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吉西他滨联合长春瑞滨与联合紫杉醇姑息治疗铂类耐药的Ⅳ期鼻咽癌患者的随机对照试验 被引量:6

Randomized controlled trial of gemcitabine combined with vinorelbine and gemcitabine combined with paclitaxel as palliative chemotherapy regimens in treating platinum- resistant stage Ⅳ nasopharyngeal cancer patients
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摘要 目的:观察吉西他滨联合长春瑞滨与联合紫杉醇方案作为姑息治疗方案治疗铂类耐药的Ⅳ期鼻咽癌患者的有效性及安全性。方法:收集2012年7月至2014年7月含铂一线治疗失败的晚期鼻咽癌患者共105例的临床资料,随机分为吉西他滨联合长春瑞滨组(GV组)与吉西他滨联合紫杉醇组(GT组),比较两方案在总有效率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)及不良反应发生率等方面的差异。采用Log-rank检验比较PFS及OS。结果:两组间的ORR无统计学差异(P=0.491),DCR存在统计学差异(GT组较优,P=0.034)。两组间的PFS、OS的差别均无统计学意义(P=0.387,P=0.673)。不良反应方面,GV组Ⅰ度感觉异常较多,而GT组Ⅲ度白细胞降低、Ⅰ度疲乏无力、过敏反应、肌肉关节疼痛、脱发及Ⅱ度脱发较多,差别均有统计学意义。结论:GV、GT两种方案治疗铂类耐药的晚期鼻咽癌患者在总有效率、无进展生存期及总生存期上近似,GT方案可提高患者疾病控制率(DCR),不良反应较GV方案多,多为轻中度,患者可耐受。 Objective: To investigate the effectiveness and safety of two palliative chemotherapy regimens which were gemcitabine combined with vinorelbine and gemcitabine combined with paclitaxel in treating platinum- resistant stage Ⅳ nasopharyngeal cancer patients. Methods: From 2012 to 2014,the clinical data of 105 stage Ⅳ nasopharyngeal cancer patients who had received platinum- based regimens as first- line chemotherapy was collected and randomized divided into gemcitabine combined with vinorelbine group( GV group) and gemcitabine combined with paclitaxel group( GT group). The overall response rate( ORR),disease control rate( DCR),progression- free survival( PFS),overall survival( OS) and the incidence rate of adverse events were compared between each group. Chi square test was used to compare the ORR,DCR and the incidence rate of adverse events. Log- rank test was used to compare the PFS and OS. Results: There were no statistical differences in overall response rate( P = 0. 491),progression- free survival( P = 0. 387) and overall survival( P = 0. 673). GT group had better results in disease control rate and the difference was statistical significant( P = 0. 034). GV group had more cases of gradeⅠparesthesia and,on the opposite,GT group had more cases of grade Ⅲ leucopenia,gradeⅠfatigue,allergic reaction,myodynia or arthralgia,gradeⅠand gradeⅡ alopecia and all of which had significant statistical difference. Conclusion: The therapeutic results of the ORR,PFS and OS between GV and GT regimens as palliative chemotherapy regimens in treating platinum- resistant stage Ⅳ nasopharyngeal cancer patients had no statistical difference in spite of GT group had more cases of DCR.GT regimens had more adverse events than GV group but most of which was mild and well tolerated.
出处 《现代肿瘤医学》 CAS 2016年第5期716-720,共5页 Journal of Modern Oncology
基金 成都医学院课题"鸵鸟计划"专项基金(编号:CYX12-025)
关键词 吉西他滨联合长春瑞滨 吉西他滨联合紫杉醇 姑息化疗 铂类耐药 Ⅳ期鼻咽癌 gemcitabine combined with vinorelbine gemcitabine combined with paclitaxel palliative chemotherapy platinum-resistant stage Ⅳ nasopharyngeal cancer
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