TAS-102在转移性结直肠癌真实世界患者中的疗效及危险因素，EROTAS-R研究
Effects and risk factors of TAS-102 in real-world patients with metastatic colorectal cancer, EROTAS-R study.
作者信息
Yoshida Naohisa, Kuriu Yoshiaki, Ikeda Jun, Kudou Michihiro, Kirishima Toshihiko, Okayama Tetsuya, Miyagawa Koji, Takagi Tsuyoshi, Nakanishi Masayoshi, Doi Toshifumi, Ishikawa Takeshi, Itoh Yoshito, Otsuji Eigo
机构信息
Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-Cho, Kawaramachi-Hirokoji, Kamigyo-Ku, Kyoto, 602-8566, Japan.
Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
出版信息
Int J Clin Oncol. 2023 Oct;28(10):1378-1387. doi: 10.1007/s10147-023-02389-9. Epub 2023 Aug 14.
BACKGROUND
Trifluridine/tipiracil (TAS-102) is an anticancer drug for metastatic colorectal cancer (CRC). This study aimed to analyze the effects and risk factors about effects of TAS-102 in real-world patients with metastatic CRC (the EROTAS-R study).
METHODS
This study retrospectively analyzed 271 patients aged ≥ 20 years who underwent TAS-102 for metastatic CRC at nine related institutions from 2014 to 2021. Therapeutic results of TAS-102 + bevacizumab (Bev) and TAS-102, effect predictors, adverse events (AE), and AE predictors were examined.
RESULTS
The backgrounds of all cases were as follows: average age, 66.7 ± 10.9 years; male ratio, 59.5%; performance status (PS) 0/1/2, 43.5%/50.6%/5.9%; and tumor site right/left, 25.5%/74.5%. The therapeutic results of 109 cases receiving TAS-102 + Bev and 162 cases receiving TAS-102 were as follows: disease control rate, 53.2% vs. 28.0% (p < 0.01); progressive free survival (PFS), 6.2 vs. 4.2 months (p < 0.01); and overall survival (S), 11.8 vs. 9.3 months (p = 0.03). Multivariate analysis for effect-related factors (odds ratio (OR), 95%confidence interval (CI)) showed the following: PS1 + 2 (0.257, 0.134-0.494, p < 0.01) and a combination of Bev (3.052, 1.598-5.827, p < 0.01). The rates of grade 3 AE for TAS-102 + Bev and TAS-102 were 53.2% and 48.8%, respectively (p = 0.47). Various AE predictors were as follows: male sex (p = 0.69), age ≥ 75 years (p = 0.59), PS1 + 2 (p = 0.20), body surface area < 1.53 m (p = 0.26), eGFR < 50 ml/min (p = 0.02), and AST ≥ 50 IU/L (p = 0.64).
CONCLUSION
A better OS and PFS comparing TAS-102 + Bev to TAS-102 for CRC was achieved in a large number of real-world patients.
背景
曲氟尿苷/替匹嘧啶（TAS-102）是一种用于转移性结直肠癌（CRC）的抗癌药物。本研究旨在分析TAS-102在真实世界转移性CRC患者中的疗效及疗效相关危险因素（EROTAS-R研究）。
方法
本研究回顾性分析了2014年至2021年期间在9家相关机构接受TAS-102治疗转移性CRC的271例年龄≥20岁的患者。研究了TAS-102联合贝伐单抗（Bev）和TAS-102的治疗效果、疗效预测因素、不良事件（AE）及AE预测因素。
结果
所有病例的基线特征如下：平均年龄66.7±10.9岁；男性比例59.5%；体能状态（PS）0/1/2分别为43.5%/50.6%/5.9%；肿瘤部位右/左分别为25.5%/74.5%。109例接受TAS-102联合Bev治疗和162例接受TAS-102治疗的疗效如下：疾病控制率分别为53.2%和28.0%（p<0.01）；无进展生存期（PFS）分别为6.2个月和4.2个月（p<0.01）；总生存期（OS）分别为11.8个月和9.3个月（p=0.03）。疗效相关因素的多因素分析（比值比（OR），95%置信区间（CI））结果如下：PS1+2（0.257，0.134-0.494，p<0.01）和联合使用Bev（3.052，1.598-5.827，p<0.01）。TAS-102联合Bev组和TAS-102组3级AE发生率分别为53.2%和48.8%（p=0.47）。各种AE预测因素如下：男性（p=0.69）、年龄≥75岁（p=0.59）、PS1+2（p=0.20）、体表面积<1.53 m²（p=0.26）、估算肾小球滤过率（eGFR）<50 ml/min（p=0.02）、天门冬氨酸氨基转移酶（AST）≥50 IU/L（p=0.64）。
结论
在大量真实世界患者中，与单独使用TAS-102相比，TAS-102联合Bev治疗CRC可获得更好的OS和PFS。
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