regorafenib 单药治疗或联合免疫检查点抑制剂作为转移性结直肠癌的二线治疗：中国多中心真实世界回顾性研究。
Regorafenib monotherapy or combined with an immune-checkpoint inhibitor as later-line treatment for metastatic colorectal cancer: a multicenter, real-world retrospective study in China.
机构信息
Department of Medical Oncology, National Clinical Research Center for Cancer/Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Department of Medical Oncology, Affiliated Hospital of Qingdao University, Qingdao, 266000, China.
出版信息
BMC Cancer. 2024 Jan 2;24(1):22. doi: 10.1186/s12885-023-11700-w.
OBJECTIVE
To evaluate the efficacy and safety of regorafenib monotherapy or in combination with immune-checkpoint inhibitor while treating Chinese patients with metastatic colorectal cancer (mCRC): a real-world study.
METHODS
The data of patients with metastatic colorectal cancer who received regorafenib-containing regimen as the third or later line treatment at ten Chinese hospitals from Aug 2017 to Jun 2020 were retrospectively analyzed, including dosing details, survival data as well as adverse events. Survival analysis was further performed for patients administrated with regorafenib monotherapy and combined with an immune-checkpoint inhibitor based on Kaplan-Meier and Cox regression methods. The primary endpoint was overall survival.
RESULTS
A total of 537 patients were included with a median age of 61, among whom 376 received regorafenib monotherapy and 245 received regorafenib combined with immune-checkpoint inhibitors. The clinicopathological characteristics of the two groups at baseline were mainly balanced. No significant difference in progression-free survival (PFS) was observed in patients receiving regorafenib monotherapy or combination therapy (3.8 vs. 5.5 months, p = 0.170). In contrast, patients receiving combination therapy had a more prolonged overall survival (OS) than those receiving regorafenib monotherapy (13.5 vs. 10.0 months, p = 0.001). The treatment regimen and regorafenib dosage were significant prognostic factors in the multivariate analysis. Significant benefits in PFS and OS were achieved in KRAS mutant and anti-angiogenesis treatment-naïve subgroups receiving combination therapy compared to monotherapy. No apparent increase was recorded in treatment-related adverse events in patients receiving combination therapy.
CONCLUSION
Regorafenib plus an immune-checkpoint inhibitor has already been a widely adopted strategy in the later-line treatment for mCRC in the real world. The combination therapy yielded a significantly prolonged overall survival than regorafenib alone, with a manageable safety profile in Chinese patients, and warrants further investigation.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04835324. Registered 6th April 2021.
目的
评估regorafenib 单药或联合免疫检查点抑制剂治疗中国转移性结直肠癌（mCRC）患者的疗效和安全性：一项真实世界研究。
方法
回顾性分析 2017 年 8 月至 2020 年 6 月，10 家中国医院接受含regorafenib 方案作为三线或三线以上治疗的转移性结直肠癌患者的数据，包括剂量细节、生存数据和不良反应。基于 Kaplan-Meier 和 Cox 回归方法对接受regorafenib 单药治疗和联合免疫检查点抑制剂治疗的患者进行生存分析。主要终点为总生存期。
结果
共纳入 537 例患者，中位年龄为 61 岁，其中 376 例接受regorafenib 单药治疗，245 例接受regorafenib 联合免疫检查点抑制剂治疗。两组患者的基线临床病理特征主要平衡。接受regorafenib 单药或联合治疗的患者无进展生存期（PFS）无显著差异（3.8 与 5.5 个月，p=0.170）。相反，接受联合治疗的患者总生存期（OS）长于接受regorafenib 单药治疗的患者（13.5 与 10.0 个月，p=0.001）。多变量分析显示，治疗方案和regorafenib 剂量是独立的预后因素。与单药治疗相比，KRAS 突变和抗血管生成治疗初治亚组患者接受联合治疗后 PFS 和 OS 均有显著获益。联合治疗组患者的治疗相关不良反应无明显增加。
结论
regorafenib 联合免疫检查点抑制剂已成为中国 mCRC 三线及以上治疗的广泛应用策略。与单药治疗相比，联合治疗可显著延长总生存期，且在安全性方面表现良好，值得进一步研究。
试验注册
ClinicalTrials.gov 标识符：NCT04835324。于 2021 年 4 月 6 日注册。
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