比较西妥昔单抗双周与每周方案联合FOLFOX/XELOX一线治疗KRAS/RAS野生型转移性结直肠癌的回顾性研究  

FOLFOX/XELOX plus cetuximab administered weekly versus biweekly as a first-line treatment for patients with KRAS/RAS wild-type metastatic colorectal cancer: a retrospective study

作　　者：俞悦 张雯 孙永琨 杨林 崔成旭 曾益新 周爱萍[1] Yue Yu;Wen Zhang;Yongkun Sun;Lin Yang;Chengxu Cui;Yixin Zeng;Aiping Zhou(Department of Medical Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;National Cancer Center/National Clinical ResearchCenter for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;State Key Laboratory of Oncology in Southern China,Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou 510060,China)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院肿瘤内科,北京市100021 [2]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院 [3]中山大学肿瘤防治中心,华南肿瘤学国家重点实验室,肿瘤医学协同创新中心

出　　处：《中国肿瘤临床》2018年第23期1210-1214,共5页Chinese Journal of Clinical Oncology

摘　　要：目的:比较西妥昔单抗双周和每周方案联合FOLFOX/XELOX一线治疗KRAS/RAS野生型转移性结直肠癌的疗效和安全性。方法:回顾性收集2010年7月至2017年12月在中国医学科学院肿瘤医院接受FOLFOX/XELOX联合双周或每周西妥昔单抗一线治疗的KRAS/RAS野生型转移性结直肠癌患者的资料。比较两组间治疗的客观缓解率(objective response rate,ORR)、无进展生存期(progression-free survival,PFS)、总生存期(overall survival,OS)和不良反应发生率。结果:共98例符合入组条件。其中西妥昔单抗双周治疗组55例,每周治疗组43例。双周组的ORR显著高于每周组,分别为76.3%和54.8%(P=0.025)。双周组与每周组的PFS分别为10.3个月和8.8个月(P=0.288),OS分别33.5个月和27.4个月(P=0.563),结果差异均无统计学意义。双周组的口腔黏膜炎发生率显著高于每周组(32.7%vs. 14.0%,P=0.032),痤疮样皮疹(80.0%vs. 62.8%,P=0.058)、白细胞和/或中性粒细胞减少(72.7%vs. 55.8%,P=0.081)等不良反应发生率有升高的趋势。双周组与每周组3/4级皮疹的发生率分别为18.2%和7.0%(P=0.105),全部3/4级不良反应发生率差异均无统计学意义(P>0.05)。结论:双周西妥昔单抗联合化疗一线治疗转移性结直肠癌的疗效与每周方案相当,缓解率可能更高,是临床可选择的治疗方案。治疗过程中应关注一些不良反应的发生率增加。Objective: To compare the efficacy and safety of cetuximab biweekly regimen with those of standard weekly regimen as a first-line therapy of KRAS/RAS wild-type metastatic colorectal cancer. Methods: Patients who received weekly or biweekly administration of cetuximab plus FOLFOX/XELOX as a first-line therapy from July 2010 to December 2017 in Cancer Hospital, Chinese Academy of Medical Sciences were retrospectively screened for eligibility. Objective response rate(ORR), progression-free survival(PFS), overall survival(OS), and frequencies of adverse events(AEs) between the two groups were compared. Results: Of 152 eligible patients, 55 were in the biweekly group and 43 were in the weekly group. The biweekly group had significantly higher ORR than the weekly group(76.3% vs. 54.8%, P=0.025). Median PFS in the biweekly and weekly groups were 10.3 and 8.8 months, respectively(P=0.288), and the median OS were 33.5 and 27.4 months, respectively(P=0.563). The two groups showed no significant difference in PFS and OS. For overall AEs, the biweekly group presented significantly more stomatitis(32.7% vs. 14.0%, P=0.032) and tended to show substantially more acne-like rash(80.0% vs. 62.8%, P=0.058) and leukopenia and/or neutropenia(72.7% vs. 55.8%, P=0.081). The frequency of 3/4grade acne-like rash in the biweekly and weekly groups were 18.2% and 7.0%, respectively(P=0.105). The frequency of all grade 3/4AEs between the two groups showed no significant difference(P>0.05). Conclusions: Biweekly regimen of cetuximab plus FOLFOX/XELOX had similar efficacy and higher ORR compared with those of standard weekly regimen. Cetuximab administered biweekly may be an optional choice in clinical practice, with close attention paid to increased frequency of certain AEs.

关 键 词：西妥昔单抗 双周方案 转移性结直肠癌 一线治疗 

分 类 号：R735.34[医药卫生—肿瘤]