Kim Hyunho, Shin Kabsoo, An Ho Jung, Kim In-Ho, Bae Jung Hoon, Lee Yoon Suk, Lee In Kyu, Lee MyungAh, Park Se Jun
Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon 16247, Republic of Korea.
Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea.
Biomedicines. 2025 Apr 16;13(4):976. doi: 10.3390/biomedicines13040976.
Patients with metastatic colorectal cancer (mCRC) who are refractory to standard chemotherapy face limited treatment options. While trifluridine-tipiracil (FTD-TPI) and regorafenib have shown modest efficacy in prior clinical trials, recent data from the SUNLIGHT trial demonstrated that combining FTD-TPI with bevacizumab (FTD-TPI+BEV) may improve overall survival compared to FTD-TPI alone. However, supporting evidence from real-world populations remains scarce. : This retrospective study assessed the real-world effectiveness and safety of FTD-TPI+BEV versus FTD-TPI monotherapy in patients with refractory mCRC treated at two institutions from June 2020 to October 2024. : A total of 106 patients were included, with 47 treated with FTD-TPI+BEV and 59 with FTD-TPI alone. Median progression-free survival (PFS) was significantly longer with FTD-TPI+BEV compared to FTD-TPI alone (4.1 vs. 2.1 months; HR = 0.56; = 0.004), while median overall survival showed a non-significant trend favoring FTD-TPI+BEV (8.4 vs. 6.3 months; HR = 0.74; = 0.189). The disease control rate was also significantly higher with FTD-TPI+BEV (59.6% vs. 25.4%, = 0.001). Subgroup analyses showed consistent PFS benefits. Grade 3-5 adverse events occurred at comparable rates between groups. : FTD-TPI+BEV may represent a preferred salvage treatment option for refractory mCRC.
对标准化疗耐药的转移性结直肠癌（mCRC）患者的治疗选择有限。虽然三氟尿苷-替匹嘧啶（FTD-TPI）和瑞戈非尼在先前的临床试验中显示出一定疗效，但SUNLIGHT试验的最新数据表明，与单独使用FTD-TPI相比，FTD-TPI联合贝伐单抗（FTD-TPI+BEV）可能改善总生存期。然而，来自真实世界人群的支持证据仍然匮乏。这项回顾性研究评估了2020年6月至2024年10月在两家机构接受治疗的难治性mCRC患者中，FTD-TPI+BEV与FTD-TPI单药治疗的真实世界有效性和安全性。总共纳入了106例患者，其中47例接受FTD-TPI+BEV治疗，59例仅接受FTD-TPI治疗。与单独使用FTD-TPI相比，FTD-TPI+BEV的中位无进展生存期（PFS）显著更长（4.1个月对2.1个月；风险比[HR]=0.56；P=0.004），而中位总生存期显示出有利于FTD-TPI+BEV的非显著趋势（8.4个月对6.3个月；HR=0.74；P=0.189）。FTD-TPI+BEV的疾病控制率也显著更高（59.6%对25.4%，P=0.001）。亚组分析显示PFS获益一致。3-5级不良事件在两组中的发生率相当。FTD-TPI+BEV可能是难治性mCRC的首选挽救治疗选择。
