Abstract
Enfortumab Vedotin Ineligible criTeriA (EVITA) were proposed for the selection of patients to receive enfortumab vedotin (EV) and pembrolizumab treatment. However, the usefulness of these criteria has not been fully verified. We retrospectively analyzed data from 301 patients with unresectable or metastatic urothelial carcinoma who underwent first-line chemotherapy and 135 patients with EV monotherapy in real-world practice. We evaluated the numbers of patients fulfilling the modified EVITA (mEVITA; excluding ocular abnormalities) and the relationship of the mEVITA to the safety and efficacy in patients with EV monotherapy. Of the 301 patients who received first-line chemotherapy, 4.3% (n = 13) met the mEVITA criteria. The primary factor contributing to mEVITA ≥ 2 was renal dysfunction. Of the 135 patients who underwent subsequent EV therapy, the number of the mEVITA had no influence on the frequency of all-grade and grade ≥ 3 adverse events. However, the mEVITA ≥ 2 was significantly associated with temporary EV interruption. Oncological outcomes were not associated with the number of the mEVITA. In conclusion, 4.3% and 14.8% of patients met the mEVITA criteria at the time of first-line and subsequent EV therapy, respectively. Having mEVITA ≥ 2 may be associated with temporary interruption of EV therapy.