西妥昔单抗联合FOLFOX4/FOLFIRI治疗晚期结肠癌的Meta分析
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摘要
目的:评价西妥昔单抗联合FOLFOX4/FOLFIRI治疗晚期结肠癌的疗效及安全性。方法:检索PubM ed、Cochrane library、Web of Science、EMBASE、中国生物医学文献服务系统(China Biology Medicine,CBM)、中国知网、维普、万方等8个数据库。收集关于西妥昔单抗联合FOLFOX4/FOLFIRI治疗晚期结肠癌的随机对照试验,提取资料并且评价文献质量,采用Rev Man5. 3软件进行统计分析,95%可信区间估计。结果:两组有效率相比,差异有统计学意义[OR=2. 45,95%CI=(1. 78,3. 36),P <0. 000 01]。两组疾病控制率相比,差异具有统计学意义[OR=3. 36,95%CI=(2. 20,5. 14),P <0. 000 01]。实验组白细胞减少[OR=1. 10,95%CI=(0. 60,2. 02),P=0. 76]、皮疹[OR=11. 11,95%CI=(6. 71,18. 38),P <0. 000 01]、血小板减少[OR=1. 14,95%CI=(0. 64,2. 02),P=0. 66]、恶心呕吐[OR=1. 06,95%CI=(0. 71,1. 58),P=0. 76]、周围神经毒性[OR=0. 97,95%CI=(0. 62,1. 53),P=0. 91]、肝功能异常[OR=0. 88,95%CI=(0. 53,1. 45),P=0. 61]、骨髓抑制[OR=0. 77,95%CI=(0. 45,1. 32),P=0. 34]。发生率与对照组相比,除皮疹发生率远高于对照组,差异有统计学意义外,其余毒副反应差异均无统计学意义。结论:西妥昔单抗联合FOLFOX4/FOLFIRI治疗晚期结肠癌可以提高治疗效果,但不会明显增加毒副反应的发生率。
Objective: To evaluate the effectiveness and safety of FOLFOX4/FOLFIRI combined with cetuximab for metastatic/advanced colon cancer. Methods: Retrieval from PubM ed,Cochrane library,Web of Science,EMBASE,China Biology Medicine( CBM),China National Knowledge Infrastructure,VIP,Wan fang),randomized controlled trial about FOLFOX4/FOLFIRI combined with cetuximab for metastatic/advanced colon cancer were collected. Meta-analysis was conducted by Rev Man5. 3 software after data extraction and quality evaluation. Results: There was statistical significance in therapeutic efficacy of metastatic/advanced colon cancer between 2 groups[OR = 2. 45,95% CI =( 1. 78,3. 36),P < 0. 000 01],disease control rate[OR = 3. 36,95% CI =( 2. 20,5. 14),P < 0. 000 01]. The incidence of leukopenia[OR = 1. 10,95% CI =( 0. 60,2. 02),P = 0. 76],rash[OR = 11. 11,95% CI =( 6. 71,18. 38),P< 0. 000 1],thrombocytopenia[OR = 1. 14,95% CI =( 0. 64,2. 02),P = 0. 66],nausea and vomiting[OR = 1. 06,95% CI =( 0. 71,1. 58),P = 0. 76],peripheral nerve toxicity[OR = 0. 97,95% CI =( 0. 62,1. 53),P = 0. 91],abnormal liver function[OR = 0. 88,95% CI =( 0. 53,1. 45),P = 0. 61 ],myelosuppression[OR = 0. 77,95% CI =( 0. 45,1. 32),P = 0. 34]in trail group,the incidence of rash was much higher than that in the control group,and the difference was statistically significance,and the differences in the other adverse reactions were not statistically significance. Conclusion: FOLFOX4/FOLFIRI regimens combined with cetuximab has better therapeutic effect in the treatment of metastatic/advanced colon cancer than chemotherapy alone. which can distinctly relieve the patients' disease,and it does not significantly increase the incidence of toxic side effects.
Objective: To evaluate the effectiveness and safety of FOLFOX4/FOLFIRI combined with cetuximab for metastatic/advanced colon cancer. Methods: Retrieval from PubM ed,Cochrane library,Web of Science,EMBASE,China Biology Medicine( CBM),China National Knowledge Infrastructure,VIP,Wan fang),randomized controlled trial about FOLFOX4/FOLFIRI combined with cetuximab for metastatic/advanced colon cancer were collected. Meta-analysis was conducted by Rev Man5. 3 software after data extraction and quality evaluation. Results: There was statistical significance in therapeutic efficacy of metastatic/advanced colon cancer between 2 groups[OR = 2. 45,95% CI =( 1. 78,3. 36),P < 0. 000 01],disease control rate[OR = 3. 36,95% CI =( 2. 20,5. 14),P < 0. 000 01]. The incidence of leukopenia[OR = 1. 10,95% CI =( 0. 60,2. 02),P = 0. 76],rash[OR = 11. 11,95% CI =( 6. 71,18. 38),P< 0. 000 1],thrombocytopenia[OR = 1. 14,95% CI =( 0. 64,2. 02),P = 0. 66],nausea and vomiting[OR = 1. 06,95% CI =( 0. 71,1. 58),P = 0. 76],peripheral nerve toxicity[OR = 0. 97,95% CI =( 0. 62,1. 53),P = 0. 91],abnormal liver function[OR = 0. 88,95% CI =( 0. 53,1. 45),P = 0. 61 ],myelosuppression[OR = 0. 77,95% CI =( 0. 45,1. 32),P = 0. 34]in trail group,the incidence of rash was much higher than that in the control group,and the difference was statistically significance,and the differences in the other adverse reactions were not statistically significance. Conclusion: FOLFOX4/FOLFIRI regimens combined with cetuximab has better therapeutic effect in the treatment of metastatic/advanced colon cancer than chemotherapy alone. which can distinctly relieve the patients' disease,and it does not significantly increase the incidence of toxic side effects.
引文
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[25]Wang R,Zhao D,Jiang L,et al.Meta-analysis of cetuximab combined with chemotherapy in the treatment of advanced gastric cancer[J].Tumor,2016,36(12):1344-1353.
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[2]Colucci G,Gebbia V,Paoletti G,et al.PhaseⅢrandomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer:A multicenter study of the Gruppo Oncologico Dell'Italia Meridionale[J].J Clin Oncol,2005,23(22):4866-4875.
[3]Kemeny N,Garay CA,Gurtler J,et al.Randomized multicenter phaseⅡtrial of bolus plus infusional fluorouracil/leucovorin compared with fluorouracil/leucovorin plus oxaliplatin as third-line treatment of patients with advanced colorectal cancer[J].J Clin Oncol,2004,22(23):4753-4761.
[4]Shinagawa T,Tanaka T,Nozawa H,et al.Comparison of the guidelines for colorectal cancer in Japan,the USA and Europe[J].Ann Gastroenterol Surgery,2018,2(1):6-12.
[5]Zhang XP.The task and challenge of tumor imaging from the development of solid tumor efficacy evaluation criteria[J].Chinese J Radiol,2010,44(4):341-342.
[6]Luo J,Leng WD.Systematic evaluation/Meta analysis theory and practice[J].Chinese J Evidence-Bases Cardiovascular Medicine,2013,5(02):115.
[7]Zhang B.FOLFOX4 chemotherapy combined with cetuximab in the treatment of metastatic colon cancer[J].J Clin Res,2015,32(7):1393-1395.
[8]Ji L.Analysis of the efficacy of cetuximab combined with FOLFIRIchemotherapy in the treatment of advanced colon cancer[J].Psychol Doctor,2017,23(28):119-120.
[9]Zhou Q.Therapeutic effect of cetuximab combined with FOLFIRIchemotherapy on advanced colon cancer[J].Shandong Med J,2014,54(24):66-67.
[10]Long LM.Observation of the efficacy of cetuximab combined with FOLFIRI chemotherapy in the treatment of advanced colon cancer[J].World Clin Med,2017,11(8):13,15.
[11]Wang LH.Observation on the efficacy of cetuximab combined with FOLFIRI chemotherapy in the treatment of advanced colon cancer[J].Henan J Surg,2015,21(04):69-70.
[12]Wang YP.Analysis of adverse reactions and tolerability of cetuximab combined with FOLFIRI in the treatment of advanced colon cancer[J].Chinese J Cancer Prev Treat,2015,22(B11):137-138.
[13]Huang M.Clinical efficacy of cetuximab combined with FOLFOX4and FOLFOX4 alone in the treatment of advanced colon cancer[J]Health World,2016,6(34):117-118.
[14]Li XH.Clinical value of cetuximab and FOLFIRI chemotherapy in the treatment of advanced colon cancer[J].China Continuing Medical Education,2015,7(23):137-138.
[15]Chen W,Zheng R,Baade PD,et al.Cancer statistics in China,2015[J].Cancer J Clinicians,2016,66(2):115-132.
[16]Beije N,Helmijr JC,Weerts MJA,et al.Somatic mutation detection using various targeted detection assays in paired samples of circulating tumor DNA,primary tumor and metastases from patients undergoing resection of colorectal liver metastases[J].Mol Oncol,2016,10(10):1575-1584.
[17]Tie J,Wang Y,Tomasetti C,et al.Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stageⅡcolon cancer[J].Sci Translational Med,2016,8(346):346ra92.
[18]Chung CC,Ng DC,Tsang WW,et al.Hand-assisted laparoscopic versus open right colectomy:A randomized controlled trial[J].Ann Surg,2007,246(5):728-733.
[19]Miyamoto R,Nagai K,Kemmochi A,et al.Three-dimensional reconstruction of the vascular arrangement including the inferior mesenteric artery and left colic artery in laparoscope-assisted colorectal surgery[J].Surgical Endoscopy,2016,30(10):4400-4404.
[20]Virdee PS,Moschandreas J.Protocol for combined analysis of FOXFIRE,SIRFLOX,and FOXFIRE-global randomized phaseⅢTrials of chemotherapy+/-selective internal radiation therapy as first-line treatment for patients with metastatic colorectal cancer[J].Cancer,2017,6(3):e43.
[21]Koizumi N,Nakase Y,Takagi T,et al.Combination of self-expandable metallic stent insertion and laparoscopic surgery as a less invasive treatment of obstructive left-sided colon cancer[J].Gan to Kagaku Ryoho Cancer&Chemotherapy,2014,41(12):1583-1585.
[22]Segelman J,Singnomklao T,Hellborg H,et al.Differences in multidisciplinary team assessment and treatment between patients with stageⅣcolon and rectal cancer[J].Colorectal Disease,2009,11(7):768-774.
[23]Bianco F,DE Franciscis S,Belli A,et al.Surgery has a key role for quality assurance of colorectal cancer screening programs:Impact of the third level multidisciplinary team on lymph nodal staging[J].International J Colorectal Disease,2016,31(3):587-592.
[24]Engstrand J,Kartalis N,Stromberg C,et al.The impact of a hepatobiliary multidisciplinary team assessment in patients with colorectal cancer liver metastases:A population-based study[J].Oncologist,2017,22(9):1067-1074.
[25]Wang R,Zhao D,Jiang L,et al.Meta-analysis of cetuximab combined with chemotherapy in the treatment of advanced gastric cancer[J].Tumor,2016,36(12):1344-1353.
[26]Alberts SR,Sargent DJ,Nair S,et al.Effect of oxaliplatin,fluorouracil,and leucovorin with or without cetuximab on survival among patients with resected stageⅢcolon cancer:A randomized trial[J].JAMA,2012,307(13):1383-1393.
[27]Huang J,Nair SG,Mahoney MR,et al.Comparison of FOLFIRIwith or without cetuximab in patients with resected stageⅢcolon cancer;NCCTG(Alliance)intergroup trial N0147[J].Clin Colorectal Cancer,2014,13(2):100-109.
[28]Taieb J,Tabernero J,Mini E,et al.Oxaliplatin,fluorouracil,and leucovorin with or without cetuximab in patients with resected stageⅢcolon cancer(PETACC-8):An open-label,randomised phase 3 trial[J].Lancet Oncol,2014,15(8):862-873.