曲妥珠单抗联合SOX方案在HER2阳性局部进展期胃癌新辅助治疗中的疗效

Effective observation of trastuzumab combined with SOX regimen in neoadjuvant treatment of HER2-positive locally advanced gastric cancer

[目的]观察曲妥珠单抗联合SOX方案在HER2阳性局部进展期胃癌新辅助治疗中的临床疗效及安全性。[方法]将62例初始确诊的HER2阳性局部进展期胃癌患者随机分为观察组和对照组,分别接受2周期新辅助治疗后评估手术,可手术者给予手术治疗。对照组(31例)给予SOX方案化疗,观察组(31例)给予曲妥珠单抗联合SOX方案治疗,比较2组患者术前疗效、手术切除情况、病理学肿瘤缩退分级及不良反应发生情况。[结果]对照组和观察组的总有效率分别是25.8%、41.9%,疾病控制率分别是67.7%、87.1%,2组总有效率(χ~2=1.800,P=0.180)和疾病控制率(χ~2=3.321,P=0.068)比较差异无统计学意义。观察组较对照组D2切除术比例(96.7%、75.0%,χ~2=5.718,P=0.017)和R0切除率(93.3%、67.9%,χ~2=6.116,P=0.013)明显提高,病理学TRG 3级所占比例(23.3%、50.0%,χ~2=4.459,P=0.035)明显下降,均差异有统计学意义。不良反应主要表现为恶心、呕吐、骨髓抑制、外周神经毒性,2组均差异无统计学意义(P>0.05)。[结论]曲妥珠单抗联合SOX方案较单纯SOX方案在HER2阳性局部进展期胃癌的新辅助治疗中有更高的D2切除术比例、R0手术切除率和病理学肿瘤缩退,且未显著增加不良反应,耐受性好。

[Objective]To observe the clinical efficacy and safety of trastuzumab combined with SOX regimen in neoadjuvant treatment of HER2-positive locally advanced gastric cancer.[Methods]Sixty-two patients with locally advanced gastric cancer with HER-2 positive initial diagnosis were randomly divided into observation group and control group,evaluation of surgery after 2 cycles of neoadjuvant therapy,surgical treatment for operable patients.The control group(31 cases)received SOX regimen chemotherapy,Observation group(31 cases)was treated with trastuzumab combined with SOX regimen,The preoperative efficacy,surgical resection rate,pathological grade of tumor regression and incidence of adverse reactions were compared between the two groups.[Results]The ORR of the control group and the observation group were 25.8%and 41.9%respectively,while the DCR of the control group and the observation group were 67.7%and 87.1%respectively,there was no significant difference in ORR(χ~2=1.800,P=0.180)and DCR(χ~2=3.321,P=0.068)between the two groups.The resection rate of D2(96.7%vs 75.0%,χ~2=5.718,P=0.017)and R0(93.3%vs 67.9%,χ~2=6.116,P=0.013)in the observation group were significantly higher than those in the control group、the proportion of pathological TRG grade 3(23.3%vs 50.0%,χ~2=4.459,P=0.035)decreased significantly,the differences were statistically significant.The main adverse reactions were nausea,vomiting,bone marrow suppression and peripheral neurotoxicity,there was no significant difference between the two groups(P>0.05).[Conclusion]Compared with SOX alone,trastuzumab combined with SOX regimen has higher D2 resection rate、R0 resection rate and pathological remission in HER2-positive locally advanced gastric cancer,and has no significant increase in adverse reactions and good tolerance.