仙蟾片联合曲妥珠单抗和mFOLFOX6方案治疗老年HER2阳性晚期胃癌的临床研究
|
摘要
目的观察仙蟾片联合曲妥珠单抗和mFOLFOX6方案治疗老年表皮生长因子受体-2(HER2)阳性晚期胃癌的临床疗效。方法选取2011年1月—2014年1月在延安市人民医院就诊的老年HER2阳性晚期胃癌患者212例,随机分为对照组和治疗组,每组各106例。两组患者均给予mFOLFOX6方案化疗,每个治疗周期为21 d。对照组在此基础上于第1天静脉滴注注射用曲妥珠单抗8 mg/kg,然后每个周期第1天给予6 mg/kg。治疗组在对照组的基础上口服给予仙蟾片,4片/次,3次/d。两组患者均治疗6个周期。观察两组患者近期和远期疗效,同时比较治疗前后两组患者血清生化指标和不良反应。结果治疗后,对照组临床有效率和控制率分别为60.3%、78.3%,均显著低于治疗组的73.5%、89.6%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者血清纤维母细胞特异性蛋白-1(FSP-l)、骨髓相关蛋白-14(MRP-l4)、趋化因子受体-4(CXCR4)和基质衍生因子-1(SDF-1)均明显降低(P<0.05),且治疗组上述血清生化指标明显低于对照组(P<0.05)。远期疗效结果显示,对照组有效病例中平均无疾病进展生存时间(PFS)和总生存时间(OS)均分别明显小于治疗组患者,两组比较差异具有统计学意义(P<0.05)。治疗期间,治疗组的不良反应发生率均明显低于对照组,两组比较差异具有统计学意义(P<0.05)。结论仙蟾片联合曲妥珠单抗和mFOLFOX6方案治疗老年人表皮生长因子受体-2(HER2)阳性晚期胃癌患者临床疗效较好,能够有效延长生存时间,具有一定的临床推广应用价值。
Objective To observe the clinical effects of Xianchan Tablets combined with trastuzumab and mFOLFOX6 in treatment of elderly with advanced gastric cancer of HER2 positive. Methods Patients(212 cases) with advanced gastric cancer of HER2 positive in Yan'an People's Hospital from January 2011 to January 2014 were randomly divided into control and treatment groups, and each group had 106 cases. All patients were given mFOLFOX6 chemotherapy, and each treatment cycle was 21 d. Patients in the control group were iv administered with Trastuzumab Injection for the first day of each cycle, and the 1 st time was 8 mg/kg, then 6 mg/kg. Patients in the treatment group were po administered with Xianchan Tablets on the basis of the control group, 4 tablets/time, three times daily. Patients in two groups were treated for 6 cycles. After treatment, the short-term and long-term efficacy was evaluated, the serum biochemical indexes and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical efficacy and the clinical control rate were 60.3% and 78.3%, which were significantly lower than 73.5% and 89.6% in the treatment group, respectively, and there were differences between two groups(P < 0.05).After treatment, the FSP-l, MRP-l4, CXCR4 and SDF-1 in two groups were significantly decreased(P < 0.05), and the serum biochemical indexes in the treatment group after treatment was significantly lower than those in the control group(P < 0.05). Long-term efficacy result showed that the PFS and OS of valid cases in the control group were lower than those in the treatment group, with significant difference between two groups(P < 0.05). During the treatment, the adverse reactions rates in the treatment group were significantly lower than those in the control group, with significant difference between two groups(P < 0.05). Conclusion Xianchan Tablets combined with trastuzumab and mFOLFOX6 in treatment of elderly with advanced gastric cancer of HER2 positive has good effect, and can effectively prolong the survival time, which has a certain clinical application value.
Objective To observe the clinical effects of Xianchan Tablets combined with trastuzumab and mFOLFOX6 in treatment of elderly with advanced gastric cancer of HER2 positive. Methods Patients(212 cases) with advanced gastric cancer of HER2 positive in Yan'an People's Hospital from January 2011 to January 2014 were randomly divided into control and treatment groups, and each group had 106 cases. All patients were given mFOLFOX6 chemotherapy, and each treatment cycle was 21 d. Patients in the control group were iv administered with Trastuzumab Injection for the first day of each cycle, and the 1 st time was 8 mg/kg, then 6 mg/kg. Patients in the treatment group were po administered with Xianchan Tablets on the basis of the control group, 4 tablets/time, three times daily. Patients in two groups were treated for 6 cycles. After treatment, the short-term and long-term efficacy was evaluated, the serum biochemical indexes and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical efficacy and the clinical control rate were 60.3% and 78.3%, which were significantly lower than 73.5% and 89.6% in the treatment group, respectively, and there were differences between two groups(P < 0.05).After treatment, the FSP-l, MRP-l4, CXCR4 and SDF-1 in two groups were significantly decreased(P < 0.05), and the serum biochemical indexes in the treatment group after treatment was significantly lower than those in the control group(P < 0.05). Long-term efficacy result showed that the PFS and OS of valid cases in the control group were lower than those in the treatment group, with significant difference between two groups(P < 0.05). During the treatment, the adverse reactions rates in the treatment group were significantly lower than those in the control group, with significant difference between two groups(P < 0.05). Conclusion Xianchan Tablets combined with trastuzumab and mFOLFOX6 in treatment of elderly with advanced gastric cancer of HER2 positive has good effect, and can effectively prolong the survival time, which has a certain clinical application value.
引文
[1]Cancer Genome Atlas Research N.Comprehensive molecular characterization of gastric adenocarcinoma[J].Nature,2014,513(7517):202-209.
[2]季加孚,陕飞,苗儒林.循证医学时代的胃癌进展30年回顾[J].实用肿瘤杂志,2016,31(2):99-103.
[3]寇梦瑛,王朝阳.Her-2和胃癌诊疗进展[J].现代肿瘤医学,2015,23(8):1139-1141.
[4]赵红,李小龙,崔洁,等.曲妥珠单抗治疗胃癌的研究进展[J].延安大学学报:医学科学版,2012,10(1):25-27.
[5]李秀翠,姜维美.m FOLFOX6方案治疗28例进展期胃癌的临床研究[J].安徽医药,2012,16(1):102-103.
[6]朱海洪,李贻文,杨婷,等.仙蟾片对肺癌患者TNF-α和NK活性的影响分析[J].陕西中医,2014,5:569-572.
[7]中华人民共和国卫生部医政司.中国常见恶性肿瘤诊治规范[M].第2版.北京:北京医科大学中国协和医科大学联合出版社,1996:16.
[8]周际昌.实用肿瘤内科学[M].北京:人民卫生出版社,1999:22.
[9]Shimizu T,Saijo N.Common toxicity criteria:version2.0,an improved reference for grading the adverse reaction of cancer treatment[J].Nihon Rinsho,2003,61(6):937-942.
[10]Li Q,Jiang H,Li H,et al.Efficacy of trastuzumab beyond progression in HER2 positive advanced gastric cancer:a multicenter prospective observational cohort study[J].Oncotarget,2016,7(31):50656-50665.
[11]宋杰,陈凤格,赵伟,等.胃癌的发病率现状与治疗研究进展[J].中国慢性病预防与控制,2016,24(9):704-707.
[12]冯睿,张小田,杨升.胃癌靶向治疗的研究现状与进展[J].中华胃肠外科杂志,2016,19(10):1191-1196.
[13]王霞.内镜活检胃癌组织中HER-2蛋白表达及临床意义[J].现代消化及介入诊疗,2017,22(3):307-310.
[14]陈锦章,郑航,陈斌,VEGF、HER-2蛋白在胃癌组织中的表达及临床意义[J].南方医科大学学报,2008,28(4):617-619.
[15]李新,孙光斌.曲妥珠单抗对人表皮生长因子受体2阳性晚期胃癌患者的疗效观察[J].山东医药,2016,56(44):67-69.
[16]孙杰,潘赛英,陈倩琪,等.曲妥珠单抗联合FOLFIRI治疗HER2阳性晚期胃癌的疗效观察[J].南方医科大学学报,2011,31(8):1458-1460.
[17]马保来,吕红凤.FOLFOX4与FOLFOX6两种化疗方案治疗晚期胃癌的临床分析[J].中国实用医药,2011,6(9):91-92.
[18]康婷,刘敏,鲍慧,等.仙蟾片联合GP化疗方案治疗老年中晚期非小细胞肺癌的临床研究[J].现代药物与临床,2017,32(10):1980-1984.
[19]苏林,辛彦.E-cadherin和FSP-1/S100A4在胃癌及其癌前病变中的表达与临床病理意义[J].现代肿瘤医学,2014,22(12):2903-2908.
[20]谢家泰,曾志荣.b FGF和MRP-1在胃癌中的表达及意义[J].中国老年保健医学,2016,14(5):13-15.
[21]陈友权,于燕妮.胃癌中SDF-1、CXCR4、MMP-2和MMP-9的表达及意义[J].临床与实验病理学杂志,2012,28(2):135-139.
[2]季加孚,陕飞,苗儒林.循证医学时代的胃癌进展30年回顾[J].实用肿瘤杂志,2016,31(2):99-103.
[3]寇梦瑛,王朝阳.Her-2和胃癌诊疗进展[J].现代肿瘤医学,2015,23(8):1139-1141.
[4]赵红,李小龙,崔洁,等.曲妥珠单抗治疗胃癌的研究进展[J].延安大学学报:医学科学版,2012,10(1):25-27.
[5]李秀翠,姜维美.m FOLFOX6方案治疗28例进展期胃癌的临床研究[J].安徽医药,2012,16(1):102-103.
[6]朱海洪,李贻文,杨婷,等.仙蟾片对肺癌患者TNF-α和NK活性的影响分析[J].陕西中医,2014,5:569-572.
[7]中华人民共和国卫生部医政司.中国常见恶性肿瘤诊治规范[M].第2版.北京:北京医科大学中国协和医科大学联合出版社,1996:16.
[8]周际昌.实用肿瘤内科学[M].北京:人民卫生出版社,1999:22.
[9]Shimizu T,Saijo N.Common toxicity criteria:version2.0,an improved reference for grading the adverse reaction of cancer treatment[J].Nihon Rinsho,2003,61(6):937-942.
[10]Li Q,Jiang H,Li H,et al.Efficacy of trastuzumab beyond progression in HER2 positive advanced gastric cancer:a multicenter prospective observational cohort study[J].Oncotarget,2016,7(31):50656-50665.
[11]宋杰,陈凤格,赵伟,等.胃癌的发病率现状与治疗研究进展[J].中国慢性病预防与控制,2016,24(9):704-707.
[12]冯睿,张小田,杨升.胃癌靶向治疗的研究现状与进展[J].中华胃肠外科杂志,2016,19(10):1191-1196.
[13]王霞.内镜活检胃癌组织中HER-2蛋白表达及临床意义[J].现代消化及介入诊疗,2017,22(3):307-310.
[14]陈锦章,郑航,陈斌,VEGF、HER-2蛋白在胃癌组织中的表达及临床意义[J].南方医科大学学报,2008,28(4):617-619.
[15]李新,孙光斌.曲妥珠单抗对人表皮生长因子受体2阳性晚期胃癌患者的疗效观察[J].山东医药,2016,56(44):67-69.
[16]孙杰,潘赛英,陈倩琪,等.曲妥珠单抗联合FOLFIRI治疗HER2阳性晚期胃癌的疗效观察[J].南方医科大学学报,2011,31(8):1458-1460.
[17]马保来,吕红凤.FOLFOX4与FOLFOX6两种化疗方案治疗晚期胃癌的临床分析[J].中国实用医药,2011,6(9):91-92.
[18]康婷,刘敏,鲍慧,等.仙蟾片联合GP化疗方案治疗老年中晚期非小细胞肺癌的临床研究[J].现代药物与临床,2017,32(10):1980-1984.
[19]苏林,辛彦.E-cadherin和FSP-1/S100A4在胃癌及其癌前病变中的表达与临床病理意义[J].现代肿瘤医学,2014,22(12):2903-2908.
[20]谢家泰,曾志荣.b FGF和MRP-1在胃癌中的表达及意义[J].中国老年保健医学,2016,14(5):13-15.
[21]陈友权,于燕妮.胃癌中SDF-1、CXCR4、MMP-2和MMP-9的表达及意义[J].临床与实验病理学杂志,2012,28(2):135-139.