培美曲塞二钠治疗晚期非小细胞肺癌的效果及毒副作用
|
摘要
目的探讨经一线化疗失败的晚期非小细胞肺癌(NSCLC)患者使用培美曲塞二钠单药治疗的近远期效果及毒副作用,为晚期NSCLC患者二线治疗药物选择提供参考。方法共收集84例经一线化疗失败的晚期NSCLC患者,临床分期Ⅲb-Ⅳ期。采用单盲随机数表法将其分为对照组和观察组,两组各42例。其中对照组接受多西他赛单药化疗,剂量75 mg/m~2;观察组采用培美曲塞二钠化疗,500 mg/m~2,两组均21天/周期。持续4个周期后采用实体瘤评价标准(RECIST)判定疗效,采用美国国家癌症研究院(NCI)制定的毒性评价标准(CTC)评估两组毒性作用情况。结合1年随访统计两组远期生存情况。结果对照组肿瘤治疗有效率(RR)(完全缓解是CR,部分缓解是PR; RR是CR+PR例数占总例数比例)和疾病控制率(DCR)分别为14.29%(6/42)、64.29%(27/42),观察组RR和DCR分别为16.67%(7/42)、69.05%(29/42),两组间差异均无统计学意义(P> 0.05)。观察组白细胞下降、恶心呕吐、脱发、肝功能损伤发生率均显著低于对照组,差异有统计学意义(χ~2=4.421、4.613、4.459、5.126,P均<0.05)。对照组和观察组6个月、1年生存率和总生存期(OS)比较,差异均无统计学意义(P均> 0.05)。结论一线化疗失败的晚期NSCLC患者采用培美曲塞二钠治疗,化疗近远期效果同多西他赛,但毒性作用明显减轻,未出现严重不良反应,安全性良好,可作为晚期NSCLC患者二线治疗药物的优先选择。
Objective To investigate the short-term and long-term efficacy and toxicity of pemetrexed disodium monotherapy in patients with advanced non-small cell carcinoma(NSCLC) who failed to first-line chemotherapy,and to provide references for the selection of second-line drugs for advanced NSCLC patients.Methods A total of 84 patients with advanced NSCLC who failed to first-line chemotherapy were enrolled in this hospital.The clinical stage was stage Ⅲb to Ⅳ.The patients were divided into control group and observation group by single blind random number table,42 cases in each group.The control group received docetaxel single-drug chemotherapy at a dose of 75 mg/m~2,while the observation group received pemetrexed disodium chemotherapy at a dose of 500 mg/m~2.Both groups received 21 days/cycle for four cycles.The efficacy was assessed by Response Evaluation Criteria in Solid Tumors(RECIST) solid tumor evaluation criteria,and the toxicity and side effects were assessed by the Common Terminology Criteria(CTC) developed by the National Cancer Institute(NCI).The long-term survival of the two groups was analyzed with 1-year follow-up.Results Response rate(RR) and disease control rate(DCR) were 14.29%(6/42) and 64.29%(27/42) in the control group,while RR and DCR in the observation group were 16.67%(7/42) and 69.05%(29/42),respectively.There were no significant difference between the two groups(P > 0.05).The incidences of leukopenia,nausea,vomiting,alopecia and liver function damage in the observation group were significantly lower those in the control group(χ~2= 0.035,0.032,0.035,0.024.all P < 0.05).There were 2 cases and 3 cases in the control group and the observation group who lost follow-up in one year.There was no significant difference in the 6-month,1-year survival rate and total survival time(OS) between the two groups(P > 0.05).Conclusion Pemetrexed disodium can be used for advanced NSCLC patients with first-line chemotherapy failure.The short-term and long-term effect of chemotherapy is similar to that of docetaxel,and the toxicity and side effects are obviously reduced.The safety of pemetrexed disodium is remarkable.It can be used as a preferred choice for second-line therapy.
Objective To investigate the short-term and long-term efficacy and toxicity of pemetrexed disodium monotherapy in patients with advanced non-small cell carcinoma(NSCLC) who failed to first-line chemotherapy,and to provide references for the selection of second-line drugs for advanced NSCLC patients.Methods A total of 84 patients with advanced NSCLC who failed to first-line chemotherapy were enrolled in this hospital.The clinical stage was stage Ⅲb to Ⅳ.The patients were divided into control group and observation group by single blind random number table,42 cases in each group.The control group received docetaxel single-drug chemotherapy at a dose of 75 mg/m~2,while the observation group received pemetrexed disodium chemotherapy at a dose of 500 mg/m~2.Both groups received 21 days/cycle for four cycles.The efficacy was assessed by Response Evaluation Criteria in Solid Tumors(RECIST) solid tumor evaluation criteria,and the toxicity and side effects were assessed by the Common Terminology Criteria(CTC) developed by the National Cancer Institute(NCI).The long-term survival of the two groups was analyzed with 1-year follow-up.Results Response rate(RR) and disease control rate(DCR) were 14.29%(6/42) and 64.29%(27/42) in the control group,while RR and DCR in the observation group were 16.67%(7/42) and 69.05%(29/42),respectively.There were no significant difference between the two groups(P > 0.05).The incidences of leukopenia,nausea,vomiting,alopecia and liver function damage in the observation group were significantly lower those in the control group(χ~2= 0.035,0.032,0.035,0.024.all P < 0.05).There were 2 cases and 3 cases in the control group and the observation group who lost follow-up in one year.There was no significant difference in the 6-month,1-year survival rate and total survival time(OS) between the two groups(P > 0.05).Conclusion Pemetrexed disodium can be used for advanced NSCLC patients with first-line chemotherapy failure.The short-term and long-term effect of chemotherapy is similar to that of docetaxel,and the toxicity and side effects are obviously reduced.The safety of pemetrexed disodium is remarkable.It can be used as a preferred choice for second-line therapy.
引文
[1]董雯婷,陈娴,范艳妮,等.2005年-2015年非小细胞肺癌住院病例特征分析及趋势预测[J].中国病案,2018,19(5):50-53.
[2]刘聪,刘元水,张学德,等.晚期非小细胞肺癌靶向药物临床应用进展[J].山西医药杂志,2016,45(22):2627-2630.
[3]SORIA J C,DSW T,CHIARI R,et al.First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer(ASCEND-4):a randomised,open-label,phase 3 study.[J].Lancet,2017,389(10072):917-929.
[4]WANG B Y,ZHANG Q S,LUO Y.Confused reference in the article entitle:pharmacogenomics of platinum-based chemotherapy in non-small cell lung cancer-focusing on DNA repair systems.[J].Medical Oncology,2017,34(6):106-111.
[5]卢宏全,黄国定,潘敏丽,等.恩度联合含铂类化疗方案治疗晚期非小细胞肺癌胸腔积液急性发作的临床疗效观察[J].临床与病理杂志,2016,36(10):1652-1657.
[6]POPAT S,MELLEMGAARD A,RECK M,et al.Nintedanib plus docetaxel as second-line therapy in patients with non-small-cell lung cancer of adenocarcinoma histology:a network meta-analysis vs new therapeutic options[J].Future Oncology,2017,13(13):1159-1171.
[7]徐向勇,王清,许平,等.晚期非小细胞肺癌组织ER-CC1和BRCA1表达与铂类化疗敏感性临床研究[J].中华肿瘤防治杂志,2017,24(3):178-182.
[8]赵青春,张子禾,陈军.2017 ASCOⅣ期非小细胞肺癌指南解读[J].中国医学前沿杂志:电子版,2017,9(9):20-27.DOI:10.12037/YXQY.2017.09-05.
[9]2015版美国国立综合癌症网络(Ncc N)指南:非小细胞肺癌更新要点[J].实用心脑肺血管病杂志,2015,23(2):55-55.
[10]王正,王娟,郭春惠,等.应用RECIST1.1评价标准评估晚期非小细胞肺癌化疗疗效[J].影像研究与医学应用,2017,1(7):54-55.
[11]POPAT S,MELLEMGAARD A,RECK M,et al.Nintedanib plus docetaxel as second-line therapy in patients with non-small-cell lung cancer of adenocarcinoma histology:a network meta-analysis vs new therapeutic options.[J].Future Oncology,2017,13(13):1159-1171.
[12]刘海英,孙贵富.非小细胞肺癌患者多西他赛化疗前后T淋巴细胞亚群的变化及意义[J].中国生化药物杂志,2017,37(5):313-315.
[13]TANINO R,TSUBATA Y,HARASHIMA N,et al.Novel drug-resistance mechanisms of pemetrexed-treated nonsmall cell lung cancer.[J].Oncotarget,2018,9(24):16807.
[14]孟娟,王美清,李建旺,等.克唑替尼对比培美曲塞二钠联合顺铂一线治疗ALK阳性晚期非小细胞肺癌的临床研究[J].国际肿瘤学杂志,2018,45(1):63-64.
[15]GANDARA D R,LEIGHL N,DELORD J P,et al.A Phase1/1b study evaluating trametinib plus docetaxel or pemetrexed in patients with advanced non-small cell lung cancer[J].JTO,2017,12(3):556-566.
[16]田洁,张媛,俞邓枝,等.培美曲塞二钠或多西他赛单药二线治疗晚期非小细胞肺癌的疗效和毒性分析[J].实用癌症杂志,2017,32(7):1146-1148.
[17]王青,孙开宇,张文利,等.培美曲塞二钠和多西他赛对非小细胞肺癌化疗患者血清Survivin、VEGF水平的影响[J].肿瘤药学,2017,7(2):230-234.
[18]POPAT S,MELLEMGAARD A,RECK M,et al.Nintedanib plus docetaxel as second-line therapy in patients with non-small-cell lung cancer of adenocarcinoma histology:a network meta-analysis vs new therapeutic options.[J].Future Oncology,2017,13(13):1159-1171.
[2]刘聪,刘元水,张学德,等.晚期非小细胞肺癌靶向药物临床应用进展[J].山西医药杂志,2016,45(22):2627-2630.
[3]SORIA J C,DSW T,CHIARI R,et al.First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer(ASCEND-4):a randomised,open-label,phase 3 study.[J].Lancet,2017,389(10072):917-929.
[4]WANG B Y,ZHANG Q S,LUO Y.Confused reference in the article entitle:pharmacogenomics of platinum-based chemotherapy in non-small cell lung cancer-focusing on DNA repair systems.[J].Medical Oncology,2017,34(6):106-111.
[5]卢宏全,黄国定,潘敏丽,等.恩度联合含铂类化疗方案治疗晚期非小细胞肺癌胸腔积液急性发作的临床疗效观察[J].临床与病理杂志,2016,36(10):1652-1657.
[6]POPAT S,MELLEMGAARD A,RECK M,et al.Nintedanib plus docetaxel as second-line therapy in patients with non-small-cell lung cancer of adenocarcinoma histology:a network meta-analysis vs new therapeutic options[J].Future Oncology,2017,13(13):1159-1171.
[7]徐向勇,王清,许平,等.晚期非小细胞肺癌组织ER-CC1和BRCA1表达与铂类化疗敏感性临床研究[J].中华肿瘤防治杂志,2017,24(3):178-182.
[8]赵青春,张子禾,陈军.2017 ASCOⅣ期非小细胞肺癌指南解读[J].中国医学前沿杂志:电子版,2017,9(9):20-27.DOI:10.12037/YXQY.2017.09-05.
[9]2015版美国国立综合癌症网络(Ncc N)指南:非小细胞肺癌更新要点[J].实用心脑肺血管病杂志,2015,23(2):55-55.
[10]王正,王娟,郭春惠,等.应用RECIST1.1评价标准评估晚期非小细胞肺癌化疗疗效[J].影像研究与医学应用,2017,1(7):54-55.
[11]POPAT S,MELLEMGAARD A,RECK M,et al.Nintedanib plus docetaxel as second-line therapy in patients with non-small-cell lung cancer of adenocarcinoma histology:a network meta-analysis vs new therapeutic options.[J].Future Oncology,2017,13(13):1159-1171.
[12]刘海英,孙贵富.非小细胞肺癌患者多西他赛化疗前后T淋巴细胞亚群的变化及意义[J].中国生化药物杂志,2017,37(5):313-315.
[13]TANINO R,TSUBATA Y,HARASHIMA N,et al.Novel drug-resistance mechanisms of pemetrexed-treated nonsmall cell lung cancer.[J].Oncotarget,2018,9(24):16807.
[14]孟娟,王美清,李建旺,等.克唑替尼对比培美曲塞二钠联合顺铂一线治疗ALK阳性晚期非小细胞肺癌的临床研究[J].国际肿瘤学杂志,2018,45(1):63-64.
[15]GANDARA D R,LEIGHL N,DELORD J P,et al.A Phase1/1b study evaluating trametinib plus docetaxel or pemetrexed in patients with advanced non-small cell lung cancer[J].JTO,2017,12(3):556-566.
[16]田洁,张媛,俞邓枝,等.培美曲塞二钠或多西他赛单药二线治疗晚期非小细胞肺癌的疗效和毒性分析[J].实用癌症杂志,2017,32(7):1146-1148.
[17]王青,孙开宇,张文利,等.培美曲塞二钠和多西他赛对非小细胞肺癌化疗患者血清Survivin、VEGF水平的影响[J].肿瘤药学,2017,7(2):230-234.
[18]POPAT S,MELLEMGAARD A,RECK M,et al.Nintedanib plus docetaxel as second-line therapy in patients with non-small-cell lung cancer of adenocarcinoma histology:a network meta-analysis vs new therapeutic options.[J].Future Oncology,2017,13(13):1159-1171.
© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号 地址：北京市海淀区学院路29号 邮编：100083 电话：办公室：(+86 10)66554848；文献借阅、咨询服务、科技查新：66554700 |