Table 1.
Baseline demographics and clinical characteristics.
| Characteristic | Avelumab 1LM (n = 214) |
|---|---|
| Age at la/mUC diagnosis, years | |
| Mean (Std Dev) | 69.0 (9.2) |
| Median (Q1, Q3) | 70.0 (64.0, 76.0) |
| Year of index date, n (%) | |
| 2020 | 43 (20.1) |
| 2021 | 75 (35.0) |
| 2022 | 96 (44.9) |
| Sex, n (%) | |
| Male | 164 (76.6) |
| Female | 50 (23.4) |
| Race, n (%) | |
| White | 142 (66.4) |
| Other | 31 (14.5) |
| Black or African American | 6 (2.8) |
| Asian | 2 (0.9) |
| Unknown | 33 (15.4) |
| Region of residence, n (%) | |
| South | 99 (46.3) |
| Northeast | 37 (17.3) |
| Midwest | 30 (14.0) |
| West | 23 (10.7) |
| Other | 1 (0.5) |
| Unknown | 24 (11.2) |
| Practice type, n (%) | |
| Community | 191 (89.3) |
| Academic | 18 (8.4) |
| Both | 5 (2.3) |
| Site of disease, n (%) | |
| Bladder | 158 (73.8) |
| Renal pelvis | 30 (14.0) |
| Ureter | 24 (11.2) |
| Urethra | 2 (0.9) |
| Disease grade, n (%) | |
| High grade (G2/G3/G4) | 174 (81.3) |
| Low grade (G1) | 12 (5.6) |
| Unknown/not documented | 28 (13.1) |
| Stage at initial diagnosis, n (%) | |
| 0 | 2 (0.9) |
| I | 3 (1.4) |
| II | 9 (4.2) |
| III | 7 (3.3) |
| IV | 99 (46.3) |
| Unknown/not documented | 94 (43.9) |
| ECOG PS at la/mUC diagnosis date, n (%) | |
| 0 | 69 (32.2) |
| 1 | 96 (44.9) |
| 2+ | 21 (9.8) |
| Unknown/not documented | 28 (13.1) |
| Body mass index, kg/m2, n (%) | |
| Underweight (<18.5) | 9 (4.2) |
| Normal (18.5–24.9) | 69 (32.2) |
| Overweight (25–29.9) | 59 (27.6) |
| Obese (≥30) | 60 (28.0) |
| Unknown | 17 (7.9) |
| Sites of metastases, n (%) | |
| Distant lymph node | 122 (57.0) |
| Bone | 63 (29.4) |
| Lung | 58 (27.1) |
| Liver | 37 (17.3) |
| Soft tissue | 21 (9.8) |
| Peritoneum | 8 (3.7) |
| Other | 6 (2.8) |
| Pleura | 5 (2.3) |
| Adrenal | 5 (2.3) |
| Brain | 2 (0.9) |
| Skin | 1 (0.5) |
| Kidney | 1 (0.5) |
| PD-L1 status, n (%) | |
| Positive | 25 (11.7) |
| Negative | 39 (18.2) |
| Unknown/not documented | 150 (70.1) |
| Follow-up time, months | |
| Median (Q1, Q3) | 8.7 (4.5, 15.7) |
| 1L carboplatin-based regimens (n = 99, 46.3%), n (%) | |
| Carboplatin plus gemcitabine | 98 (99.0) |
| Carboplatin plus paclitaxel | 1 (1.0) |
| 1L cisplatin-based regimens (n = 115, 53.7%), n (%) | |
| Cisplatin plus gemcitabine | 101 (87.8) |
| MVAC | 8 (7.0) |
| Cisplatin monotherapy | 2 (1.7) |
| Cisplatin, bicalutamide, gemcitabine, and leuprolide | 1 (0.9) |
| Cisplatin, gemcitabine, and hydroxyurea | 1 (0.9) |
| Cisplatin plus paclitaxel | 1 (0.9) |
| MVAC plus leuprolide | 1 (0.9) |
| Best response to 1L PBC *, n (%) | |
| rwCR | 14 (6.9) |
| rwPR | 159 (78.7) |
| rwSD | 29 (14.4) |
Due to rounding, percentages may not add up to 100%. Abbreviations: 1L, first line; 1LM, first-line maintenance; ECOG PS, Eastern Cooperative Oncology Group performance status; G, grade; la/mUC, locally advanced/metastatic urothelial carcinoma; MVAC, methotrexate, vinblastine sulfate, doxorubicin, and cisplatin; PBC, platinum-based chemotherapy; Q1, first quartile; Q3, third quartile; rwCR, real-world complete response; rwPR, real-world partial response; rwSD, real-world stable disease; Std Dev, standard deviation. * 202 patients had a recorded response to 1L PBC.