Phase II clinical trial using novel peptide cocktail vaccine as a postoperative adjuvant treatment for surgically resected pancreatic cancer patients. Issue 4 (21st November 2016)

• Record Type: Journal Article
• Authors: Miyazawa, Motoki; Katsuda, Masahiro; Maguchi, Hiroyuki; Katanuma, Akio; Ishii, Hiroshi; Ozaka, Masato; Yamao, Kenji; Imaoka, Hiroshi; Kawai, Manabu; Hirono, Seiko; Okada, Ken‐ichi; Yamaue, Hiroki
• Is Part Of: International journal of cancer. Volume 140:Issue 4(2017:Feb. 15)
• Page Start: 973
• Page End: 982
• Publication Date: 2016-11-21
• Subjects: pancreatic cancer -- adjuvant therapy -- peptide vaccine -- KIF20A -- predictive marker; Cancer -- Periodicals; Cancer -- Prevention -- Periodicals; 616.994
• DOI: 10.1002/ijc.30510
• Languages: English
• ISSNs: 0020-7136

Abstract

Abstract : We investigated peptide cocktail vaccine OCV‐C01 containing epitope peptides derived from KIF20A, vascular endothelial growth factor receptor (VEGFR)1 and VEGFR2 combined with gemcitabine in the adjuvant treatment for resected pancreatic cancer patients. A single‐arm multicenter phase II study was performed on 30 patients with pancreatic ductal carcinoma who underwent pancreatectomy. At each 28‐day treatment cycle, patients received weekly subcutaneous injection of OCV‐C01 for 48 weeks and gemcitabine was administered intravenously at 1, 000 mg/m 2 on days 1, 8 and 15 for 24 weeks. Patients were followed for 18 months. The primary endpoint was disease‐free survival (DFS) and secondary endpoints included safety, overall survival (OS) and immunological assays on peptide‐specific cytotoxic T lymphocyte (CTL) activity and KIF20A expression in resected pancreatic cancer. The median DFS was 15.8 months [95% confidence interval (CI), 11.1–20.6] and the DFS rate at 18 months was 34.6% (95% CI, 18.3–51.6). The median OS was not reached and the OS rate at 18 months was 69.0% (95% CI, 48.8–82.5). The administration of OCV‐C01 was well tolerated. In the per protocol set, there were significant differences in DFS between patients with KIF20A‐specific CTL responses and without ( p = 0.027), and between patients with KIF20A expression and without ( p = 0.014). In addition, all four patients who underwent R0 resection with KIF20A expression had no recurrence of pancreatic cancer with KIF20A‐specific CTL responses. OCV‐C01 combined with gemcitabine was tolerable with a median DFS of 15.8 months, which was favorable compared with previous data for resected pancreatic cancer. Abstract : What's new? Developing effective cancer vaccines still presents significant challenges. One promising strategy is to use a cocktail of peptides to induce an immune response against several cancer‐related antigens. In this phase II study, the authors tested a multi‐peptide vaccine for pancreatic cancer therapy, containing peptides derived from VEGFR and a kinesin‐family protein (KIF20A). The results indicate that the disease‐free survival (DFS) of patients whose tumors express KIF20A might be prolonged by use of this vaccine after resection.