In comparison to chemotherapy, enfortumab vedotin (EV) prolonged overall survival in patients with previously treated advanced urothelial carcinoma in EV-301. The objective of the present study was to assess patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life (HRQoL).
For patients in the phase 3 EV-301 trial randomized to EV or chemotherapy we assessed responses to the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, weekly for the first 12 wk, and then every 12 wk until discontinuation. We analyzed the QLQ-C30 change from baseline to week 12, the confirmed improvement rate, and the time to improvement or deterioration.
Baseline PRO compliance rates were 91% for the EV arm (n = 301) and 89% for the chemotherapy arm (n = 307); the corresponding average rates from baseline to week 12 were 70% and 67%. Patients receiving EV versus chemotherapy had reduced pain (difference in change from baseline to week 12: -5.7, 95% confidence interval [CI] -10.8 to -0.7; p = 0.027) and worsening appetite loss (7.3, 95% CI 0.90-13.69; p = 0.026). Larger proportions of patients in the EV arm reported HRQoL improvement from baseline than in the chemotherapy arm; the odds of a confirmed improvement across ten QLQ-C30 function/symptom scales were 1.67 to 2.76 times higher for EV than for chemotherapy. Patients in the EV arm had a shorter time to first confirmed improvement in global health status (GHS)/QoL, fatigue, pain, and physical, role, emotional, and social functioning (all p < 0.05). EV delayed the time to first confirmed deterioration in GHS/QoL (p = 0.027), but worsening appetite loss occurred earlier (p = 0.009) in comparison to chemotherapy.
HRQoL with EV was maintained, and deterioration in HRQoL was delayed with EV in comparison to chemotherapy. Better results with EV were reported for some scales, with the greatest difference observed for pain. These findings reinforce the EV safety and efficacy outcomes and benefits observed in EV-301.
Patients with previously treated advanced cancer of the urinary tract receiving the drug enfortumab vedotin maintained their HRQoL in comparison to patients treated with chemotherapy. The EV-301 trial is registered on ClinicalTrials.gov as NCT03474107 and on EudraCT as 2017-003344-21.
European urology. 2024 Feb 27 [Epub ahead of print]
Jonathan E Rosenberg, Ronac Mamtani, Guru P Sonpavde, Yohann Loriot, Ignacio Duran, Jae-Lyun Lee, Nobuaki Matsubara, Christof Vulsteke, Daniel Castellano, Srikala S Sridhar, Helle Pappot, Howard Gurney, Jens Bedke, Michiel S van der Heijden, Luca Galli, Bhumsuk Keam, Naoya Masumori, Johannes Meran, Peter H O'Donnell, Se Hoon Park, Enrique Grande, Lisa Sengeløv, Hiroji Uemura, Konstantina Skaltsa, Mary Campbell, Maria Matsangou, Chunzhang Wu, Zsolt Hepp, Caroline McKay, Thomas Powles, Daniel P Petrylak
Memorial Sloan Kettering Cancer Center, New York City, NY, USA. Electronic address: ., Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA., Gustave Roussy, Université Paris-Saclay, Villejuif, France., Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain., Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea., National Cancer Center Hospital East, Chiba, Japan., Center for Oncological Research, University of Antwerp, Integrated Cancer Center Ghent, Ghent, Belgium., Hospital Universitario 12 de Octubre, Madrid, Spain., Princess Margaret Cancer Center, Toronto, Canada., Region Hovedstaden, Hillerød, Denmark., Macquarie University, Sydney, Australia., Faculty of Medicine, Eberhard Karls University Tübingen, Tübingen, Germany., Netherlands Cancer Institute, Amsterdam, The Netherlands., Azienda Ospedaliero-Universitaria Pisana Spedali Riuniti S. Chiara, Pisa, Italy., Seoul National University Hospital, Seoul, South Korea., Sapporo Medical University, Sapporo, Japan., Internal Medicine 2, Krankenhaus der Barmherzigen Brüder Wien, Vienna, Austria., University of Chicago, Chicago, IL, USA., Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea., MD Anderson Cancer Center Madrid, Madrid, Spain., Herlev Gentofte Hospital, Herlev, Denmark., Yokohama City University Medical Center, Yokohama, Japan., IQVIA, Barcelona, Spain., Seagen, Bothell, WA, USA., Astellas Pharma, Northbrook, IL, USA., Barts Cancer Centre, Queen Mary University of London, London, UK., Smilow Cancer Center, Yale School of Medicine, New Haven, CT, USA.