PMID- 24363758 OWN - NLM STAT- MEDLINE DCOM- 20140804 LR - 20211021 IS - 1740-2530 (Electronic) IS - 1740-2522 (Print) IS - 1740-2522 (Linking) VI - 2013 DP - 2013 TI - 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. PG - 262967 LID - 10.1155/2013/262967 [doi] LID - 262967 AB - We previously identified a human leukocyte antigen (HLA)-A24-restricted antigenic peptide, survivin-2B80-88, a member of the inhibitor of apoptosis protein family, recognized by CD8+cytotoxic T lymphocytes (CTL). In a phase I clinical trial of survivin-2B80-88 vaccination for metastatic urothelial cancer (MUC), we achieved clinical and immunological responses with safety. Moreover, our previous study indicated that interferon alpha (IFN alpha ) enhanced the effects of the vaccine for colorectal cancer. Therefore, we started a new phase I clinical trial of survivin-2B80-88 vaccination with IFN alpha for MUC patients. Twenty-one patients were enrolled and no severe adverse event was observed. HLA-A24/survivin-2B80-88 tetramer analysis and ELISPOT assay revealed a significant increase in the frequency of the peptide-specific CTLs after vaccination in nine patients. Six patients had stable disease. The effects of IFN alpha on the vaccination were unclear for MUC. Throughout two trials, 30 MUO patients received survivin-2B80-88 vaccination. Patients receiving the vaccination had significantly better overall survival than a comparable control group of MUO patients without vaccination (P = 0.0009). Survivin-2B80-88 vaccination may be a promising therapy for selected patients with MUC refractory to standard chemotherapy. This trial was registered with UMIN00005859. FAU - Tanaka, Toshiaki AU - Tanaka T AD - Department of Urology, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan. FAU - Kitamura, Hiroshi AU - Kitamura H AD - Department of Urology, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan. FAU - Inoue, Ryuta AU - Inoue R AD - Department of Urology, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan. FAU - Nishida, Sachiyo AU - Nishida S AD - Department of Urology, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan. FAU - Takahashi-Takaya, Akari AU - Takahashi-Takaya A AD - 1st Department of Pathology, Sapporo Medical University School of Medicine, South-1, West-17, Chuo-ku, Sapporo 060-8556, Japan. FAU - Kawami, Sachiyo AU - Kawami S AD - 1st Department of Pathology, Sapporo Medical University School of Medicine, South-1, West-17, Chuo-ku, Sapporo 060-8556, Japan. FAU - Torigoe, Toshihiko AU - Torigoe T AD - 1st Department of Pathology, Sapporo Medical University School of Medicine, South-1, West-17, Chuo-ku, Sapporo 060-8556, Japan. FAU - Hirohashi, Yoshihiko AU - Hirohashi Y AD - 1st Department of Pathology, Sapporo Medical University School of Medicine, South-1, West-17, Chuo-ku, Sapporo 060-8556, Japan. FAU - Tsukamoto, Taiji AU - Tsukamoto T AD - Department of Urology, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan. FAU - Sato, Noriyuki AU - Sato N AD - 1st Department of Pathology, Sapporo Medical University School of Medicine, South-1, West-17, Chuo-ku, Sapporo 060-8556, Japan. FAU - Masumori, Naoya AU - Masumori N AD - Department of Urology, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan. LA - eng PT - Clinical Trial, Phase I PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20131120 PL - Egypt TA - Clin Dev Immunol JT - Clinical & developmental immunology JID - 101183692 RN - 0 (BIRC5 protein, human) RN - 0 (Cancer Vaccines) RN - 0 (Inhibitor of Apoptosis Proteins) RN - 0 (Interferon-alpha) RN - 0 (Peptide Fragments) RN - 0 (Survivin) RN - 0 (Vaccines, Subunit) SB - IM MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Cancer Vaccines/adverse effects/*immunology MH - Female MH - Humans MH - Inhibitor of Apoptosis Proteins/adverse effects/chemistry/*immunology MH - Interferon-alpha/*therapeutic use MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local MH - Neoplasm Staging MH - Peptide Fragments/immunology MH - Prognosis MH - Survivin MH - T-Lymphocytes, Cytotoxic/immunology MH - Treatment Outcome MH - Urologic Neoplasms/*immunology/mortality/pathology/*therapy MH - Vaccines, Subunit/adverse effects/*immunology PMC - PMC3863714 EDAT- 2013/12/24 06:00 MHDA- 2014/08/05 06:00 PMCR- 2013/11/20 CRDT- 2013/12/24 06:00 PHST- 2013/08/05 00:00 [received] PHST- 2013/09/30 00:00 [accepted] PHST- 2013/12/24 06:00 [entrez] PHST- 2013/12/24 06:00 [pubmed] PHST- 2014/08/05 06:00 [medline] PHST- 2013/11/20 00:00 [pmc-release] AID - 10.1155/2013/262967 [doi] PST - ppublish SO - Clin Dev Immunol. 2013;2013:262967. doi: 10.1155/2013/262967. Epub 2013 Nov 20.