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- W2162284249 abstract "TO THE EDITOR: In the September 1, 2009, issue of Journal of Clinical Oncology, McNeel et al reported the results of a phase I clinical trial of a DNA vaccine encoding prostatic acid phosphatase in men with nonmetastatic prostate cancer. They reported that nine of 22 (41%) participants developed prostatic acid phosphatase–specific T cell proliferation and seven of 22 (32%) had a post-treatment prostatespecific antigen doubling time (PSA DT) of greater than 200% of the baseline PSA DT. They offer the observed T cell responses and increased PSA DT as evidence of biologic activity and recommend a multi-institutional phase II trial to evaluate clinical efficacy. Although the observed T cell responses are compelling, the changes in PSA DT after vaccine treatment are similar to outcomes previously reported in placebo-treated participants. In two randomized controlled trials of men with rising PSA after prior surgery or radiation therapy for prostate cancer, post-treatment PSA DT of greater than 200% of the baseline PSA DT was observed in 20% to 31% of the participants assigned to placebo. The observed rates of positive PSA outcomes after placebo treatment appear to be explained primarily by variation in serial assessment of PSA DT. We conclude that the post-treatment changes in PSA DT after vaccine treatment do not provide evidence of biologic activity. Additional studies are necessary to assess the relationship between PSA kinetics and clinical outcomes and to evaluate the utility of post-treatment PSA DT or PSA velocity in the development of new drugs." @default.
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- W2162284249 date "2010-02-01" @default.
- W2162284249 modified "2023-10-16" @default.
- W2162284249 title "Changes In PSA Kinetics After DNA Vaccine Therapy–Not So Fast!" @default.
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- W2162284249 doi "https://doi.org/10.1200/jco.2009.26.3111" @default.
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