Long-term administration of Wilms tumor-1 peptide vaccine in combination with gemcitabine causes severe local skin inflammation at injection sites.

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.

• Authors: Atsuko Soeda, Yuriko Morita-Hoshi, Miho Kaida, Takako Wakeda, Yuni Yamaki, Yasushi Kojima, Hideki Ueno, Shunsuke Kondo, Chigusa Morizane, Masafumi Ikeda, Takuji Okusaka, Yuji Heike
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 40 Issue 12 Pg. 1184-8 (Dec 2010) ISSN: 1465-3621 [Electronic] England
• PMID: 20656693 (Publication Type: Case Reports, Journal Article)

Chemical References

• Antimetabolites, Antineoplastic
• Cancer Vaccines
• Cell Cycle Proteins
• Nuclear Proteins
• RNA Splicing Factors
• WTAP protein, human
• Deoxycytidine
• Gemcitabine

Topics

• Adenocarcinoma (drug therapy, secondary)
• Aged
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects)
• Bone Neoplasms (drug therapy, radiotherapy, secondary)
• Cancer Vaccines (administration & dosage, adverse effects, immunology)
• Cell Cycle Proteins
• Chemotherapy, Adjuvant
• Cholangiocarcinoma (drug therapy, secondary)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Dermatitis (etiology, immunology)
• Drug Administration Schedule
• Female
• Gallbladder Neoplasms (pathology)
• Humans
• Injections, Intradermal (adverse effects)
• Liver Neoplasms (drug therapy, pathology, secondary)
• Lymphocytes (immunology)
• Nuclear Proteins (administration & dosage, adverse effects, immunology)
• Palliative Care (methods)
• RNA Splicing Factors
• Radiotherapy, Adjuvant
• Skin (drug effects, immunology)
• Gemcitabine