Potential Survival Benefit of Anti-Apoptosis Protein: Survivin-Derived Peptide Vaccine with and without Interferon Alpha Therapy for Patients with Advanced or Recurrent Urothelial Cancer—Results from Phase I Clinical Trials

Table 3

Baseline characteristics and immunological responses in Study 1 and Study 2.

	Study 1	Study 2	P value
𝑛	9	21
Age	58.1 ± 9.1	65.7 ± 10.3	0.0593
Sex (male/female)	4/5	15/6	0.2252
Primary site (UUT/bladder)	1/8	11/10	0.0492
Visceral metastases	4 (44.4%)	11 (52.4%)	0.9999
Prior chemotherapy	9 (100%)	18 (85.7%)	0.2320
ECOG PS (0/1/2)	4/5/0	10/9/2	0.9999
Induction of CTLs	5 (71.4%)*	9 (42.8%)	0.3845
Non-PD in clinical response	2 (33.3%)^†	6 (28.6%)	0.6424

 *Immunological results were obtained in 7 of 9 cases. ^†Clinical responses were assessed in 6 cases. UUT: upper urinary tract; ECOG PS: Eastern Cooperative Oncology Group performance status; CTL: cytotoxic T-lymphocyte; PD: progressive disease.