Abstract：
BACKGROUND: Monoclonal antibody (mAb) therapies have improved the prognosis for locally advanced or metastatic urothelial cancers (la/mUC) but little is known about health-related quality of life (HRQoL) with this mode of treatment.
OBJECTIVE: To conduct a systematic review of changes in HRQoL global health and domain scores in patients with la/mUC receiving mAb therapies.
METHODS: MEDLINE and the American Society of Clinical Oncology and European Society for Medical Oncology meeting databases were searched from January 2015 to June 18, 2022 in accordance with the Preferred Reported Items for Systematic Reviews and Meta-Analyses guidelines. Data were updated on February 3, 2023. Eligible studies were prospective trials assessing HRQoL in patients with la/mUC treated with mAbs. Patients treated for local disease or with radiotherapy or chemotherapy alone were excluded. Meta-analyses, reviews, and case reports were excluded. The validity of randomized trials was assessed using the Risk-of-Bias-2 (RoB2) tool and the strength of outcome evidence was rated using the Grading of Recommendations Assessment, Development and Evaluation approach. The data were analyzed via qualitative synthesis of the evidence.
RESULTS: Of the 1066 studies identified, nine were included (2364 patients); eight were interventional trials and one was an observational study. The mean change in global health score ranged from -2.8 to 1.9. Constipation, fatigue and pain symptoms, and emotional, physical, role and social functioning improved with treatment in at least two studies. No study demonstrated a significant improvement in global health score. Eight studies reported stability. In the RANGE trial, the global health score decreased. Only two studies had high internal validity according to RoB2 assessment. The HRQoL domain certainty was low, with moderate certainty only for the pain symptom domain. Disease- and treatment-related symptoms, tumor shrinkage, and disease recurrence were correlated to HRQoL.
CONCLUSIONS: Patient HRQoL with mAb therapies for la/mUC did not worsen over time. HRQoL is influenced by several factors related to treatment, tumor characteristics, and the patient\'s health condition. Evidence was moderate at best and further studies are needed.
RESULTS: We reviewed the evidence on health-related quality-of-life for patients with advanced bladder cancer treated with antibody therapies. We found that quality of life does not worsen on treatment, and sometimes improves. We conclude that these treatments do not negatively affect quality of life, but further studies are needed to draw solid conclusions.
OBJECTIVE: To conduct a systematic review of changes in HRQoL global health and domain scores in patients with la/mUC receiving mAb therapies.
METHODS: MEDLINE and the American Society of Clinical Oncology and European Society for Medical Oncology meeting databases were searched from January 2015 to June 18, 2022 in accordance with the Preferred Reported Items for Systematic Reviews and Meta-Analyses guidelines. Data were updated on February 3, 2023. Eligible studies were prospective trials assessing HRQoL in patients with la/mUC treated with mAbs. Patients treated for local disease or with radiotherapy or chemotherapy alone were excluded. Meta-analyses, reviews, and case reports were excluded. The validity of randomized trials was assessed using the Risk-of-Bias-2 (RoB2) tool and the strength of outcome evidence was rated using the Grading of Recommendations Assessment, Development and Evaluation approach. The data were analyzed via qualitative synthesis of the evidence.
RESULTS: Of the 1066 studies identified, nine were included (2364 patients); eight were interventional trials and one was an observational study. The mean change in global health score ranged from -2.8 to 1.9. Constipation, fatigue and pain symptoms, and emotional, physical, role and social functioning improved with treatment in at least two studies. No study demonstrated a significant improvement in global health score. Eight studies reported stability. In the RANGE trial, the global health score decreased. Only two studies had high internal validity according to RoB2 assessment. The HRQoL domain certainty was low, with moderate certainty only for the pain symptom domain. Disease- and treatment-related symptoms, tumor shrinkage, and disease recurrence were correlated to HRQoL.
CONCLUSIONS: Patient HRQoL with mAb therapies for la/mUC did not worsen over time. HRQoL is influenced by several factors related to treatment, tumor characteristics, and the patient\'s health condition. Evidence was moderate at best and further studies are needed.
RESULTS: We reviewed the evidence on health-related quality-of-life for patients with advanced bladder cancer treated with antibody therapies. We found that quality of life does not worsen on treatment, and sometimes improves. We conclude that these treatments do not negatively affect quality of life, but further studies are needed to draw solid conclusions.
摘要：
背景：单克隆抗体（mAb）治疗改善了局部晚期或转移性尿路上皮癌（la/mUC）的预后，但对这种治疗方式的健康相关生活质量（QoHRL）知之甚少。
目的：对接受mAb治疗的la/mUC患者的HRQoL全球健康和领域评分的变化进行系统评价。
方法：从2015年1月至2022年6月18日，根据系统评价和荟萃分析指南的首选报告项目，搜索了MEDLINE和美国临床肿瘤学会和欧洲医学肿瘤学会会议数据库。数据于2023年2月3日更新。符合条件的研究是评估接受mAb治疗的la/mUC患者HRQoL的前瞻性试验。排除接受局部疾病治疗或单纯放疗或化疗的患者。荟萃分析，reviews,病例报告被排除.使用风险偏倚-2（RoB2）工具评估随机试验的有效性，并使用建议分级评估对结果证据的强度进行评级。开发和评估方法。通过定性综合证据分析数据。
结果：在确定的1066项研究中，纳入9例患者(2364例患者);8例是介入试验,1例是观察性研究.全球健康评分的平均变化范围为-2.8至1.9。便秘,疲劳和疼痛症状，和情感，物理，在至少两项研究中，角色和社会功能随着治疗而改善。没有研究表明全球健康评分有显著改善。8项研究报告了稳定性。在RANGE审判中,全球健康评分下降。根据RoB2评估，只有两项研究具有较高的内部效度。HRQoL域确定性较低，仅在疼痛症状领域具有中等确定性。与疾病和治疗相关的症状，肿瘤缩小,疾病复发与HRQoL相关。
结论：mAb治疗la/mUC的患者HRQoL并未随时间恶化。HRQoL受与治疗相关的几个因素的影响，肿瘤特征，以及病人的健康状况。证据充其量是适度的，需要进一步的研究。
结果：我们回顾了抗体治疗晚期膀胱癌患者与健康相关的生活质量的证据。我们发现生活质量不会因为治疗而恶化,有时会有所改善。我们得出结论，这些治疗不会对生活质量产生负面影响，但是需要进一步的研究才能得出可靠的结论。
目的：对接受mAb治疗的la/mUC患者的HRQoL全球健康和领域评分的变化进行系统评价。
方法：从2015年1月至2022年6月18日，根据系统评价和荟萃分析指南的首选报告项目，搜索了MEDLINE和美国临床肿瘤学会和欧洲医学肿瘤学会会议数据库。数据于2023年2月3日更新。符合条件的研究是评估接受mAb治疗的la/mUC患者HRQoL的前瞻性试验。排除接受局部疾病治疗或单纯放疗或化疗的患者。荟萃分析，reviews,病例报告被排除.使用风险偏倚-2（RoB2）工具评估随机试验的有效性，并使用建议分级评估对结果证据的强度进行评级。开发和评估方法。通过定性综合证据分析数据。
结果：在确定的1066项研究中，纳入9例患者(2364例患者);8例是介入试验,1例是观察性研究.全球健康评分的平均变化范围为-2.8至1.9。便秘,疲劳和疼痛症状，和情感，物理，在至少两项研究中，角色和社会功能随着治疗而改善。没有研究表明全球健康评分有显著改善。8项研究报告了稳定性。在RANGE审判中,全球健康评分下降。根据RoB2评估，只有两项研究具有较高的内部效度。HRQoL域确定性较低，仅在疼痛症状领域具有中等确定性。与疾病和治疗相关的症状，肿瘤缩小,疾病复发与HRQoL相关。
结论：mAb治疗la/mUC的患者HRQoL并未随时间恶化。HRQoL受与治疗相关的几个因素的影响，肿瘤特征，以及病人的健康状况。证据充其量是适度的，需要进一步的研究。
结果：我们回顾了抗体治疗晚期膀胱癌患者与健康相关的生活质量的证据。我们发现生活质量不会因为治疗而恶化,有时会有所改善。我们得出结论，这些治疗不会对生活质量产生负面影响，但是需要进一步的研究才能得出可靠的结论。
