Long-term Patient-reported Outcomes in Patients Receiving Avelumab Maintenance - Expert Commentary
Patient reported outcomes (PRO) were assessed using two validated instruments: the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBlSI-18) and EuroQol 5-level EQ-5D (EQ-5D-5L). The study included 350 patients in the avelumab plus best supportive care (BSC) arm, with a subgroup of 118 patients who received ≥12 months of treatment. Completion rates for PRO assessments remained >80% throughout treatment. Analyses showed FBlSI-18 total and EQ-5D-5L index scores remained stable throughout 24 months of treatment with no clinically important changes from baseline in either the overall avelumab arm or the ≥12-month treatment subgroup. Quality-adjusted time without symptoms or toxicity (Q-TWiST) was calculated by partitioning overall survival into three health states and applying utility weights derived from EQ-5D-5L scores. The mean Q-TWiST was significantly longer with avelumab plus BSC versus BSC alone (18.46 versus 15.13 months; p < 0.0036), representing a 22% relative improvement that exceeds the established 10% threshold for clinical relevance. In patients treated ≥12 months, mean FBlSI-18 total and EQ-5D-5L index scores remained stable even after treatment discontinuation, suggesting potentially greater durability of health-related quality of life.
Limitations of this analysis include potential bias from the open-label design and small patient numbers at later assessment cycles. A comparative analysis between treatment arms was not possible long-term since few patients in the BSC-alone arm remained on study at later time points.
These findings demonstrate that avelumab first-line maintenance preserves health-related quality of life with control of cancer-related symptoms and manageable toxicity, while providing clinically meaningful improvement in quality-adjusted survival. Comparing the quality of life of different therapeutic interventions for patients with metastatic UC is a critical aspect of understand their impact on patients’ lives.
Written by: Bishoy M. Faltas, MD, Chief Research Officer, Englander Institute for Precision Medicine, Gellert Family - John P. Leonard, MD, Research Scholar, Associate Professor of Medicine, Cell and Developmental Biology, Weill Cornell Medicine, New York- Presbyterian Hospital, NY
References:
Read the Abstract