曲妥珠单抗联合SOX方案治疗HER-2高表达胃癌患者的疗效观察

Efficacy of trastuzumab combined with SOX regimen for HER2-positive gastric cancer

目的观察注射用曲妥珠单抗联合替吉奥与奥沙利铂(SOX方案)治疗人表皮生长因子受体2(HER-2)高表达胃癌患者的临床疗效。方法选取2012年6月至2016年6月间河南省内乡县人民医院收治的96例HER-2高表达(≥75%)胃癌患者,采用随机数字表法分为观察组与对照组,每组48例。对照组患者采用常规SOX方案治疗,观察组患者在此基础上联合注射用曲妥珠单抗治疗。比较两组患者的临床疗效、治疗前后Kamofsky(KPS)评分变化及不良反应发生情况,检测实体肿瘤长径及血清肿瘤标志物水平变化。结果治疗后,观察组患者总有效率为60.4%,高于对照组的41.7%;两组患者实体肿瘤长径均降低,且观察组患者降低更明显;两组患者肿瘤标志物阳性率均较治疗前下降,且观察组患者各指标改善均优于对照组;观察组患者KPS改善率为89.6%,显著高于对照组的81.3%,两组比较,差异均有统计学意义(均P<0.05)。两组患者不良反应发生情况比较,差异无统计学意义(P>0.05)。结论采用注射用曲妥珠单抗联合SOX方案治疗HER-2高表达胃癌,能显著提高临床疗效,降低肿瘤标志物水平,改善生存质量,不良反应少,值得临床推广。

Objective To observe the efficacy of trastuzumab injection combined with tegafur plus oxaliplatin（ SOX） regimen in the treatment of human epidermal growth factor receptor 2（ HER-2） positive gastric cancer. Methods Ninety-six patients with HER2-positive（ ≥75%） gastric cancer treated at Neixiang County People＇s Hospital between June 2012 and June 2016 were selected. The patients were randomly divided into an observation group and a control group using a random number table with 48 patients in each group. The observation group was given trastuzumab combined with SOX regimen and the control group was treated with SOX regimen. Efficacy,changes in Karnofsky performance status（ KPS） and adverse reactions were compared between the two groups. Changes in the length of solid tumor and the level of serum tumor marker were detected. Results After the treatment,the overall efficacy rate was 60. 4% in the observation group which was higher than 41. 7% of the control group. the length of solid tumor decreased in both groups and reduction was more statistically significant in the observation group than in the control group. The positive rate of tumor markers decreased in the two groups compared with before the treatment and the improvement in the indexes was better in the observation group than in the control group. The improvement rate of KPS was 89. 6% in the observation group which was significantly higher than 81. 3% of the control group（ all P〈0. 05）. There was no difference in adverse reactions between the two groups（ P〈0. 05）.Conclusion The trastuzumab combined with SOX regimen can significantly improve the efficacy,quality of life and decrease the level of tumor markers in patients with HER-2 positive gastric cancer and is worthy of clinical popularization.