Table 1.
Patients’ characteristics
| Parameters | Results in 16 patients treated with EV |
|
|---|---|---|
| Median (range) age at start of EV (years) | 72 (47–82) | |
| Male sex, n (5) | 14 (87.5) | |
| Ethnicity: white, n (%) | 16 (100) | |
| Median (range) BMI at start of EV [kg/m2] | 25.6 (18.6–32.8) | |
| Current or former smoker, n (%) | 2 (12.5) | |
| Primary tumour site | ||
| Bladder, n (%) | 10 (62.5) | |
| Renal pelvis, n (%) | 4 (25.0) | |
| Both, n (%) | 1 (6.25) | |
| Histology | ||
| Pure transitional cell, n (%) | 15 (93.8) | |
| Neuroendocrine, n (%) | 1 (6.2) | |
| Grade | ||
| High grade, n (%) | 15 (93.8) | |
| Low grade, n (%) | 1 (6.2) | |
| TNM at diagnosis | ||
| T1, n (%) | 2 (12.5) | |
| T2, n (%) | 5 (31.2) | |
| T3, n (%) | 1 (6.2) | |
| T4, n (%) | 8 (50.0) | |
| N0, n (%) | 4 (25.0) | |
| N1, n (%) | 3 (18.8) | |
| N2, n (%) | 6 (37.5) | |
| Nx, n (%) | 3 (18.8) | |
| M0, n (%) | 10 (62.5) | |
| M1, n (%) | 6 (37.5) | |
| Median (range) time from diagnosis to metastatic disease (months) | 8.4 (0–94.0) | |
| Sites of metastasis at diagnosis of metastatic disease | ||
| Lung, n (%) | 8 (50.0) | |
| Liver, n (%) | 3 (18.8) | |
| Lymph nodes, n (%) | 10 (62.5) | |
| Soft tissue, n (%) | 2 (12.5) | |
| Stomach, n (%) | 1 (6.2) | |
| Prostate, n (%) | 1 (6.2) | |
| Urethra, n (%) | 1 (6.2) | |
| Local recurrence, n (%) | 1 (6.2) | |
| Treatment before EV | ||
| Neoadjuvant chemotherapy, n (%) | 2 (12.5) | |
| BCG for NMIBC, n (%) | 3 (18.8) | |
| Surgery | ||
| Cystoprostatectomy, n (%) | 5 (31.2) | |
| Nephrectomy, n (%) | 5 (31.2) | |
| Cystectomy, n (%) | 1 (6.2) | |
| Adjuvant systemic therapy, n (%) | 2 (12.5) | |
| First-line chemotherapy for metastatic disease | ||
| Cisplatin + gemcitabine, n (%) | 10 (62.5) | |
| Carboplatin + gemcitabine, n (%) | 2 (12.5) | |
| Other, n (%) | 3 (18.8) | |
| No first-line chemotherapy, early progression on neoadjuvant therapy | 1 (6.2) | |
| No data | 1 (6.2) | |
| Avelumab maintenance therapy, n (%) | 11 (68.8) | |
| Best response PR, n (%) | 2 (12.5) | |
| Best response DS, n (%) | 3 (18.8) | |
| Best response PD, n (%) | 6 (37.5) | |
| Progression, n (%) | 9 (56.2) | |
| Second-line immunotherapy, n (%) | 5 (31.2) | |
| Pembrolizumab, n (%) | 1 (6.20 | |
| Nivolumab, n (%) | 1 (6.2) | |
| Atezolizumab, n (%) | 1 (6.2) | |
| Pembrolizumab + lenvatinib | 1 (6.2) | |
| ECOG performance score at the start of EV | ||
| 0, n (%) | 1 (6.2) | |
| 1, n (%) | 14 (87.5) | |
| 2, n (%) | 1 (6.2) | |
| Metastases at the start of EV | ||
| Lung, n (%) | 8 (50.0) | |
| Bone, n (%) | 2 (12.5) | |
| Liver, n (%) | 6 (37.5) | |
| Soft tissue, n (%) | 4 (25.0) | |
| Lymph nodes, n (%) | 13 (81.2) | |
| Stomach, n (%) | 1 (6.2) | |
| Prostate, n (%) | 1 (6.2) | |
| Urethra, n (%) | 1 (6.2) | |
| Local recurrence, n (%) | 1 (6.2) | |
| Laboratory tests’ results at the start of EV | ||
| Median (range) haemoglobin, g/dl | 11.4 (9.5–14.3) | |
| Median (range) neutrophil count, × 103/µl | 5.92 (1.64–10.38) | |
| Median (range) lymphocyte count, × 103/µl | 1.58 (0.62–2.77) | |
| Median (range) NLR | 3.75 (0.98–11.0) | |
| Median (range) platelet count, × 103/µl | 233 (102–518) | |
| Median (range) PLR | 173 (88–266) | |
BCG – bacillus calmette-guerin, BMI – body mass index, DS – disease stabilization, EV – enfortumab vedotin, NLR – neutrophile-lymphocyte ratio, NMBIC – for non-muscle-invasive bladder cancer, PLR – platelet-lymphocyte ratio, TNM – tumour-node-metastasis