曲妥珠单抗生物类似药与原研曲妥珠单抗联合帕妥珠单抗治疗HER2阳性乳腺癌患者疗效与安全性的回顾性队列研究_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

吴云秋 , 杨瑜瑾 , 胡美雪 , 周丹 , 李艺贤 ,  权毅

1. ;

Corresponding author：

权毅, Email: 20783833@qq.com

Keywords：

人表皮生长因子受体2 阳性; 乳腺癌; 汉曲优; 新辅助治疗; 病理完全缓解; 不良事件

DOI：

10.7507/1007-9424.202310022

Video：

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目的比较HER2阳性乳腺癌患者在新辅助治疗中原研曲妥珠单抗与生物类似药的病理完全缓解（pathologic complete response，pCR）率及不良事件发生率的差异。方法采用回顾性分析法，收集 2021年1月至2022年10月期间在西南医科大学附属医院乳腺外科完成TCbHP方案新辅助治疗及手术治疗的 117例人类表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）阳性乳腺癌患者的临床病理资料。疗效评价依据实体肿瘤疗效评价标准(RECIST)1.1和 Miller-Payne（MP）系统，采用不良事件通用术语标准5.0进行不良事件发生率统计。结果 117例患者中达到总体病理完全缓解（total pathologic complete response，tpCR）者曲妥珠单抗生物类似药汉曲优（HLX02，Zercepac）组占比70.2% (33/47)，原研曲妥珠单抗赫赛汀组占比72.9% (51/70)，2组比较差异无统计学意义（P=0.755）；达到乳腺病理完全缓解（breast pathologic complete response，bpCR）者汉曲优组占比76.6% (36/47)，赫赛汀组占比74.3.9% (52/70)，2组比较差异无统计学意义（P=0.777）。分子分型为HER2⁺HR⁺ （三阳性）组与HER2⁺HR^–（HER2过表达）组患者的tpCR率比较差异有统计学意义（61.6%比88.6%，P=0.002），bpCR率比较差异也有统计学意义（67.1%比88.6%，P=0.009）。在HER2⁺HR⁺患者中汉曲优组与赫赛汀组的tpCR率比较差异无统计学意义（66.7%比57.5%，P=0.423），bpCR率比较差异也无统计学意义（75.8%比60.0%，P=0.154）；在HER2⁺HR^–患者中汉曲优组与赫赛汀组的的tpCR率比较差异无统计学意义（78.6%比93.3%，P=0.354），bpCR率比较差异也无统计学意义（78.6%比93.3%，P=0.354）。治疗后所有患者均出现了可控的不良事件， 2组患者在心脏、血液系统和肝肾功能方面的不良事件发生率以及 ≥3 级不良事件的发生率均相似，差异均无统计学意义（P＞0.05）。结论赫赛汀与其生物类似药汉曲优在新辅助治疗中的疗效和安全性相似，这为 HER2 阳性乳腺癌患者提供了更多的治疗选择。

Citation： 吴云秋, 杨瑜瑾, 胡美雪, 周丹, 李艺贤, 权毅. 曲妥珠单抗生物类似药与原研曲妥珠单抗联合帕妥珠单抗治疗HER2阳性乳腺癌患者疗效与安全性的回顾性队列研究. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2024, 31(3): 349-353. doi: 10.7507/1007-9424.202310022 Copy

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.
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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检测指南(2019版)》编写组. 乳腺癌HER2检测指南(2019版). 中华病理学杂志, 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.	中国医师协会肿瘤医师分会乳腺癌学组, 中国抗癌协会国际医疗交流分会. 白蛋白结合型紫杉醇治疗乳腺癌的中国专家共识. 中华肿瘤杂志, 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检测指南(2019版)》编写组. 乳腺癌HER2检测指南(2019版). 中华病理学杂志, 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. 中国医师协会肿瘤医师分会乳腺癌学组, 中国抗癌协会国际医疗交流分会. 白蛋白结合型紫杉醇治疗乳腺癌的中国专家共识. 中华肿瘤杂志, 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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曲妥珠单抗生物类似药与原研曲妥珠单抗联合帕妥珠单抗治疗HER2阳性乳腺癌患者疗效与安全性的回顾性队列研究

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