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Phase I clinical trial of peptide vaccination with URLC10 and VEGFR1 epitope peptides in patients with advanced gastric cancer.

Higashihara Y, Kato J, Nagahara A, Izumi K, Konishi M, Kodani T, Serizawa N, Osada T, Watanabe S - Int. J. Oncol. (2013)

Bottom Line: The secondary end‑points were immunological responses and clinical outcome, which were compared between the HLA-A*2402-positive and HLA-A*2402-negative groups.The median overall survival time (MST) for the 12 patients was 3.9 months.The MSTs in the HLA-A*2402‑positive and HLA-A*2402‑negative groups were, 4.2 and 3.6 months (p=0.9164), respectively.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.

ABSTRACT
Peptide vaccine treatment has attracted attention in recent years as a new therapy option for chemotherapy‑resistant, advanced, unresectable cancer. The safety of peptide vaccination with HLA-A*2402-restricted URLC10-A24-177 and VEGFR1-A12-9 1084 epitope peptides (fixed 2-mg dose) was investigated in a phase I clinical trial of patients with advanced gastric cancer who were refractory to chemotherapy. We determined the HLA genotype of the subjects after enrollment, results of which were held by the evaluation committee and kept from both patients and investigators until completion of the study. The primary end‑point was safety of the peptide vaccination. The secondary end‑points were immunological responses and clinical outcome, which were compared between the HLA-A*2402-positive and HLA-A*2402-negative groups. The peptides were subcutaneously administered on day 1, 8, 15 and 22 within a 28-day treatment cycle. A total of 14 patients was enrolled in this study; 12 of the 14 patients received 4 or more vaccinations (at least 1 course). No patient had a severe treatment-related adverse event. Findings from evaluation of clinical responses after a single course showed that 4 cases had stable disease and 8 cases had progressive disease. The median overall survival time (MST) for the 12 patients was 3.9 months. The MSTs in the HLA-A*2402‑positive and HLA-A*2402‑negative groups were, 4.2 and 3.6 months (p=0.9164), respectively. The results of this study showed that vaccination with URLC10 and VEGFR1 peptides was a safe treatment for advanced gastric cancer. This trial was registered with University Hospital Medical Information Network (UMIN, no. 000002409).

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Kaplan-Meier overall survival curve. The MSTs in HLA-A*2402-positive group and HLA-A*2402-negative group were 4.2 and 3.6 months (p= 0.9164), respectively. There was no significant difference.
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f1-ijo-44-03-0662: Kaplan-Meier overall survival curve. The MSTs in HLA-A*2402-positive group and HLA-A*2402-negative group were 4.2 and 3.6 months (p= 0.9164), respectively. There was no significant difference.

Mentions: The evaluation after 1 course showed stable disease in 4 cases and progressive disease in 8 cases (Table III). The 3 cases with stable disease were HLA-A*2402-positive. The MST was 3.9 months when all 12 patients were analyzed. The MSTs in the HLA-A*2402-positive group and the HLA-A*2402-negative group were 4.2 and 3.6 months (p=0.9164), respectively (Fig. 1).


Phase I clinical trial of peptide vaccination with URLC10 and VEGFR1 epitope peptides in patients with advanced gastric cancer.

Higashihara Y, Kato J, Nagahara A, Izumi K, Konishi M, Kodani T, Serizawa N, Osada T, Watanabe S - Int. J. Oncol. (2013)

Kaplan-Meier overall survival curve. The MSTs in HLA-A*2402-positive group and HLA-A*2402-negative group were 4.2 and 3.6 months (p= 0.9164), respectively. There was no significant difference.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3928476&req=5

f1-ijo-44-03-0662: Kaplan-Meier overall survival curve. The MSTs in HLA-A*2402-positive group and HLA-A*2402-negative group were 4.2 and 3.6 months (p= 0.9164), respectively. There was no significant difference.
Mentions: The evaluation after 1 course showed stable disease in 4 cases and progressive disease in 8 cases (Table III). The 3 cases with stable disease were HLA-A*2402-positive. The MST was 3.9 months when all 12 patients were analyzed. The MSTs in the HLA-A*2402-positive group and the HLA-A*2402-negative group were 4.2 and 3.6 months (p=0.9164), respectively (Fig. 1).

Bottom Line: The secondary end‑points were immunological responses and clinical outcome, which were compared between the HLA-A*2402-positive and HLA-A*2402-negative groups.The median overall survival time (MST) for the 12 patients was 3.9 months.The MSTs in the HLA-A*2402‑positive and HLA-A*2402‑negative groups were, 4.2 and 3.6 months (p=0.9164), respectively.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.

ABSTRACT
Peptide vaccine treatment has attracted attention in recent years as a new therapy option for chemotherapy‑resistant, advanced, unresectable cancer. The safety of peptide vaccination with HLA-A*2402-restricted URLC10-A24-177 and VEGFR1-A12-9 1084 epitope peptides (fixed 2-mg dose) was investigated in a phase I clinical trial of patients with advanced gastric cancer who were refractory to chemotherapy. We determined the HLA genotype of the subjects after enrollment, results of which were held by the evaluation committee and kept from both patients and investigators until completion of the study. The primary end‑point was safety of the peptide vaccination. The secondary end‑points were immunological responses and clinical outcome, which were compared between the HLA-A*2402-positive and HLA-A*2402-negative groups. The peptides were subcutaneously administered on day 1, 8, 15 and 22 within a 28-day treatment cycle. A total of 14 patients was enrolled in this study; 12 of the 14 patients received 4 or more vaccinations (at least 1 course). No patient had a severe treatment-related adverse event. Findings from evaluation of clinical responses after a single course showed that 4 cases had stable disease and 8 cases had progressive disease. The median overall survival time (MST) for the 12 patients was 3.9 months. The MSTs in the HLA-A*2402‑positive and HLA-A*2402‑negative groups were, 4.2 and 3.6 months (p=0.9164), respectively. The results of this study showed that vaccination with URLC10 and VEGFR1 peptides was a safe treatment for advanced gastric cancer. This trial was registered with University Hospital Medical Information Network (UMIN, no. 000002409).

Show MeSH
Related in: MedlinePlus