Table 3.

Objective response rates by baseline subgroups

Subgroup	Patients	Objective response rate, n (% [95% CI])*
All patients	119	27 (23% [16–31])
Demographics and prior treatment
Age ≥80 years	25	7 (28% [12–49])
Perioperative chemotherapy†	22	8 (36% [17–59])
Primary tumour sites‡
Bladder/urethra	85	14 (17% [9–26])
Upper tract	33	13 (39% [23–58])
Metastatic sites at baseline
Lymph node only	31	10 (32% [17–51])
Visceral§	78	11 (14% [7–24])
Liver	25	2 (8% [1–26])
Cisplatin ineligibility criteria
Impaired renal function	83	21 (25% [16–36])
ECOG PS 2	24	6 (25% [10–47])
Hearing loss, 25 dB	17	2 (12% [2–36])
Peripheral neuropathy, grade ≥2	7	1 (14% [0–58])
Renal impairment and ECOG PS 2	8	2 (25% [3–65])
Bajorin risk factors‖
0	35	12 (34% [19–52])
1	66	13 (20% [11–31])
2	18	2 (11% [1–35])

ECOG PS=Eastern Cooperative Oncology Group performance status. NE=not estimable.

^*Includes objective response rate per Response Evaluation Criteria In Solid Tumors version 1.1 (independent review facility).

^†Includes adjuvant or neoadjuvant treatment with disease progression experienced beyond 12 months.

^‡One patient with prostatic urethra primary site not included.

^§Visceral metastasis defined as liver, lung, bone, or any non–lymph node or soft tissue metastasis.

^‖Risk factors include baseline ECOG PS >1 and baseline visceral metastasis. Data cutoff: July 4, 2016.