Zhao Hui, Shen Chan, Laureano Jaime J, Lei Xiudong, Niu Jiangong, Giordano Sharon H, Chavez-MacGregor Mariana
Department of Health Services Research Unit 1362, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
Department of Public Health Sciences, College of Medicine, The Pennsylvania State University, Hershey, PA, USA.
Breast Cancer Res Treat. 2025 Feb;210(1):191-203. doi: 10.1007/s10549-024-07552-y. Epub 2024 Nov 22.
Chemotherapy in combination with trastuzumab is the standard neoadjuvant and adjuvant therapy for human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). Assessing the regimens administered to patients with HER2-positive BC in the real world is lacking. We evaluated neoadjuvant and adjuvant regimen patterns among HER2-positive BC patients (2007 to 2021) identified in a health insurance claims database.
Female BC patients ≥ 18 years who received chemotherapy, surgery, and trastuzumab were chosen from Optum's de-identified Clinformatics® Data Mart database. Summary statistics, Joinpoint models, Kaplan-Meier survival curves, and Cox regression models were used to analyze the data.
We identified 6474 patients (median age 60 years), 71.7% were White, 10.9% were Black, 8.6% were Hispanic, 4.1% were Asian, and 4.7% had unknown race/ethnicity. About 33.8% received neoadjuvant therapy and neoadjuvant therapy use increased with an annual percent change of 10.24% (P < .001). The three most common regimens were adjuvant docetaxel, carboplatin, and trastuzumab (TCH; 29.0%); adjuvant paclitaxel and trastuzumab (17.7%); and neoadjuvant TCH with pertuzumab followed by adjuvant trastuzumab (17.7%). The 5-year overall survival (OS) was 96% (95% CI, 95-96%). Patients had an increased risk of death if they were ≥ 59 years at diagnosis, had a health maintenance organization or other insurance plan, had dual Medicare/Medicaid eligibility, had a mastectomy, did not receive 18 cycles of trastuzumab, or received regimens not recommended by the National Comprehensive Cancer Network.
Treatment regimen patterns for HER2-positive BC evolved in correspondence with the U.S. Food and Drug Administration's approval of new drugs for this cancer and National Comprehensive Cancer Network treatment guidelines.
化疗联合曲妥珠单抗是人类表皮生长因子受体2（HER2）阳性乳腺癌（BC）的标准新辅助和辅助治疗方案。目前尚缺乏对现实世界中HER2阳性BC患者所采用治疗方案的评估。我们评估了在一个医疗保险理赔数据库中识别出的HER2阳性BC患者（2007年至2021年）的新辅助和辅助治疗方案模式。
从Optum的去识别化Clinformatics®数据集市数据库中选取年龄≥18岁、接受过化疗、手术和曲妥珠单抗治疗的女性BC患者。使用汇总统计、Joinpoint模型、Kaplan-Meier生存曲线和Cox回归模型对数据进行分析。
我们识别出6474例患者（中位年龄60岁），其中71.7%为白人，10.9%为黑人，8.6%为西班牙裔，4.1%为亚洲人，4.7%的种族/族裔未知。约33.8%的患者接受了新辅助治疗，新辅助治疗的使用以每年10.24%的百分比变化增加（P < 0.001）。三种最常见的方案是辅助多西他赛、卡铂和曲妥珠单抗（TCH；29.0%）；辅助紫杉醇和曲妥珠单抗（17.7%）；以及新辅助TCH联合帕妥珠单抗，随后辅助曲妥珠单抗（17.7%）。5年总生存率（OS）为96%（95%CI，95 - 96%）。如果患者诊断时年龄≥59岁、拥有健康维护组织或其他保险计划、具备医疗保险/医疗补助双重资格、接受了乳房切除术、未接受18个周期的曲妥珠单抗治疗或接受了美国国立综合癌症网络不推荐的方案，则死亡风险增加。
HER2阳性BC的治疗方案模式随着美国食品药品监督管理局对该癌症新药的批准以及美国国立综合癌症网络治疗指南的变化而演变。
