The posttreatment period is a key part of the management of pediatric cancer.During this time,school and psychological difficulties have been described in childhood cancer survivors(CCS)and can be prognostic for the s...The posttreatment period is a key part of the management of pediatric cancer.During this time,school and psychological difficulties have been described in childhood cancer survivors(CCS)and can be prognostic for the success of social reintegration.This study estimated the influence of the household’s socioeconomic status(SES)on these psychosocial difficulties.This study is based on a prospective multicentric database and focused on children who received a psychosocial evaluation during their follow-up from 2013 to 2020.We retrieved data on school and psychological difficulties.Household SES was estimated by a social deprivation score.Data from1003 patients were analyzed.School difficulties were noted in 22%of CCS.A greater social deprivation was significantly associated with school difficulty.Tumor relapse,treatment with hematopoietic stem cell transplantation,and central nervous system(CNS)tumors remained significant risk factors.In the subgroup of CNS tumors,school difficulties were increased and associated with greater social deprivation.Psychological difficulties were not associated with the deprivation score.There is a link between SES and school difficulties in CCS.Further investigations should be carried out for children with CNS tumors,which is the population of the greatest concern.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
基金supported by a grant from SFCE INCa (Institut National du Cancer)GOCE (Grand Ouest Cancer de l’Enfant).
文摘The posttreatment period is a key part of the management of pediatric cancer.During this time,school and psychological difficulties have been described in childhood cancer survivors(CCS)and can be prognostic for the success of social reintegration.This study estimated the influence of the household’s socioeconomic status(SES)on these psychosocial difficulties.This study is based on a prospective multicentric database and focused on children who received a psychosocial evaluation during their follow-up from 2013 to 2020.We retrieved data on school and psychological difficulties.Household SES was estimated by a social deprivation score.Data from1003 patients were analyzed.School difficulties were noted in 22%of CCS.A greater social deprivation was significantly associated with school difficulty.Tumor relapse,treatment with hematopoietic stem cell transplantation,and central nervous system(CNS)tumors remained significant risk factors.In the subgroup of CNS tumors,school difficulties were increased and associated with greater social deprivation.Psychological difficulties were not associated with the deprivation score.There is a link between SES and school difficulties in CCS.Further investigations should be carried out for children with CNS tumors,which is the population of the greatest concern.
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。
