曲妥珠單抗生物類似藥與原研曲妥珠單抗聯合帕妥珠單抗治療HER2陽性乳腺癌患者療效與安全性的回顧性隊列研究_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

吳云秋 , 楊瑜瑾 , 胡美雪 , 周丹 , 李藝賢 ,  權毅

1. ;

Corresponding?author：

權毅, Email: 20783833@qq.com

Keywords：

人表皮生長因子受體2 陽性; 乳腺癌; 漢曲優; 新輔助治療; 病理完全緩解; 不良事件

DOI：

10.7507/1007-9424.202310022

Video：

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目的比較HER2陽性乳腺癌患者在新輔助治療中原研曲妥珠單抗與生物類似藥的病理完全緩解（pathologic complete response，pCR）率及不良事件發生率的差異。方法采用回顧性分析法，收集 2021年1月至2022年10月期間在西南醫科大學附屬醫院乳腺外科完成TCbHP方案新輔助治療及手術治療的 117例人類表皮生長因子受體2（human epidermal growth factor receptor 2，HER2）陽性乳腺癌患者的臨床病理資料。療效評價依據實體腫瘤療效評價標準(RECIST)1.1和 Miller-Payne（MP）系統，采用不良事件通用術語標準5.0進行不良事件發生率統計。結果 117例患者中達到總體病理完全緩解（total pathologic complete response，tpCR）者曲妥珠單抗生物類似藥漢曲優（HLX02，Zercepac）組占比70.2% (33/47)，原研曲妥珠單抗赫賽汀組占比72.9% (51/70)，2組比較差異無統計學意義（P=0.755）；達到乳腺病理完全緩解（breast pathologic complete response，bpCR）者漢曲優組占比76.6% (36/47)，赫賽汀組占比74.3.9% (52/70)，2組比較差異無統計學意義（P=0.777）。分子分型為HER2⁺HR⁺ （三陽性）組與HER2⁺HR^–（HER2過表達）組患者的tpCR率比較差異有統計學意義（61.6%比88.6%，P=0.002），bpCR率比較差異也有統計學意義（67.1%比88.6%，P=0.009）。在HER2⁺HR⁺患者中漢曲優組與赫賽汀組的tpCR率比較差異無統計學意義（66.7%比57.5%，P=0.423），bpCR率比較差異也無統計學意義（75.8%比60.0%，P=0.154）；在HER2⁺HR^–患者中漢曲優組與赫賽汀組的的tpCR率比較差異無統計學意義（78.6%比93.3%，P=0.354），bpCR率比較差異也無統計學意義（78.6%比93.3%，P=0.354）。治療后所有患者均出現了可控的不良事件， 2組患者在心臟、血液系統和肝腎功能方面的不良事件發生率以及 ≥3 級不良事件的發生率均相似，差異均無統計學意義（P＞0.05）。結論赫賽汀與其生物類似藥漢曲優在新輔助治療中的療效和安全性相似，這為 HER2 陽性乳腺癌患者提供了更多的治療選擇。

Citation： 吳云秋, 楊瑜瑾, 胡美雪, 周丹, 李藝賢, 權毅. 曲妥珠單抗生物類似藥與原研曲妥珠單抗聯合帕妥珠單抗治療HER2陽性乳腺癌患者療效與安全性的回顧性隊列研究. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2024, 31(3): 349-353. doi: 10.7507/1007-9424.202310022 Copy

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2.	Boér K, Kahán Z, Landherr L, et al. Pathologic complete response rates after neoadjuvant pertuzumab and trastuzumab with chemotherapy in early stage HER2-positive breast cancer—Increasing Rates of Breast Conserving Surgery: A real-world experience. Pathol Oncol Res, 2021, 27: 1609785.
3.	Xu B, Zhang Q, Sun T, et al. Efficacy, safety, and immunogenicity of HLX02 compared with reference trastuzumab in patients with recurrent or metastatic HER2-positive breast cancer: A randomized phase Ⅲequivalence trial. BioDrugs, 2021, 35(3): 337-350.
4.	Mischel AM, Rosielle DA. Eastern Cooperative Oncology Group Performance Status #434. J Palliat Med, 2022, 25(3): 508-510.
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6.	Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol, 2010, 28(16): 2784-2795.
7.	《乳腺癌HER2檢測指南(2019版)》編寫組. 乳腺癌HER2檢測指南(2019版). 中華病理學雜志, 2019, 48(3): 169-175.
8.	Dowsett M, Nielsen TO, A'Hern R, et al. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group. J Natl Cancer Inst, 2011, 103(22): 1656-1664.
9.	Hurvitz SA, Martin M, Symmans WF, et al. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol, 2018, 19(1): 115-126.
10.	中國醫師協會腫瘤醫師分會乳腺癌學組, 中國抗癌協會國際醫療交流分會. 白蛋白結合型紫杉醇治療乳腺癌的中國專家共識. 中華腫瘤雜志, 2023, 45(3): 203-211.
11.	Gradishar WJ, Moran MS, Abraham J, et al. Breast Cancer, Version 3. 2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw, 2022, 20(6): 691-722.
12.	Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1. 1). Eur J Cancer, 2009, 45(2): 228-247.
13.	Ogston KN, Miller ID, Payne S, et al. A new histological grading system to assess response of breast cancers to primary chemotherapy: prognostic significance and survival. Breast, 2003, 12(5): 320-327.
14.	Freites-Martinez A, Santana N, Arias-Santiago S, et al. Using the common terminology criteria for adverse events (CTCAE-Version 5. 0) to evaluate the severity of adverse events of anticancer therapies. Actas Dermosifiliogr (Engl Ed), 2021, 112(1): 90-92.
15.	Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol, 2012, 13(1): 25-32.
16.	Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol, 2017, 18(7): 917-928.
17.	Bae SJ, Kim JH, Ahn SG, et al. Real-world clinical outcomes of biosimilar trastuzumab (CT-P6) in HER2-positive early-stage and metastatic breast cancer. Front Oncol, 2021, 11: 689587.
18.	Berg T, Jensen MB, Jakobsen EH, et al. Neoadjuvant chemotherapy and HER2 dual blockade including biosimilar trastuzumab (SB3) for HER2-positive early breast cancer: Population based real world data from the Danish Breast Cancer Group (DBCG). Breast, 2020, 54: 242-247.

1. Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2021, 71(3): 209-249.
2. Boér K, Kahán Z, Landherr L, et al. Pathologic complete response rates after neoadjuvant pertuzumab and trastuzumab with chemotherapy in early stage HER2-positive breast cancer—Increasing Rates of Breast Conserving Surgery: A real-world experience. Pathol Oncol Res, 2021, 27: 1609785.
3. Xu B, Zhang Q, Sun T, et al. Efficacy, safety, and immunogenicity of HLX02 compared with reference trastuzumab in patients with recurrent or metastatic HER2-positive breast cancer: A randomized phase Ⅲequivalence trial. BioDrugs, 2021, 35(3): 337-350.
4. Mischel AM, Rosielle DA. Eastern Cooperative Oncology Group Performance Status #434. J Palliat Med, 2022, 25(3): 508-510.
5. Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol, 2018, 36(20): 2105-2122.
6. Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol, 2010, 28(16): 2784-2795.
7. 《乳腺癌HER2檢測指南(2019版)》編寫組. 乳腺癌HER2檢測指南(2019版). 中華病理學雜志, 2019, 48(3): 169-175.
8. Dowsett M, Nielsen TO, A'Hern R, et al. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group. J Natl Cancer Inst, 2011, 103(22): 1656-1664.
9. Hurvitz SA, Martin M, Symmans WF, et al. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol, 2018, 19(1): 115-126.
10. 中國醫師協會腫瘤醫師分會乳腺癌學組, 中國抗癌協會國際醫療交流分會. 白蛋白結合型紫杉醇治療乳腺癌的中國專家共識. 中華腫瘤雜志, 2023, 45(3): 203-211.
11. Gradishar WJ, Moran MS, Abraham J, et al. Breast Cancer, Version 3. 2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw, 2022, 20(6): 691-722.
12. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1. 1). Eur J Cancer, 2009, 45(2): 228-247.
13. Ogston KN, Miller ID, Payne S, et al. A new histological grading system to assess response of breast cancers to primary chemotherapy: prognostic significance and survival. Breast, 2003, 12(5): 320-327.
14. Freites-Martinez A, Santana N, Arias-Santiago S, et al. Using the common terminology criteria for adverse events (CTCAE-Version 5. 0) to evaluate the severity of adverse events of anticancer therapies. Actas Dermosifiliogr (Engl Ed), 2021, 112(1): 90-92.
15. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol, 2012, 13(1): 25-32.
16. Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol, 2017, 18(7): 917-928.
17. Bae SJ, Kim JH, Ahn SG, et al. Real-world clinical outcomes of biosimilar trastuzumab (CT-P6) in HER2-positive early-stage and metastatic breast cancer. Front Oncol, 2021, 11: 689587.
18. Berg T, Jensen MB, Jakobsen EH, et al. Neoadjuvant chemotherapy and HER2 dual blockade including biosimilar trastuzumab (SB3) for HER2-positive early breast cancer: Population based real world data from the Danish Breast Cancer Group (DBCG). Breast, 2020, 54: 242-247.

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曲妥珠單抗生物類似藥與原研曲妥珠單抗聯合帕妥珠單抗治療HER2陽性乳腺癌患者療效與安全性的回顧性隊列研究

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