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Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA‐A24‐positive pancreatic adenocarcinoma
by
Asanuma, Hiroko
, Shima, Hiroaki
, Nakatsugawa, Munehide
, Hayashi, Hiroshi
, Tsukahara, Tomohide
, Hirata, Koichi
, Tokita, Serina
, Watanabe, Kazue
, Kanaseki, Takayuki
, Torigoe, Toshihiko
, Kutomi, Goro
, Wada, Satoshi
, Ota, Yasunori
, Kubo, Terufumi
, Yasui, Hiroshi
, Nakae, Yutaka
, Kimura, Yasutoshi
, Ito, Yoichi M.
, Sato, Noriyuki
, Miyakoshi, Takashi
, Murai, Aiko
, Takemasa, Ichiro
, Tsurita, Giichiro
, Hirohashi, Yoshihiko
, Mizuguchi, Toru
, Imai, Kohzoh
, Sugita, Osamu
in
Adenocarcinoma
/ Adenocarcinoma - drug therapy
/ Adult
/ Aged
/ Aged, 80 and over
/ Antigens
/ Cancer therapies
/ Cancer Vaccines - therapeutic use
/ Chemotherapy
/ Clinical trials
/ Deoxycytidine - analogs & derivatives
/ Deoxycytidine - therapeutic use
/ Double-Blind Method
/ Enrollments
/ Female
/ Gemcitabine
/ Histocompatibility antigen HLA
/ Humans
/ Immune response
/ Immunology
/ immunotherapy
/ interferon beta
/ Interferon-beta - therapeutic use
/ Male
/ Metastasis
/ Middle Aged
/ Mortality
/ Original
/ Pancreas
/ Pancreatic cancer
/ Pancreatic Neoplasms
/ Pancreatic Neoplasms - drug therapy
/ Patients
/ peptide vaccination
/ Peptides
/ Peptides - therapeutic use
/ Placebos
/ Prognosis
/ Progression-Free Survival
/ Proteins
/ Radiation therapy
/ Registration
/ Statistical analysis
/ Survival
/ Survivin
/ Survivin - therapeutic use
/ Tegafur
/ Vaccination
/ Vaccination - methods
/ Vaccines, Subunit - therapeutic use
/ β-Interferon
2019
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Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA‐A24‐positive pancreatic adenocarcinoma
by
Asanuma, Hiroko
, Shima, Hiroaki
, Nakatsugawa, Munehide
, Hayashi, Hiroshi
, Tsukahara, Tomohide
, Hirata, Koichi
, Tokita, Serina
, Watanabe, Kazue
, Kanaseki, Takayuki
, Torigoe, Toshihiko
, Kutomi, Goro
, Wada, Satoshi
, Ota, Yasunori
, Kubo, Terufumi
, Yasui, Hiroshi
, Nakae, Yutaka
, Kimura, Yasutoshi
, Ito, Yoichi M.
, Sato, Noriyuki
, Miyakoshi, Takashi
, Murai, Aiko
, Takemasa, Ichiro
, Tsurita, Giichiro
, Hirohashi, Yoshihiko
, Mizuguchi, Toru
, Imai, Kohzoh
, Sugita, Osamu
in
Adenocarcinoma
/ Adenocarcinoma - drug therapy
/ Adult
/ Aged
/ Aged, 80 and over
/ Antigens
/ Cancer therapies
/ Cancer Vaccines - therapeutic use
/ Chemotherapy
/ Clinical trials
/ Deoxycytidine - analogs & derivatives
/ Deoxycytidine - therapeutic use
/ Double-Blind Method
/ Enrollments
/ Female
/ Gemcitabine
/ Histocompatibility antigen HLA
/ Humans
/ Immune response
/ Immunology
/ immunotherapy
/ interferon beta
/ Interferon-beta - therapeutic use
/ Male
/ Metastasis
/ Middle Aged
/ Mortality
/ Original
/ Pancreas
/ Pancreatic cancer
/ Pancreatic Neoplasms
/ Pancreatic Neoplasms - drug therapy
/ Patients
/ peptide vaccination
/ Peptides
/ Peptides - therapeutic use
/ Placebos
/ Prognosis
/ Progression-Free Survival
/ Proteins
/ Radiation therapy
/ Registration
/ Statistical analysis
/ Survival
/ Survivin
/ Survivin - therapeutic use
/ Tegafur
/ Vaccination
/ Vaccination - methods
/ Vaccines, Subunit - therapeutic use
/ β-Interferon
2019
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Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA‐A24‐positive pancreatic adenocarcinoma
by
Asanuma, Hiroko
, Shima, Hiroaki
, Nakatsugawa, Munehide
, Hayashi, Hiroshi
, Tsukahara, Tomohide
, Hirata, Koichi
, Tokita, Serina
, Watanabe, Kazue
, Kanaseki, Takayuki
, Torigoe, Toshihiko
, Kutomi, Goro
, Wada, Satoshi
, Ota, Yasunori
, Kubo, Terufumi
, Yasui, Hiroshi
, Nakae, Yutaka
, Kimura, Yasutoshi
, Ito, Yoichi M.
, Sato, Noriyuki
, Miyakoshi, Takashi
, Murai, Aiko
, Takemasa, Ichiro
, Tsurita, Giichiro
, Hirohashi, Yoshihiko
, Mizuguchi, Toru
, Imai, Kohzoh
, Sugita, Osamu
in
Adenocarcinoma
/ Adenocarcinoma - drug therapy
/ Adult
/ Aged
/ Aged, 80 and over
/ Antigens
/ Cancer therapies
/ Cancer Vaccines - therapeutic use
/ Chemotherapy
/ Clinical trials
/ Deoxycytidine - analogs & derivatives
/ Deoxycytidine - therapeutic use
/ Double-Blind Method
/ Enrollments
/ Female
/ Gemcitabine
/ Histocompatibility antigen HLA
/ Humans
/ Immune response
/ Immunology
/ immunotherapy
/ interferon beta
/ Interferon-beta - therapeutic use
/ Male
/ Metastasis
/ Middle Aged
/ Mortality
/ Original
/ Pancreas
/ Pancreatic cancer
/ Pancreatic Neoplasms
/ Pancreatic Neoplasms - drug therapy
/ Patients
/ peptide vaccination
/ Peptides
/ Peptides - therapeutic use
/ Placebos
/ Prognosis
/ Progression-Free Survival
/ Proteins
/ Radiation therapy
/ Registration
/ Statistical analysis
/ Survival
/ Survivin
/ Survivin - therapeutic use
/ Tegafur
/ Vaccination
/ Vaccination - methods
/ Vaccines, Subunit - therapeutic use
/ β-Interferon
2019
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Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA‐A24‐positive pancreatic adenocarcinoma
Journal Article
Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA‐A24‐positive pancreatic adenocarcinoma
2019
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Overview
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). Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA‐A24‐positive pancreatic adenocarcinoma is reported. Although peptide vaccination did not improved progression‐free survival, subgroup analysis revealed that longer peptide vaccination might confer survival benefit.
Publisher
John Wiley & Sons, Inc,John Wiley and Sons Inc
Subject
/ Adenocarcinoma - drug therapy
/ Adult
/ Aged
/ Antigens
/ Cancer Vaccines - therapeutic use
/ Deoxycytidine - analogs & derivatives
/ Deoxycytidine - therapeutic use
/ Female
/ Histocompatibility antigen HLA
/ Humans
/ Interferon-beta - therapeutic use
/ Male
/ Original
/ Pancreas
/ Pancreatic Neoplasms - drug therapy
/ Patients
/ Peptides
/ Placebos
/ Proteins
/ Survival
/ Survivin
/ Tegafur
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