摘要
目的探讨V-raf鼠肉瘤病毒癌基因同源体B(BRAF)抑制剂联合西妥昔单抗联合或不联合MEK抑制剂治疗中国晚期不可切除BRAF^V600E突变型结直肠癌的安全性及疗效。方法回顾性收集2018年9月至2019年11月接受西妥昔单抗+BRAF抑制剂(维莫非尼11例,达拉非尼2例)治疗的13例BRAF^V600E突变型晚期结直肠癌患者,其中5例在西妥昔单抗+BRAF抑制剂的基础上联合MEK抑制剂(曲美替尼)。采集患者的临床病理信息,统计有效率(RR)、疾病控制率(DCR)、无进展生存时间(PFS)和不良反应。结果13例患者的中位治疗周期数为6个周期(范围:3~16个周期),无CR病例,获PR 4例、SD 7例、PD 2例,RR为30.8%,DCR为84.6%,中位PFS为6.7个月(95%CI:1.7~11.7个月)。所有患者均发生不同程度的不良反应,最常见的不良反应为痤疮样皮疹(69.2%)、发热(46.2%)和关节痛(23.1%),3级及3级以上不良反应的发生率为38.5%,包括低磷血症(15.4%)、痤疮样皮疹(7.7%)、脂膜炎(7.7%)和谷草转氨酶升高(7.7%)。结论BRAF抑制剂联合西妥昔单抗±MEK抑制剂治疗BRAF^V600E突变型中国晚期结直肠癌的疗效较好,经剂量调整后不良反应整体可控。
Objective To evaluate the safety and efficacy of cetuximab combined with v-rafmurine sarcoma viral oncogene homolog B(BRAF)inhibitor±MEK inhibitor in Chinses unresectable BRAF^V600E mutated metastatic colorectal cancer(mCRC).Methods From September 2018 to November 2019,thirteen patients with unresectable BRAF^V600E mutated mCRC who received cetuximab combined with BRAF inhibitor(11 with vemurafenib,2 with dabrafenib)were enrolled in this study.Five patients received MEK inhibitor(trametinib)simultaneously.Clinicopathological characteristics,response rate(RR),disease control rate(DCR),progression free survival(PFS)and adverse events were observed and evaluated.Results The median treatment cycle number of the 13 patients was 6(range:3-16).No complete response case was observed.Number of patients who reached the best efficacy of PR,SD and PD were 4,7 and 2,respectively.The RR was 30.8%and the DCR was 84.6%.The median PFS of the 13 patients was 6.7 months(95%CI:1.7-11.7 months).All patients experienced different degrees of adverse effects during treatment.The most common adverse effects were acneiform rash(69.2%),pyrexia(46.2%)and arthralgia(23.1%).The incidence of grade 3/4 adverse events was 38.5%,including hypophosphatemia(15.4%),acneiform rash(7.7%),panniculitis(7.7%)and aspartate elevation(7.7%).Conclusion Cetuximab combined with BRAF inhibitor±MEK inhibitor regimen has favorable efficacy and tolerable toxicity for Chinses BRAF^V600E mutated mCRC.
作者
许婷
王晰程
李健
张小田
陆明
龚继芳
刘丹
曹彦硕
周军
彭智
齐长松
李艳艳
沈琳
XU Ting;WANG Xicheng;LI Jian;ZHANG Xiaotian;LU Ming;GONG Jifang;LIU Dan;CAO Yanshuo;ZHOU Jun;PENG Zhi;QI Changsong;LI Yanyan;SHEN Lin(Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing 100142, China)
出处
《临床肿瘤学杂志》
CAS
北大核心
2020年第7期613-618,共6页
Chinese Clinical Oncology