2026 年第 7 期 第 21 卷

皮下与静脉双靶联合白蛋白结合型紫杉醇新辅助治疗人表皮生长因子受体2阳性早期乳腺癌的效果与药物经济学评价

Efficacy and pharmacoeconomic evaluation of subcutaneous and intravenous dual-target therapy combined with albumin-bound paclitaxel as neoadjuvant therapy for human epidermal growth factor receptor 2-positive early breast cancer

作者：付晓艳张春栗辰王芹芹褚福涛禹雪孟祥志

英文作者：Fu Xiaoyan Zhang Chun Li Chen Wang Qinqin Chu Futao Yu Xue Meng Xiangzhi

单位：北京大学国际医院乳腺外科，北京102206

英文单位：Department of Breast Surgery Peking University International Hospital Beijing 102206 China

关键词：人表皮生长因子受体2阳性乳腺癌；新辅助治疗；皮下注射；目标试验模拟；药物经济学

英文关键词：Humanepidermalgrowthfactorreceptor2-positivebreastcancer;Neoadjuvanttherapy;Subcutaneousinjection;Targettrialemulation;Pharmacoeconomics

• 摘要：

• 目的 评估皮下注射制剂(SC)与静脉给药途径在人表皮生长因子受体2（HER-2）阳性乳腺癌降阶梯的“双靶联合非蒽环类”方案（nab-PHP方案）中的临床结局与真实世界药物经济学价值。方法 回顾性选取北京大学国际医院2024年1月至2025年12月收治的HER-2阳性早期浸润性乳腺癌并计划接受新辅助治疗的女性患者72例，根据给药方式将患者分为SC组（37例）和IV组（静脉对照组，35例）。应用稳定逆概率处理加权（IPTW）平衡组间基线协变量。主要临床终点为总体病理完全缓解率，预设非劣效性界值为-10%。主要经济学终点为总直接医疗成本，采用时间驱动作业成本法（TDABC）精确测算医护人力与时间成本，并进行成本-最小化分析。结果 经IPTW加权后，2组基线资料实现均衡（标准化均数差<0.1）。在临床疗效方面，SC组与IV组总体病理完全缓解率的绝对差异仅为0.6%（95%置信区间：-4.8%~6.0%），证实了SC途径的绝对非劣效性（Pnon-inf<0.001）。在安全性方面，SC组任意级别输注相关反应发生率低于IV组［2.7%（1/37）比17.1%（6/35）］（P＜0.05）。基于TDABC的医疗资源核算显示，SC组单次给药椅旁时间、静脉配置中心药师配药时间、给药操作与监测时间均短于IV组（均P<0.001）。综合统计结果表明，SC组完成新辅助全程的总成本低于IV组（P<0.001）。结论 在HER-2阳性早期乳腺癌的降阶梯新辅助治疗中，SC-nab-PHP方案在病理完全缓解率上非劣效于传统静脉方案，提高了安全性，降低了医疗成本。

• Objective To evaluate the clinical outcomes and real-world pharmacoeconomic value of subcutaneous (SC) versus intravenous (IV) administration in the de-escalated dual-target non-anthracycline regimen combined with albumin-bound paclitaxel (nab-PHP regimen) for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Methods A total of 72 female patients with HER2-positive early invasive breast cancer scheduled for neoadjuvant therapy admitted to Peking University International Hospital from January 2024 to December 2025 were retrospectively enrolled and divided into SC group (37 cases) and IV group (intravenous control group, 35 cases) according to administration route. Inverse probability of treatment weighting (IPTW) was applied to balance baseline covariates between groups. The primary clinical endpoint was overall pathological complete response rate, with a prespecified non-inferiority margin of -10%. The primary economic endpoint was total direct medical cost. Time-driven activity-based costing (TDABC) was adopted to accurately calculate medical staff labor and time costs, and cost-minimization analysis was conducted. Results After IPTW weighting, baseline characteristics were well balanced between the two groups (standardized mean difference <0.1). For clinical efficacy, the absolute difference in overall pathological complete response rate between the SC group and IV group was merely 0.6% (95% confidence interval: -4.8%-6.0%), which verified the absolute non-inferiority of subcutaneous administration (Pnon-inf<0.001). In terms of safety, the incidence of all-grade infusion-related reactions in the SC group was lower than that in the IV group ［2.7%(1/37) vs 17.1%(6/35)］(P＜0.05). Medical resource accounting based on TDABC showed that per-cycle chair-side administration time, pharmacy preparation time in intravenous admixture service, drug delivery and monitoring time were all shorter in the SC group (all P<0.001). Comprehensive statistical results demonstrated that the total cost for completing the full course of neoadjuvant therapy in the SC group was lower than that in the IV group (P<0.001). Conclusions For de-escalated neoadjuvant therapy of HER2-positive early breast cancer, the SC-nab-PHP regimen is non-inferior to the conventional intravenous regimen in pathological complete response rate, with improved safety and reduced medical costs.