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Table 1 Baseline demographics, disease characteristics, and prior therapies

From: Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS)

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)
  1. ECOG PS Eastern Cooperative Oncology Group performance status; HRD homologous recombination deficiency; LOH loss of heterozygosity.
  2. Data cutoff: February 20, 2020.
  3. a Based on ≥10% genomic LOH cutoff.
  4. 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.
  5. c Patients had an ECOG PS score of 1 at screening but were classified with an ECOG PS score of 2 at baseline.
  6. d Categories are not mutually exclusive.
  7. e Bellmunt risk factors were an ECOG PS score >0, a hemoglobin level <10 g/dL, and presence of liver metastases [29].