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

Meirong Zhou; Shouman Wang; Nengbin Wan; Songlin Yuan; Xiongqiang Hu; Wei Zhou; Bohua Qing; Mingwen Liu; Weihua Sun; Peizhi Fan; Jianguo Wang; Hong Cao; Haifan Xu; Bin Dai; Peizhi Tang; Liyuan Qian; Xi Zhao; Jun Xiao; Huaiying Zhou; Jinhui Hu; Li Ding; Domenico Tripodi; Nicholas Zdenkowski; Thomas J O'Keefe; Alejandro Martin Sanchez; Li Chen; Ping Zhang; Feng Xu

doi:10.21037/atm-22-6054

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

Ann Transl Med. 2022 Dec;10(24):1387. doi: 10.21037/atm-22-6054.

Authors

Meirong Zhou¹, Shouman Wang², Nengbin Wan³, Songlin Yuan⁴, Xiongqiang Hu⁵, Wei Zhou⁶, Bohua Qing⁷, Mingwen Liu⁸, Weihua Sun⁹, Peizhi Fan¹⁰, Jianguo Wang¹¹, Hong Cao¹², Haifan Xu¹³, Bin Dai¹⁴, Peizhi Tang¹⁵, Liyuan Qian¹⁶, Xi Zhao¹⁷, Jun Xiao¹⁸, Huaiying Zhou¹⁹, Jinhui Hu²⁰, Li Ding²¹, Domenico Tripodi²², Nicholas Zdenkowski²³, Thomas J O'Keefe²⁴, Alejandro Martin Sanchez²⁵, Li Chen¹, Ping Zhang¹, Feng Xu¹

Affiliations

¹ Department of General Surgery, Xiangya Second Hospital, Central South University, Changsha, China.
² Department of Breast Surgery, Xiangya Hospital, Central South University, Changsha, China.
³ Department of Breast Surgery 2, Hunan Cancer Hospital, Changsha, China.
⁴ Department of Breast and Thyroid Surgery, The First People's Hospital of Changde City, Changde, China.
⁵ Surgical Oncology of Breast and Thyroid, Chenzhou No. 1 People's Hospital, Chenzhou, China.
⁶ Department of Breast Surgery, Xiangya Hospital Zhuzhou, Central South University, Zhuzhou, China.
⁷ Head and Neck Tumor Department of Mammary Gland, The Central Hospital of Yongzhou, Yongzhou, China.
⁸ Breast and Thyroid Surgery, The First People's Hospital of Xiangtan City, Xiangtan, China.
⁹ Department of Breast Surgery, Huaihua Cancer Hospital, Huaihua, China.
¹⁰ Surgical Department of Breast and Thyroid Gland, Hunan Provinscial People's Hospital, the First Affiliated Hospital of Hunan Normal University, Changsha, China.
¹¹ Second Department of General Surgery, Xiangtan Central Hospital, Xiangtan, China.
¹² Breast and Thyroid Surgery, The Second Affiliated Hospital of University of South China, Hengyang, China.
¹³ Breast and Thyroid Surgery, The First Affiliated Hospital of University of South China, Hengyang, China.
¹⁴ Department of Breast and Thyroid Surgery, The Central Hospital of Shaoyang, Shaoyang, China.
¹⁵ Breast and Thyroid Surgery, Xiangxi Autonomous Prefecture People's Hospital, Xiangxi Tujia and Miao Autonomous Prefecture, China.
¹⁶ Breast and Thyroid Surgery, The Third Xiangya Hospital of Central South University, Changsha, China.
¹⁷ Department of Breast Surgery, Hunan Province Directly Affiliated TCM Hospital, Changsha, China.
¹⁸ Department of Breast Surgery, Yueyang Central Hospital, Yueyang, China.
¹⁹ Oncology Department, Yongzhou Third People's Hospital, Yongzhou, China.
²⁰ Department of Breast Surgery, The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha, China.
²¹ Breast and Thyroid Surgery, The First People's Hospital of Huaihua, Huaihua, China.
²² Department of Surgical, Division of Breast Surgery Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
²³ School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.
²⁴ Division of Breast Surgery and the Comprehensive Breast Health Center, University of California San Diego, La Jolla, CA, USA.
²⁵ Multidisciplinary Breast Center, Fondazione Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.

Abstract

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.

Keywords: Breast cancer (BC); neoadjuvant; pertuzumab; real-world; trastuzumab.