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誘導(dǎo)化療聯(lián)合同步放化療對(duì)局部晚期頭頸鱗癌療效和安全性的Meta分析

發(fā)布時(shí)間:2019-04-15 18:02
【摘要】:目的:通過(guò)Meta分析,客觀評(píng)估誘導(dǎo)化療聯(lián)合同步放化療與單純同步放化療治療局部晚期頭頸部鱗狀細(xì)胞癌的療效和安全性,為臨床治療提供指導(dǎo)。方法:按照Cochrane協(xié)作組要求,計(jì)算機(jī)檢索PUBMED、EMBASE、Cochrane Library、CBM等數(shù)據(jù)庫(kù)中的隨機(jī)對(duì)照臨床試驗(yàn)。選擇治療組為誘導(dǎo)化療聯(lián)合同步放化療,對(duì)照組為單純同步放化療。由2名評(píng)價(jià)員分別獨(dú)立按以上檢索策略收集相關(guān)文獻(xiàn),并按納入、排除標(biāo)準(zhǔn)入選。主要提取指標(biāo)為總體生存時(shí)間(overall survival,OS)、無(wú)進(jìn)展生存時(shí)間(progression-free survival,PFS)、總體反應(yīng)率(overall response rate,ORR),次要提取指標(biāo)為3-4級(jí)不良反應(yīng)如:白細(xì)胞減少、中性粒細(xì)胞減少、血小板減少、口腔粘膜炎、皮膚反應(yīng)、惡心及嘔吐、吞咽困難等。結(jié)果采用危險(xiǎn)比(relative risk,RR)、比值比(odds ratio,OR)、平均差(mean difference,MD)及其95%可信區(qū)間(confidence interval,CI)表示。結(jié)果:最終共納入6篇隨機(jī)對(duì)照研究,其中英文5篇,中文1篇,共計(jì)1141例患者,誘導(dǎo)化療聯(lián)合同步放化療組:659例,同步放化療組482例。兩組患者的腫瘤完全緩解(complete remission,CR)、部分緩解(partial remission,PR)、穩(wěn)定進(jìn)展(stable disease,SD)、疾病進(jìn)展(progressive disease,PD)以及總體反應(yīng)率情況均無(wú)顯著統(tǒng)計(jì)學(xué)差異(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均無(wú)顯著統(tǒng)計(jì)學(xué)差異(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P(guān)FS、2年P(guān)FS、3年P(guān)FS和5年P(guān)FS均無(wú)顯著統(tǒng)計(jì)學(xué)差異(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)。誘導(dǎo)化療聯(lián)合同步放化療組較同步放化療組有較明顯的發(fā)熱性中性粒細(xì)胞減少癥及口腔炎/口腔粘膜炎發(fā)生率(OR=6.99,95%CI:2.43~20.12;OR=1.92,95%CI:1.43~2.58),其他不良反應(yīng)事件的發(fā)生率兩組未見顯著統(tǒng)計(jì)學(xué)差異。結(jié)論:目前對(duì)于局部晚期頭頸鱗癌患者,誘導(dǎo)化療聯(lián)合同步放化療較同步放化療治療,前者并不能有效提高患者總體反應(yīng)率及總體生存率,不能有效延長(zhǎng)無(wú)進(jìn)展生存時(shí)間,其發(fā)熱性中性粒細(xì)胞減少癥及口腔炎/口腔粘膜炎發(fā)生率增加,其他不良反應(yīng)事件的發(fā)生率兩組未見顯著統(tǒng)計(jì)學(xué)差異。
[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.
【學(xué)位授予單位】:河北醫(yī)科大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2017
【分類號(hào)】:R739.91

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