Table 1.

Patient baseline characteristics (FAS, n = 32)a.

Characteristicn (%)
Median age, years (range)66.5 (44–81)
 ≥18 to <6513 (40.6)
 ≥65 to <8819 (59.4)
Sex
 Male26 (81.3)
 Female6 (18.8)
Race
 Caucasian21 (65.6)
 Black or African American0
 Asian10 (31.3)
 Other1 (3.1)
ECOG PS
 019 (59.4)
 113 (40.6)
Previous disease-related treatment modalities
 Cytotoxic chemotherapy29 (90.6)
 Neoadjuvant3 (9.4)
 Adjuvant4 (12.5)
 First line22 (68.8)
 Second lineb3 (9.4)
 Palliative4 (12.5)
 Not applicableb2 (6.3)
Radiotherapy13 (40.6)
 Adjuvant2 (6.3)
 Definitive1 (3.1)
 Palliative10 (31.3)
 Not applicable2 (6.3)
Primary tumor location
 Bladder26 (81.3)
 Ureter3 (9.4)
 Renal pelvis2 (6.3)
 Unknown1 (3.1)
Metastatic diseasec32 (100)
 Lymph nodes24 (75.0)
 Respiratory16 (50)
 Bone and locomotor12 (37.5)
 Hepatic (liver and gallbladder)11 (34.4)
 Genitourinary10 (31.3)
 Other6 (18.8)
 Gastrointestinal1 (3.1)
 Pericardial effusion1 (3.1)
  • Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; FAS, full analysis set; UC, urothelial carcinoma.

  • aFAS comprises all enrolled patients.

  • bImportant protocol deviations were recorded for 2 patients with second-line chemotherapy in the urothelial carcinoma cohort. One patient received first-line treatment with methotrexate, vinblastine, doxorubicin, and cisplatin, which was recorded in error as second-line treatment. Another patient, E7801006 in the urothelial carcinoma cohort, did not receive any prior chemotherapy; this was not recorded as an important protocol deviation due to error; however, it will be documented during the final analysis.

  • cPatients with an overall disease classification of metastatic may have sites with locally advanced disease.