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- W1987443556 abstract "An overwhelming amount of experimental and observational information about the basic processes underlying carcinogenesis obtained during the 1970s to 1990s, led to a series of translational and eventually definitive placebo-controlled, double blind randomized controlled trials (RCT), involving patients at increased risk for breast, prostate, non-melanoma skin, cervix, chronic myelogenous leukemia (CML), and colon cancer. Despite clear evidence of the favorable effects on the primary endpoints, regulatory approval has been low and usage of those compounds, which have been approved, has been minimal to non-existent. How come? And what can we do to improve this situation, as we move ahead to the next generation of clinical studies?For cervical cancer and CML, respectively, we have the good news that a highly effective vaccine and a targeted therapy (Imatinib) supplanted retinoids as the intervention of choice.[1,2] However, it is probably still worth looking into the vitamin A status of patients who develop cervical cancer, who have received the vaccine, or CML patients who relapse on Imatinib.For the remaining malignancies the issues are very similar. We have recently presented a comprehensive review of this topic, including for those interested, a discussion of regulatory and business challenges.[3] In this current perspective we will focus on the issues of particular concern to the audience being served at this symposium: Scientific, translational, and clinical issues related to colorectal cancer.The major questions that need to be asked and addressed regardless of the organ site are contained in these five areas:What relevance do cellular, animal studies, and epidemiological observations have to the cancer in ‘at-risk individuals′?How can we better identify those at true risk, to develop a more favorable risk-benefit profile?How can we better assess toxicity, and thus a potential risk-benefit in our preclinical experiments?How can we better convey the risks and benefits to trial participants in prevention studies? to regulatory bodies (FDA, EMA, etc.) after a positive RCT? or to potential future patients after a drug is approved?How should we move forward?" @default.
- W1987443556 created "2016-06-24" @default.
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- W1987443556 date "2011-01-01" @default.
- W1987443556 modified "2023-10-17" @default.
- W1987443556 title "Therapeutic prevention of colorectal carcinogenesis" @default.
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- W1987443556 doi "https://doi.org/10.4103/1477-3163.79682" @default.
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