Martínez-Pérez Julia, Espinosa-Montaño Marta, Luque-Caro Natalia, Aviñó-Tarazona Victoria
Medical Oncology Department, University Hospital Virgen del Rocio, Seville, Spain.
Institute of Biomedicine of Seville (IBIS) (HUVR/University of Sevilla/CSIC), Seville, Spain.
J Gastrointest Oncol. 2023 Apr 29;14(2):692-704. doi: 10.21037/jgo-22-517. Epub 2023 Feb 24.
The combination of trifluridine and tipiracil is indicated in patients with metastatic colorectal cancer previously treated or non-candidates to chemotherapy and biological therapies. This study in routine clinical practice aimed to describe the effectiveness and safety of trifluridine and tipiracil and identify prognostic factors in patients with metastatic colorectal cancer in Spain.
This analysis was a retrospective, observational, multicenter study that included patients aged ≥18 years who had received treatment with trifluridine/tipiracil for metastatic colorectal cancer in third- or subsequent lines.
Overall, 294 were evaluated. Trifluridine/tipiracilmedian (minimum, maximum) treatment duration was 3.5 (1.0-29.0) months, and 128 (43.5%) patients received subsequent treatments. One hundred (34%) patients showed disease control rate, and the median progression-free survival and overall survival from trifluridine/tipiracil treatment onset were 3.7 and 7.5 months, respectively. The most frequently reported adverse events were asthenia (all grades, 57.9%) and neutropenia (all grades, 51.3%). A 39.1% and 4.4% of the participants had a dose reduction and a treatment interruption due to toxicity. Patients with age ≥65 years, low tumor burden, ≤2 metastasis sites, treatment dose reduction, neutropenia, and ≥6 cycles, had significantly higher overall survival, progression-free survival, and response rate.
This real-life study indicates that trifluridine/tipiracil shows effectiveness and safety in treating patients with metastatic colorectal cancer. The results show a profile of metastatic colorectal cancer patients with previously unknown prognostic factors who have a more significant benefit from treatment with trifluridine/tipiracil in routine clinical practice.
曲氟尿苷和替匹嘧啶联合用药适用于既往接受过治疗或不适合化疗及生物治疗的转移性结直肠癌患者。本项常规临床实践研究旨在描述曲氟尿苷和替匹嘧啶的有效性和安全性，并确定西班牙转移性结直肠癌患者的预后因素。
本分析为一项回顾性、观察性、多中心研究，纳入年龄≥18岁、接受过三线或后续治疗的曲氟尿苷/替匹嘧啶治疗转移性结直肠癌患者。
共评估294例患者。曲氟尿苷/替匹嘧啶的中位（最小，最大）治疗持续时间为3.5（1.0 - 29.0）个月，128例（43.5%）患者接受了后续治疗。100例（34%）患者显示疾病控制率，从曲氟尿苷/替匹嘧啶治疗开始的中位无进展生存期和总生存期分别为3.7个月和7.5个月。最常报告的不良事件为乏力（所有级别，57.9%）和中性粒细胞减少（所有级别，51.3%）。39.1%的参与者因毒性而降低剂量，4.4%的参与者因毒性而中断治疗。年龄≥65岁、肿瘤负荷低、转移部位≤2个、治疗剂量降低、中性粒细胞减少以及治疗周期≥6个周期的患者，总生存期、无进展生存期和缓解率显著更高。
这项真实世界研究表明，曲氟尿苷/替匹嘧啶在治疗转移性结直肠癌患者中显示出有效性和安全性。结果显示了一组具有先前未知预后因素的转移性结直肠癌患者，他们在常规临床实践中从曲氟尿苷/替匹嘧啶治疗中获益更大。
