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• W2597125412 abstract "2547 Background: Theratope is an investigational therapeutic cancer vaccine consisting of a synthetic form of STn conjugated to KLH. Phase III study results showed a trend for increased survival in MBC pts concurrently treated with Theratope (T) and hormone therapy (HT) (38.2mo (T) vs. 30.7mo (control, C), Cox P= 0.07). Methods: MBC pts with no evidence of disease or non-progressive disease following any first-line chemotherapy were eligible for a randomized, controlled, double-blind, multicenter study. Study arms were adjuvant plus T or adjuvant plus KLH (C). All pts received a single IV dose of cyclophosphamide (300mg/m2) 72 hr before vaccine. Primary endpoints were overall survival (OS) and time to progression. Secondary endpoints were humoral (IgG) responses to the KLH (carrier), STn (synthetic monomeric form), and OSM (naturally occurring clustered STn) antigens in MBC pts +/- HT treated with T. IgG was measured using ELISA assays for STn, OSM, and KLH at week-12 of vaccine therapy. Median OS was prospectively assessed as a function of IgG titers. Results: Of a planned accrual of 950 pts, 1030 were enrolled and 1028 randomized to recive adjuvant + T(n=523) or C (n=505). As of September 2003, median duration of follow-up was 22.2 mo. Median titer of anti-OSM IgG was 320 in the T group and 0 in the C group. Median OS was significantly greater in T treated pts who received concurrent HT and who had IgG titers of anti-OSM equal to or higher than the median titer (41.1 vs. 25.4 mo, log-rank p=0.01) (see Table). OS was not influenced by anti-STn or anti-KLH titers, indicating that only titers of the naturally occurring clustered STn antigen are predictive of increased OS. Conclusions: Experimental vaccine trials suggest that the ability to mount an immune response is associated with favorable clinical outcomes. Our data from this large, prospective trial indicate that the magnitude of the immune response to the relevant and specific antigen is most predictive of a favorable clinical outcome. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Biomira, Inc.; EMD Pharmaceuticals Biomira, Inc. Biomira, Inc.; EMD Pharmaceuticals Biomira, Inc.; Merck KGaA" @default.
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• W2597125412 date "2004-07-15" @default.
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• W2597125412 title "Humoral immune-response to naturally occurring STn in metastatic breast cancer patients (MBC pts) treated with STn-KLH vaccine" @default.
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