PMID- 29541190 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201001 IS - 1792-1074 (Print) IS - 1792-1082 (Electronic) IS - 1792-1074 (Linking) VI - 15 IP - 4 DP - 2018 Apr TI - Multicenter, phase II clinical trial of peptide vaccination with oral chemotherapy following curative resection for stage III colorectal cancer. PG - 4241-4247 LID - 10.3892/ol.2018.7905 [doi] AB - The safety and immunological responsiveness of a peptide vaccine of ring finger protein 43 and 34-kDa translocase of the outer mitochondrial membrane combined with uracil-tegafur/leucovorin (UFT/LV) was previously demonstrated in metastatic colorectal cancer (CRC) in a phase I clinical trial. To clarify the survival benefit of a peptide vaccine combined with UFT/LV as adjuvant treatment, a phase II clinical trial was conducted involving patients with stage III CRC. All enrolled patients, whose human leukocyte antigen (HLA)-A status was double-blinded, were administered the same regime of a peptide vaccine and UFT/LV chemotherapy. The primary objective of the study was to compare relapse-free survival (RFS) in patients with HLA-A*2402 vs. those without HLA-A*2402. Secondary objectives included comparisons between the two groups regarding overall survival, safety, tolerability and peptide-specific activities of cytotoxic T lymphocytes (CTLs) as measured by the ELISPOT assay. Between December 2009 and December 2014, a total of 46 patients were enrolled to the present study. Three-year RFS was not significantly different between HLA-A*2402 matched and unmatched groups [67.8 vs. 73.6%, respectively; hazard ratio (HR)=1.254, 95% confidence interval (CI): 0.48-4.63; P=0.706]. Three-year RFS was significantly better in patients with positive CTL responses in the HLA-A*2402 matched group compared with those without (85.7 and 33.3%, respectively; HR=0.159, 95% CI: 0.023-0.697; P=0.011). In conclusion, vaccination-induced immune responses combined with UFT/LV were positively associated with survival benefit in patients with HLA-A*2402-positive stage III CRC. Further study is required to clarify whether vaccination-induced immune responses shortly following the initiation of therapy can predict the therapeutic effect and help develop a promising therapeutic strategy for patients with stage III CRC. FAU - Kawamura, Junichiro AU - Kawamura J AD - Department of Surgery, Kindai University Faculty of Medicine, Osakasayama, Osaka 589-8511, Japan. FAU - Sugiura, Fumiaki AU - Sugiura F AD - Department of Surgery, Seishukai Aiwa Hospital, Amagasaki, Hyougo 661-0953, Japan. FAU - Sukegawa, Yasushi AU - Sukegawa Y AD - Institute of Immunotherapy for Cancer, Kindai University Faculty of Medicine, Osakasayama, Osaka 589-8511, Japan. FAU - Yoshioka, Yasumasa AU - Yoshioka Y AD - Department of Surgery, Kindai University Faculty of Medicine, Osakasayama, Osaka 589-8511, Japan. FAU - Hida, Jin-Ichi AU - Hida JI AD - Department of Surgery, Kindai University Faculty of Medicine, Osakasayama, Osaka 589-8511, Japan. FAU - Hazama, Shoichi AU - Hazama S AD - Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan. AD - Department of Translational Research and Developmental Therapeutics against Cancer, Yamaguchi University School of Medicine, Ube, Yamaguchi 755-8505, Japan. FAU - Okuno, Kiyotaka AU - Okuno K AD - Department of Surgery, Kindai University Faculty of Medicine, Osakasayama, Osaka 589-8511, Japan. LA - eng PT - Journal Article DEP - 20180129 PL - Greece TA - Oncol Lett JT - Oncology letters JID - 101531236 PMC - PMC5835896 OTO - NOTNLM OT - and adjuvant chemotherapy OT - clinical trial OT - colorectal cancer OT - oral chemotherapy OT - peptide vaccine therapy EDAT- 2018/03/16 06:00 MHDA- 2018/03/16 06:01 PMCR- 2018/01/29 CRDT- 2018/03/16 06:00 PHST- 2017/11/01 00:00 [received] PHST- 2018/01/22 00:00 [accepted] PHST- 2018/03/16 06:00 [entrez] PHST- 2018/03/16 06:00 [pubmed] PHST- 2018/03/16 06:01 [medline] PHST- 2018/01/29 00:00 [pmc-release] AID - OL-0-0-7905 [pii] AID - 10.3892/ol.2018.7905 [doi] PST - ppublish SO - Oncol Lett. 2018 Apr;15(4):4241-4247. doi: 10.3892/ol.2018.7905. Epub 2018 Jan 29.