Clinical Study of Nimotuzumab Combined with Chemotherapy in the Treatment of Late Stage Gastric Cancer
Clinical Study of Nimotuzumab Combined with Chemotherapy in the Treatment of Late Stage Gastric Cancer
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DOI：
10.7314/apjcp.2014.15.23.10273
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发表时间：
2014-01-01
影响因子：
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通讯作者：
Xu, Chong-De
中科院分区：
文献类型：
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作者：
Xu, Chong-De
目的：探讨尼莫妥珠单抗联合化疗治疗晚期胃癌的临床疗效。方法：选择经组织病理学和/或细胞学证实的晚期胃癌复发或转移患者34例，随机分为观察组和对照组，每组17例。对照组采用标准的DCF方案治疗，观察组加用尼莫珠单抗治疗。观察两组近期和远期疗效及不良反应。结果：观察组客观有效率和疾病控制率分别为64.7%(11/17)和82.4%(14/17)，对照组分别为25.0%(4/16)和37.5%(6/16)，两组客观有效率和疾病控制率分别为x(2)=5.2412，P=0.0221和x(2)=6.9453，P=0.0084。中位无进展生存期(PFS)和中位总生存期(OS)观察组分别为6.5个月和12.50个月，对照组分别为4.5个月和8.25个月(P=0.0212；P=0.0255)。两组主要毒副反应为白细胞和血红蛋白降低，胃肠道反应和脱发，经对症治疗和营养支持治疗后缓解。两组毒副作用发生率差异无统计学意义。结论：尼莫单抗联合DCF方案治疗晚期胃癌疗效确切。现在需要一项更大规模的研究来证实这一发现。
Objective: To explore the clinical effects of nimotuzumab combined with chemotherapy in the treatment of late gastric cancer. Methods: A total of 34 reoccurrence or metastatic patients with late stage gastric cancer who were confirmed by histopathology and/or cytology were selected and randomly divided into observational and control groups, of 17 cases each. Patients in the control group were treated with the standard DCF plan, while patients in observational group additionally received nimotuzumab. The short-term and long-term efficacy and adverse reactions in the 2 groups were followed. Results: The objective response rate (ORR) and disease control rate (DCR) were 64.7% (11/17) and 82.4% (14/17) in observational group and 25.0%(4/16) and 37.5%(6/16) in the control group(ORR and DCR between 2 groups, chi(2)=5.2412, P=0.0221 and chi(2)=6.9453, P=0.0084). The median progression-free survival (PFS) time and median overall survival (OS) time were 6.50 months and 12.50 months in observational group and 4.50 months and 8.25 months in the control group (P=0.0212; P=0.0255). The main toxic and side effects in the 2 groups were reduced leukocytes and hemoglobin, gastrointestinal reactions and hair loss and these were relieved after symptomatic treatment and nutrition support therapy. There were no differences in the occurrence of toxic and side effects between the 2 groups. Conclusions: Nimotuzumab combined with DCF plan is effective in treating late stage gastric cancer. A larger scale study is now warranted for confirmation of the findings.