Li Ning, Deng Wenying, Zhang Guifang, Du Yali, Guo Yanwei, Ma Yijie, Wei Chen, Bie Liangyu, Zhang Chi, Song Tao, Luo Suxia, Fang Baijun
Department of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
Department of Medical Oncology, Xinxiang Central Hospital, Xixiang, China.
Front Oncol. 2021 Sep 2;11:728854. doi: 10.3389/fonc.2021.728854. eCollection 2021.
Apatinib is an approved third-line treatment for metastatic gastric cancer in China and demonstrates good safety, tolerability, and efficacy in other advanced solid tumors. The aim of this prospective, single-arm, multicenter, phase 2 study was to assess the efficacy and safety of low-dose apatinib combined with S-1 in the treatment of refractory mCRC.
Patients with refractory mCRC were enrolled and administered apatinib combined with S-1 until disease progression, patient decision to withdraw, or unacceptable toxic effects. The primary endpoint was investigator-evaluated progression-free survival (PFS) and the secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR).
From December 2017 to December 2018, 30 patients were enrolled and 29 patients were eligible for the evaluation of efficacy and safety. The median PFS (mPFS) and OS (mOS) were 7.9 and 12.9 months, respectively. Exploratory analysis revealed that patients administered S-1 ≥ 70 days achieved longer mPFS and mOS. Four patients achieved a partial response, 22 achieved stable disease, and three had progressive disease, attributing to an ORR of 13.79% and a DCR of 89.66%. Ten grade 3 adverse events were reported and the frequency of each grade 3 adverse event was less than 5%. No grade 4 side events were observed.
These results indicated that apatinib combined with S-1 showed promising efficacy and manageable toxicity in patients with progressive mCRC after at least 2 prior lines of therapy, making it a promising therapeutic option for mCRC treatment.
https://clinicaltrials.gov/ct2/show/NCT03397199, identifier NCT03397199.
阿帕替尼在中国是转移性胃癌的获批三线治疗药物，并且在其他晚期实体瘤中显示出良好的安全性、耐受性和疗效。这项前瞻性、单臂、多中心2期研究的目的是评估低剂量阿帕替尼联合S-1治疗难治性转移性结直肠癌（mCRC）的疗效和安全性。
纳入难治性mCRC患者，给予阿帕替尼联合S-1治疗，直至疾病进展、患者决定退出或出现不可接受的毒性反应。主要终点是研究者评估的无进展生存期（PFS），次要终点是总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）。
2017年12月至2018年12月，共纳入30例患者，其中29例符合疗效和安全性评估标准。中位PFS（mPFS）和OS（mOS）分别为7.9个月和12.9个月。探索性分析显示，接受S-1治疗≥70天的患者mPFS和mOS更长。4例患者达到部分缓解，22例病情稳定，3例病情进展，ORR为13.79%，DCR为89.66%。报告了10例3级不良事件，各3级不良事件的发生率均低于5%。未观察到4级不良事件。
这些结果表明，阿帕替尼联合S-1在至少接受过2线前期治疗的进展期mCRC患者中显示出有前景的疗效和可管理的毒性，使其成为mCRC治疗的一个有前景的治疗选择。
https://clinicaltrials.gov/ct2/show/NCT03397199，标识符NCT03397199。
