Context: 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.
Evidence acquisition: 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.
Evidence synthesis: 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.
Patient summary: 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.
Keywords: Bladder cancer; EORTC QLQ-C30; Enfortumab vedotin; Immune checkpoint inhibitors; Monoclonal antibodies; Quality of life; Ramucirumab; Systematic review; Urinary bladder neoplasms; Urothelial carcinoma.
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