手术联合辅助治疗与单纯手术治疗可切除胰腺癌临床疗效的Meta分析

Clinical effect of surgery combined with adjuvant therapy and single surgery for resectable pancreatic cancer: a Meta analysis

    摘要
  • 摘要: 目的:系统评价手术联合辅助治疗(术后放化疗或化疗)与单纯手术治疗可切除胰腺癌的临床疗效。
    方法:以pancreatic cancer、adjuvant therapy、chemoradiotherapy、radiochemotherapy、chemotherapy、radiotherapy及胰腺癌、辅助治疗、化学治疗、放射治疗为检索词，系统检索PubMed、Embase、Science Citation Index Expanded、Cochrane Central Register of Controlled Trials 以及中国生物医学文献数据库。检索时间为建库至2016年10月。纳入比较手术治疗联合术后放化疗或化疗与单纯手术治疗可切除胰腺癌的临床随机对照试验研究(RCT)，由两名文献评价员独立筛选文献和提取数据，并进行质量评价。手术治疗联合术后放化疗为治疗1组，手术治疗联合术后化疗为治疗2组，单纯手术治疗为对照组。采用倒方差法合并风险比(HR)及其相关统计量。总生存时间和无病生存时间的评价采用HR及95%可信区间，中位生存时间和1、2、5年生存率的评价采用相对危险度(RR)和95%可信区间，采用I2对异质性进行分析。
    结果:最终纳入9篇文献11项RCT，累积样本量为1 482例，治疗1组238例；治疗2组545例；对照组699例。Meta分析结果：①总生存时间：治疗1组和对照组患者总生存时间比较，差异无统计学意义(HR=0.87，95%可信区间：0.56~1.17，P>0.05)。治疗2组和对照组患者总生存时间比较，差异有统计学意义(HR=0.68，95%可信区间：0.55~0.80，P<0.05)。②无病生存时间：治疗1组和对照组患者无病生存时间比较，差异无统计学意义(HR=0.78，95%可信区间：0.53~1.03，P>0.05)。治疗2组和对照组患者无病生存时间比较，差异有统计学意义(HR=0.56，95%可信区间：0.45~0.67，P<0.05)。③中位生存时间：治疗1组和对照组患者中位生存时间比较，差异有统计学意义(RR=1.82，95%可信区间：1.35~2.45，P<0.05)。治疗2组和对照组患者中位生存时间比较，差异有统计学意义(RR=1.32，95%可信区间：1.07~1.62，P<0.05)。④1、2、5年生存率：治疗1组和对照组患者1、2、5年生存率比较，差异均无统计学意义(RR=1.24，2.47，1.15，95%可信区间：0.72~2.12，0.82~7.41，0.71~1.84，P>0.05)。治疗2组和对照组患者1年生存率比较，差异无统计学意义(RR=1.15，95%可信区间：0.99~1.34，P>0.05)，两组患者2、5年生存率比较，差异有统计学意义(RR=1.24，1.73，95%可信区间：1.01~1.50，1.32~2.27，P<0.05)。
    结论:与单纯手术治疗比较，手术联合术后放化疗并未改善可切除胰腺癌患者总生存时间和无病生存时间；而手术联合化疗可以延长患者总生存时间和无病生存时间。

     

    Abstract: Objective:To systematically evaluate the clinical effect of surgery combined with adjuvant therapy (postoperative chemoradiotherapy or chemotherapy) and single surgery for resectable pancreatic cancers.
    Methods:Literatures were researched using PubMed, Embase, Science Citation Index Expanded, Cochrane Central Register of Controlled Trials and China Biology Medicine disc with the key words including “pancreatic cancer, adjuvant therapy, chemoradiotherapy, radiochemotherapy, chemotherapy, radiotherapy, 胰腺癌, 辅助治疗, 化学治疗 and 放射治疗” from the time of database building to October 2016. Two reviewers independently screened literatures, extracted data and assessed the risk of bias. All the patients undergoing surgery combined with adjuvant chemoradiotherapy, surgery combined with adjuvant chemotherapy and single surgery were respectively allocated into the first treatment group, second treatment group and control group. The inverse variance was used for mergering hazard ratio (HR) and related statistic data. HR and 95% confidence interval (CI) were used for assessing the overall survival time and disease-free survival time. The median survival time and 1-, 2-, 5-year survival rates were evaluated by the relative risk (RR) and 95%CI. The heterogeneity of the studies was analyzed using the I2 test.
    Results:Eleven randomized controlled trials (RCTs) of 9 literatures were retrieved, and the total sample size was 1 482 patients, including 238 patients in the first treatment group, 545 in the second treatment group and 699 in the control group. Results of Meta analysis: ① overall survival time: there was no significant difference in overall survival time between the first treatment group and control group (HR=0.87, 95%CI: 0.56-1.17, P>0.05). There was a significant difference in overall survival time between the second treatment group and control group (HR=0.68, 95%CI: 0.55-0.80, P<0.05). ② Disease-free survival time: there was no significant difference in disease-free survival time between the first treatment group and control group (HR=0.78, 95%CI: 0.53-1.03, P>0.05). There was a significant difference in disease-free survival time between the second treatment group and control group (HR=0.56, 95%CI: 0.45-0.67, P<0.05). ③ Median survival time: there were significant differences in median survival time between the first treatment group and control group (RR=1.82, 95%CI: 1.35-2.45, P<0.05) between the second group and control group (RR=1.32, 95%CI: 1.07-1.62, P<0.05). ④ One-, 2-, 5-year survival rates: there was no significant difference in 1-, 2-, 5- year survival rates between the first treatment group and control group (RR=1.24, 2.47, 1.15, 95%CI: 0.72-2.12, 0.82-7.41, 0.71-1.84, P>0.05). One-year survival rate in the second treatment group was compared with that in the control group, with no significant difference (RR=1.15, 95%CI: 0.99-1.34, P>0.05). There were significant differences in 2- and 5-year survival rates between the second treatment group and control group (RR=1.24, 1.73, 95%CI: 1.01-1.50, 1.32-2.27, P<0.05).
    Conclusions:Compared with single surgery, surgery combined with postoperative chemoradiotherapy cannot significantly improve the overall survival time and disease-free survival time of patients. However, surgery combined with adjuvant chemotherapy can prolong the overall survival time and disease-free survival time of patients.

     

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