帕尼单抗和紫杉醇一线治疗复发或转移性头颈肿瘤Ⅱ期患者效果观察  

Panitan single resistance and taxol as the first-line treatment of recurrent or metastatic head and neck cancer: a phase Ⅱ study

作　　者：罗通勇[1] 杨华清[1] 岳胜清[1] 贾全凡[1] 袁龙[1] LUO Tongyong;YANG Huaqing;YUE Shengqing;JIA Quanfan;YUAN Long(Department of Otorhinolaryngology, Guangyuan Central Hospital, Guangyuan 628000, Sichuan, China)

机构地区：[1]四川省广元市中心医院耳鼻咽喉科

出　　处：《山东大学耳鼻喉眼学报》2019年第4期71-75,共5页Journal of Otolaryngology and Ophthalmology of Shandong University

摘　　要：目的探讨帕尼单抗和紫杉醇一线治疗复发或转移性头颈肿瘤Ⅱ期患者的临床效果。方法选取复发或转移性头颈肿瘤Ⅱ期患者86例作为研究对象,按照治疗方法不同将其分为对照组和研究组各43例,对照组给予紫杉醇注射液联合化疗治疗,静脉滴注70~100 mg/m2,2次/d,连续静脉滴注3 d;研究组在给予紫杉醇注射液的基础上联合帕尼单抗药物治疗,在第4天给予帕尼单抗注射液治疗,静脉滴注80~85 mg/m^2,1次/d。两组均治疗1个月,对比观察近期疗效、不良反应发生情况、生存率及治疗前后生活质量评分。结果研究组、对照组治疗有效率分别为83.7%、60.5%,两组比较差异有统计学意义(χ^2=15.472,P<0.001),研究组、对照组不良反应发生率分别为7.0%、27.9%,两组比较差异有统计学意义(χ^2=12.648,P<0.001)。研究组不良反应严重程度Ⅰ级1例(2.3%),Ⅱ级1例(2.3%),Ⅲ级1例(2.3%);对照组不良反应严重程度Ⅰ级5例(11.6%),Ⅱ级3例(7.0%),Ⅲ级3例(7.0%),Ⅳ级1例(2.3%),两组不良反应严重程度比较差异有统计学意义(χ^2分别为5.394、6.391、5.125、4.935,P<0.001)。研究组1年的OS、RS分别为93.0%和95.3%,对照组分别为88.4%、86.0%,两组比较差异有统计学意义(χ^2分别为9.26、8.89,P<0.001);研究组3年的OS、RS分别为60.5%和65.1%,对照组分别为55.8%、58.1%,两组比较差异有统计学意义(χ^2分别为8.57、8.45,P<0.001);治疗后研究组社会功能、躯体功能、角色功能及认知功能、生活质量评分分别为(80.5±4.8)、(80.3±3.8)、(81.5±5.1)、(80.6±4.8)分,对照组分别为(74.2±4.8)、(71.2±3.3)、(71.6±3.8)、(74.3±3.5)分,两组差异有统计学意义(P<0.001)。结论对复发或转移性头颈肿瘤Ⅱ期患者应用帕尼单抗联合紫杉醇的治疗方案疗效确切,不良反应发生率低,患者的远期生存率高,生存时间长,生活质量高。Objective To investigate the clinical effects of panitumumab and paclitaxel as the first-line treatment in patients with stage II recurrent or metastatic head and neck cancer. Methods Eighty-six patients with stage II recurrent or metastatic head and neck cancer were enrolled in this study. According to the different treatment methods, the patients were divided into the control group and the study group, respectively. The control group was administered paclitaxel injection in combination with chemotherapy by continuous intravenous infusion at a dose of 70-100 mg/m^2 twice daily for 3 days. The study group was treated with paclitaxel alone along with panitumumab injection on the fourth day by intravenous drip at a dose of 80-85 mg/m2 once daily. Both the groups were treated for one month. The short-term efficacy, adverse reactions, survival rate, and quality of life before and after the treatment were compared. Results The effective response rates in the study group and the control group were 83.7% and 60.5%, respectively, which were significantly different(χ^2=15.472, P<0.001). The incidence of adverse reactions in the study group and the control group were 7.0% and 27.9%, respectively, which were significantly different(χ^2=12.648, P<0.001). The severity of adverse reactions in the study group were Grade Ⅰ(1.3%),Ⅱ(1.3%), and Ⅲ(1.3%), and control group(5.6%)(11.6%). There were 3 cases(7.0%)of grade Ⅲ and 1 case(2.3%)of grade Ⅳ adverse reactions. There was a statistically significant difference in the severity of adverse reactions between the two groups(χ^2 were 5.394, 6.391, 5.125, and 4.935 respectively;P were all< 0.001). The 3 years-OS and RS in the study group were 93.0% and 95.3%, respectively, which were significantly higher than those in the control group(88.4% and 86.0%)(χ^2 were 9.26 and 8.89, respectively, P were all< 0.001). The scores were 60.5% and 65.1%, which were significantly higher than those in the control group(55.8% and 58.1%)(P were all< 0.001 ). The quality of life scores in t

关 键 词：头颈肿瘤 帕尼单抗 紫杉醇 治疗结局 

分 类 号：R739.91[医药卫生—肿瘤]