瑞戈非尼单药后线治疗转移性结直肠癌的疗效观察:一项回顾性研究

The efficacy of regorafenib monotherapy as the third-and later-line treatment for metastatic colorectal cancer:a retrospective study

目的探讨瑞戈非尼单药后线治疗转移性结直肠癌患者的疗效和安全性。方法回顾性分析2018年11月13日至2022年2月28日于郑州大学第一附属医院接受瑞戈非尼单药后线治疗的32例转移性结直肠癌患者的临床资料。本研究的主要终点为无进展生存期(PFS)和总生存期(OS),次要终点为客观缓解率(ORR)、疾病控制率(DCR)和不良反应。结果32例患者中,0例(0%,0/32)为CR,1例(3.1%,1/32)为PR,20例(62.5%,20/32)为SD,11例(34.4%,11/32)为PD,ORR为3.1%,DCR为65.6%。中位PFS和OS分别为3.7个月(95%CI:2.4~8.1)和17.4个月(95%CI:8.9~未达到)。既往未使用过贝伐珠单抗接受瑞戈非尼单药后线治疗患者的DCR、PFS均优于使用过的患者(P=0.029、P=0.041)。原发灶未切除(P=0.022)和转移灶个数≥3个(P=0.033)是影响患者OS的独立危险因素。常见的不良反应为谷丙转氨酶/谷草转氨酶增高(9/32,28.1%)、手足综合征(8/32,25%)和碱性磷酸酶增高(7/32,21.9%)。共有7例患者出现Ⅲ~Ⅳ级不良反应。未出现危及生命或不可控制的不良事件。结论瑞戈非尼单药后线治疗转移性结直肠癌疗效尚可,不良反应可控。

Objectives To investigate the efficacy and safety of regorafenib monotherapy as the third-and later-line treatment for metastatic colorectal cancer.Methods This was a retrospective analysis of 32 patients with metastatic colorectal cancer receiving regorafenib monotherapy as the third-and later-line treatment between November 13,2018,and February 28,2022,at the First Affiliated Hospital of Zhengzhou University.Primary endpoints included progression-free survival(PFS)and overall survival(OS).Secondary endpoints included objective response rate(ORR),disease control rate(DCR),and adverse events.Results Of the 32 patients,none(0%,0/32)achieved complete response,1(3.1%,1/32)achieved partial response,20(62.5%,20/32)achieved stable disease,and 11(34.4%,11/32)achieved progressive disease.ORR was 3.1%.DCR was 65.6%.Median PFS and OS were 3.7 months(95%confidence interval:2.4~8.1)and 17.4 months(95%CI:8.9~infinite),respectively.DCR and PFS were both significantly higher in patients who had not previously used bevacizumab and received regorafenib monotherapy as the thirdand later-line treatment were better than those who had used bevacizumab(P=0.029 and P=0.041,respectively).Independent risk factors for OS were primary lesions that have not been resected(P=0.022)and more than three metastasized lesions(P=0.033).The common adverse events were alanine aminotransferase/aspartate aminotransferase elevation(9/32,28.1%),hand-foot syndrome(8/32,25%),and alkaline phosphatase elevation(7/32,21.9%).Seven patients had adverse events of gradesⅢtoⅣ.No patients had life-threatening or uncontrollable adverse events.Conclusion Regorafenib monotherapy as the third-and later-line treatment shows acceptable efficacy and manageable safety for metastatic colorectal cancer.