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目的 :通过荟萃分析,探讨卡培他滨(CAP)单独或联合化疗方案在治疗进展期胰腺癌中的疗效与安全性。方法:通过Pub Med、Web of Knowledge及Cochrane数据库检索相关文献,选择治疗组中含CAP,对照组不含CAP的胰腺癌随机对照试验(RCT),由2位评价者分别检索收集资料,按纳入标准筛选文献。应用Revman 5.2.0软件对总生存时间(OS)、无进展生存时间(PFS)、客观缓解率(ORR)以及3/4级毒副反应进行荟萃分析。结果:最终入选6篇RCT,共1 269例,其中CAP治疗组669例,对照组600例。与对照组相比,治疗组显著提高了OS(HR=0.84,95%CI:0.74~0.95,P=0.006)、PFS(HR=0.83,95%CI:0.74~0.93,P=0.001)和ORR(OR=1.51,95%CI:1.08~2.12,P=0.02)。在毒副反应方面,除了手足综合征在治疗组中相对发生率较高(P=0.001),其他3/4级毒副反应在两组间均无统计学差异。在亚组分析中,治疗组为CAP联合吉西他滨(GEM),对照组为GEM单药治疗,共入选3篇RCT,共935例,分为CAP-GEM组468例,GEM单药组467例。与GEM单药化疗相比,CAP-GEM显著提高OS(HR=0.85,95%CI:0.74~0.98,P=0.03)、PFS(HR=0.80,95%CI:0.71~0.91,P=0.000 9)、ORR(OR=1.53,95%CI:1.04~2.24,P=0.03)。CAP-GEM在中性粒细胞减少和手足综合征方面发生率增高,其余3/4级毒副反应较GEM单药均无明显增高。结论:CAP单独或联合化疗方案在未明显增加毒副反应的前提下显著提高了进展期胰腺癌OS,改善了PFS和ORR。
Objective: To investigate the efficacy and safety of capecitabine (CAP) alone or in combination with chemotherapy in the treatment of advanced pancreatic cancer through meta-analysis. Methods: According to Pub Med, Web of Knowledge and Cochrane database, the randomized controlled trials (RCTs) of pancreatic cancer with CAP in the treatment group and those in the control group without CAP were selected, and the data were collected from 2 evaluators, Standard screening literature. A meta-analysis of overall survival (OS), progression-free survival time (PFS), objective response rate (ORR), and grade 3/4 toxicities was performed using Revman 5.2.0 software. Results: Six RCTs were finally enrolled in the study, of which 1,269 were CAP patients, including 669 CAP patients and 600 patients in the control group. Compared with the control group, the treatment group significantly increased the OS (HR = 0.84, 95% CI: 0.74-0.95, P = 0.006), PFS (HR = 0.83, 95% CI: 0.74-0.93, P = 0.001) (OR = 1.51, 95% CI: 1.08-2.12, P = 0.02). Toxic side effects, in addition to hand-foot syndrome in the treatment group, the relative incidence of higher (P = 0.001), other 3/4 grade toxicity was no significant difference between the two groups. In the subgroup analysis, the treatment group was CAP combined with gemcitabine (GEM) and the control group was GEM monotherapy. A total of 935 patients were enrolled in the study. Three RCTs were included, of which 468 were CAP-GEM and 467 were GEM monotherapy. CAP-GEM significantly improved OS (HR = 0.85, 95% CI: 0.74-0.98, P = 0.03), PFS (HR = 0.80, 95% CI: 0.71-0.91, P = 0.000 9 ), ORR (OR = 1.53, 95% CI: 1.04-2.24, P = 0.03). The incidence of CAP-GEM in neutropenia and hand-foot syndrome increased, and the remaining three or four toxic side effects than GEM single drug did not significantly increased. CONCLUSION: CAP alone or in combination with chemotherapy regimen significantly improves OS of advanced pancreatic cancer and improves PFS and ORR without significantly increasing toxicity.