Why Most Randomized Phase II Cervical Cancer Chemoprevention Trials are Uninformative: Lessons for the Future
Year: 2001
Type: article
Abstract: According to the worldwide cancer incidence database maintained by the World Health Organization, cervical cancer is the third most common malignancy in women worldwide, exceeded in incidence only by breast and colorectal cancers (1). Cervical cancer is an important cause of mortality in women worldwide, and the cervix is a well-established clinical and histopathologic model of carcinogenesis. Human papillomavirus (HPV) is the major etiologic agent in cervical cancer. The cervix is easily accessible for examination, and colposcopy provides a visual model of angiogenesis and tumor development, making the cervix a good model for preventive interventions (2). The precursor lesions to cervical cancer are squamous intraepithelial lesions (SILs) or cervical intraepithelial neoplasia (CIN). SILs are used in the cytologic classification, and CINs are used in the histopathologic classification. Several chemoprevention trials have been conducted in women with SIL/CIN by use of retinoids, micronutrients, α-difluoromethylornithine, and indole-3-carbinol. Although the results of phase I/IIa studies have appeared to be promising, the phase IIb/III studies have usually been negative (3–13) (Table 1).1 The failure of the phase IIb/III studies to demonstrate an effect may be due to several factors not being adequately considered in the design of these trials.
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2139323561