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Japanese Journal of Clinical Oncology
Year: 2010  |  Volume: 40  |  Issue: 12  |  Page No.: 1184 - 1188

Long-Term Administration of Wilms Tumor-1 Peptide Vaccine in Combination with Gemcitabine Causes Severe Local Skin Inflammation at Injection Sites

A Soeda, Y Morita Hoshi, M Kaida, T Wakeda, Y Yamaki, Y Kojima, H Ueno, S Kondo, C Morizane, M Ikeda, T Okusaka and Y. Heike    

Abstract:

The skin toxicity of vaccine therapy at injection sites is generally limited to Grades 1–2 due to the nature of their function. We experienced two cases of severe and prolonged local adverse effects in 25 patients following a Phase I study of gemcitabine and Wilms tumor-1 peptide vaccine mixed with incomplete Freund's adjuvant for inoperable pancreatic or biliary tract cancer. These patients requested to continue the treatment after the study period; however, in the course of compassionate use, they developed unacceptable local skin reactions and terminated their vaccine treatment. One patient (human leukocyte antigen, A0201, 3 mg) developed Grade 3 ulceration at the 10th vaccination and another (human leukocyte antigen, A2402, 1 mg) developed Grade 2 indulation and fibrosis at the 16th vaccination. Skin toxicity occurred at 6.4–8.4 months and continued for several months after the final vaccination during gemcitabine treatment. In these cases, activation or induction of Wilms tumor-1-specific T lymphocytes was not apparent in the peripheral blood despite their severe local reactions. Therefore, we need to monitor patients for late-onset, severe and long-lasting skin reactions at injection sites in Wilms tumor-1 cancer vaccine therapy, particularly for combination treatment with gemcitabine.

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