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Oncoimmunology. 2016 Jan 19;5(5):e1129483. doi: 10.1080/2162402X.2015.1129483. eCollection 2016 May.

Phase II study of the GPC3-derived peptide vaccine as an adjuvant therapy for hepatocellular carcinoma patients.

Author information

1
Division of Cancer Immunotherapy, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, Japan; Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Kanazawa-ku, Yokohama, Japan.
2
Division of Cancer Immunotherapy, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center , Kashiwa, Chiba, Japan.
3
Division of Cancer Immunotherapy, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, Japan; Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Kita-ku, Okayama, Japan.
4
Division of Surgery, National Cancer Center, Hospital East , Kashiwa, Chiba, Japan.
5
Aichi Cancer Center Hospital , Chikusa-ku, Nagoya, Japan.
6
Division of Hepatobiliary & Pancreatic Medical Oncology, National Cancer Center Hospital East , Kashiwa, Chiba, Japan.
7
Department of Dermatology, National Cancer Center Hospital , Chuo-ku, Tokyo, Japan.
8
Department of Digestive Surgery, Nihon University School of Medicine , Itabashi-ku, Tokyo, Japan.
9
Department of Gastroenterology, Aichi Cancer Center Hospital , Chikusa-ku, Nagoya, Japan.
10
Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center Hospital , Sunto- Nagaizumi, Shizuoka, Japan.
11
Department of Medical Oncology, Kyorin University School of Medicine , Mitaka-shi, Tokyo, Japan.
12
Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine , Kanazawa-ku, Yokohama, Japan.

Abstract

The recurrence rates of Hepatocellular carcinoma (HCC) are high, necessitating novel and effective adjuvant therapies. Therefore, we conducted a phase II study of glypican-3 (GPC3) peptide vaccine as an adjuvant therapy for HCC patients. Forty-one patients with initial HCC who had undergone surgery or radiofrequency ablation (RFA) were analyzed in this phase II, open-label, single-arm trial. Ten vaccinations were performed for 1 y after curative treatment. We also investigated case-control subjects, where selected patients treated surgically during the same period were analyzed. The expression of GPC3 in the available primary tumors was determined by immunohistochemical analysis. Six patients received RFA therapy while 35 received surgery. The recurrence rate tended to be lower in the 35 patients treated with surgery plus vaccination compared to 33 patients who underwent surgery alone (28.6% vs. 54.3% and 39.4% vs. 54.5% at 1 and 2 y, respectively; p = 0.346, 0.983). Twenty-five patients treated with surgery and vaccination had GPC3-positive tumors; the recurrence rate in this group was significantly lower compared to that in 21 GPC3-positive patients who received surgery only (24% vs. 48% and 52.4% vs. 61.9% at 1 and 2 y, respectively; p = 0.047, 0.387). The GPC3 peptide vaccine improved the 1-y recurrence rate in patients with GPC3-positive tumors. This study demonstrated that GPC3 expression by the primary tumor may be used as a biomarker in a putative larger randomized clinical trial to determine the efficacy of the GPC3-derived peptide vaccine.

KEYWORDS:

Adjuvant therapy; CTL; HCC; glypican-3; peptide vaccine

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