Sueda Toshinori, Sakai Daisuke, Kudo Toshihiro, Sugiura Takashi, Takahashi Hidekazu, Haraguchi Naotsugu, Nishimura Junichi, Hata Taishi, Hayashi Taro, Mizushima Tsunekazu, Doki Yuichiro, Mori Masaki, Satoh Taroh
Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Graduate School of Medicine, Osaka, Japan
Anticancer Res. 2016 Aug;36(8):4299-306.
Regorafenib and TAS-102 are novel antitumor agents for patients with metastatic colorectal cancer (mCRC) whose disease has progressed after standard therapies. In randomized trials, regorafenib and TAS-102 prolonged survival in patients with mCRC. However, the appropriate selection of regorafenib or TAS-102 in treatment strategy has not yet been established.
We performed a retrospective analysis, between March 2013 and July 2015, on the efficacy and safety of regorafenib or TAS-102.
Thirty-seven patients with mCRC treated with regorafenib or TAS-102 were included. Of these 37 patients, 23 first received regorafenib and 14 received TAS-102. The median progression-free survival and overall survival were 3.0 and 5.8 months, respectively, in the regorafenib group and 2.1 and 6.3 months, respectively, in the TAS-102 group. Drug-related adverse events (AEs) and grade ≥3 AEs were 23 (100%) and 10 (43.5%), respectively, in the regorafenib group and 13 (92.9%) and 2 (14.3%), respectively, in the TAS-102 group. The most frequent grade ≥3 AEs were hepatotoxicity (17.4%) and hand-foot syndrome (13.0%) in the regorafenib group, and neutropenia (14.3%) in the TAS-102 group. In subgroup analysis, the median overall survival was 11.5 months in patients receiving crossover treatment with regorafenib to TAS-102, and 7.6 months in those receiving crossover treatment with TAS-102 to regorafenib.
Our results showed that regorafenib and TAS-102 have comparable efficacy but different toxicity profiles in patients with mCRC. Both are considered new salvage treatment options. Differences in the toxicity profiles between the two treatments will help in choosing regorafenib or TAS-102.
瑞戈非尼和TAS-102是用于转移性结直肠癌（mCRC）患者的新型抗肿瘤药物，这些患者的疾病在标准治疗后出现进展。在随机试验中，瑞戈非尼和TAS-102延长了mCRC患者的生存期。然而，在治疗策略中对瑞戈非尼或TAS-102的适当选择尚未确立。
我们在2013年3月至2015年7月期间对瑞戈非尼或TAS-102的疗效和安全性进行了回顾性分析。
纳入了37例接受瑞戈非尼或TAS-102治疗的mCRC患者。在这37例患者中，23例首先接受瑞戈非尼治疗，14例接受TAS-102治疗。瑞戈非尼组的中位无进展生存期和总生存期分别为3.0个月和5.8个月，TAS-102组分别为2.1个月和6.3个月。瑞戈非尼组与药物相关的不良事件（AE）和≥3级AE分别为23例（100%）和10例（43.5%），TAS-102组分别为13例（92.9%）和2例（14.3%）。瑞戈非尼组最常见的≥3级AE是肝毒性（17.4%）和手足综合征（13.0%），TAS-102组是中性粒细胞减少（14.3%）。在亚组分析中，接受从瑞戈非尼交叉至TAS-102治疗的患者中位总生存期为11.5个月，接受从TAS-102交叉至瑞戈非尼治疗的患者中位总生存期为7.6个月。
我们的结果表明，瑞戈非尼和TAS-102在mCRC患者中疗效相当，但毒性特征不同。两者均被视为新的挽救治疗选择。两种治疗方法毒性特征的差异将有助于选择瑞戈非尼或TAS-102。
