論文

査読有り 国際誌
2020年5月

Mixed 20-peptide cancer vaccine in combination with docetaxel and dexamethasone for castration-resistant prostate cancer: a randomized phase II trial.

Cancer immunology, immunotherapy : CII
  • Masanori Noguchi
  • Gaku Arai
  • Shin Egawa
  • Chikara Ohyama
  • Seiji Naito
  • Kazumasa Matsumoto
  • Hirotsugu Uemura
  • Masayuki Nakagawa
  • Yasutomo Nasu
  • Masatoshi Eto
  • Shigetaka Suekane
  • Tetsuro Sasada
  • Shigeki Shichijo
  • Akira Yamada
  • Tatsuyuki Kakuma
  • Kyogo Itoh
  • 全て表示

69
5
開始ページ
847
終了ページ
857
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s00262-020-02498-8

A novel cancer vaccine consisting of 20 mixed peptides (KRM-20) was designed to induce cytotoxic T lymphocytes (CTL) against twelve different tumor-associated antigens. The aim of this phase II trial was to examine whether KRM-20 in combination with docetaxel and dexamethasone enhances the antitumor effects in patients with castration-resistant prostate cancer (CRPC). In this double-blind, placebo-controlled, randomized phase II study, we enrolled chemotherapy-naïve patients with CRPC from ten medical centers in Japan. Eligible patients were randomly assigned 1:1 centrally to receive either KRM-20 combined with docetaxel and dexamethasone (n = 25) or placebo with docetaxel and dexamethasone (n = 26). The primary endpoint was the difference in prostate-specific antigen (PSA) decline between each treatment. The rates of > 50% PSA decline in the two arms were similar (56.5% versus 53.8%; P = 0.851). Human leukocyte antigen (HLA)-matched peptide-specific immunoglobulin G (P = 0.018) and CTL (P = 0.007) responses in the KRM-20 arm significantly increased after treatment. The addition of KRM-20 did not increase toxicity. There were no between-group differences in progression-free or overall survival (OS). The addition of KRM-20 was safe, and similar PSA decline and HLA-matched peptide-specific CTL and IgG responses increased in combination with docetaxel and dexamethasone in CRPC patients. Subgroup analysis suggested that this treatment is favorable for CRPC patients with ≥ 26% lymphocytes or PSA levels of < 11.2 ng/ml, but further clinical trials comparing OS are required.

リンク情報
DOI
https://doi.org/10.1007/s00262-020-02498-8
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/32025848
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183507
ID情報
  • DOI : 10.1007/s00262-020-02498-8
  • PubMed ID : 32025848
  • PubMed Central 記事ID : PMC7183507

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