Real-world use, dose intensity, and adherence to enfortumab vedotin in locally advanced or metastatic urothelial cancer.

Autor: Mamtani R; Division of Hematology and Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: Ronac.Mamtani@pennmedicine.upenn.edu., Tsingas K; Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA., Parikh RB; Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA., Elsouda D; Astellas Pharma Inc., Northbrook, IL., Mucha L; Astellas Pharma Inc., Northbrook, IL., Fuldeore R; Astellas Pharma Inc., Northbrook, IL., Hubbard RA; Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA.
Jazyk: angličtina
Zdroj: Urologic oncology [Urol Oncol] 2024 Jun; Vol. 42 (6), pp. 177.e1-177.e4. Date of Electronic Publication: 2024 Mar 19.
DOI: 10.1016/j.urolonc.2024.03.001
Abstrakt: Background: Enfortumab vedotin (EV) monotherapy is approved for the treatment of advanced urothelial cancer as later-line therapy (post-immunotherapy and -platinum-chemotherapy) and as earlier-line therapy (cisplatin-ineligible, at least 1 prior therapy). We examined real-world EV monotherapy use, dose intensity and adherence across 280 US cancer clinics.
Methods: This postmarketing study used data from a nationwide (United States) deidentified patient-level electronic health record-derived database. Included were patients with advanced urothelial cancer initiating EV on or after December 19, 2019 (date of accelerated approval). We summarized characteristics of EV users using descriptive statistics and computed metrics of EV use, EV dose intensity, and EV treatment adherence.
Results: We identified 416 advanced urothelial cancer patients initiating EV monotherapy. More than half of patients (55.3%) received EV as later-line therapy (3L+), and nearly half (44.7%) received EV as earlier line therapy (1 or 2L). Dosing frequency (mean [SD] 2.4 [0.5] treatments per 28 day cycle) and dose (1.1 [0.2] mg/kg) were lower than label indication guidelines (1.25 mg/kg, Day 1, 8, 15 of a 28 day cycle). Only 58.8% of patients received an average of >2 treatments per 28-day cycle.
Conclusions: Among patients with advanced urothelial cancer treated with EV monotherapy in contemporary practice, EV dosing frequency, and dosage was lower in clinical practice than recommended in the product labeling. Further research is required to understand clinical factors and outcomes associated with the differences observed.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ravi Parikh and Ronac Mamtani have received personal fees from Flatiron Health. Ravi Parikh has received grant funding from Humana, personal fees and equity from GNS Healthcare Inc and Onc.AI, and personal fees from the Cancer Study Group and Nanology outside the submitted work. Dina Elsouda, Lisa Mucha, and Rupali Fuldeore report employment at Astellas. Rebecca Hubbard has received grant funding (to institution) from Pfizer, Johnson & Johnson, and Merck. Ronac Mamtani has received grant funding (to institution) from Merck and Astellas, and personal fees from BMS, Astellas, and SEAGEN.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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