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A Journal on Internal Medicine

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Panminerva Medica 2002 March;44(1):41-5

language: English

The advancement of cancer chemoprevention by revision of clinical trial strategies

Sharma R. A.

From the Cancer Biomarkers and Prevention Group Oncology Department University of Leicester Leicester, UK


After a quar­ter of a cen­tu­ry of rap­id advanc­es in can­cer ­research, the ­focus of onco­log­i­cal ­drug devel­op­ment has shift­ed ­from cyto­tox­ic chem­o­ther­a­py to ration­al­ly ­designed ­agents ­that tar­get spe­cif­ic mole­cules asso­ciat­ed ­with malig­nant ­cells or ­their envi­ron­ment. As a con­se­quence of great­er pub­lic aware­ness of ­health relat­ed ­issues and pop­u­la­tion screen­ing, the detec­tion of ear­ly can­cer or prem­a­lig­nant ­lesions has dem­on­strat­ed the poten­tial ­that ­exists for tar­get­ing the ­same mole­cules dur­ing car­cin­o­gen­e­sis. One meth­od of ­such inter­ven­tion is chem­o­pre­ven­tion, the inhi­bi­tion, retar­da­tion or rever­sal of car­cin­o­gen­ic pro­cess­es by chem­i­cal ­means. Tamoxifen and cel­e­cox­ib ­have ­been ­licensed in the USA for the chem­o­pre­ven­tion of ­breast and color­ec­tal can­cers respec­tive­ly in cer­tain ­well-­defined “at ­risk” indi­vid­u­als. Unfortunately, ­many ­large-­scale can­cer chem­o­pre­ven­tion ­trials ­have yield­ed neg­a­tive ­results, and a few may ­even ­have ­caused ­harm to ­healthy indi­vid­u­als con­sid­ered at ­risk of devel­op­ing can­cer. In ­this arti­cle, the impor­tance of not put­ting the ­cart ­before the ­horse is ­argued. In par­tic­u­lar, two fac­tors in chem­o­pre­ven­tive ­agent devel­op­ment ­will be empha­sised: phase I/II stud­ies in ­patients ­with can­cer or ­patients at ­risk of sec­ond pri­mary ­tumors and the val­i­da­tion and incor­po­ra­tion of bio­mark­ers of car­cin­o­gen­e­sis ­from the ear­li­est phas­es of clin­i­cal devel­op­ment. This struc­tured ­approach cur­rent­ly emerg­ing is pro­vid­ing phar­mac­o­log­i­cal and mechan­is­tic ­data on nov­el ­agents ­which ­will ­prove essen­tial in the plan­ning of larg­er-­scale com­mit­ments.

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