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


ABSTRACT: 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

SUBMITTER: Noguchi M 

PROVIDER: S-EPMC7183507 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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

Noguchi Masanori M   Arai Gaku G   Egawa Shin S   Ohyama Chikara C   Naito Seiji S   Matsumoto Kazumasa K   Uemura Hirotsugu H   Nakagawa Masayuki M   Nasu Yasutomo Y   Eto Masatoshi M   Suekane Shigetaka S   Sasada Tetsuro T   Shichijo Shigeki S   Yamada Akira A   Kakuma Tatsuyuki T   Itoh Kyogo K  

Cancer immunology, immunotherapy : CII 20200205 5


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 m  ...[more]

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