单克隆抗体治疗头颈部鳞癌试验研究的疗效及安全性的Meta分析
|
摘要
目的:评价单克隆抗体治疗头颈部鳞癌(head and neck squamous cell carcinoma,HNSCC)的疗效及安全性。方法:检索维普、CBM、CNKI、万方、Pub Med、EMBASE、OVID等数据库,采用Cochrane协作网提供的统计软件Rev Man5. 3对纳入资料进行统计学分析。结果:共检索文献85篇,其中中文文献23篇,英文文献62篇。根据纳入与排除标准,最终纳入10篇RCT文献进行研究,研究总病例数为2 227。Meta分析结果显示联合应用单克隆抗体可提高治疗HNSCC的有效率和控制率[95%CI(1. 33,2. 31),P <0. 000 1; 95%CI(1. 11,2. 12),Z=2. 61,P=0. 009],并可明显减少样本中疾病进展人数[OR:0. 33,95%CI(0. 14,0. 79),Z=2. 51,P=0. 01];不良反应(Ⅲ/Ⅳ级)发生情况无明显统计学差异。结论:联合应用单克隆抗体可提高治疗HNSCC的有效率和疾病控制率,减少患者中疾病进展人数,且具备良好的安全性。
Objective: To evaluate the efficacy and safety of monoclonal antibodies in the treatment of head and neck squamous cell carcinoma. Methods: Searching CBM,CNKI,VIP,Wan Fang,Pub Med,EMBASE,OVID database,using Rev Man5. 3 to incorporate data for statistical analysis. Results: A total of 85 literatures were retrieved,including 23 Chinese literatures and 62 English literatures. According to inclusion and exclusion criteria,10 RCT documents were included in the study,and the total number of cases was 2 227. Meta analysis results showed that the combined application of monoclonal antibody HNSCC can improve the treatment efficiency and control rate [95% CI( 1. 33,2. 31),P < 0. 000 1. 95% CI( 1. 11,2. 12),Z = 2. 61,P = 0. 009],and significantly reduce the number of disease progression in the samples. Adverse reactions( Ⅲ/Ⅳ) had no statistically significant difference. Conclusion:The combination of monoclonal antibody can improve the efficiency and disease control rate of head and neck squamous cell carcinoma,reduce the number of patients with disease progression,and has good safety.
Objective: To evaluate the efficacy and safety of monoclonal antibodies in the treatment of head and neck squamous cell carcinoma. Methods: Searching CBM,CNKI,VIP,Wan Fang,Pub Med,EMBASE,OVID database,using Rev Man5. 3 to incorporate data for statistical analysis. Results: A total of 85 literatures were retrieved,including 23 Chinese literatures and 62 English literatures. According to inclusion and exclusion criteria,10 RCT documents were included in the study,and the total number of cases was 2 227. Meta analysis results showed that the combined application of monoclonal antibody HNSCC can improve the treatment efficiency and control rate [95% CI( 1. 33,2. 31),P < 0. 000 1. 95% CI( 1. 11,2. 12),Z = 2. 61,P = 0. 009],and significantly reduce the number of disease progression in the samples. Adverse reactions( Ⅲ/Ⅳ) had no statistically significant difference. Conclusion:The combination of monoclonal antibody can improve the efficiency and disease control rate of head and neck squamous cell carcinoma,reduce the number of patients with disease progression,and has good safety.
引文
[1] Wang Tian,Ding Hao,Wang Shengzi. Application of induced chemotherapy in head and neck squamous cell carcinoma[J]. Chinese Journal of Ophthalmology and Otorhinolaryngology,2018,18(1):52-55.[王天,丁浩,王胜资.诱导化疗在头颈部鳞状细胞癌中的应用[J].中国眼耳鼻喉科杂志,2018,18(1):52-55.]
[2] Luo Wenjuan,Guo Yuanwen,Xu Xuemei. Epidermal growth factor receptor and its related antineoplastic agents[J]. Modern Oncology,2010,18(3):587-590.[罗文娟,郭远文,许雪梅.表皮生长因子受体及其相关抗肿瘤药物[J].现代肿瘤医学,2010,18(3):587-590.]
[3] Sun Lili,Bai Yuxian. Progress in targeted therapy of head and neck squamous cell carcinoma[J]. Chinese J Clinicians,2013,7(22):10271-10274.[孙丽立,白玉贤.头颈鳞癌的靶向治疗进展[J].中华临床医师杂志,2013,7(22):10271-10274.]
[4] Ye Rui,Zhao Zhifei,Gao Lingling,et al. Efficacy of bevacizumab combined with concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck[J]. Academic J PLA Postgraduate Medical School,2016,9(37):919-922.[叶蕊,赵志飞,高灵灵等.贝伐珠单抗联合同步放化疗在局部晚期头颈部鳞癌中的疗效观察[J].解放军医学院学报,2016,9(37):919-922.]
[5] Gu Qianping,Meng Jian,Zhuang Qianwei,et al. Netuzumab combined with docetaxel-cisplatin-fluorouracil in the treatment of advanced head and neck squamous cell carcinoma[J]. Chinese J Stomatological Res,2013,7(6):466-469.[顾倩平,孟箭,庄乾伟等.尼妥珠单抗联合多西他赛-顺铂-氟尿嘧啶治疗晚期头颈鳞状细胞癌[J].中华口腔医学研究杂志,2013,7(6):466-469.]
[6] Guo Bing. Panitumumab combined with chemotherapy for advanced head and neck cancer[J]. J Clin Exp Med,2013,12(22):1811-1813.[郭兵.帕尼单抗联合化疗治疗晚期头颈部肿瘤的研究[J].临床和实验医学杂志,2013,12(22):1811-1813.]
[7] Keun-Wooklee,Youngilkoh,Sung-Baekim,et al. A randomized,multicenter,phaseⅡstudy of cetuximab with docetaxel and cisplatin as induction chemotherapy in unresectable,locally advanced head and neck cancer[J]. Oncologist,2015,20:1119-1120.
[8] Salama JK,Haraf DJ,Stenson KM,et al. A randomized phaseⅡstudy of 5-fluorouracil,hydroxyurea,and twice-daily radiotherapy compared with bevacizumab plus 5-fluorouracil,hydroxyurea,and twice-daily radiotherapy for intermediate-stage and T4N0-1head and neck cancers[J]. Ann Oncol,2011,22:2304-2309.
[9] Burtness B,Goldwasser MA,Flood W,et al. PhaseⅢrandomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer:An eastern cooperative oncology group study[J]. J Clin Oncol,2005,23(34):8646-8654.
[10] Vermorken JB,Mesia R,Rivera F,et al. Platinum-based chemotherapy plus Cetuximab in head and neck cancer[J]. N Engl J Med,2008,359(11):1116-1127.
[11] Bonner JA,Harari PM,Giralt J,et al. Radiotherapy plus Cetuximab for locoregionally advanced head and neck cancer:5-year survival data from a phase 3 randomised trial,and relation between Cetuximab-induced rash and survival[J]. Lancet Oncol,2010,11(1):21-28.
[12] Ang KK,Zhang Q,Rosenthal DI,et al. Randomized phaseⅢtrial of concurrent accelerated radiation plus Cisplatin with or without Cetuximab for stageⅢtoⅣhead and neck carcinoma:RTOG0522[J]. J Clin Oncol,2014,32(27):2940-2950.
[13] Glisson BS,Tseng J,Marur S,et al. Randomized phaseⅡtrial of Cixutumumab(CIX)alone or with Cetuximab(CET)for refractory recurrent/metastatic squamous cancer of head and neck(R/MSCCHN)[J]. J Clin Oncol,2013,31(15):6030.
[14] Concu R,Cordeiro Mnds. Looking for new inhibitors for the epidermal growth factor receptor[J]. Curr Top Med Chem,2018,18(3):219-232.
[15] Echarri MJ,Lopez-Martin A,Hitt R. Targeted therapy in locally advanced and recurrent/metastatic head and neck squamous cell carcinoma(LA-R/M HNSCC)[J]. Cancers(Basel)2016,8(3):27.
[16] Concu R,Cordeiro Mnds. Cetuximab and the head and neck squamous cell cancer[J]. Curr Top Med Chem,2018,18(3):192-198.
[17] Rodríguez MO,Rivero TC,del Castillo Bahi R,et al. Nimotuzumab plus radiotherapy for unresectable squamous-cell carcinoma of the head andneck[J]. Cancer Biol Ther,2010,9:343-349.
[18] Babu,Viswanath,Reddy,et al. An open-label,randomized,study of h-r3mab(nimotuzumab)in patients with advanced(stageⅢorⅣa)Squamous cell carcinoma of head and neck(SCCHN):Four-year survival results from a phaseⅡbstudy[J]. J Clin Oncol,2010,28(Suppl 15):5530.
[2] Luo Wenjuan,Guo Yuanwen,Xu Xuemei. Epidermal growth factor receptor and its related antineoplastic agents[J]. Modern Oncology,2010,18(3):587-590.[罗文娟,郭远文,许雪梅.表皮生长因子受体及其相关抗肿瘤药物[J].现代肿瘤医学,2010,18(3):587-590.]
[3] Sun Lili,Bai Yuxian. Progress in targeted therapy of head and neck squamous cell carcinoma[J]. Chinese J Clinicians,2013,7(22):10271-10274.[孙丽立,白玉贤.头颈鳞癌的靶向治疗进展[J].中华临床医师杂志,2013,7(22):10271-10274.]
[4] Ye Rui,Zhao Zhifei,Gao Lingling,et al. Efficacy of bevacizumab combined with concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck[J]. Academic J PLA Postgraduate Medical School,2016,9(37):919-922.[叶蕊,赵志飞,高灵灵等.贝伐珠单抗联合同步放化疗在局部晚期头颈部鳞癌中的疗效观察[J].解放军医学院学报,2016,9(37):919-922.]
[5] Gu Qianping,Meng Jian,Zhuang Qianwei,et al. Netuzumab combined with docetaxel-cisplatin-fluorouracil in the treatment of advanced head and neck squamous cell carcinoma[J]. Chinese J Stomatological Res,2013,7(6):466-469.[顾倩平,孟箭,庄乾伟等.尼妥珠单抗联合多西他赛-顺铂-氟尿嘧啶治疗晚期头颈鳞状细胞癌[J].中华口腔医学研究杂志,2013,7(6):466-469.]
[6] Guo Bing. Panitumumab combined with chemotherapy for advanced head and neck cancer[J]. J Clin Exp Med,2013,12(22):1811-1813.[郭兵.帕尼单抗联合化疗治疗晚期头颈部肿瘤的研究[J].临床和实验医学杂志,2013,12(22):1811-1813.]
[7] Keun-Wooklee,Youngilkoh,Sung-Baekim,et al. A randomized,multicenter,phaseⅡstudy of cetuximab with docetaxel and cisplatin as induction chemotherapy in unresectable,locally advanced head and neck cancer[J]. Oncologist,2015,20:1119-1120.
[8] Salama JK,Haraf DJ,Stenson KM,et al. A randomized phaseⅡstudy of 5-fluorouracil,hydroxyurea,and twice-daily radiotherapy compared with bevacizumab plus 5-fluorouracil,hydroxyurea,and twice-daily radiotherapy for intermediate-stage and T4N0-1head and neck cancers[J]. Ann Oncol,2011,22:2304-2309.
[9] Burtness B,Goldwasser MA,Flood W,et al. PhaseⅢrandomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer:An eastern cooperative oncology group study[J]. J Clin Oncol,2005,23(34):8646-8654.
[10] Vermorken JB,Mesia R,Rivera F,et al. Platinum-based chemotherapy plus Cetuximab in head and neck cancer[J]. N Engl J Med,2008,359(11):1116-1127.
[11] Bonner JA,Harari PM,Giralt J,et al. Radiotherapy plus Cetuximab for locoregionally advanced head and neck cancer:5-year survival data from a phase 3 randomised trial,and relation between Cetuximab-induced rash and survival[J]. Lancet Oncol,2010,11(1):21-28.
[12] Ang KK,Zhang Q,Rosenthal DI,et al. Randomized phaseⅢtrial of concurrent accelerated radiation plus Cisplatin with or without Cetuximab for stageⅢtoⅣhead and neck carcinoma:RTOG0522[J]. J Clin Oncol,2014,32(27):2940-2950.
[13] Glisson BS,Tseng J,Marur S,et al. Randomized phaseⅡtrial of Cixutumumab(CIX)alone or with Cetuximab(CET)for refractory recurrent/metastatic squamous cancer of head and neck(R/MSCCHN)[J]. J Clin Oncol,2013,31(15):6030.
[14] Concu R,Cordeiro Mnds. Looking for new inhibitors for the epidermal growth factor receptor[J]. Curr Top Med Chem,2018,18(3):219-232.
[15] Echarri MJ,Lopez-Martin A,Hitt R. Targeted therapy in locally advanced and recurrent/metastatic head and neck squamous cell carcinoma(LA-R/M HNSCC)[J]. Cancers(Basel)2016,8(3):27.
[16] Concu R,Cordeiro Mnds. Cetuximab and the head and neck squamous cell cancer[J]. Curr Top Med Chem,2018,18(3):192-198.
[17] Rodríguez MO,Rivero TC,del Castillo Bahi R,et al. Nimotuzumab plus radiotherapy for unresectable squamous-cell carcinoma of the head andneck[J]. Cancer Biol Ther,2010,9:343-349.
[18] Babu,Viswanath,Reddy,et al. An open-label,randomized,study of h-r3mab(nimotuzumab)in patients with advanced(stageⅢorⅣa)Squamous cell carcinoma of head and neck(SCCHN):Four-year survival results from a phaseⅡbstudy[J]. J Clin Oncol,2010,28(Suppl 15):5530.