诱导化疗联合同步放化疗对局部晚期头颈鳞癌疗效和安全性的Meta分析

发布时间：2019-04-15 18:02

【摘要】：目的:通过Meta分析,客观评估诱导化疗联合同步放化疗与单纯同步放化疗治疗局部晚期头颈部鳞状细胞癌的疗效和安全性,为临床治疗提供指导。方法:按照Cochrane协作组要求,计算机检索PUBMED、EMBASE、Cochrane Library、CBM等数据库中的随机对照临床试验。选择治疗组为诱导化疗联合同步放化疗,对照组为单纯同步放化疗。由2名评价员分别独立按以上检索策略收集相关文献,并按纳入、排除标准入选。主要提取指标为总体生存时间(overall survival,OS)、无进展生存时间(progression-free survival,PFS)、总体反应率(overall response rate,ORR),次要提取指标为3-4级不良反应如:白细胞减少、中性粒细胞减少、血小板减少、口腔粘膜炎、皮肤反应、恶心及呕吐、吞咽困难等。结果采用危险比(relative risk,RR)、比值比(odds ratio,OR)、平均差(mean difference,MD)及其95%可信区间(confidence interval,CI)表示。结果:最终共纳入6篇随机对照研究,其中英文5篇,中文1篇,共计1141例患者,诱导化疗联合同步放化疗组:659例,同步放化疗组482例。两组患者的肿瘤完全缓解(complete remission,CR)、部分缓解(partial remission,PR)、稳定进展(stable disease,SD)、疾病进展(progressive disease,PD)以及总体反应率情况均无显著统计学差异(OR=2.04,95%CI:0.85~4.89,P=0.11;OR=0.50,95%CI:0.22~1.18,P=0.11;OR=0.66,95%CI:0.34~1.27,P=0.21;OR=0.89,95%CI:0.43~1.84,P=0.76;OR=1.03,95%CI:0.69~1.53,P=0.89)。1年、2年、3年和5年OS均无显著统计学差异(RR=1.05,95%CI:0.97~1.14,P=0.25;RR=0.97,95%CI:0.85~1.11,P=0.71;RR=0.96,95%CI:0.82~1.13,P=0.66;RR=0.95,95%CI:0.71~1.27,P=0.71)。1年PFS、2年PFS、3年PFS和5年PFS均无显著统计学差异(RR=1.01,95%CI:0.91~1.13,P=0.85;RR=1.08,95%CI:0.91~1.28,P=0.37;RR=1.04,95%CI:0.87~1.26,P=0.65;RR=1.01,95%CI:0.73~1.40,P=0.95)。诱导化疗联合同步放化疗组较同步放化疗组有较明显的发热性中性粒细胞减少症及口腔炎/口腔粘膜炎发生率(OR=6.99,95%CI:2.43~20.12;OR=1.92,95%CI:1.43~2.58),其他不良反应事件的发生率两组未见显著统计学差异。结论:目前对于局部晚期头颈鳞癌患者,诱导化疗联合同步放化疗较同步放化疗治疗,前者并不能有效提高患者总体反应率及总体生存率,不能有效延长无进展生存时间,其发热性中性粒细胞减少症及口腔炎/口腔粘膜炎发生率增加,其他不良反应事件的发生率两组未见显著统计学差异。
[Abstract]:Aim: to evaluate objectively the efficacy and safety of induction chemotherapy combined with concurrent radiotherapy and chemotherapy in the treatment of locally advanced squamous cell carcinoma of the head and neck by Meta analysis in order to provide guidance for clinical treatment. Methods: according to the requirement of Cochrane collaboration group, the randomized controlled clinical trials in PUBMED,EMBASE,Cochrane Library,CBM and other databases were searched by computer. The treatment group was treated with induction chemotherapy combined with concurrent radiotherapy and chemotherapy, while the control group was treated with simultaneous radiotherapy and chemotherapy. The relevant documents were collected independently by two evaluators according to the above retrieval strategies, and were selected according to the inclusion and exclusion criteria. The main indexes of extraction were total survival time (overall survival,OS), no progress survival time (progression-free survival,PFS), total reaction rate (overall response rate,ORR), secondary extraction indexes were grade 3, grade 4 adverse reactions such as leukopenia, Neutropenia, thrombocytopenia, oral mucositis, skin reaction, nausea and vomiting, dysphagia, etc. Results risk ratio (relative risk,RR), ratio (odds ratio,OR), mean difference (mean difference,MD) and 95% confidence interval (confidence interval,CI) were used. Results: a total of 6 randomized controlled studies were included, including 5 in English and 1 in Chinese. 1141 patients were treated with induction chemotherapy combined with concurrent radiotherapy: 659 patients in the induction chemotherapy group and 482 patients in the concurrent radiotherapy group. Tumor complete remission (complete remission,CR), partial remission (partial remission,PR), stable progression (stable disease,SD), and disease progression in both groups (progressive disease,) There was no significant difference in PD and overall response rate (OR=2.04,95%CI:0.85~4.89,P=0.11;). OR=0.50,95%CI:0.22~1.18,P=0.11;OR=0.66,95%CI:0.34~1.27,P=0.21;OR=0.89,95%CI:0.43~1.84,P=0.76; OR=1.03,95%CI:0.69~1.53,P=0.89). There was no significant difference in OS between 1 year, 2 years, 3 years and 5 years (RR=1.05,95%CI:0.97~1.14,P=0.25;RR=0.97,95%CI:0.85~1.11,P=0.71;). RR=0.96,95%CI:0.82~1.13,P=0.66;RR=0.95,95%CI:0.71~1.27,P=0.71). 1 year PFS, 2 years PFS, 3 years PFS and 5 years PFS had no significant difference (RR=1.01,95%CI:0.91~1.13,P=0.85;). RR=1.08,95%CI:0.91~1.28,P=0.37;RR=1.04,95%CI:0.87~1.26,P=0.65;RR=1.01,95%CI:0.73~1.40,P=0.95) The incidence of febrile neutropenia and stomatitis / oral mucositis in the induction chemotherapy combined with concurrent radiotherapy group was significantly higher than that in the concurrent radiotherapy group (OR=6.99,95%CI:2.43~20.12;). There was no significant difference in the incidence of other adverse events between the two groups (OR=1.92,95%CI:1.43~2.58). Conclusion: for patients with locally advanced squamous cell carcinoma of the head and neck, induction chemotherapy combined with concurrent radiotherapy and chemotherapy can not effectively improve the overall response rate and overall survival rate, and can not effectively prolong the progression-free survival time compared with the concurrent radiotherapy and chemotherapy, the former can not effectively improve the overall response rate and overall survival rate of the patients. The incidence of febrile neutropenia and stomatitis / oral mucositis increased, but there was no significant difference in the incidence of other adverse events between the two groups.
【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R739.91

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