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© 2019. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

The prognosis of advanced pancreatic adenocarcinoma is still extremely poor. This study sought to determine the efficacy of, and immunological response to, peptide vaccination therapy in patients with this disease. In this multicenter randomized phase II study, patients with advanced pancreatic adenocarcinoma after gemcitabine and/or tegafur/gimeracil/oteracil were randomly assigned to 3 groups that each received a 2‐step treatment course. In Step 1, the groups received treatments of: (i) survivin 2B peptide (SVN‐2B) plus interferon‐β (IFNβ); (ii) SVN‐2B only; or (iii) placebo until the patients show progression. In Step 2, all patients who consented to participate received 4 treatments with SVN‐2B plus IFNβ. The primary endpoint was progression‐free survival (PFS) after initiation of Step 1 treatment. Secondary endpoints included immunological effects assessed by analysis of PBMCs after Step 1. Eighty‐three patients were randomly assigned to receive SVN‐2B plus IFNβ (n = 30), SVN‐2B (n = 34), or placebo (n = 19). No significant improvement in PFS was observed. Survivin 2B‐specific CTLs were found to be increased in the SVN‐2B plus IFNβ group by tetramer assay. Among patients who participated in Step 2, those who had received SVN‐2B plus IFNβ in Step 1 showed better overall survival compared with those who had received placebo in Step 1. Patients vaccinated with SVN‐2B plus IFNβ did not have improved PFS, but showed significant immunological reaction after vaccination. Subgroup analysis suggested that a longer SVN‐2B plus IFNβ vaccination protocol might confer survival benefit. (Clinical trial registration number: UMIN 000012146).

Details

Title
Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA ‐A24‐positive pancreatic adenocarcinoma
Author
Shima, Hiroaki 1 ; Tsurita, Giichiro 2 ; Wada, Satoshi 3 ; Hirohashi, Yoshihiko 4   VIAFID ORCID Logo  ; Yasui, Hiroshi 5 ; Hayashi, Hiroshi 6 ; Miyakoshi, Takashi 6 ; Watanabe, Kazue 4 ; Murai, Aiko 4 ; Asanuma, Hiroko 7 ; Tokita, Serina 4 ; Kubo, Terufumi 4 ; Nakatsugawa, Munehide 4 ; Kanaseki, Takayuki 4 ; Tsukahara, Tomohide 4   VIAFID ORCID Logo  ; Nakae, Yutaka 8 ; Sugita, Osamu 6 ; Ito, Yoichi M 9 ; Ota, Yasunori 10 ; Kimura, Yasutoshi 1 ; Kutomi, Goro 1 ; Hirata, Koichi 1 ; Mizuguchi, Toru 1 ; Imai, Kohzoh 5 ; Takemasa, Ichiro 1 ; Sato, Noriyuki 4 ; Torigoe, Toshihiko 4 

 Department of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan 
 Department of Surgery, Research Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan 
 Department of Clinical Diagnostic Oncology, Showa University, Tokyo, Japan; Cancer Vaccine Center, Kanagawa Cancer Center, Kanagawa, Japan 
 Department of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan 
 The Institute of Medical Science, The University of Tokyo, Tokyo, Japan 
 Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan 
 Department of Surgical Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan 
 Collaboration Center for Community and Industry, Sapporo Medical University School of Medicine, Sapporo, Japan 
 Department of Biostatistics, Hokkaido University Graduate School of Medicine, Sapporo, Japan 
10  Department of Pathology, Research Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan 
Pages
2378-2385
Section
ORIGINAL ARTICLES
Publication year
2019
Publication date
Aug 2019
Publisher
John Wiley & Sons, Inc.
ISSN
13479032
e-ISSN
13497006
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2490379542
Copyright
© 2019. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.