Table 1.
Baseline demographics, disease characteristics, and prior therapies
| Characteristic | HRD subgroupa | Overall (N = 97) | ||
|---|---|---|---|---|
| Positive (n = 20) | Negative (n = 30) | Indeterminateb (n = 47) | ||
| Age, median (range), y | 71 (39–87) | 66 (47–85) | 66 (50–85) | 66 (39–87) |
| Sex, n (%) | ||||
| Male | 11 (55.0) | 27 (90.0) | 38 (80.9) | 76 (78.4) |
| Female | 9 (45.0) | 3 (10.0) | 9 (19.1) | 21 (21.6) |
| Race, n (%) | ||||
| White | 18 (90.0) | 24 (80.0) | 32 (68.1) | 74 (76.3) |
| Black or African American | 0 | 2 (6.7) | 1 (2.1) | 3 (3.1) |
| Other | 0 | 1 (3.3) | 2 (4.3) | 3 (3.1) |
| Unknown | 2 (10.0) | 3 (10.0) | 12 (25.5) | 17 (17.5) |
| ECOG PS, n (%) | ||||
| 0 | 6 (30.0) | 9 (30.0) | 14 (29.8) | 29 (29.9) |
| 1 | 14 (70.0) | 20 (66.7) | 32 (68.1) | 66 (68.0) |
| 2c | 0 | 1 (3.3) | 1 (2.1) | 2 (2.1) |
| Histology, n (%) | ||||
| Urothelial | 14 (70.0) | 25 (83.3) | 30 (63.8) | 69 (71.1) |
| Urothelial with variant | 5 (25.0) | 2 (6.7) | 7 (14.9) | 14 (14.4) |
| Unknown | 1 (5.0) | 3 (10.0) | 10 (21.3) | 14 (14.4) |
| Tumor location in bladder, n (%) | ||||
| Lower tract | 17 (85.0) | 22 (73.3) | 37 (78.7) | 76 (78.4) |
| Upper tract | 3 (15.0) | 8 (26.7) | 10 (21.3) | 21 (21.6) |
| No. of prior therapies, n (%) | ||||
| 1 | 11 (55.0) | 16 (53.3) | 26 (55.3) | 53 (54.6) |
| 2 | 9 (45.0) | 14 (46.7) | 21 (44.7) | 44 (45.4) |
| Prior therapies, n (%)d | ||||
| Cisplatin-based chemotherapy | 13 (65.0) | 20 (66.7) | 26 (55.3) | 59 (60.8) |
| Carboplatin-based chemotherapy | 5 (25.0) | 8 (26.7) | 21 (44.7) | 34 (35.1) |
| Immune checkpoint inhibitor | 14 (70.0) | 23 (76.7) | 34 (72.3) | 71 (73.2) |
| Platinum-based chemotherapy and immune checkpoint inhibitor | 12 (60.0) | 21 (70.0) | 34 (72.3) | 67 (69.1) |
| Cystectomy/nephroureterectomy | 8 (40.0) | 17 (56.7) | 22 (46.8) | 47 (48.5) |
| Time from prior systemic therapy, n (%) | ||||
| <3 months | 15 (75.0) | 18 (60.0) | 27 (57.4) | 60 (61.9) |
| ≥3 months | 5 (25.0) | 12 (40.0) | 20 (42.6) | 37 (38.1) |
| De novo metastases, n (%) | 12 (60.0) | 6 (20.0) | 12 (25.5) | 30 (30.9) |
| Site of metastases, n (%)d | ||||
| Nodal metastases | 3 (15.0) | 7 (23.3) | 14 (29.8) | 24 (24.7) |
| Visceral metastases | 9 (45.0) | 20 (66.7) | 23 (48.9) | 52 (53.6) |
| Liver metastases | 9 (45.0) | 12 (40.0) | 14 (29.8) | 35 (36.1) |
| No. of Bellmunt risk factors, n (%)e | ||||
| 0 | 3 (15.0) | 6 (20.0) | 8 (17.0) | 17 (17.5) |
| 1 | 9 (45.0) | 10 (33.3) | 23 (48.9) | 42 (43.3) |
| 2 | 7 (35.0) | 11 (36.7) | 14 (29.8) | 32 (33.0) |
| 3 | 1 (5.0) | 3 (10.0) | 2 (4.3) | 6 (6.2) |
ECOG PS Eastern Cooperative Oncology Group performance status; HRD homologous recombination deficiency; LOH loss of heterozygosity.
Data cutoff: February 20, 2020.
a Based on ≥10% genomic LOH cutoff.
b Tumor sample was either not received or not evaluable for percentage of genomic LOH because of insufficient tissue volume, low tumor content, inadequate DNA extraction, or the sample did not meet quality control metrics resulting in reduced sequencing specificity.
c Patients had an ECOG PS score of 1 at screening but were classified with an ECOG PS score of 2 at baseline.
d Categories are not mutually exclusive.
e Bellmunt risk factors were an ECOG PS score >0, a hemoglobin level <10 g/dL, and presence of liver metastases [29].