Jiang Z C, Sun Y K, Zhang W, Yang L, Cui C X, Wang H Y, Zhang H G, Yihebali Chi, Zhou A P
Department of Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Zhonghua Yi Xue Za Zhi. 2020 Jul 14;100(26):2018-2022. doi: 10.3760/cma.j.cn112137-20200424-01304.
To evaluate the dose, efficacy and tolerability of regorafenib in a real-world clinical setting of metastatic colorectal cancer patients. The clinical data of patients with metastatic colorectal cancer who had received at least two previous treatment lines treated with regorafenib from May 2018 to December 2019 at National Cancer Center/Cancer Hospital was retrospectively analyzed. Patients'demographics, treatment, dosimetry, safety and survival data were collected. The primary endpoint was overall survival (OS). A total of 114 patients were enrolled in this study, including male 83 and female 31, with a median age of 61.Of all patients, 83 were treated with regorafenib and 31 were given combination therapy with regorafenib. Starting dose was 80 mg in 57 (50.0%) patients, 120 mg in 24 (21.1%) patients, and 160 mg in 28 (24.6%) patients. Dose increases were observed in 30.9% (25/81) of patients receiving 80 mg and 120 mg as the initial dose. Forty-five (39.5%) and 36 (31.6%) patients took the last daily dose of 80 mg and 120 mg, respectively. Median follow-up time was 8.5 months.Objective response rate (ORR) and disease control rate(DCR) were 1.0% and 52.1%, respectively. The median progression free survivalrate (PFS) was 2.4 moths (95: 0.80-10.57), median OS was 11.0 moths(95: 9.03-not available). The difference of the PFS and OS in the different dose groups was not statistically significant. But patients who received 120 mg regorafenib showed much longer survival with a median OS of 16.7 month. The difference of survival between the regorafenib group and combination group was not statistically significant either. Twenty patients continued with regorafenib as treatment even after progression. These patients had longer survival compared with those (52) who stopped regorafenib with median OS of 16.7 month vs 9.1 month (χ(2)=2.305, 0.116), respectively.There were 7.9%(9/114) of the patients who discontinued regorafenib therapy because of the adverse event, such as hand-foot skin reaction (HFSR), gastrointestinal bleeding, proteinuria and liver function injury. Patients with advanced colorectal cancer who failed to respond to standard therapy have a good survival benefit. The initial dose of 120 mg of regorafenib has a better risk/benefit ratio and is more suitable for patients with advanced colorectal cancer.
评估瑞戈非尼在转移性结直肠癌患者真实临床环境中的剂量、疗效和耐受性。回顾性分析了2018年5月至2019年12月在国家癌症中心/癌症医院接受至少两线先前治疗且接受瑞戈非尼治疗的转移性结直肠癌患者的临床资料。收集了患者的人口统计学、治疗、剂量测定、安全性和生存数据。主要终点为总生存期（OS）。本研究共纳入114例患者，其中男性83例，女性31例，中位年龄61岁。所有患者中，83例接受瑞戈非尼治疗，31例接受瑞戈非尼联合治疗。起始剂量为80mg的患者有57例（50.0%），120mg的患者有24例（21.1%），160mg的患者有28例（24.6%）。初始剂量为80mg和120mg的患者中，分别有30.9%（25/81）的患者出现剂量增加。45例（39.5%）和36例（31.6%）患者最后每日服用剂量分别为80mg和120mg。中位随访时间为8.5个月。客观缓解率（ORR）和疾病控制率（DCR）分别为1.0%和52.1%。中位无进展生存期（PFS）为2.4个月（95%CI：0.80-10.57），中位OS为11.0个月（95%CI：9.03-未获得）。不同剂量组的PFS和OS差异无统计学意义。但接受120mg瑞戈非尼治疗的患者生存期明显更长，中位OS为16.7个月。瑞戈非尼组与联合治疗组之间的生存差异也无统计学意义。20例患者即使在疾病进展后仍继续接受瑞戈非尼治疗。这些患者的生存期比停止使用瑞戈非尼的患者（52例）更长，中位OS分别为16.7个月和9.1个月（χ(2)=2.305，P=0.116）。有7.9%（9/114） 的患者因不良事件（如手足皮肤反应（HFSR）、胃肠道出血蛋白尿和肝功能损伤）而停用瑞戈非尼治疗。对标准治疗无反应的晚期结直肠癌患者有良好的生存获益。瑞戈非尼初始剂量120mg具有更好的风险/效益比，更适合晚期结直肠癌患者。
