Chang Ya-Wen, Kuo Chun-Nan, Chang Chia-Lun, Hsu Jason C, Ko Yu
Department of Clinical Pharmacy, School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.
Department of Pharmacy, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.
Cancer Res Treat. 2024 Nov 18. doi: 10.4143/crt.2024.376.
This study aimed to examine the real-world effectiveness and safety of regorafenib and trifluridine/tipiracil (TAS-102) in metastatic colorectal cancer (mCRC) patients in Taiwan.
Data were extracted from Taiwan's National Health Insurance Research Database to evaluate the clinical outcomes of mCRC patients treated with either regorafenib or TAS-102 between 2016 and 2019. Overall survival (OS) was compared using Kaplan-Meier curves and Cox's proportional hazard models, adjusting for age, gender, Quan-CCI score, liver metastases, number of metastatic sites, and the use of anti-EGFR medications. Additionally, OS was compared between regorafenib monotherapy and TAS-102 monotherapy, excluding patients who had received both regorafenib and TAS-102.
A total of 2,608 patients in the regorafenib group and 521 patients in the TAS-102 group were identified. The median OS was 6.5 months for regorafenib and 7.5 months for TAS-102, with a significant difference observed (p=0.001). The mean duration of treatment was similar for regorafenib and TAS-102 (108 days vs. 101 days) with no significant difference. The safety profiles of the two drugs were distinct; a higher proportion of patients in the regorafenib group had hypertension and hand-foot skin reaction while nausea and vomiting were more common in the TAS-102 group. In the subgroup analysis, patients receiving TAS-102 monotherapy showed significantly longer OS than those receiving regorafenib monotherapy.
The findings of this study indicated that TAS-102 had superior survival outcomes compared to regorafenib in mCRC patients. This study provides insights into the effectiveness and safety profiles of regorafenib and TAS-102 in Taiwan.
本研究旨在探讨瑞戈非尼和曲氟尿苷/替匹嘧啶（TAS-102）在台湾转移性结直肠癌（mCRC）患者中的真实世界有效性和安全性。
从台湾国民健康保险研究数据库中提取数据，以评估2016年至2019年间接受瑞戈非尼或TAS-102治疗的mCRC患者的临床结局。使用Kaplan-Meier曲线和Cox比例风险模型比较总生存期（OS），并对年龄、性别、全因合并症指数（Quan-CCI）评分、肝转移、转移部位数量和抗表皮生长因子受体（EGFR）药物的使用情况进行校正。此外，比较瑞戈非尼单药治疗和TAS-102单药治疗的OS，排除同时接受过瑞戈非尼和TAS-102治疗的患者。
瑞戈非尼组共纳入2608例患者，TAS-102组共纳入521例患者。瑞戈非尼组的中位OS为6.5个月，TAS-102组为7.5个月，差异有统计学意义（p=0.001）。瑞戈非尼和TAS-102的平均治疗持续时间相似（108天对101天），无显著差异。两种药物的安全性特征不同；瑞戈非尼组高血压和手足皮肤反应的患者比例较高，而TAS-102组恶心和呕吐更为常见。在亚组分析中，接受TAS-102单药治疗的患者OS显著长于接受瑞戈非尼单药治疗的患者。
本研究结果表明，在mCRC患者中，TAS-102的生存结局优于瑞戈非尼。本研究为瑞戈非尼和TAS-102在台湾的有效性和安全性概况提供了见解。
