medwireNews: The quality of life (QoL) data from the phase 3 EV-301 study add support for the use of enfortumab vedotin (EV) in previously treated patients with advanced urothelial carcinoma.
These results were reported in a poster at the 2021 ASCO Annual Meeting by Ronac Mamtani (University of Pennsylvania, Philadelphia, USA) and colleagues, and follow on from the primary analysis showing a significant overall survival gain with EV versus single-agent chemotherapy after progression on platinum-based chemotherapy and checkpoint inhibitors.
The 608 trial participants were asked to complete the EORTC QLQ-C30 questionnaire at baseline, then weekly for the first 12 weeks, and then every 12 weeks until study discontinuation. The compliance rate – calculated as the number of patients who completed at least one questionnaire domain divided by the number expected to have assessments – was around 90% in both the EV and chemotherapy arms at baseline, while the average rates during the course of the study were 70.2% and 66.9%, respectively.
At the 12-week timepoint, the global health status scores were comparable between the patients who received the nectin-4-targeted antibody–drug conjugate and those given chemotherapy.
“[B]ut chemotherapy was associated with numerically greater deterioration and more variability in QoL over the first 12 weeks,” and EV was favored numerically on the global health status, physical functioning, and role functioning domains, noted Mamtani and co-workers.
The symptom scores at 12 weeks were also similar for the treatment groups, except for pain, which was significantly improved among EV- than chemotherapy-treated patients, with a least squares mean change from baseline of –5.62 versus 0.11 points, while the converse was true for appetite loss, at 8.55 versus 1.26 points.
The researchers also highlighted that a significantly greater proportion of EV- than chemotherapy-treated patients reported confirmed improvements based on prespecified thresholds in the global health status score, across all functioning domains (role, physical, emotional, social, and cognitive), and some symptom scales (pain, fatigue, dyspnea, and constipation).
The magnitude of improvement with EV versus chemotherapy ranged from 1.67 times for global health status to 2.76 times for pain.
“QoL was maintained across the course of study treatment [in] patients receiving EV,” summarized Mamtani et al.
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This independent news story was supported by an educational grant from Pfizer and Merck Healthcare KGaA, Darmstadt, Germany