Pankreaserkrankungen und Therapie
Offener Zugang
ISSN: 2165-7092
ISSN: 2165-7092
Junko Kato, Akihito Nagahara, Tomohiro Kodani, Yoshie Higashihara, Yuji Matsumura, Taro Osada, Takashi Yoshizawa, Masafumi Suyama and Sumio Watanabe
We investigated the safety of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides in patients with advanced pancreatic cancer that was refractory to chemotherapy. This was a prospective nonrandomized, single-arm, phase I clinical trial with a fixed 2-mg dose of KIF20A and VEGFR1 peptides for patients with advanced unresectable pancreatic cancer. We determined the HLA genotype of the subjects after enrollment, results of which were held by the evaluative committee and kept from both patients and investigators until completion of the study. The primary endpoint was safety of the peptide vaccination with secondary endpoints being the immunological responses and clinical outcome. We compared study endpoints between the HLA-A*2402-positive and HLA-A*2402- negative groups. KIF20A and VEGFR1 peptides were subcutaneously administered on days 1, 8, 15, and 22 within a 28-day treatment cycle. Nineteen patients diagnosed with unresectable pancreatic cancer were enrolled from May 2009 to January 2010 at our Hospital. Twelve of the 19 patients received 4 or more vaccinations (at least one course). No patient had a severe adverse event in relation to this treatment. Findings from evaluation of clinical responses after one course showed that 2 cases had stable disease and 10 progressive disease. The median overall survival time (MST) for the 12 patients was 5.3 months. In the HLA-A*2402-positive group and HLA-A*2402-negative group, the MST was 6.0 months and 2.3 months (p=0.0373), respectively. Results of this study showed that vaccination with KIF20A and VEGFR1 peptides was a safe treatment, might be a promising treatment. This trial was registered with University Hospital Medical Information Network (UMIN) number UMIN000002022.