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Phase II study of personalized peptide vaccination for castration‐resistant prostate cancer patients who failed in docetaxel‐based chemotherapy
Author(s) -
Noguchi Masanori,
Moriya Fukuko,
Suekane Shigetaka,
Matsuoka Kei,
Arai Gaku,
Matsueda Satoko,
Sasada Tetsuro,
Yamada Akira,
Itoh Kyogo
Publication year - 2011
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/pros.21485
Subject(s) - docetaxel , medicine , dbc , prostate cancer , hazard ratio , oncology , chemotherapy , vaccination , cancer , confidence interval , immunology , physics , phase noise , optics
BACKGROUND Docetaxel‐based chemotherapy (DBC) showed limited clinical efficacy for castration‐resistant prostate cancer (CRPC) patients. To explore cancer vaccine as a new treatment modality, we conducted a phase II study of personalized peptide vaccine (PPV) for DBC‐resistant CRPC patients. METHODS Twenty DBC‐resistant CRPC patients and 22 patients with no prior DBC, as a control, were treated with PPV using peptides chosen from 31 peptides in patients, respectively. Cytokines, inflammatory markers, and immune responses were measured as candidate biomarkers. DBC‐resistant CRPC patients without PPV was set as a historical control for evaluation of clinical benefit of PPV. RESULTS Median overall survival (OS) time from the first vaccination was 14.8 months or not reached in DBC‐resistant CRPC patients and patients with no prior DBC (log‐rank; P = 0.07), respectively. Median OS time from the first day of progression disease was 17.8 and 10.5 months in DBC‐resistant CRPC patients receiving PPV and those with no PPV ( P = 0.1656), respectively. Elevated IL‐6 levels before vaccination was an unfavorable factor for OS of DBC‐resistant CRPC patients ( P = 0.0161, hazard ratio (HR): 0.024, 95% CI:0.001–0.499) as well as all 42 patients with PPV( P = 0.0011, HR: 0.212, 95% CI:0.068–0.661) by multivariable analysis. CONCLUSIONS Further clinical study of PPV is recommended for DBC‐resistant CRPC patients, because of the safety and possible prolongation of MST. Control of elevated IL‐6 by combined therapy may provide much better clinical outcome. Prostate 72:834–845, 2012. © 2011 Wiley Periodicals, Inc.