曲妥珠单抗联合奥沙利铂、5-氟尿嘧啶治疗HER-2/neu高表达晚期胃癌的临床疗效观察

Clinical observation on efficacy of herceptin combined with oxaliplatin,5-fluorouracil in treatment of advanced gastric cancer with HER-2/neu high expression

目的观察曲妥珠单抗联合奥沙利铂、5-氟尿嘧啶治疗HER-2/neu高表达晚期胃癌的临床疗效与安全性。方法选择2009年10月—2011年4月收治的晚期胃癌患者84例为研究对象,随机分为观察组(44例)与对照组(40例),对照组给予奥沙利铂联合5-氟尿嘧啶化疗方案,观察组在此基础上加用曲妥珠单抗,2组均化疗4个周期,并进行24个月随访观察,对比2组化疗结束后临床疗效、化疗期间药物毒性反应及24个月内存活情况。结果(1)2组化疗结束后1个月,观察组总体有效率为63.6%,KPS评分为(79.6±6.4)分,均高于对照组的42.5%和(75.8±5.7)分,HER-2细胞外定量(28.4±6.6)μg/L低于对照组的(31.5±7.2)μg/L,差异均有统计学意义(P<0.05)。(2)观察组心脏毒性、发热或寒战、皮疹发生率显著高于对照组(分别为15.9%vs 2.5%、25.0%vs 10.0%、29.5%vs 7.5%),差异均有统计学意义(P<0.05)。(3)观察组化疗结束后24个月平均生存率为(43.5±7.1)%,平均存活时间为(16.9±3.1)个月,均高于对照组的(39.7±5.8)%和(14.6±2.8)个月,差异有统计学意义(P<0.05)。结论对HER-2/neu高表达晚期胃癌患者在行奥沙利铂联合5-氟尿嘧啶化疗基础上使用曲妥珠单抗,能明显提高临床疗效,延长患者存活时间;同时需密切监测曲妥珠单抗的药物毒性尤其是心脏毒性。

Objective To observe and discuss clinical efficacy of herceptin combined with oxaliplatin, fluorouracil in treatment of advanced gastric cancer with human epidermal growth factor receptor-2/neu（HER-2/neu） high expression. Methods Eight-four admitted cases from Oct. 2009 to Apr. 2011 were selected as study objects, which were randomized into observation group （44 cases） and control group （40 cases）. Control group were given oxaliplatin 5-fluorouracil chemotherapy program, on the basis of the observation group plus trastuzumab, two groups were four cycles of chemotherapy and were fol- lowed up for 24 months, compared to two groups after chemotherapy clinical efficacy, drug toxicity during chemotherapy, and 24 months memory live situation. Results （1） One month after the end of chemotherapy, the overall effective rate of obser- vation group was 63.6%, KPS score was （79.6 ±6.4） points,were higher than the 42.5% and （75.8 ±5.7） points in the control group, HER-2 extracellular quantitative （28.4 ± 6.6） μg/L was lower than the control group （ 31.5 ± 7.2） μg/L, the differences were statistically significant （ P 〈 0.05）. （2） The observation group cardiotoxicity, fever or chills, rash inci- dence was significantly higher （respectively 15.9% vs. 2.5%, 25.0% vs. 10.0%, 29.5% vs. 7.5% ）, the differences were statistically significant （ P 〈 0.05 ）. （3） 24 months after the end of chemotherapy, the average survival rate in the observation group was （43.5 ±7.1 ） %, mean survival time （ 16.9 ± 3.1 ） months, were higher than control group （39.7 ± 5.8）% and （14.6±2.8） months, the difference was statistically significant （ P 〈0.05）. Conclusion High expression on HER 2/neu line advanced gastric cancer oxaliplatin 5-fluorouracil chemotherapy based on the use of trastuzumab, can significantly improve the clinical efficacy and prolong survival time; also need to closely monitor trastuzumab anti-drug toxicity, especially cardiac toxicity.