Baseline characteristics of patients with la/mUC diagnosed between October 2024 and December 2025: comparison between 1L EVP vs 1L non-EVP cases.
| Variables | 1L EVP | Non-EVP | P value | |
|---|---|---|---|---|
| n | 55 | 10 | - | |
| Age, years-old | Median (IQR) | 74 (66–78) | 79 (77–85) | 0.01 |
| Sex | Male | 40 (72.7%) | 8 (80.0%) | 0.72 |
| Female | 15 (27.3%) | 2 (20.0%) | ||
| Smoking history | Never | 17 (30.9%) | 3 (30.0%) | 0.97 |
| Former | 20 (36.4%) | 4 (40.0%) | ||
| Current | 10 (18.2%) | 2 (20.0%) | ||
| Unknown | 8 (14.5%) | 1 (10.0%) | ||
| Charlson Comorbidity Score-Category | None (score 0) | 29 (52.7%) | 6 (60.0%) | 0.78 |
| Mild (score 1 or 2) | 22 (40.0%) | 4 (40.0%) | ||
| Moderate (score 3 or 4) | 4 (7.3%) | 0 | ||
| Severe (score 5 or more) | 0 | 0 | ||
| Radical surgery | None | 30 (54.5%) | 6 (60.0%) | 0.38 |
| Cystectomy | 16 (29.1%) | 1 (10.0%) | ||
| Nephroureterectomy | 8 (14.5%) | 3 (30.0%) | ||
| Both | 1 (1.8%) | 0 | ||
| Diabetes mellitus | No | 48 (87.3%) | 6 (60.0%) | 0.09 |
| Yes | 7 (12.7%) | 4 (40.0%) | ||
| Clinical T category, the 8th edition | Tis | 3 (5.5%) | 0 | 0.55 |
| T1 | 6 (10.9%) | 1 (10.0%) | ||
| T2 | 10 (18.2%) | 2 (20.0%) | ||
| T3 | 16 (29.1%) | 5 (50.0%) | ||
| T4 | 20 (36.4%) | 2 (20.0%) | ||
| Primary disease | Bladder cancer | 29 (52.7%) | 6 (60.0%) | 0.75 |
| UTUC | 26 (47.3%) | 4 (40.0%) | ||
| Unresectable or metastatic lesions | Local lesion | 31 (56.4%) | 5 (50.0%) | 0.76 |
| Lymph nodes | 40 (72.7%) | 7 (70.0%) | 0.73 | |
| Lung | 17 (30.9%) | 3 (30.0%) | 1.00 | |
| Liver | 13 (23.6%) | 0 | 0.68 | |
| Bone | 9 (16.4%) | 0 | 0.20 | |
| Peritoneum | 2 (3.6%) | 0 | 1.00 | |
| Retroperitoneum | 7 (12.7%) | 0 | 0.34 | |
| Adrenal grand | 1 (1.8%) | 0 | 1.00 | |
| SLD at baseline (mm), RECIST v1.1 | Median (IQR) | 49 (34–81) | 32 (25–34) | 0.04 |
| EVITA | HbA1c ≥ 8% | 1 (1.8%) | 1 (10.0%) | 0.28 |
| Grade ≥ 2 sensory or motor neuropathy | 0 | 0 | NA | |
| Any corneal or retinal abnormality | 1 (1.8%) | 0 | NA | |
| eGFR < 45 mL/min/1.73 m2 | 22 (40.0%) | 6 (60.0%) | 0.75 | |
| ECOG-PS ≥ 2 | 6 (10.9%) | 5 (50.0%) | <0.01 | |
| Number of EVITA | 0 | 29 (52.7%) | 1 (10.0%) | <0.01 |
| 1 | 22 (40.0%) | 6 (60.0%) | ||
| 2 | 4 (7.3%) | 3 (30.0%) | ||
| Laboratory data, median (IQR) | Neutrophil, ×103/µL | 4.1 (3.1–5.6) | 5.3 (4.3–6.5) | 0.33 |
| Albumin, g/dL | 3.8 (3.4–4.1) | 3.8 (3.3–4.0) | 0.68 | |
| eGFR, mL/min/1.73 m2 | 49.0 (39.5–61.2) | 40.8 (35.6–51.4) | 0.34 | |
| ACTH, pg/mL | 26.4 (18.6–37.0) | 21.7 (19.9–26.0) | 0.22 | |
| Cortisol, μg/dL | 12.3 (8.5–17.01) | 9.6 (8.7–11.4) | 0.32 | |
| FT3, ng/dL | 2.50 (2.12–2.72) | 2.7 (2.6–2.7) | 0.20 | |
| FT4, ng/dL | 1.11 (0.99–1.28) | 0.9 (0.9–1.0) | 0.18 | |
| TSH, μIU/mL | 1.94 (1.34–3.06) | 1.9 (1.7–3.8) | 0.78 | |
1L: first-line; ACTH: adrenocorticotropic hormone; ECOG-PS: Eastern Cooperative Oncology Group Performance Status; eGFR: estimated glomerular filtration rate; EVITA: Enfortumab Vedotin Ineligible Criteria; EVP: enfortumab vedotin plus pembrolizumab; FT3: free triiodothyronine; FT4: free thyroxine; IQR: interquartile range; la/mUC: locally advanced or metastatic urothelial carcinoma; NA: not available; RECIST: Response Evaluation Criteria in Solid Tumors; SLD: sum of longest diameter; TSH: thyroid-stimulating hormone; UTUC: upper urinary tract urothelial carcinoma.