曲妥珠单抗联合FOLFOX方案治疗HER-2阳性晚期胃癌的疗效及安全性研究

Efficacy and safety of trastuzumab combined with FOLFOX regimen in the treatment of HER-2 positive advanced gastric cancer

目的:探讨曲妥珠单抗联合FOLFOX方案治疗人表皮生长因子受体-2(HER-2)阳性晚期胃癌的疗效及安全性。方法:将70例HER-2阳性晚期胃癌患者随机分为两组,对照组35例行FOLFOX方案化疗,即奥沙利铂+亚叶酸钙+5-氟尿嘧啶治疗,观察组35例在对照组基础上加以曲妥珠单抗治疗,对比两组治疗效果,治疗前后KPS评分、肿瘤标志物水平和毒副反应发生情况。结果:观察组与对照组的近期客观总有效率(57. 14%vs 40. 00%)和疾病控制率(80. 00%vs 68. 57%)比较有统计学意义(P <0. 05);观察组治疗后的KPS评分较对照组显著提高(P <0. 05);治疗后观察组的肿瘤标志物(CA724、CA199、CEA)水平显著低于对照组(P <0. 05);两组胃肠道反应、骨髓抑制及感觉神经毒性发生率相当(P <0. 05),观察组心脏毒性、发热或寒战、皮疹毒性反应发生率分别为14. 29%、22. 86%和25. 71%,显著高于对照组的2. 86%、5. 71%和2. 86%。结论:曲妥珠单抗联合FOLFOX方案治疗HER-2阳性晚期胃癌效果显著,可显著提高近期疗效和KPS评分,但会增加心脏毒性、寒战等药物毒性反应发生率。

Objective: To evaluate the efficacy and safety of trastuzumab combined with FOLFOX regimen in the treatment of human epidermal growth factor receptor-2( HER-2) positive advanced gastric cancer. Methods: 70 patients with HER-2 positive advanced gastric cancer were randomly divided into two groups. In the control group,35 patients underwent FOLFOX chemotherapy. Namely oxaliplatin + leucovorin + 5-fluorouracil treatment,on top of which 35 patients in the observation group were treated with trastuzumab. The therapeutic effect,the KPS score,the tumor marker level and the toxic and side effects were compared between the two groups. Results: The objective total effective rate( 57. 14% vs 40. 00%) and the disease controlling rate( 80. 00% vs 68. 57%) in the two groups were statistically significant( P < 0. 05). After treatment,the KPS score of the observation group was significantly higher than that of the control group( P < 0. 05);after treatment,the levels of tumor markers( CA724,CA199,CEA) in the observation group were significantly lower than those in the control group( P < 0. 05);there was no significant difference in the incidence of gastrointestinal reactions,myelosuppression and sensory nerve toxicity between the two groups( P < 0. 05),the incidence of cardiac toxicity,fever or chills and rash toxicity in the observation group were 14. 29%,22. 86% and 25. 71%,respectively,which was significantly higher than2. 86%,5. 71% and 2. 86% in the control group. Conclusion: Trastuzumab combined with FOLFOX regimen is effective in the treatment of HER-2 positive advanced gastric cancer,which can significantly improve the short-term efficacy and KPS score,but increase the incidence of toxic reactions such as heart toxicity,chills and so on.