Chida Keigo, Kotani Daisuke, Moriwaki Toshikazu, Fukuoka Shota, Masuishi Toshiki, Takashima Atsuo, Kumekawa Yosuke, Kajiwara Takeshi, Yamazaki Kentaro, Komoda Masato, Makiyama Akitaka, Denda Tadamichi, Hatachi Yukimasa, Suto Takeshi, Sugimoto Naotoshi, Enomoto Masanobu, Ishikawa Toshiaki, Kashiwada Tomomi, Ando Koji, Yuki Satoshi, Okita Yoshihiro, Kusaba Hitoshi, Sakai Daisuke, Okamoto Koichi, Tamura Takao, Yamashita Kimihiro, Gosho Masahiko, Shimada Yasuhiro
Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Front Oncol. 2021 Mar 8;11:576036. doi: 10.3389/fonc.2021.576036. eCollection 2021.
The survival benefits of regorafenib (REG) and trifluridine/tipiracil hydrochloride (TFTD) have been demonstrated in chemorefractory patients with metastatic colorectal cancer (mCRC). However, the effects of crossover administration of REG and TFTD on patient survival remain unclear. The present study evaluated the association between exposure to REG and TFTD and overall survival (OS) in patients with mCRC using data from the REGOTAS study. We analyzed patients registered in the REGOTAS study, which retrospectively compared the efficacy and safety of use of REG or TFTD as later-line chemotherapy for chemorefractory mCRC patients. We compared the survival outcomes of cohort A (treated using both REG and TFTD) and cohort B (treated using either REG or TFTD). A total of 550 patients (cohort A, = 252; cohort B, = 298) met the inclusion criteria. The median OS was significantly increased in cohort A compared with cohort B [9.6 months (95% confidence interval (CI), 8.9-10.9 months) vs. 5.2 months (95% CI, 4.4-6.0 months), < 0.001]. Multivariate analysis revealed that cohort A was independently associated with a significant increase in OS [A vs. B: Hazard ratios (HR), 0.58; 95% CI, 0.47-0.72; < 0.001]. Subgroup analysis adjusted using multivariate Cox model revealed a consistently better trend in most subgroups for cohort A compared with cohort B. Our study revealed prolonged survival in patients treated with REG and TFTD. Therefore, all active agents, including REG and TFTD, should be made available to mCRC patients.
瑞戈非尼（REG）和曲氟尿苷/盐酸替匹嘧啶（TFTD）对难治性转移性结直肠癌（mCRC）患者的生存益处已得到证实。然而，REG和TFTD交叉给药对患者生存的影响仍不清楚。本研究使用REGOTAS研究的数据评估了mCRC患者接受REG和TFTD治疗与总生存期（OS）之间的关联。我们分析了REGOTAS研究中登记的患者，该研究回顾性比较了REG或TFTD作为难治性mCRC患者后线化疗的疗效和安全性。我们比较了A组（接受REG和TFTD治疗）和B组（接受REG或TFTD治疗）的生存结果。共有550例患者（A组，n = 252；B组，n = 298）符合纳入标准。与B组相比，A组的中位OS显著延长[9.6个月（95%置信区间（CI），8.9 - 10.9个月）vs. 5.2个月（95%CI，4.4 - 6.0个月），P < 0.001]。多变量分析显示，A组与OS显著增加独立相关[A组 vs. B组：风险比（HR），0.58；95%CI，0.47 - 0.72；P < 0.001]。使用多变量Cox模型进行的亚组分析显示，与B组相比，A组在大多数亚组中始终呈现出更好的趋势。我们的研究表明，接受REG和TFTD治疗的患者生存期延长。因此，应让mCRC患者能够使用包括REG和TFTD在内的所有活性药物。
