阿帕替尼联合替吉奥二线治疗晚期头颈部鳞癌的疗效及安全性研究

Efficacy and Safety of Apatinib Combined with S-1 in the Treatment of Advanced Head and Neck Squamous Cell Carcinoma

目的研究阿帕替尼联合替吉奥二线治疗晚期头颈部鳞癌(HNSCC)的疗效及安全性。方法选取2018年6月—2019年12月我院收治的62例经一线方案治疗失败且有病理标本的晚期HNSCC患者为研究对象,随机分为阿帕替尼组30例(阿帕替尼单药治疗)和联合组32例(阿帕替尼联合替吉奥治疗)。治疗12周后,比较两组患者的临床疗效、不良反应发生情况以及治疗前后白细胞计数、血小板计数、血管内皮生长因子(VEGF)和基质金属蛋白酶9(MMP-9)水平,并观察两组患者的无进展生存期(PFS)。结果联合组客观缓解率(ORR)和疾病控制率(DCR)分别为25.00%和87.50%,高于阿帕替尼组的13.33%和73.33%,但差异无统计学意义(P>0.05);两组患者恶心呕吐、腹泻、手足综合征、高血压的发生率均无明显差异(P>0.05),但联合组皮疹、口腔炎的发生率明显高于阿帕替尼组(P<0.05);治疗前两组患者白细胞计数、血小板计数均无明显差异(P>0.05),治疗后两组患者白细胞计数、血小板计数均明显下降(P<0.05),且联合组显著低于阿帕替尼组(P<0.05);治疗前两组患者VEGF、MMP-9水平均无明显差异(P>0.05),治疗后两组患者VEGF、MMP-9水平均显著下降(P<0.05),且联合组显著低于阿帕替尼组(P<0.05);联合组中位无进展生存时间(mPFS)为4.9个月,显著高于阿帕替尼组的3.7个月(P<0.05)。结论相较于阿帕替尼单药治疗,阿帕替尼联合替吉奥作为二线方案治疗晚期头颈部鳞癌,临床疗效满意,不良反应可耐受。

Objective To study the clinical efficacy and safety of apatinib combined with S-1 in the treatment of advanced head and neck squamous cell carcinoma(HNSCC).Methods A total of 62 patients who had pathologically diagnosed advanced HNSCC and failed first-line treatment were enrolled in Xiangya Second Hospital of Central South University between June 2018 and December 2019.They were randomly divided into two groups,with 30 cases in apatinib group(apatinib monotherapy)and 32 cases in combination group(apatinib combined with S-1).After treatment for 12 weeks,compare the clinical efficacy,adverse reactions,white blood cell count,platelet count,and the levels of vascular endothelial growth factor(VEGF)and matrix metalloproteinase-9(MMP-9)between the two groups before and after treatment.The progression free survival(PFS)of the two groups was also observed.Results The objective response rate(ORR)and disease control rate(DCR)of the combination group was 25.00%and 87.50%,respectively.Both were higher than those of the apatinib group(13.33%and 73.33%),but without statistical differences(P>0.05).There were no differences in the incidences of nausea,vomiting,diarrhea,hand-foot syndrome and hypertension between the two groups(P>0.05).But the incidences of skin rash and stomatitis were higher in the combination group than in the apatinib group(P<0.05).Before treatment,there were no significant differences in WBC and platelet count between the two groups(P>0.05).But after treatment,the WBC and platelet count decreased in both groups,and were lower in combination group than in apatinib group(P<0.05).In addition,there were no significant differences in VEGF and MMP-9 levels between the two groups before treatment(P>0.05).But after treatment,the VEGF and MMP-9 levels in the two groups were decreased after treatment,and were lower in combination group than in apatinib group(P<0.05).The median progression-free survival(mPFS)of the combination group was 4.9 months,and was significantly higher than that of the apatinib group(3.7 months)(P<0.05).Conclusion Compared with apatinib monotherapy,apatinib combined with S-1 as a second-line regimen in the treatment of advanced HNSCC has satisfactory clinical efficacy and acceptable adverse reactions.