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 2

Summary of clinical and immunological responses to vaccination with survivin-2B80-88 peptide, IFA, and IFN alpha.

No.	Adverse events (Grade)*	Tetramer staining^†	ELISPOT^‡	Clinical response	Followup; (months)	Outcome
		After/before vaccination	After/before vaccination
1	Fever (1)	3100/3300	98/3	PD	6.5	DOD
2	Fever (1)	2700/600	31/20	SD	14.5	DOD
3	Fever (1)	4400/600	62/36	SD	17.0	DOD
4	Fever (1); Induration at injection site (1)	16400/1700	49/12	SD	32.5	AWD
5	Fever (1)	500/10900	29/8	PD	2.0	DOD
6	Fever (1)	2000/300	32/29	PD	4.0	DOD
7	Induration at injection site (1)	4100/0	41/15	PD	6.5	DOD
8	Fever (1)	2100/2000	49/33	PD	14.5	DOD
9	Fever (1)	2000/500	65/21	SD	7.0	DOD
10	Fever (1)	0/4500	53/6	PD	6.5	AWD
11	None	38900/0	10/0	PD	10.0	DOD
12	Fever (1)	2400/0	117/80	SD	6.0	AWD
13	Fever (1)	0/0	28/9	PD	9.5	DOD
14	None	1200/800	95/14	PD	4.0	AWD
15	Fever (1)	1600/200	616/68	SD	8.5	AWD
16	None	700/300	11/63	PD	5.5	DOD
17	Fever (1)	200/400	39/0	PD	5.5	AWD
18	Fever (1); Induration at injection site (1)	3700/4600	61/32	PD	4.0	AWD
19	None	1400/200	7/5	PD	1.0	AWD
20	None	900/800	25/0	PD	2.0	AWD
21	None	2000/300	0/0	PD	2.0	AWD

 *Adverse events were recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). ^†Cytotoxic T-lymphocyte (CTL) frequency before and after treatment in patients was assessed with an HLA-A24-restricted survivin-2B80-88 (AYACNTSTL) peptide tetramer. An HLA-A24-restricted HIV peptide (RYLRDQQLL) tetramer was used as a negative control. The number of survivin-2B80-88 peptide tetramer-positive but HIV peptide-negative CTLs in 10⁴ CD8 T cells is shown. ^‡Interferon gamma secretion of pre- and postvaccinated patients’ CD8 T cells was assessed with enzyme-linked immunosorbent spot (ELISPOT) assay using T2-A24 cells pulsed with survivin-2B80-88 peptide. The numbers of spots in 5 × 10³ CD8 T cells are shown. SD: stable disease; PD: progressive disease; DOD: dead of disease; AWD: alive with disease.