AIM： The aim of the study was to evaluate the predictive factors of survival in patients with locally advanced squamous cell esophageal carcinoma （LASCOC） treated with definitive chemoradiotherapy （CRT） regimen b...AIM： The aim of the study was to evaluate the predictive factors of survival in patients with locally advanced squamous cell esophageal carcinoma （LASCOC） treated with definitive chemoradiotherapy （CRT） regimen based on the 5FU/CDDP combination. METHODS： All patients with LASCOC treated with a definitive CRT using the 5FU/CDDP combination between 1994 and 2000 were retrospectively included. Clinical complete response （CCR） to CRT was assessed by esophageal endoscopy and C-F-scan 2 mo after CRT completion. Prognostic factors of survival were assessed using univariate and multivariate analysis by the Cox regression model. RESULTS： A total of 116 patients were included in the study. A CCR to CRT was observed in 86/116 （74.1%）. The median survival was 20 mo （range 2-114） and the 5-year survival was 9.4%. Median survival of responder patients to CRT was 25 mo （range 3-114） as compared to 9 mo （range 2-81） in non-responder patients （P 〈 0.001）. In univariate analysis, survival was associated with CCR （P 〈 0.001）, WHO performance status 〈 2 （P = 0.01）, tumour length 〈 6 cm （P = 0.045） and weight loss 〈 10% was in limit of significance （P = 0.053）. In multivariate analysis, survival was dependant to CCR （P 〈 0.0001）, weight loss 〈 10% （P = 0.034） and WHO performance 〈 2 （P = 0.046）. CONCLUSION： Our results suggest that survival in patients with LASCOC b＇eated with definitive CRT was correlated to CCR, weight loss and WHO performance status.展开更多
目的评价信迪利单抗对比安慰剂联合化疗(顺铂加紫杉醇或顺铂加5-氟尿嘧啶)作为不可切除的局部晚期、复发或转移性食管鳞癌一线治疗的效果。设计多中心、随机、双盲、Ⅲ期临床研究。背景2018年12月14日至2021年4月9日,国内66家研究中心,...目的评价信迪利单抗对比安慰剂联合化疗(顺铂加紫杉醇或顺铂加5-氟尿嘧啶)作为不可切除的局部晚期、复发或转移性食管鳞癌一线治疗的效果。设计多中心、随机、双盲、Ⅲ期临床研究。背景2018年12月14日至2021年4月9日,国内66家研究中心,国外13家研究中心。受试者659例未曾接受过系统性治疗的成年(≥18岁)晚期或转移性食管鳞癌患者。干预受试者按1∶1的比例随机分组,每3周接受1次信迪利单抗或安慰剂(体重<60 kg者3 mg/kg,体重>60 kg者200 mg)与顺铂75 mg/m2和紫杉醇175 mg/m2的联合治疗。本研究经修订,允许研究者选择顺铂联合紫杉醇或顺铂联合5-氟尿嘧啶(800 mg/m2,第1~5天连续输注给药)化疗方案。主要结局指标所有患者和程序性细胞死亡配体1(PD-L1)表达联合阳性评分≥10的患者总生存期。结果659例患者随机分配至信迪利单抗(n=327)或安慰剂(n=332)联合化疗组。659例患者中有616例(93%)接受了信迪利单抗或安慰剂与顺铂和紫杉醇联合治疗,有43例(7%)接受了信迪利单抗或安慰剂与顺铂和5-氟尿嘧啶联合治疗。期中分析显示,在所有患者(中位总生存期16.7 vs 12.5个月,风险比0.63,95%可信区间0.51~0.78;P<0.001)和联合阳性评分≥10的患者(17.2 vs 13.6个月,0.64,0.48~0.85;P=0.002)中,信迪利单抗联合化疗组的总生存期均优于安慰剂联合化疗组。与安慰剂联合化疗相比,信迪利单抗联合化疗显著延长了所有患者(7.2 vs 5.7个月,0.56,0.46~0.68;P<0.001)和联合阳性评分≥10患者(8.3 vs 6.4个月,0.58,0.45~0.75;P<0.001)的无进展生存期。信迪利单抗联合化疗组出现治疗相关不良事件的患者人数为321/327例(98%),安慰剂联合化疗组为326/332例(98%)。在信迪利单抗联合化疗组和安慰剂联合化疗组中,3级及以上治疗相关不良事件的发生率分别为60%(196/327)和55%(181/332)。结论与安慰剂相比,信迪利单抗联合顺铂加紫杉醇作为一线治疗显著改善了晚期或转移性食管鳞癌患者的总生存期和无进展生存期。信迪利单抗联合顺铂加5-氟尿嘧啶也显示出类似的获益。临床试验注册ClinicalTrials.gov NCT03748134。展开更多
文摘AIM： The aim of the study was to evaluate the predictive factors of survival in patients with locally advanced squamous cell esophageal carcinoma （LASCOC） treated with definitive chemoradiotherapy （CRT） regimen based on the 5FU/CDDP combination. METHODS： All patients with LASCOC treated with a definitive CRT using the 5FU/CDDP combination between 1994 and 2000 were retrospectively included. Clinical complete response （CCR） to CRT was assessed by esophageal endoscopy and C-F-scan 2 mo after CRT completion. Prognostic factors of survival were assessed using univariate and multivariate analysis by the Cox regression model. RESULTS： A total of 116 patients were included in the study. A CCR to CRT was observed in 86/116 （74.1%）. The median survival was 20 mo （range 2-114） and the 5-year survival was 9.4%. Median survival of responder patients to CRT was 25 mo （range 3-114） as compared to 9 mo （range 2-81） in non-responder patients （P 〈 0.001）. In univariate analysis, survival was associated with CCR （P 〈 0.001）, WHO performance status 〈 2 （P = 0.01）, tumour length 〈 6 cm （P = 0.045） and weight loss 〈 10% was in limit of significance （P = 0.053）. In multivariate analysis, survival was dependant to CCR （P 〈 0.0001）, weight loss 〈 10% （P = 0.034） and WHO performance 〈 2 （P = 0.046）. CONCLUSION： Our results suggest that survival in patients with LASCOC b＇eated with definitive CRT was correlated to CCR, weight loss and WHO performance status.
文摘目的评价信迪利单抗对比安慰剂联合化疗(顺铂加紫杉醇或顺铂加5-氟尿嘧啶)作为不可切除的局部晚期、复发或转移性食管鳞癌一线治疗的效果。设计多中心、随机、双盲、Ⅲ期临床研究。背景2018年12月14日至2021年4月9日,国内66家研究中心,国外13家研究中心。受试者659例未曾接受过系统性治疗的成年(≥18岁)晚期或转移性食管鳞癌患者。干预受试者按1∶1的比例随机分组,每3周接受1次信迪利单抗或安慰剂(体重<60 kg者3 mg/kg,体重>60 kg者200 mg)与顺铂75 mg/m2和紫杉醇175 mg/m2的联合治疗。本研究经修订,允许研究者选择顺铂联合紫杉醇或顺铂联合5-氟尿嘧啶(800 mg/m2,第1~5天连续输注给药)化疗方案。主要结局指标所有患者和程序性细胞死亡配体1(PD-L1)表达联合阳性评分≥10的患者总生存期。结果659例患者随机分配至信迪利单抗(n=327)或安慰剂(n=332)联合化疗组。659例患者中有616例(93%)接受了信迪利单抗或安慰剂与顺铂和紫杉醇联合治疗,有43例(7%)接受了信迪利单抗或安慰剂与顺铂和5-氟尿嘧啶联合治疗。期中分析显示,在所有患者(中位总生存期16.7 vs 12.5个月,风险比0.63,95%可信区间0.51~0.78;P<0.001)和联合阳性评分≥10的患者(17.2 vs 13.6个月,0.64,0.48~0.85;P=0.002)中,信迪利单抗联合化疗组的总生存期均优于安慰剂联合化疗组。与安慰剂联合化疗相比,信迪利单抗联合化疗显著延长了所有患者(7.2 vs 5.7个月,0.56,0.46~0.68;P<0.001)和联合阳性评分≥10患者(8.3 vs 6.4个月,0.58,0.45~0.75;P<0.001)的无进展生存期。信迪利单抗联合化疗组出现治疗相关不良事件的患者人数为321/327例(98%),安慰剂联合化疗组为326/332例(98%)。在信迪利单抗联合化疗组和安慰剂联合化疗组中,3级及以上治疗相关不良事件的发生率分别为60%(196/327)和55%(181/332)。结论与安慰剂相比,信迪利单抗联合顺铂加紫杉醇作为一线治疗显著改善了晚期或转移性食管鳞癌患者的总生存期和无进展生存期。信迪利单抗联合顺铂加5-氟尿嘧啶也显示出类似的获益。临床试验注册ClinicalTrials.gov NCT03748134。
