背景与目的:化疗是晚期食管癌患者的主要治疗手段,但目前尚没有标准的一线治疗方案,通过白蛋白结合型紫杉醇联合奈达铂方案治疗晚期食管癌,评价其临床疗效及安全性。方法:收集2016年2月—2019年2月之间在长海医院诊治的晚期食管癌并有...背景与目的:化疗是晚期食管癌患者的主要治疗手段,但目前尚没有标准的一线治疗方案,通过白蛋白结合型紫杉醇联合奈达铂方案治疗晚期食管癌,评价其临床疗效及安全性。方法:收集2016年2月—2019年2月之间在长海医院诊治的晚期食管癌并有可评价病灶的患者31例,一线予以白蛋白结合型紫杉醇联合奈达铂方案化疗,具体用药为:白蛋白结合型紫杉醇130 mg/m^2,第1、8天;奈达铂70 mg/m^2,第1天;每3周重复。采用实体瘤疗效评价标准(Response Evaluation Criteria in Solid Tumors,RECIST)1.1标准评估疗效,按照美国国立癌症研究所通用毒性标准(National Cancer Institute Common Toxicity Criteria,NCI-CTC)5.0评估不良反应。结果:全部31例患者均可评价疗效,其中完全缓解(complete response,CR)1例(3.2%),部分缓解(partial response,PR)20例(64.5%),疾病稳定(stable disease,SD)9例(29.0%),疾病进展(progressive disease,PD)1例(3.2%),客观缓解率(objective response rate,ORR)为67.7%,疾病控制率(disease control rate,DCR)为96.8%,中位无进展生存期(progression-free survival,PFS)为9.4个月。常见不良反应主要包括骨髓抑制、感觉神经病变、关节酸痛、肌肉酸痛、消化道反应及脱发,无毒性相关死亡病例。结论:白蛋白结合型紫杉醇联合奈达铂一线治疗晚期食管癌疗效较好,不良反应患者可耐受,值得进一步推广。展开更多
Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into t...Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into the commonly adopted chemotherapy may produce synergistic effects.Therefore,we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first-line treatment of advanced ESCC.Methods:In this single-arm prospective phase II trial,patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg,liposomal paclitaxel 150 mg/m2,and nedaplatin 50 mg/m2 on day 1,and apatinib 250 mg on days 1-14.The treatments were repeated every 14 days for up to 9 cycles,followed by maintenance therapy with camrelizumab and apatinib.The primary endpoint was objective response rate(ORR)according to the Response Evaluation Criteria in Solid Tumors(version 1.1).Secondary endpoints included disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and safety.Results:We enrolled 30 patients between August 7,2018 and February 23,2019.The median follow-up was 24.98 months(95%confidence interval[CI]:23.05-26.16 months).The centrally assessed ORR was 80.0%(95%CI:61.4%-92.3%),with a median duration of response of 9.77 months(range:1.54 to 24.82+months).The DCR reached 96.7%(95%CI:82.8%-99.9%).The median PFS was 6.85 months(95%CI:4.46-14.20 months),and the median OS was 19.43 months(95%CI:9.93 months–not reached).The most common grade 3-4 treatmentrelated adverse events(AEs)were leukopenia(83.3%),neutropenia(60.0%),and increased aspartate aminotransferase level(26.7%).Treatment-related serious AEs included febrile neutropenia,leukopenia,and anorexia in one patient(3.3%),and single cases of increased blood bilirubin level(3.3%)and toxic epidermal necrolysis(3.3%).No treatment-related deaths occurred.Conclusions:Camrelizumab plus apatinib combined with liposomal paclitaxel and nedaplatin as first-line treatment demonstrated feas展开更多
目的探讨培美曲塞联合奈达铂治疗晚期肺腺癌临床疗效及安全性。方法选择2015年4月至2017年12月本科收治的晚期肺腺癌患者,按照随机数字法分成对照组和观察组。观察组使用培美曲塞联合奈达铂方案治疗,对照组使用培美曲塞联合顺铂方案治...目的探讨培美曲塞联合奈达铂治疗晚期肺腺癌临床疗效及安全性。方法选择2015年4月至2017年12月本科收治的晚期肺腺癌患者,按照随机数字法分成对照组和观察组。观察组使用培美曲塞联合奈达铂方案治疗,对照组使用培美曲塞联合顺铂方案治疗。剔除失访病例后,共有60例患者完成本实验,观察组31例,对照组29例。对比两组患者的临床疗效及随访结果、药物毒副作用、体力状况变化、PS标准评分及生活质量评分。结果 (1)临床疗效及患者随访结果:对照组总有效率为37.93%;观察组总有效率为41.94%,观察组及对照组有效率比较差异无统计学意义(χ2=0.073,P=0.735);两组中位无进展生存期及1年生存率比较,差异无统计学意义(P>0.05)。(2)化疗药物毒副作用:在白细胞减少的发生率上观察组Ⅲ度以上患者显著比对照组低(P<0.05)。观察组Ⅱ度以上恶心、呕吐发生率显著比对照组低(P<0.05)。(3)2组治疗前后变化PS评分比较及肿瘤患者的生活质量(quality of life,QOL)评分比较差异无统计学意义(P>0.05)。(4)治疗前后EORTC QLQ-C30评价比较:经过化学药物治疗之后,观察组患者总体的健康状态及一般情况(如困倦乏力、恶心、呕吐等)均明显优于对照组(P<0.05)。结论培美曲塞联合奈达铂方案与培美曲塞联合顺铂方案的临床疗效在晚期肺腺癌的治疗中无明显差异,但前者副作用小,安全性高,培美曲塞联合奈达铂化疗方案在针对晚期肺腺癌的治疗上值得推广。展开更多
目的:系统评价奈达铂或顺铂联合紫杉醇治疗晚期非小细胞肺癌(NSCLC)和食管癌的疗效与安全性。方法:计算机检索Pub Med、中国期刊全文数据库、万方数据库,纳入奈达铂联合紫杉醇(TN方案)或顺铂联合紫杉醇(TP方案)治疗晚期NSCLC及食管癌的...目的:系统评价奈达铂或顺铂联合紫杉醇治疗晚期非小细胞肺癌(NSCLC)和食管癌的疗效与安全性。方法:计算机检索Pub Med、中国期刊全文数据库、万方数据库,纳入奈达铂联合紫杉醇(TN方案)或顺铂联合紫杉醇(TP方案)治疗晚期NSCLC及食管癌的随机对照试验(RCT),对纳入研究进行资料提取和质量评价后采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入7项RCT,合计505例患者。Meta分析结果显示,两种方案在近期疗效[NSCLC:OR=1.08,95%CI(0.66,1.75),P=0.76;食管癌:OR=1.44,95%CI(0.68,3.06),P=0.34]、1年生存率[NSCLC:OR=1.21,95%CI(0.60,2.44),P=0.59]、2年生存率[NSCLC:OR=1.01,95%CI(0.38,2.68),P=0.99]、Ⅲ/Ⅳ度白细胞下降发生率[食管癌:OR=1.36,95%CI(0.62,2.96),P=0.44]、Ⅲ/Ⅳ度血小板下降发生率[NSCLC:OR=1.37,95%CI(0.64,2.92),P=0.42;食管癌:OR=0.97,95%CI(0.30,3.18),P=0.96]、Ⅲ/Ⅳ度中性粒细胞下降发生率[NSCLC:OR=1.38,95%CI(0.70,2.74),P=0.35]等方面比较差异均无统计学意义。但与TP方案相比,TN方案可显著降低患者恶心呕吐发生率[NSCLC:OR=0.34,95%CI(0.20,0.60),P<0.001;食管癌:OR=0.16,95%CI(0.07,0.35),P<0.001]和肾毒性发生率[食管癌:OR=0.10,95%CI(0.02,0.55),P=0.009]。结论:TN方案与TP方案治疗晚期NSCLC和食管癌疗效相当,但TN方案发生胃肠道反应及肾毒性的几率更低。展开更多
文摘背景与目的:化疗是晚期食管癌患者的主要治疗手段,但目前尚没有标准的一线治疗方案,通过白蛋白结合型紫杉醇联合奈达铂方案治疗晚期食管癌,评价其临床疗效及安全性。方法:收集2016年2月—2019年2月之间在长海医院诊治的晚期食管癌并有可评价病灶的患者31例,一线予以白蛋白结合型紫杉醇联合奈达铂方案化疗,具体用药为:白蛋白结合型紫杉醇130 mg/m^2,第1、8天;奈达铂70 mg/m^2,第1天;每3周重复。采用实体瘤疗效评价标准(Response Evaluation Criteria in Solid Tumors,RECIST)1.1标准评估疗效,按照美国国立癌症研究所通用毒性标准(National Cancer Institute Common Toxicity Criteria,NCI-CTC)5.0评估不良反应。结果:全部31例患者均可评价疗效,其中完全缓解(complete response,CR)1例(3.2%),部分缓解(partial response,PR)20例(64.5%),疾病稳定(stable disease,SD)9例(29.0%),疾病进展(progressive disease,PD)1例(3.2%),客观缓解率(objective response rate,ORR)为67.7%,疾病控制率(disease control rate,DCR)为96.8%,中位无进展生存期(progression-free survival,PFS)为9.4个月。常见不良反应主要包括骨髓抑制、感觉神经病变、关节酸痛、肌肉酸痛、消化道反应及脱发,无毒性相关死亡病例。结论:白蛋白结合型紫杉醇联合奈达铂一线治疗晚期食管癌疗效较好,不良反应患者可耐受,值得进一步推广。
基金This study was supported by the Chinese Society of Clinical Oncology(CSCO)-Hengrui Oncology Research Fund(No.Y-HR2018-364)。
文摘Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into the commonly adopted chemotherapy may produce synergistic effects.Therefore,we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first-line treatment of advanced ESCC.Methods:In this single-arm prospective phase II trial,patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg,liposomal paclitaxel 150 mg/m2,and nedaplatin 50 mg/m2 on day 1,and apatinib 250 mg on days 1-14.The treatments were repeated every 14 days for up to 9 cycles,followed by maintenance therapy with camrelizumab and apatinib.The primary endpoint was objective response rate(ORR)according to the Response Evaluation Criteria in Solid Tumors(version 1.1).Secondary endpoints included disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and safety.Results:We enrolled 30 patients between August 7,2018 and February 23,2019.The median follow-up was 24.98 months(95%confidence interval[CI]:23.05-26.16 months).The centrally assessed ORR was 80.0%(95%CI:61.4%-92.3%),with a median duration of response of 9.77 months(range:1.54 to 24.82+months).The DCR reached 96.7%(95%CI:82.8%-99.9%).The median PFS was 6.85 months(95%CI:4.46-14.20 months),and the median OS was 19.43 months(95%CI:9.93 months–not reached).The most common grade 3-4 treatmentrelated adverse events(AEs)were leukopenia(83.3%),neutropenia(60.0%),and increased aspartate aminotransferase level(26.7%).Treatment-related serious AEs included febrile neutropenia,leukopenia,and anorexia in one patient(3.3%),and single cases of increased blood bilirubin level(3.3%)and toxic epidermal necrolysis(3.3%).No treatment-related deaths occurred.Conclusions:Camrelizumab plus apatinib combined with liposomal paclitaxel and nedaplatin as first-line treatment demonstrated feas
文摘目的探讨培美曲塞联合奈达铂治疗晚期肺腺癌临床疗效及安全性。方法选择2015年4月至2017年12月本科收治的晚期肺腺癌患者,按照随机数字法分成对照组和观察组。观察组使用培美曲塞联合奈达铂方案治疗,对照组使用培美曲塞联合顺铂方案治疗。剔除失访病例后,共有60例患者完成本实验,观察组31例,对照组29例。对比两组患者的临床疗效及随访结果、药物毒副作用、体力状况变化、PS标准评分及生活质量评分。结果 (1)临床疗效及患者随访结果:对照组总有效率为37.93%;观察组总有效率为41.94%,观察组及对照组有效率比较差异无统计学意义(χ2=0.073,P=0.735);两组中位无进展生存期及1年生存率比较,差异无统计学意义(P>0.05)。(2)化疗药物毒副作用:在白细胞减少的发生率上观察组Ⅲ度以上患者显著比对照组低(P<0.05)。观察组Ⅱ度以上恶心、呕吐发生率显著比对照组低(P<0.05)。(3)2组治疗前后变化PS评分比较及肿瘤患者的生活质量(quality of life,QOL)评分比较差异无统计学意义(P>0.05)。(4)治疗前后EORTC QLQ-C30评价比较:经过化学药物治疗之后,观察组患者总体的健康状态及一般情况(如困倦乏力、恶心、呕吐等)均明显优于对照组(P<0.05)。结论培美曲塞联合奈达铂方案与培美曲塞联合顺铂方案的临床疗效在晚期肺腺癌的治疗中无明显差异,但前者副作用小,安全性高,培美曲塞联合奈达铂化疗方案在针对晚期肺腺癌的治疗上值得推广。
文摘目的:系统评价奈达铂或顺铂联合紫杉醇治疗晚期非小细胞肺癌(NSCLC)和食管癌的疗效与安全性。方法:计算机检索Pub Med、中国期刊全文数据库、万方数据库,纳入奈达铂联合紫杉醇(TN方案)或顺铂联合紫杉醇(TP方案)治疗晚期NSCLC及食管癌的随机对照试验(RCT),对纳入研究进行资料提取和质量评价后采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入7项RCT,合计505例患者。Meta分析结果显示,两种方案在近期疗效[NSCLC:OR=1.08,95%CI(0.66,1.75),P=0.76;食管癌:OR=1.44,95%CI(0.68,3.06),P=0.34]、1年生存率[NSCLC:OR=1.21,95%CI(0.60,2.44),P=0.59]、2年生存率[NSCLC:OR=1.01,95%CI(0.38,2.68),P=0.99]、Ⅲ/Ⅳ度白细胞下降发生率[食管癌:OR=1.36,95%CI(0.62,2.96),P=0.44]、Ⅲ/Ⅳ度血小板下降发生率[NSCLC:OR=1.37,95%CI(0.64,2.92),P=0.42;食管癌:OR=0.97,95%CI(0.30,3.18),P=0.96]、Ⅲ/Ⅳ度中性粒细胞下降发生率[NSCLC:OR=1.38,95%CI(0.70,2.74),P=0.35]等方面比较差异均无统计学意义。但与TP方案相比,TN方案可显著降低患者恶心呕吐发生率[NSCLC:OR=0.34,95%CI(0.20,0.60),P<0.001;食管癌:OR=0.16,95%CI(0.07,0.35),P<0.001]和肾毒性发生率[食管癌:OR=0.10,95%CI(0.02,0.55),P=0.009]。结论:TN方案与TP方案治疗晚期NSCLC和食管癌疗效相当,但TN方案发生胃肠道反应及肾毒性的几率更低。
