TABLE 1.
Baseline Demographic and Clinical Characteristics
| Patient Characteristic | RC48-C005 (n = 43) | RC48-C009 (n = 64) | Overall (n = 107) | P a |
|---|---|---|---|---|
| Age, years | ||||
| Median | 64.0 | 62.5 | 63.0 | |
| Mean (standard deviation) | 62.3 (8.18) | 61.5 (8.14) | 61.8 (8.13) | .605 |
| Min-max | 45-75 | 40-79 | 40-79 | |
| Sex, No. (%) | .699 | |||
| Male | 33 (76.7) | 47 (73.4) | 80 (74.8) | |
| Female | 10 (23.3) | 17 (26.6) | 27 (25.2) | |
| Primary lesion, No. (%) | ||||
| Bladder | 21 (48.8) | 34 (53.1) | 55 (51.4) | .664 |
| Renal pelvis | 14 (32.6) | 14 (21.9) | 28 (26.2) | .218 |
| Ureter | 10 (23.3) | 20 (31.3) | 30 (28.0) | .367 |
| HER2 status,b No. (%) | .723 | |||
| IHC 3+ or IHC2+ FISH+c | 20 (46.5) | 25 (39.1) | 45 (42.1) | |
| IHC2+ FISH– | 20 (46.5) | 33 (51.6) | 53 (49.5) | |
| IHC2+, FISH unknownd | 3 (7.0) | 6 (9.4) | 9 (8.4) | |
| Current extent of disease, No. (%) | ||||
| Metastatic | 43 (100.0) | 64 (100.0) | 107 (100.0) | |
| Metastasis sites, No. (%) | 40 (93.0) | 63 (98.4) | 103 (96.3) | |
| Lymph nodes | 32 (74.4) | 54 (84.4) | 86 (80.4) | .204 |
| Lungs | 22 (51.2) | 31 (48.4) | 53 (49.5) | .782 |
| Liver | 20 (46.5) | 28 (43.8) | 48 (44.9) | .778 |
| Bone | 16 (37.2) | 32 (50.0) | 48 (44.9) | .192 |
| No. of previous systemic therapies, No. (%) | <.001 | |||
| Only one line | 29 (67.4) | 9 (14.1) | 38 (35.5) | |
| Greater than or equal to two lines | 14 (32.6) | 55 (85.9) | 69 (64.5) | |
| Previous therapies, No. (%) | 36 (83.7) | 56 (87.5) | 92 (86.0) | |
| Cisplatin-containing chemotherapy | 35 (81.4) | 51 (79.7) | 86 (80.4) | .827 |
| PD-1/PD-L1 therapy | 8 (18.6) | 19 (29.7) | 27 (25.2) | .196 |
| Paclitaxel-containing chemotherapy | 15 (34.9) | 64 (100.0) | 79 (73.8) | <.001 |
| Bellmunt score, No. (%)e | .560 | |||
| 0 | 7 (16.3) | 18 (28.1) | 25 (23.4) | |
| 1 | 17 (39.5) | 22 (34.4) | 39 (36.4) | |
| 2 | 17 (39.5) | 21 (32.8) | 38 (35.5) | |
| 3 | 2 (4.7) | 3 (4.7) | 5 (4.7) |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group Performance Status; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; HGB, hemoglobin; IHC, immunohistochemistry; UC, urothelial carcinoma.
P values for comparison of sex, primary lesion, HER2 status, current extent of disease, metastasis sites, number of previous systemic therapies, previous therapies, and Bellmunt score are based on the chi-square test; P value for age comparison is based on the t test.
FISH testing was performed for all the patients with IHC 2+.
Forty patients (37.4%) were classified as IHC 3+, and five patients (4.7%) as IHC2+ FISH+.
The FISH testing results for nine patients are unknown.
The Bellmunt risk score categorizes patients into four risk groups by assigning a point for each of three risk factors; an ECOG PS of >0, a HGB level of <10 g/dL, and the presence of liver metastases.