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作 者:吴书胜 陈文菊 柯丽红 牛佳郁 何义富 WU Shusheng;CHEN Wenju;KE Lihong;NIU Jiayu;HE Yifu(The First Affiliated Hospital of USTC(Anhui Provincial Hospital),Hefei 230031,China)
机构地区:[1]中国科学技术大学附属第一医院(安徽省立医院),合肥230031
出 处:《西北药学杂志》2022年第1期101-107,共7页Northwest Pharmaceutical Journal
基 金:安徽省自然科学基金项目(编号:1808085MH234);安徽省卫生健康委科研项目(编号:AHWJ2021b090,AHWJ2021b105)。
摘 要:目的比较阿帕替尼联合化疗与阿帕替尼单药治疗转移性结直肠癌(mCRC)的疗效和安全性。方法共纳入62例患者,将其分为阿帕替尼联合化疗组(联合组)和阿帕替尼单药组(单药组)。记录并评估2组的无进展生存期(PFS)、总生存期(OS)、客观反应率(ORR)、疾病控制率(DCR)、治疗前后的实验室检查结果和治疗相关不良事件。此外,进行单因素和多因素Cox回归分析PFS和OS的独立预后因素。结果与单药组相比,联合组显著延长了OS(8.1 m vs 7.7 m,P=0.021),但2组PFS比较差异无统计学意义(3.65 m vs 3.15 m,P=0.100)。联合组的ORR为8.3%(3/36),DCR为80.6%(29/36),单药组的ORR和DCR分别为7.7%(2/26)、61.5%(16/26)。多因素分析提示治疗方案[风险比(HR)=1.946,95%CI:1.014~3.738,P=0.045]和原发肿瘤的位置(HR=3.486,95%CI:1.374~8.844,P=0.009)是OS的重要因素。联合组治疗后的平均红细胞体积(MCV)和平均红细胞体积与红细胞比值(MCV/RBC)均高于单药组(P<0.05),而联合组治疗后的淋巴细胞与单核细胞比值(LMR)和血红蛋白、白蛋白、淋巴细胞和血小板计数评分(HALP评分)均低于单药组(P<0.05)。联合组3/4级血小板减少(11.1%)高于单药治疗组(0%),其他不良反应2组比较差异无统计学意义。结论在mCRC后线治疗中,阿帕替尼联合化疗比单药治疗能延长OS,且未增加不良反应。Objective To compare the efficacy and safety of combined therapy of apatinib and chemotherapy with that of apatinib monotherapy in the treatment of metastatic colorectal cancer(mCRC).Methods A total of 62 patients were enrolled in this study and were divided into combined therapy group(apatinib and chemotherapy)and apatinib monotherapy group(monotherapy).Progression-free survival(PFS),overall survival(OS),objective response rate(ORR),disease control rate(DCR),laboratory findings before and after treatment,and treatment-related adverse events were recorded and evaluated in both groups.Additionally,univariate and multivariate Cox regressions were performed to analyze independent prognostic factors for PFS and OS.Results Compared with monotherapy,the combination group had significantly longer OS(8.1 m vs 7.7 m,P=0.021),but the difference in PFS was not statistically significant(3.65 m vs 3.15 m,P=0.100).The ORR was 8.3%(3/36)and DCR was 80.6%(29/36)in the combination group and 7.7%(2/26)and 61.5%(16/26)in the single agent group.Multifactorial analysis suggested that treatment regimen(HR=1.946,95%CI:1.014-3.738,P=0.045)and location of the primary tumor(HR=3.486,95%CI:1.374-8.844,P=0.009)were important factors for OS.Mean erythrocyte volume(MCV)and mean erythrocyte volume to erythrocyte ratio(MCV/RBC)were higher in the combination group than in the single-drug group(P<0.05),whereas lymphocyte to monocyte ratio(LMR)and HALP score were lower in the combination group than in the single-drug group(P<0.05).Grade 3/4 thrombocytopenia was higher in the combination group(11.1%)than in the monotherapy group(0%),and other adverse effects were not significantly different in the 2 groups.Conclusion In the postline treatment of mCRC,apatinib combined with chemotherapy may prolong OS than monotherapy with no significant increase in adverse effects.
关 键 词:阿帕替尼 转移性结直肠癌(mCRC) 疗效 安全性 淋巴细胞与单核细胞比值(LMR)
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