Nie Caiyun, Lv Huifang, Chen Beibei, Xu Weifeng, Wang Jianzheng, Liu Yingjun, Wang Saiqi, Zhao Jing, He Yunduan, Chen Xiaobing
Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China.
Front Oncol. 2022 Sep 26;12:917353. doi: 10.3389/fonc.2022.917353. eCollection 2022.
The antitumor activity of nivolumab plus regorafenib in colorectal cancer from a phase Ib REGONIVO study is encouraging. The present study was conducted to evaluate the efficacy and safety of regorafenib or fruquintinib plus sintilimab as third-line or above therapy in patients with microsatellite stable (MSS) metastatic colorectal cancer.
Patients with MSS metastatic colorectal cancer who have failed from prior treatment and received regorafenib or fruquintinib plus sintilimab as third-line or above therapy from January 2019 to December 2020 were prospectively analyzed based on real-world clinical practice. The primary end point was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
42 patients received regorafenib plus sintilimab(RS), and the other 30 patients received fruquintinib plus sintilimab(FS). In the general population, the ORR and DCR were 13.9% and 70.8%, and the median PFS and OS was 4.2(95% CI=2.9-5.5) and 10.5 (95% CI=8.6-12.4) months, respectively. There were no statistically significant differences between RS and FS group in PFS (3.5(2.2-4.8) vs. 5.5(3.5-7.5) months, P=0.434) and OS (11.0(7.0-15.0) vs. 10.5(3.8-17.2) months, P=0.486). Subgroup analysis suggested that patients without liver metastasis responded well to this combination regimen (ORR: 21.4% vs. 9.1%) and obtained better OS (26(8.8-43.2) vs. 10.0(7.4-12.6) months, P=0.016). The incidence of Grade 3-4 adverse events (AEs) was 15.3% and the toxicities were generally tolerable and manageable.
Regorafenib or fruquintinib plus sintilimab as third-line or above therapy provide a feasible treatment regimen for MSS metastatic colorectal cancer with tolerated toxicity. Patients without liver metastasis may be the preferred population for this combination regimen.
Ib期REGONIVO研究中纳武利尤单抗联合瑞戈非尼治疗结直肠癌的抗肿瘤活性令人鼓舞。本研究旨在评估瑞戈非尼或呋喹替尼联合信迪利单抗作为微卫星稳定（MSS）转移性结直肠癌患者三线及以上治疗的疗效和安全性。
对2019年1月至2020年12月期间既往治疗失败并接受瑞戈非尼或呋喹替尼联合信迪利单抗作为三线及以上治疗的MSS转移性结直肠癌患者，基于真实世界临床实践进行前瞻性分析。主要终点为无进展生存期（PFS）。次要终点包括客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和安全性。
42例患者接受瑞戈非尼联合信迪利单抗（RS）治疗，另外30例患者接受呋喹替尼联合信迪利单抗（FS）治疗。在总体人群中，ORR和DCR分别为13.9%和70.8%，中位PFS和OS分别为4.2（95%CI=2.9-5.5）个月和10.5（95%CI=8.6-12.4）个月。RS组和FS组在PFS（3.5（2.2-4.8）个月 vs. 5.5（3.5-7.5）个月，P=0.434）和OS（11.0（7.0-15.0）个月 vs. 10.5（3.8-17.2）个月，P=0.486）方面无统计学显著差异。亚组分析表明，无肝转移的患者对该联合方案反应良好（ORR：21.4% vs. 9.1%），且OS更好（26（8.8-43.2）个月 vs. 10.0（7.4-12.6）个月，P=0.016）。3-4级不良事件（AE）的发生率为15.3%，毒性一般可耐受且可控。
瑞戈非尼或呋喹替尼联合信迪利单抗作为三线及以上治疗为MSS转移性结直肠癌提供了一种可行的治疗方案，毒性可耐受。无肝转移的患者可能是该联合方案的首选人群。
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