DOX方案对比曲妥珠单抗联合DOX用于进展期胃癌新辅助治疗的疗效

Comparison of the clinical efficacy of DOX plan and trastuzumab plus DOX plan in the neo-adjuvant chemotherapy for gastric cancer

目的观察多西他赛、奥沙利铂联合卡培他滨三药(简称DOX方案)对比曲妥珠单抗联合DOX用于进展期胃癌新辅助治疗的疗效。方法对2013年1月至2016年1月于我院消化内科收治的80例行新辅助化疗的进展期胃癌患者进行回顾性分析。根据患者HER-2表达、经费及体质状况不同,以及接受新辅助化疗方案的不同分为2组:35例HER-2阳性患者采用曲妥珠单抗联合DOX(治疗组);45例HER-2阴性患者仅采用DOX方案(对照组)。每2周期复查影像学评估疗效,提交多学科讨论,通过讨论决定是否行手术治疗。观察记录两组患者的化疗疗效、相关不良反应及肿瘤降级情况,对比两组手术切除率、根治切除率及术后并发症。结果80例患者全部完成完整的预定化疗,平均化疗2.58个周期。治疗组35例患者,PD 2例(5.7%),客观有效率65.7%,可手术病例33例(94.3%),其中R0切除29例(87.9%),病理反应率为75.8%;对照组45例,PD 5例(11.1%),客观有效率53.3%,可手术病例40例(88.9%),其中R0切除16例(40%),病理反应率为65%,两组近期临床疗效比较差异无统计学意义(P=0.543),手术切除率及病理反应率比较差异有统计学意义(P<0.05)。化疗期间两组共同的不良反应主要为白细胞减少和胃肠道反应,差异有统计学意义(1.0%vs.1.35%,P=0.044)。结论曲妥珠单抗联合化疗对比单纯化疗,在新辅助治疗后肿瘤的降级、降期更明显,且能降低化疗药的毒副反应,患者耐受性较好。

Objective To compare the efficacy of docetaxel,oxaliplatin plus capecitabine（called DOX） with that of trastuzumab plus DOX as neo-adjuvant chemotherapies in the treatment of advanced gastric cancer. Methods Eighty patients with advanced gastric cancer treated with neoadjuvant chemotherapy in our hospital from January 2013 to January 2016 were retrospectively analyzed. According to the HER2 expression, funding, and physical condition, the patients were divided into two groups：treatment group （HER-2-positive in 35 patients） and control group （PIER-2-negative in 45 patients）. Treatment group was given trastuzumab combined with DOX chemotherapy. Control group was given DOX chemotherapy. Assess efficacy by imaging every two periods, and submit multidisciplinary discussion, by which it was decided whether to conduct surgical treatment. The objective response rate, adverse reaction rate during chemotherapy, and the rate of tumor resection were observed, and the rate of laparotomy,pathological downgrading and postoperative complications were compared. Results All patients finished the neo-adjuvant chemotherapy. The average was 2.58 cycles. There were 35 cases in treatment group,PD 2 （5.7%） ,the objective response rate was 65.7% ;there were 33 surgical cases （94. 3% ） ,in which R0 resection was performed in 29 cases （87.9%） ,and the pathological re- sponse rate was 75.8% ;there were 45 cases in control group,PD 5 （ ll. 1% ） ,objective response rate was 53.3% ; there were 40 surgical cases （88.9%） ,in which R0 resection was done in 16 cases （40%） ,and the pathological re- sponse rate was 65%. The two groups had no statistically significant difference in the recent clinical efficacy （ P = 0. 543 ） ,but the rate of surgical resection and pathological response was statistically significant （ P 〈 0. 05 ）. The main common adverse effects during chemotherapy were neutropenia and gastrointestinal reactions, which had significant difference between the two groups （ 1.0% vs. 1.35% , P = 0. 044）. Conclusion Trastuzumab combined with DOX has a higher rate of laparotomy and pathological downgrading and a lower adverse reaction rate than chemotherapy alone.