Fengtong Jin, Jiangtao Fu, Yating Wang, Lili Wu, Jianbo Chen, Xiaofei Wang
Department of Otorhinolaryngology Head and Neck Surgery, The Sixth Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang province 323000PR China.
Open Med (Wars). 2017 May 11;12:107-114. doi: 10.1515/med-2017-0017. eCollection 2017.
The aim of this meta-analysis was to evaluate the effects and toxicity of S-1 combined with radiotherapy in the treatment of nasopharyngeal cancer (NPC). Through a search of the databases of PubMed, Embase, the Chinese Biomedicine Database (CBM), China National Knowledge Infrastructure (CNKI), Wanfang system and Chongqing VIP Information (CQVIP), the efficacy and side effects data of S-1 combined with radiotherapy in the treatment of NPC patients from open published randomized controlled trials (RCTs) were collected. The pooled complete response (CR), partial response (PR), objective response rate (ORR), 2-year survival rate and treatment related toxicity were analyzed by Stata12.0 software. Eight RCTs with 599 cases were included and analyzed in this meta-analysis. The general quality of the 8 studies were deemed as having moderate risk of bias. Adequate sequence generation was reported in 4 studies. Incomplete outcome data address was reported in 7 publications. Five studies indicated to be free of selective reporting. Seven studies reported the treatment complete response (CR) between S-1 combined with radiotherapy and radiotherapy alone. With significant heterogeneity, the data was pooled by random effect model. The pooled results indicated that S-1 combined with radiotherapy can significant increase the CR rate compared to radiotherapy alone (RR=1.52, 95%CI:1.33-1.74, P<0.05). Eight studies reported the partial response (PR) rate between the combined treatment and radiotherapy alone. The pooled results showed that there was no statistical difference for PR between combined treatment and radiotherapy alone (RR=0.85, 95%CI:0.62-1.16, P>0.05). For the effect size of objective response rate (ORR), pooled results indicated that S-1 combined with radiotherapy can significantly increased the ORR by random effect model (RR=1.39, 95%CI:1.23-1.57, P<0.05). The pooled results showed that S-1 combined with radiotherapy significant increase the risk of developing bone marrow suppression (RR=1.94, 95%CI:1.40-2.69, P<0.05) and gastrointestinal reaction (RR=1.81, 95%CI:1.38-2.38, P<0.05) with fixed effect model. However, the pooled oral mucositis (RR=1.22, 95%CI:0.99-1.50, P>0.05) and radiodermatitis (RR=0.93, 95%CI:0.77-1.12, P<0.05) were not statistically different. Two studies reported the 2-year survival rate between the two groups. The pooled results showed the combined treatment significantly increased the 2-year survival rate for patients with nasopharyngeal carcinoma (RR=1.14, 95%CI:1.01-1.28, P<0.05). The funnel plot demonstrated significant publication bias for complete response, partial response, objective response rate and oral mucositis. The egger's line regression test indicated significant publication bias for complete response (t=5.98, P=0.002) and objective response rate(t=6.23, P=0.003). Conclusion S-1 combined with radiotherapy can significant improve the clinical efficacy with more treatment related toxicity compared to radiotherapy alone in the treatment of nasopharyngeal carcinoma.
本荟萃分析的目的是评估S-1联合放疗治疗鼻咽癌(NPC)的疗效和毒性。通过检索PubMed、Embase、中国生物医学数据库(CBM)、中国知网(CNKI)、万方系统和重庆维普资讯(CQVIP)等数据库,收集开放发表的随机对照试验(RCT)中S-1联合放疗治疗NPC患者的疗效和副作用数据。使用Stata12.0软件分析汇总的完全缓解(CR)、部分缓解(PR)、客观缓解率(ORR)、2年生存率和治疗相关毒性。本荟萃分析纳入并分析了8项RCT,共599例患者。这8项研究的总体质量被认为存在中度偏倚风险。4项研究报告了充分的随机序列产生。7篇出版物报告了不完整的结局数据处理情况。5项研究表明无选择性报告。7项研究报告了S-1联合放疗与单纯放疗之间的治疗完全缓解(CR)情况。由于存在显著异质性,采用随机效应模型对数据进行汇总。汇总结果表明,与单纯放疗相比,S-1联合放疗可显著提高CR率(RR=1.52,95%CI:1.33-1.74,P<0.05)。8项研究报告了联合治疗与单纯放疗之间的部分缓解(PR)率。汇总结果显示,联合治疗与单纯放疗之间的PR无统计学差异(RR=0.85,95%CI:0.62-1.16,P>0.05)。对于客观缓解率(ORR)的效应量,汇总结果表明,采用随机效应模型,S-1联合放疗可显著提高ORR(RR=1.39,95%CI:1.23-1.57,P<0.05)。汇总结果显示,采用固定效应模型,S-1联合放疗显著增加了发生骨髓抑制(RR=1.94,95%CI:1.40-2.69,P<0.05)和胃肠道反应(RR=1.81,95%CI:1.38-2.38,P<0.05)的风险。然而,汇总的口腔黏膜炎(RR=1.22,95%CI:0.99-1.50,P>0.05)和放射性皮炎(RR=0.93,95%CI:0.77-1.12,P>0.05)无统计学差异。2项研究报告了两组之间的2年生存率。汇总结果显示,联合治疗显著提高了鼻咽癌患者的2年生存率(RR=1.14,95%CI:1.01-1.28,P<0.05)。漏斗图显示完全缓解、部分缓解、客观缓解率和口腔黏膜炎存在显著的发表偏倚。Egger线性回归检验表明完全缓解(t=5.98,P=0.002)和客观缓解率(t=6.23,P=0.003)存在显著的发表偏倚。结论在鼻咽癌治疗中,与单纯放疗相比,S-1联合放疗可显著提高临床疗效,但治疗相关毒性更多。