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Abstract：
BACKGROUND: Atezolizumab is an immune checkpoint inhibitor (ICI) and a frontline treatment of patients with cisplatin-ineligible advanced urothelial carcinoma (UC). There is limited evidence on the prognostic value of patient reported outcomes (PROs) in advanced UC treatment, particularly in the context of ICI therapy.
OBJECTIVE: To investigate the prognostic association of PROs with survival in patients with advanced UC treated with atezolizumab.
METHODS: This study used data from 467 patients with advanced UC initiating atezolizumab in the IMvigor211 trial. Pre-treatment PROs association with overall survival (OS) and progression free survival (PFS) was assessed using Cox proportional hazard analysis. PROs were recorded via the European Organisation for Research and Treatment of Cancer QLQ-C30. Discrimination performance was assessed via the C-statistic (c).
RESULTS: Patient reported physical function, pain, appetite loss, global health, fatigue, role function, constipation, nausea and vomiting, dyspnoea, and insomnia were significantly associated with OS and PFS on univariable and adjusted analysis (P < 0.05). Physical function (c = 0.63), pain (c = 0.63), appetite loss (c = 0.62), global health status (c = 0.62), and fatigue (c = 0.62), were the most prognostic factors of OS. The OS discrimination performance of physical function (c = 0.61) was superior to ECOG PS (c = 0.58). Of patients assessed by investigators as having no performance restrictions (ECOG PS of 0), 38 (18%) and 91 (42%) self-reported low and intermediate physical function scores, respectively.
CONCLUSIONS: Pre-treatment PROs were identified as independent prognostic factors of OS and PFS. Patient-reported physical function was more prognostic of OS than ECOG PS. This highlights a potential for PROs to enable improved patient stratification in ICI trials.
OBJECTIVE: To investigate the prognostic association of PROs with survival in patients with advanced UC treated with atezolizumab.
METHODS: This study used data from 467 patients with advanced UC initiating atezolizumab in the IMvigor211 trial. Pre-treatment PROs association with overall survival (OS) and progression free survival (PFS) was assessed using Cox proportional hazard analysis. PROs were recorded via the European Organisation for Research and Treatment of Cancer QLQ-C30. Discrimination performance was assessed via the C-statistic (c).
RESULTS: Patient reported physical function, pain, appetite loss, global health, fatigue, role function, constipation, nausea and vomiting, dyspnoea, and insomnia were significantly associated with OS and PFS on univariable and adjusted analysis (P < 0.05). Physical function (c = 0.63), pain (c = 0.63), appetite loss (c = 0.62), global health status (c = 0.62), and fatigue (c = 0.62), were the most prognostic factors of OS. The OS discrimination performance of physical function (c = 0.61) was superior to ECOG PS (c = 0.58). Of patients assessed by investigators as having no performance restrictions (ECOG PS of 0), 38 (18%) and 91 (42%) self-reported low and intermediate physical function scores, respectively.
CONCLUSIONS: Pre-treatment PROs were identified as independent prognostic factors of OS and PFS. Patient-reported physical function was more prognostic of OS than ECOG PS. This highlights a potential for PROs to enable improved patient stratification in ICI trials.
摘要：
背景：Atezolizumab是一种免疫检查点抑制剂（ICI），是顺铂不合格的晚期尿路上皮癌（UC）患者的一线治疗方法。关于晚期UC治疗中患者报告结果（PROs）的预后价值的证据有限，特别是在ICI治疗的背景下。
目的：探讨应用阿特珠单抗治疗的晚期UC患者的预后与生存的关系。
方法：本研究使用了IMvenicor211试验中467例晚期UC患者的数据。使用Cox比例风险分析评估治疗前PRO与总生存期（OS）和无进展生存期（PFS）的相关性。PROs通过欧洲癌症研究和治疗组织QLQ-C30记录。通过C统计量(c)评估歧视表现。
结果：患者报告身体机能，疼痛,食欲减退,全球健康,疲劳,角色功能，便秘,恶心和呕吐，呼吸困难,单变量和校正分析显示失眠与OS和PFS显著相关(P<0.05)。物理函数（c=0.63），疼痛（c=0.63），食欲减退（c=0.62），全球健康状况(c=0.62)，和疲劳（c=0.62），是影响OS预后的主要因素。物理功能的OS辨别性能（c=0.61）优于ECOGPS（c=0.58）。在研究者评估为没有表现限制(ECOGPS为0)的患者中，38（18％）和91（42％）自我报告的低和中等身体功能得分，分别。
结论：治疗前PRO是OS和PFS的独立预后因素。患者报告的身体功能比ECOGPS更具OS预后。这凸显了PROs在ICI试验中改善患者分层的潜力。
目的：探讨应用阿特珠单抗治疗的晚期UC患者的预后与生存的关系。
方法：本研究使用了IMvenicor211试验中467例晚期UC患者的数据。使用Cox比例风险分析评估治疗前PRO与总生存期（OS）和无进展生存期（PFS）的相关性。PROs通过欧洲癌症研究和治疗组织QLQ-C30记录。通过C统计量(c)评估歧视表现。
结果：患者报告身体机能，疼痛,食欲减退,全球健康,疲劳,角色功能，便秘,恶心和呕吐，呼吸困难,单变量和校正分析显示失眠与OS和PFS显著相关(P<0.05)。物理函数（c=0.63），疼痛（c=0.63），食欲减退（c=0.62），全球健康状况(c=0.62)，和疲劳（c=0.62），是影响OS预后的主要因素。物理功能的OS辨别性能（c=0.61）优于ECOGPS（c=0.58）。在研究者评估为没有表现限制(ECOGPS为0)的患者中，38（18％）和91（42％）自我报告的低和中等身体功能得分，分别。
结论：治疗前PRO是OS和PFS的独立预后因素。患者报告的身体功能比ECOGPS更具OS预后。这凸显了PROs在ICI试验中改善患者分层的潜力。
