摘要
目的 对比曲妥珠单抗生物类似药汉曲优与原研药赫赛汀分别联合多西他赛及卡铂新辅助治疗早期HER2阳性乳腺癌的有效性和心脏安全性，为临床广泛使用汉曲优提供循证依据。方法 本研究为开放、随机、头对头前瞻性试验，纳入32例II-III期HER2阳性乳腺癌患者，随机分为汉曲优组（n=14）与赫赛汀组（n=18），两组基线特征（年龄、ECOG评分、LVEF）均衡（P>0.05）。治疗方案：曲妥珠单抗类药物（赫赛汀/汉曲优）联合多西他赛（75 mg/m²）及卡铂（AUC 5），每3周1周期，共6周期。疗效通过RECIST 1.1标准及Miller&Payne（MP）分级评估，心脏安全性通过治疗前后左心室射血分数（LVEF）监测。结果 汉曲优组、赫赛汀组MP分级分布无显著差异（G3：1 vs. 2；G4：7 vs. 6；G5：6 vs. 10；χ²=0.99，p=0.61），疗效均达部分缓解（PR,100%）。治疗前汉曲优组LVEF为62.9±2.6%，赫赛汀组为63.0±3.5%（p=0.950）；治疗后分别为61.8±2.0% vs. 63.1±4.1%（p=0.294），组间差异无统计学意义（p=0.469）。结论 汉曲优联合化疗与赫赛汀方案在疗效和安全性上等效，为临床选择曲妥珠单抗生物类似药提供了直接证据。
关键词： 汉曲优；赫赛汀；HER-2阳性乳腺癌；新辅助治疗
Abstract
Objective To compare the efficacy and cardiac safety of trastuzumab biosimilar (Hankyu) versus originator trastuzumab (Herceptin) combined with docetaxel and carboplatin in neoadjuvant therapy for early-stage HER2-positive breast cancer, and to provide evidence-based support for the clinical application of Hankyu. Methods This open-label, randomized, head-to-head prospective trial enrolled 32 patients with stage II-III HER2-positive breast cancer, who were randomly assigned to the Hankyu group (n=14) or Herceptin group (n=18). Baseline characteristics (age, ECOG performance status, LVEF) were balanced between groups (P>0.05). The treatment regimen consisted of trastuzumab (Herceptin/Hankyu) combined with docetaxel (75 mg/m²) and carboplatin (AUC 5), administered every 3 weeks for 6 cycles. Efficacy was evaluated using RECIST 1.1 criteria and Miller & Payne (MP) grading. Cardiac safety was monitored via left ventricular ejection fraction (LVEF) measurements before and after treatment. Results There was no significant difference in MP grading distribution between the Hankyu and Herceptin groups (G3: 1 vs. 2; G4: 7 vs. 6; G5: 6 vs. 10; χ²=0.99, p=0.61). All patients achieved partial response (PR, 100%). Pre-treatment LVEF was 62.9±2.6% in the Hankyu group and 63.0±3.5% in the Herceptin group (p=0.950). Post-treatment LVEF values were 61.8±2.0% vs. 63.1±4.1% (p=0.294), with no statistically significant intergroup difference (p=0.469). Conclusion Hankyu combined with chemotherapy demonstrated equivalent efficacy and safety to the Herceptin regimen, providing direct evidence for the clinical use of trastuzumab biosimilars.
Key words： Hankyu; Herceptin; HER2-positive breast cancer; Neoadjuvant therapy
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