Treatment and prevention of intraepithelial neoplasia: an important target for accelerated new agent development.
Precancer or intraepithelial neoplasia (IEN) is a noninvasive lesion that has genetic abnormalities, loss of cellular control functions, and some phenotypic characteristics of invasive cancer and that predicts for a substantial likelihood of developing invasive cancer. The AACR Task Force on the Treatment and Prevention of IEN has delineated the relationship between IEN and cancer risk as well as the clinical benefit that can be derived from reducing IEN burden. Although several effective endoscopic and surgical treatments for IEN have become standard medical practice, these interventions can confer morbidity and do not treat the entire epithelial field at risk. The incidence of many epithelial cancers is continuing to rise, the number of individuals at risk is increasing with the aging population, and the rapid advancement of imaging and molecular diagnostics is bringing to light precancers that were heretofore clinically silent. There is therefore an urgent need to rapidly develop new treatment and prevention agents for IEN. The AACR IEN Task Force recommends focusing on established precancers as the target for new agent development because of the close association between dysplasia and invasive cancer and because a convincing reduction in IEN burden provides patient benefit by reducing cancer risk and/or by decreasing the need for invasive interventions. The IEN Task Force proposes several clinical trial designs that provide practical and feasible approaches to the rapid development of new agents to treat and prevent precancer.
O'Shaughnessy
Joyce A
JA
Baylor-Sammons Cancer Center, US Oncology, Collins 5, 3535 Worth Street, Dallas, TX 75246, USA.
Kelloff
Gary J
GJ
Gordon
Gary B
GB
Dannenberg
Andrew J
AJ
Hong
Waun Ki
WK
Fabian
Carol J
CJ
Sigman
Caroline C
CC
Bertagnolli
Monica M
MM
Stratton
Steven P
SP
Lam
Stephen
S
Nelson
William G
WG
Meyskens
Frank L
FL
Alberts
David S
DS
Follen
Michele
M
Rustgi
Anil K
AK
Papadimitrakopoulou
Vali
V
Scardino
Peter T
PT
Gazdar
Adi F
AF
Wattenberg
Lee W
LW
Sporn
Michael B
MB
Sakr
Wael A
WA
Lippman
Scott M
SM
Von Hoff
Daniel D
DD
D000970:Antineoplastic Agents / Q000494:pharmacology; D001471:Barrett Esophagus / Q000628:therapy; D002278:Carcinoma in Situ / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control* / Q000628:therapy*; D002318:Cardiovascular Diseases / Q000628:therapy; D002986:Clinical Trials as Topic; D015179:Colorectal Neoplasms / Q000628:therapy; D005260:Female; D006801:Humans; D007642:Keratosis / Q000628:therapy; D008297:Male; D009062:Mouth Neoplasms / Q000628:therapy; D009369:Neoplasms / Q000517:prevention & control; D019048:Prostatic Intraepithelial Neoplasia / Q000628:therapy; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000628:therapy; D002578:Uterine Cervical Dysplasia / Q000628:therapy
D000970:Antineoplastic Agents