复方苦参注射液联合TAC方案新辅助化疗对局部晚期乳腺癌患者疗效及预后的影响
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摘要
目的:探讨复方苦参注射液联合TAC方案新辅助化疗治疗局部晚期乳腺癌的疗效,以及对患者预后的影响。方法:纳入75例采用TAC方案新辅助化疗(对照组)和75例采用复方苦参注射液联合TAC方案新辅助化疗(研究组)的晚期乳腺癌患者进行研究,RECIST1.1实体肿瘤化疗疗效评价标准和美国国立癌症研究所化疗毒性反应及分度标准(NCI-CTCAEV4.0)评价疗效和安全性,Kaplan-Meier分析患者3年生存率、外周血淋巴细胞免疫表型(CD_3~+、CD_4~+、CD_8~+及CD_4~+/CD_8~+)进行比较分析。结果:研究组患者CR23例,PR15例,SD30例,PD7例,DCR 90.67%,高于对照组(P<0.05),RR 50.67%,与对照组无差异(P>0.05),研究组不良反应率为5.33%,对照组14.67%,两组对比差异具有统计学意义(χ~2=13.925,P<0.05)。两组患者随访3-5年,中位随访2.8年,研究组1年生存率与对照组对比差异无统计学意义(83.25%VS 81.05%,P>0.05),2年生存率对比(75.92%VS 63.42%),3年生存率对比(67.38%VS 53.49%),差异具有统计学意义(P<0.05)。观察组CD_3~+、CD_4~+及CD_4~+/CD_8~+水平均高于对照组,差异具有统计学意义(F=4.14、6.20、5.21,P<0.05);观察组CD_8~+水平低于对照组,差异具有统计学意义(F=6.78,P=0.01)。结论:复方苦参注射液联合TAC方案新辅助化疗可提高局部晚期乳腺癌治疗疗效和生存率,降低不良反应。
Objective: To investigate the effect of Compound Kushen Injection combined with TAC regimen neoadjuvant chemotherapy in the treatment of locally advanced breast cancer and its effect on prognosis. Methods: Seventy-five patients with advanced breast cancer who underwent neoadjuvant chemotherapy with TAC regimen( control group) and 75 patients with neoadjuvant chemotherapy with TAC regimen( group) were studied. RECIST1. 1 solid tumor chemotherapy efficacy evaluation. The standard and the National Cancer Institute's Chemotherapy Response and Grading Criteria( NCI-CTCAEV4. 0) were used to evaluate efficacy and safety,and Kaplan-Meier analysis of patients' 3-year survival rate. Peripheral blood lymphocyte immunophenotype( CD_3~+,CD_4~+,CD_8~+and CD_4~+/CD_8~+) were comparatively analyzed. Results: There were 23 cases of CR in the study group,15 cases of PR,30 cases of SD,7 cases of PD,DCR 90. 67%,higher than the control group( P < 0. 05),RR 50. 67%,and no difference with the control group( P > 0. 05). The adverse reaction rate was 5. 33% and the control group was 14. 67%. There was a statistically significant difference between the two groups( χ~2= 13. 925,P < 0. 05). The two groups of patients were followed up for 3-5 years. The median follow-up period was 2. 8 years. There was no significant difference between the 1-year survival rate of the study group and the control group( 83. 25% VS 81. 05%,P > 0. 05),and the 2-year survival rate comparison( 75. 92%VS 63. 42%),3-year survival rate comparison( 67. 38% VS 53. 49%),the difference was statistically significant( P < 0. 05).The levels of CD_3~+,CD_4~+and CD_4~+/CD_8~+in the observation group were higher than those in the control group( F = 4. 14,6. 20,5. 21,P < 0. 05),and the levels of CD_8~+in the observation group were lower than those in the control group( F = 6. 78,P =0. 01). Conclusion: Compound Kushen Injection combined with TAC regimen for neoadjuvant chemotherapy can improve the therapeutic efficacy and survival rate of locally advanced breast cancer and reduce adverse reactions.
Objective: To investigate the effect of Compound Kushen Injection combined with TAC regimen neoadjuvant chemotherapy in the treatment of locally advanced breast cancer and its effect on prognosis. Methods: Seventy-five patients with advanced breast cancer who underwent neoadjuvant chemotherapy with TAC regimen( control group) and 75 patients with neoadjuvant chemotherapy with TAC regimen( group) were studied. RECIST1. 1 solid tumor chemotherapy efficacy evaluation. The standard and the National Cancer Institute's Chemotherapy Response and Grading Criteria( NCI-CTCAEV4. 0) were used to evaluate efficacy and safety,and Kaplan-Meier analysis of patients' 3-year survival rate. Peripheral blood lymphocyte immunophenotype( CD_3~+,CD_4~+,CD_8~+and CD_4~+/CD_8~+) were comparatively analyzed. Results: There were 23 cases of CR in the study group,15 cases of PR,30 cases of SD,7 cases of PD,DCR 90. 67%,higher than the control group( P < 0. 05),RR 50. 67%,and no difference with the control group( P > 0. 05). The adverse reaction rate was 5. 33% and the control group was 14. 67%. There was a statistically significant difference between the two groups( χ~2= 13. 925,P < 0. 05). The two groups of patients were followed up for 3-5 years. The median follow-up period was 2. 8 years. There was no significant difference between the 1-year survival rate of the study group and the control group( 83. 25% VS 81. 05%,P > 0. 05),and the 2-year survival rate comparison( 75. 92%VS 63. 42%),3-year survival rate comparison( 67. 38% VS 53. 49%),the difference was statistically significant( P < 0. 05).The levels of CD_3~+,CD_4~+and CD_4~+/CD_8~+in the observation group were higher than those in the control group( F = 4. 14,6. 20,5. 21,P < 0. 05),and the levels of CD_8~+in the observation group were lower than those in the control group( F = 6. 78,P =0. 01). Conclusion: Compound Kushen Injection combined with TAC regimen for neoadjuvant chemotherapy can improve the therapeutic efficacy and survival rate of locally advanced breast cancer and reduce adverse reactions.
引文
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[6]中国抗癌协会乳腺癌专业委员会.中国抗癌协会乳腺癌诊治指南与规范(2015版)[J].中国癌症杂志,2015,25(9):692-754.
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[12]刘晶晶,张瑾.乳腺癌新辅助化疗研究进展[J].中华乳腺病杂志(电子版),2012,6(1):40-43.
[13]梁全琨,张永松,钟玲,等.新辅助化疗对腔镜乳腺癌改良根治术后并发症及疗效的影响[J].中华乳腺病杂志(电子版),2015,(1):18-22.
[14]李瑶,齐晓伟,杨新华,等.TEC及TE方案在乳腺癌新辅助化疗中的近期疗效及不良反应的对比分析[J].中华乳腺病杂志(电子版),2014(6):17-22.
[15]Zhang QA,Tong JL,Chen HJ,et al.A Novel Magnetic Nanoparticle Hyperthermia Combined with ACMF-Dependant Drug Release by DAMMs Injection in VX-2 Liver Tumors[J].Journal of nanoscience and nanotechnology,2012,12(1):127-131.
[16]阿达来提·牙生,艾小叶,张贾震男,等.复方苦参注射液对乳腺癌术后化疗患者的疗效及不良反应的影响[J].辽宁中医杂志,2016,43(10):2101-2102.
[2]陆颖,黄海欣,李桂生.局部晚期乳腺癌术后后程同步放化疗及序贯治疗的临床对比研究[J].中华肿瘤防治杂志,2014,21(11):854-857.
[3]赵广章,刘海英,刘启龙,等.TAC方案新辅助化疗治疗局部晚期乳腺癌临床疗效观察[J].中国普通外科杂志,2013,22(11):1495-1497.
[4]韩新臣,刘世育,陈光侠,等.复方苦参联合热疗对肝癌腹水患者的疗效分析[J].浙江临床医学,2013,15(7):967-969.
[5]马其辉,方黎明,陈日,等.复方苦参注射液在胃癌恶性腹水患者顺铂腹腔灌注化疗中的应用及对免疫功能的影响[J].中国生化药物杂志,2017,37(2):109-112.
[6]中国抗癌协会乳腺癌专业委员会.中国抗癌协会乳腺癌诊治指南与规范(2015版)[J].中国癌症杂志,2015,25(9):692-754.
[7]Eisenhauera EA,Therasseb P,Bogaerts J,et al.New response evaluation criteria in solid tumours:revised RECIST guideline(version1.1)[J].Eur J Cancer,2009(45):228-247.
[8]齐兴菊,冯杰.MTHFR及TPMT基因多态性对儿童急性淋巴细胞白血病化疗不良反应的影响[J].重庆医学,2018,47(10):1343-1350.
[9]刘晓东,佟仲生,李淑芬,等.局部晚期乳腺癌1081例临床病理特征及预后分析[J].肿瘤,2011,31(10):18-923.
[10]田英,杨碎胜,张志艳,等.新辅助化疗对乳腺癌患者血清hMAM水平影响的观察[J].中华肿瘤防治杂志,2013,20(12):939-941,948.
[11]潘蕊,杨奔,左文述,等.乳腺癌新辅助化疗后前哨淋巴结活检临床应用价值的探讨[J].中华肿瘤防治杂志,2012,19(24):1883-1888.
[12]刘晶晶,张瑾.乳腺癌新辅助化疗研究进展[J].中华乳腺病杂志(电子版),2012,6(1):40-43.
[13]梁全琨,张永松,钟玲,等.新辅助化疗对腔镜乳腺癌改良根治术后并发症及疗效的影响[J].中华乳腺病杂志(电子版),2015,(1):18-22.
[14]李瑶,齐晓伟,杨新华,等.TEC及TE方案在乳腺癌新辅助化疗中的近期疗效及不良反应的对比分析[J].中华乳腺病杂志(电子版),2014(6):17-22.
[15]Zhang QA,Tong JL,Chen HJ,et al.A Novel Magnetic Nanoparticle Hyperthermia Combined with ACMF-Dependant Drug Release by DAMMs Injection in VX-2 Liver Tumors[J].Journal of nanoscience and nanotechnology,2012,12(1):127-131.
[16]阿达来提·牙生,艾小叶,张贾震男,等.复方苦参注射液对乳腺癌术后化疗患者的疗效及不良反应的影响[J].辽宁中医杂志,2016,43(10):2101-2102.