Objective: To compare the efficacy, safety, and cost-effectiveness of the trastuzumab originator (HST) versus its biosimilar (HLX02) combined with pertuzumab and chemotherapy as neoadjuvant treatment in patients with HER-2-positive breast cancer. Methods: This retrospective cohort study included 175 patients with HER-2-positive breast cancer who received neoadjuvant therapy followed by curative surgery at the Cancer Hospital Chinese Academy of Medical Sciences between October 2020 and January 2024. Patients were divided into two groups based on the trastuzumab formulation used: the HST group (n=89) and the HLX02 group (n=86).The efficacy, safety, and trastuzumab-related treatment costs were compared between the two groups. Moreover, using Logistic regression model to identify the factors influencing total pathological complete response (tpCR) rates. Results: There were statistically significant differences in clinical T stage and surgical approach between the HST and HLX02 groups (P＜0.05). Other clinicopathological characteristics, such as age and histological grade, showed no statistically significant differences (P＞0.05), with most baseline characteristics remaining balanced between the two groups. There were no significant differences in tpCR rates (P=0.957) or Miller-Payne (MP) grading rates (P=0.991) between the HST and HLX02 groups. The tpCR rates for the two groups were 55.1% (49/89) and 54.7% (47/86), respectively. The rates of achieving grade 5 (G5) in the postoperative MP pathological grading system were 55.1% (49/89) and 55.8% (48/86), respectively, with no statistically significant difference (P=0.991). Univariate and multivariate Logistic regression analyses showed that hormone receptor status is an independent risk factor affecting tpCR (OR=0.31, 95% CI; 0.16-0.61, P＜0.001). The incidence of adverse event during neoadjuvant therapy was similar between the groups, with no occurrences of trastuzumab-related cardiac toxicity. The HLX02 regimen showed a lower cost-effectiveness ratio (586.48 vs. 604.96) and reduced trastuzumab treatment costs during neoadjuvant therapy compared to HST [tpCR:(31 208.37±2 191.00) CNY vs. (33 224.49±2 741.00) CNY; non-tpCR: 33 030.05±5 787.00) CNY vs. (33 412.50±4 203.00) CNY, P＜0.05]. Conclusions: In the neoadjuvant treatment of early-stage HER-2-positive breast cancer, HLX02 combined with pertuzumab and chemotherapy demonstrates similar efficacy and safety to the trastuzumab originator, while offering a significant cost advantage.
目的： 比较曲妥珠单抗生物类似药（HLX02）与原研药（HST）联合帕妥珠单抗及化疗在人表皮生长因子受体2（HER-2）阳性乳腺癌患者中作为新辅助治疗的疗效、安全性和成本效益。 方法： 研究采用回顾性队列研究设计，纳入2020年10月至2024年1月于中国医学科学院肿瘤医院接受新辅助治疗并完成根治性手术治疗的175例HER-2阳性乳腺癌患者。根据所用曲妥珠单抗的不同，将患者分为HST治疗组（89例）和HLX02治疗组（86例），比较两组患者的新辅助治疗的有效性、安全性和曲妥珠单抗成本效益，并采用logistic回归模型分析影响总体病理完全缓解（tpCR）率的因素。 结果： HST组和HLX02组患者临床T分期、手术方式差异有统计学意义（均P＜0.05），其他临床病理特征如年龄、组织学分级等差异均无统计学意义（均P＞0.05），大部分基线临床病理特征均衡（均P＞0.05）。HST组与HLX02组患者的tpCR率分别为55.1%（49/89）和54.7%（47/86，P=0.957），术后病理Miller-Payne分级中G5的比率分别为55.1%（49/89）及55.8%（48/86，P=0.991），差异无统计学意义。单因素和多因素回归分析显示，激素受体状态是影响pCR率的独立危险因素（OR=0.31，95% CI：0.16～0.61，P＜0.001）。HST组与HLX02组患者在新辅助治疗期间的不良事件发生情况类似，均未出现曲妥珠单抗相关的心脏不良反应。成本效益分析显示，HLX02方案的成本-效果比为586.48，低于HST方案的604.96，并且比较平均费用成本，HLX02组在新辅助治疗期间曲妥珠单抗治疗费用低于HST组［tpCR患者：（31 208.37±2 191.00）元和（33 224.49±2 741.00）元，非tpCR患者：（33 030.05±5 787.00）元和（33 412.50±4 203.00）元，均P＜0.05］。 结论： 在HER-2阳性早期乳腺癌的新辅助治疗中，曲妥珠单抗类似药HLX02联合帕妥珠单抗及化疗的疗效与安全性与原研药相似，成本效益更高。.