Vaccination of high-risk breast cancer patients with mucin-1 (MUC1) keyhole limpet hemocyanin conjugate plus QS-21.
2000
Our
objective was to determine whether an immune response can be generated
against MUC1 peptide and against tumor cell MUC1 after vaccination with
MUC1-keyhole limpet hemocyanin (KLH) conjugate plus QS-21 in breast
cancer patients. Nine patients with a history of breast cancer but without evidence of
disease were treated with MUC1-KLH conjugate plus QS-21, containing 100μ
g of MUC1 and 100 μg of QS-21. s.c. vaccinations were administered
at weeks 1, 2, 3, 7, and 19. Peripheral blood was drawn at frequent
intervals to assess antibody titers. Skin tests were placed at weeks 1,
3, 9, and 21 to determine delayed type hypersensitivity reactions. Common toxicities included a local skin reaction at the site of the
vaccine, usually of 4–5 days’ duration, and mild flu-like symptoms
usually of 1–2 days’ duration. High IgM and IgG antibody titers
against synthetic MUC1 were detected. IgG antibody titers remain
elevated from a minimum of 106–137 weeks after the first vaccination.
Binding of IgM antibody to MCF-7 tumor cells was observed in seven
patients, although there was minimal binding of IgG antibody. Two
patients developed significant antibody titers post-high-dose
chemotherapy and stem cell reinfusion. There was no evidence of T cell
activation. This MUC1-KLH conjugate plus QS-21 was immunogenic and well tolerated
in breast cancer patients. Additional trials are ongoing to determine
the optimal MUC1 peptide for use in larger clinical trials. Further
investigation of vaccine therapy in high-risk breast cancer is
warranted.
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