Camejo Natalia, Castillo Cecilia, Amarillo Dahiana, de Los Santos Heber, Samurio Gaston, Silva-Marquez Ahinara, Sosa Franco, Vera Claudia, Xavier Rocio, Herrera Guadalupe, Alonso Isabel, Krygier Gabriel
Department of Clinical Oncology, School of Medicine, University of Uruguay, Montevideo, Uruguay.
School of Medicine, University of Uruguay, Montevideo, Uruguay.
World J Oncol. 2024 Jun;15(3):454-462. doi: 10.14740/wjon1829. Epub 2024 Apr 15.
The first-line treatment for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) involves a combination of trastuzumab, pertuzumab, and a taxane (TPH). This study assessed the efficacy of trastuzumab and pertuzumab (PH) in routine practice, following the treatment protocols of Uruguay's National Resources Fund (FNR), akin to clinical trials.
Patients with advanced MBC treated with PH between 2008 and 2022 per FNR protocols were evaluated. The Kaplan-Meyer method and log-rank test were utilized for analyzing overall survival (OS). Demographic and clinical variables, including age, menopausal status, and hormone receptors (HR), were analyzed.
The study included 318 PH-treated patients. The median age was 56 years, with 63.2% being postmenopausal and 60.4% HR and HER-2 positive. With a median follow-up of 17.2 months, the median OS was 29 months. OS varied based on HR status and the presence of metastases at different sites, significantly lower in patients with brain, cutaneous/subcutaneous, and pulmonary metastases. Additionally, OS was higher in patients treated at private institutions compared to public ones.
This study demonstrates the disparity in oncological treatment efficacy between clinical trials and clinical reality in Uruguay, emphasizing the importance of authentic environment research for more representative and effective medicine in Latin America.
人表皮生长因子受体2阳性(HER2+)转移性乳腺癌(MBC)的一线治疗包括曲妥珠单抗、帕妥珠单抗和紫杉烷(TPH)联合使用。本研究按照乌拉圭国家资源基金(FNR)的治疗方案,类似于临床试验,评估了曲妥珠单抗和帕妥珠单抗(PH)在常规临床实践中的疗效。
对2008年至2022年期间按照FNR方案接受PH治疗的晚期MBC患者进行评估。采用Kaplan-Meyer方法和对数秩检验分析总生存期(OS)。分析人口统计学和临床变量,包括年龄、绝经状态和激素受体(HR)。
该研究纳入了318例接受PH治疗的患者。中位年龄为56岁,63.2%为绝经后患者,60.4%的患者HR和HER-2呈阳性。中位随访时间为17.2个月,中位OS为29个月。OS因HR状态和不同部位转移灶的存在而有所不同,脑、皮肤/皮下和肺转移患者的OS显著较低。此外,私立机构治疗的患者的OS高于公立机构治疗的患者。
本研究表明乌拉圭临床试验与临床实际在肿瘤治疗疗效上存在差异,强调了在拉丁美洲进行真实环境研究对于获得更具代表性和有效性药物的重要性。