CHU Nîmes, Institut de Cancérologie du Gard, Nîmes, France; CHU Montpellier, Université de Montpellier, Montpellier, France.
CHU Nîmes, Institut de Cancérologie du Gard, Nîmes, France; Institut de Recherche en Cancérologie de Montpellier, Institut régional du Cancer Montpellier, INSERM U896, Université de Montpellier, Montpellier, France.
Eur Urol Oncol. 2023 Oct;6(5):467-476. doi: 10.1016/j.euo.2023.05.001. Epub 2023 May 25.
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.
To conduct a systematic review of changes in HRQoL global health and domain scores in patients with la/mUC receiving mAb therapies.
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.
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.
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.
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.
单克隆抗体 (mAb) 疗法改善了局部晚期或转移性尿路上皮癌 (la/mUC) 患者的预后，但对于这种治疗方式对健康相关生活质量 (HRQoL) 的影响知之甚少。
系统评价接受 mAb 治疗的 la/mUC 患者 HRQoL 全球健康和领域评分的变化。
根据系统评价和荟萃分析的首选报告项目指南，从 2015 年 1 月至 2022 年 6 月 18 日在 MEDLINE 和美国临床肿瘤学会和欧洲肿瘤内科学会会议数据库中进行检索。数据于 2023 年 2 月 3 日更新。合格的研究是评估接受 mAb 治疗的 la/mUC 患者 HRQoL 的前瞻性试验。排除仅接受局部治疗或放疗或化疗的患者。排除了荟萃分析、综述和病例报告。使用风险偏倚 2 (RoB2) 工具评估随机试验的有效性，并使用推荐评估、制定和评估方法评估结果证据的强度。通过对证据进行定性综合分析来分析数据。
在确定的 1066 项研究中，有 9 项研究被纳入（2364 名患者）；八项为干预性试验，一项为观察性研究。全球健康评分的平均变化范围为-2.8 至 1.9。至少有两项研究表明，便秘、疲劳和疼痛症状以及情绪、身体、角色和社会功能得到改善。没有研究表明全球健康评分有显著改善。八项研究报告稳定。在 RANGE 试验中，全球健康评分下降。只有两项研究根据 RoB2 评估具有较高的内部有效性。HRQoL 领域的确定性较低，仅对疼痛症状领域有中度确定性。疾病和治疗相关症状、肿瘤缩小和疾病复发与 HRQoL 相关。
接受 mAb 治疗的 la/mUC 患者的 HRQoL 不会随着时间的推移而恶化。HRQoL 受到与治疗、肿瘤特征和患者健康状况相关的几个因素的影响。证据充其量是中等的，需要进一步研究。
我们回顾了接受抗体治疗的晚期膀胱癌患者健康相关生活质量的证据。我们发现治疗期间生活质量没有恶化，有时还会改善。我们的结论是，这些治疗方法不会对生活质量产生负面影响，但需要进一步的研究来得出确凿的结论。
