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- Title
A phase I/IIa study of adjuvant immunotherapy with tumour antigen-pulsed dendritic cells in patients with hepatocellular carcinoma.
- Authors
Lee, Jeong-Hoon; Lee, Yoon; Lee, Minjong; Heo, Min Kyu; Song, Jae-Sung; Kim, Ki-Hwan; Lee, Hyunah; Yi, Nam-Joon; Lee, Kwang-Woong; Suh, Kyung-Suk; Bae, Yong-Soo; Kim, Yoon Jun
- Abstract
<bold>Background: </bold>To date, no adjuvant treatment has been shown to have a clear benefit in patients with hepatocellular carcinoma (HCC). In this prospective phase I/IIa study, we evaluated the safety and efficacy of adjuvant dendritic cell (DC) therapy in HCC patients who received primary treatment for HCC.<bold>Methods: </bold>Twelve HCC patients who had no viable tumour after primary treatments were included. Dendritic cell vaccines pulsed with cytoplasmic transduction peptide-attached alpha-fetoprotein, glypican-3 and melanoma-associated antigen 1 recombinant fusion proteins were injected subcutaneously near to inguinal lymph nodes. Adverse effects, time to progression (TTP), and associated immune responses were evaluated after DC vaccination.<bold>Results: </bold>Nine of 12 patients had no tumour recurrence up to 24 weeks after DC vaccination. Among a total of 144 adverse events, 129 events (89.6%) were regarded as adverse drug reactions, all of which were grade 1 or 2. The majority of patients showed enhanced anti-tumour immune responses after DC vaccination. Recurrence-free patients exhibited relatively stronger anti-tumour immune responses than patients who developed recurrence after DC vaccination, as evidenced by lymphocyte proliferation and IFN-γ ELISPOT assays. The median time of TTP was 36.6 months in the DC-vaccination group and 11.8 months in the control group (hazard ratio, 0.41; 95% confidence interval, 0.18-0.95; P=0.0031 by log-rank test).<bold>Conclusions: </bold>Adjuvant DC vaccine for HCC was safe and well tolerated in phase I/IIa study, and preliminary efficacy data are encouraging to warrant further clinical study in patients with HCC after primary treatments.
- Subjects
LIVER tumors; TUMOR treatment; HEPATOCELLULAR carcinoma; CELL transplantation; CLINICAL trials; COMPARATIVE studies; DENDRITIC cells; IMMUNOTHERAPY; RESEARCH methodology; MEDICAL cooperation; RESEARCH; TUMOR antigens; EVALUATION research; TREATMENT effectiveness; THERAPEUTICS
- Publication
British Journal of Cancer, 2015, Vol 113, Issue 12, p1666
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/bjc.2015.430