曲妥珠单抗和帕妥珠单抗联合化疗对HER2阳性乳腺癌新辅助治疗的真实世界研究

马祥敏; 张香梅; 周新平; 任晓菲; 张玮芳; 刘运江

doi:10.3971/j.issn.1000-8578.2022.21.0802

曲妥珠单抗和帕妥珠单抗联合化疗对HER2阳性乳腺癌新辅助治疗的真实世界研究

Real-world Research of Trastuzumab and Pertuzumab Combined with Chemotherapy in Neoadjuvant Treatment of HER2-positive Breast Cancer

摘要

摘要:
目的分析曲妥珠单抗（H）和帕妥珠单抗（P）联合化疗对HER2阳性乳腺癌新辅助治疗的疗效和安全性。
方法回顾性分析行HP联合化疗新辅助治疗并完成手术的HER2阳性乳腺癌患者的临床资料，主要研究终点为总体病理完全缓解（tpCR）（ypT0/isypN0），次要研究终点为乳腺病理完全缓解（bpCR）（ypT0/is）和腋窝病理完全缓解（apCR）（ypN0），分析影响tpCR因素。
结果 63例纳入分析，其中23例使用TCbHP方案，27例使用THP方案，13例使用AC-THP方案。总tpCR率为65.1%，其中TCbHP为73.9%，THP为55.6%，AC-THP为69.2%。HR阴性者的tpCR率为79.2%高于HR阳性者的56.4%。总bpCR率为69.8%，总apCR率为81.0%。单因素分析显示HER2状态是影响tpCR（P=0.023）的相关因素。MRI评估总有效率为87.3%。TCbHP方案发生3级和4级不良反应稍高于THP方案和AC-THP方案。
结论 HP联合化疗取得了较高的pCR，HER2状态是影响tpCR相关因素，HP联合化疗新辅助治疗乳腺癌不良反应可控。

Abstract:
Objective To analyze the efficacy and safety of trastuzumab (H) and pertuzumab (P) combined with different chemotherapy regiments in neoadjuvant therapy for HER2-positive breast cancer.
Methods We retrospectively analyzed the clinical data of the patients with HER2-positive breast cancer who received HP combined with chemotherapy as neoadjuvant therapy and completed surgery. The primary endpoint was total pathologic complete response (tpCR) (ypT0/isypN0), the secondary endpoints were breast pathologic complete response(bpCR) (ypT0/is) and axillary pathologic complete response (apCR) (ypN0), and the factors influencing pCR were analyzed.
Results A total of 63 patients were included, of whom 23 were treated with TCbHP, 27 were treated with THP regimen, and 13 were treated with AC-THP. The overall tpCR rate was 65.1%, of which TCbHP was 73.9%, THP was 55.6%, and AC-THP was 69.2%. The tpCR rate of HR-negative patients was 79.2%, higher than that of HR-positive 56.4%. The overall bpCR rate was 69.8%, and apCR rate was 81.0%. Univariate analysis showed that HER2 status was a related factor affecting tpCR (P=0.023). The total effective rate by MRI was 87.3%. The level 3 and 4 toxicity of the TCbHP regimen was slightly higher than those of the THP and the AC-THP regimens.
Conclusion HP combined with chemotherapy have achieved relatively high pCR. HER2 status is a related factor that affects tpCR. The adverse reactions are controllable.

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