Zhang, Ping Xu, Feng Ann Transl Med Original Article BACKGROUND: Pertuzumab plus trastuzumab combined with chemotherapy has become a standard neoadjuvant therapy option for patients with high-risk human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). There is still not enough evidence for the efficacy and safety of neoadjuvant pertuzumab and trastuzumab plus chemotherapy in HER2-positive BC patients in China, both in clinical trials and real-world settings. This study aimed to assess the efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy in Chinese patients with HER2-positive BC in real-world clinical application. METHODS: We retrospectively collected the data from the electronic medical records of HER2-positive patients treated with neoadjuvant trastuzumab and pertuzumab plus chemotherapy from December 2018 to May 2021 at 21 hospitals located in Hunan Province, China, including age, American Joint Committee on Cancer (AJCC) stage, clinical tumor size, clinical lymph node status, pathological characteristics (before neoadjuvant systemic therapy), treatment approach, adverse events to neoadjuvant therapy, and achievement of pathological complete response (pCR). The primary endpoint was the total rate of pCR, and the secondary endpoints were the rate of pCR of each subgroup and the safety of dual anti-HER2 therapy. RESULTS: A total of 188 patients met the inclusion criteria and were included in the analysis. Of the 188 patients, 119 (63.3%) were diagnosed at stage II and 64 (34.0%) at stage III; 163 (86.7%) were cT2-3; 149 patients (79.3%) were ≥ cN1; 84 patients (44.7%) were hormone receptor (HR)-positive. pCR was observed in 88 of 188 patients (46.8%). The pCR rate of HR-negative patients (54.8%) was higher (P=0.014) than that of HR-positive patients (36.9%). Patients with Ki-67 <15% achieved a higher (P=0.033) pCR rate (68.2%) than those with Ki-67 ≥15% (44.0%). Anemia was the most common adverse event (63.4%), and the most common grade 3–4 adverse event was nausea and vomiting (8.5%). CONCLUSIONS: Our study confirmed the benefit of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy on pCR with a tolerable safety profile in routine clinical practice in Chinese patients with HER2-positive BC. HR-negativity and Ki-67 <15% were associated with pCR in these patients. AME Publishing Company 2022-12 /pmc/articles/PMC9843401/ /pubmed/36660637 http://dx.doi.org/10.21037/atm-22-6054 Text en 2022 Annals of Translational Medicine. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) .
spellingShingle Original Article
Zhou, Meirong
Wang, Shouman
Wan, Nengbin
Yuan, Songlin
Hu, Xiongqiang
Zhou, Wei
Qing, Bohua
Liu, Mingwen
Sun, Weihua
Fan, Peizhi
Wang, Jianguo
Cao, Hong
Xu, Haifan
Dai, Bin
Tang, Peizhi
Qian, Liyuan
Zhao, Xi
Xiao, Jun
Zhou, Huaiying
Hu, Jinhui
Ding, Li
Tripodi, Domenico
Zdenkowski, Nicholas
O’Keefe, Thomas J.
Sanchez, Alejandro Martin
Chen, Li
Zhang, Ping
Xu, Feng
Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study
title Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study
title_full Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study
title_fullStr Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study
title_full_unstemmed Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study
title_short Efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in Chinese patients with HER2-positive early breast cancer: a real-world retrospective multi-center cohort study
title_sort efficacy and safety of neoadjuvant pertuzumab plus trastuzumab in combination with chemotherapy regimen in chinese patients with her2-positive early breast cancer: a real-world retrospective multi-center cohort study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9843401/
https://www.ncbi.nlm.nih.gov/pubmed/36660637
http://dx.doi.org/10.21037/atm-22-6054
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