Table 4.

Major cancer target organs and clinical cohorts for evaluation of cancer chemoprevention strategies

ProstateColonBreast
Cancer burdenIn the U.S., most common cancer in men: 32.7% (232,090) of total new cancer cases in men (estimated 2005), 10.3% (30,350) of cancer deaths in men (estimated 2005)In the U.S., fourth most common cancer overall: 11% (145,000) total new cases; 10% (56,000) total associated deaths (estimated 2005)In the U.S., most common cancer in women: 15% (211,240) of total new cancer cases, 7% (40,410) of cancer deaths, 15% of cancer deaths on females (estimated 2005)
30% Prevalence of latent disease (from autopsy data)Estimated 6% of U.S. population will develop invasive colorectal cancer over their lifetimes
Clinical cohorts/end pointsProstate cancer patients scheduled for radical prostatectomy (treated between diagnostic biopsy and surgery, ∼4-6 wk)/biomarker modulationFAP patients (treated for ≥6 mo)/prevention or regression of polypsPatients scheduled for breast cancer surgery (treated between diagnostic biopsy and surgery, ∼4-6 wk)/biomarker modulation
Patients with HGPIN and other risk factors at highrisk for developing prostate cancer (40% over 3 y, 80% over 10 y)/prostate cancer incidenceHNPCC patients/carriers (treated for ≥1 y)/biomarker modulation and prevention of colorectal cancersPatients with LCIS or mammographically detected calcifications (DCIS; treated for ≥1 y)/biomarker modulation, breast cancer incidence
Patients with organ-confined prostate cancer undergoing watchful waiting (no prostatectomy, radiation or chemotherapy)/biomarker modulation to correlate with clinical end points; time to disease progressionPatients with previous colon cancer or adenomatous polyps (treated for 3 y/treated and/or followed for up to 6 y)/adenomatous polyp incidenceHigh risk with multiple biomarker abnormalities (treated for ≥1 y)/biomarker modulation, breast cancer incidence
Men at high risk (e.g., PSA >4 ng/mL and negative biopsy)/prostate cancer incidenceFAP carriers (treated during adolescence)/prevention or delay of polyp occurrenceWomen ≥60, or 35-59 y old with Gail risk factors for 60 y old/breast cancer incidence
Men at normal risk (age ≥55 y, normal PSA and DRE)/prostate cancer incidencePatients with previous breast cancer (adjuvant setting)/breast cancer incidence

Lung
Head and neck
Esophagus

Cancer burdenIn the U.S., second most common cancer and leading cause of cancer deaths in men and women; 13% (172,570) of total new cancer cases, 29% (163,510) of cancer-related deaths (estimated 2005)In the U.S., represents 3% (39,250) of total new cancers, 2% (11,090) of cancer-related deaths (estimated 2005)In the U.S., all esophageal cancers represent 1% (14,520) of all cases and 2% (13,570) of cancer-related deaths; ∼60% of new esophageal cancers are adenocarcinomas (Barrett's dysplasia is precursor)
Clinical cohorts/end pointsChronic/former smokers at high risk (e.g., with squamous metaplasia/dysplasia)/biomarker or dysplasia modulationPatients with dysplastic leukoplakia/dysplasia regression, oral cancer incidencePatients with low-grade, intestinal type Barrett's esophagus with or without dysplasia/Barrett's progression
Patients with recently resected stage I lung or laryngeal cancer/lung cancer incidencePatients with previous head and neck cancers/second primary cancersPatients with high grade Barrett's esophagus/Barrett's progression, esophageal cancer incidence
Men exposed to asbestos or patients with asbestosis, who are chronic or heavy cigarette smokers/lung cancer incidenceSubjects at high risk (e.g., smokers and tobacco chewers)/head and neck cancer incidencePatients at high risk for esophageal adenocarcinoma (e.g., gastroesophageal reflux disease)/esophageal cancer incidence
Patients with previous lung and head or neck cancers/second primary cancers

Liver
Cervix
Ovary
Endometrium
Cancer burdenIn the U.S., 1% (17,550) of all cancers and rising and 3% (15,420) of cancer-related deaths; much more important worldwide (estimated 2005)In the U.S., 1% (10,370) of total new cancers in females and 1% (3,710) of total cancer-related deaths in females; much more important worldwide (estimated 2005)In the U.S., 3% (22,220) of total new cancers in females and 6% (16,210) cancer-related deaths in females (estimated 2005)In the U.S., 6% (40,880) of total new cancers in females and 3% (7,310) of total cancer-related deaths in females (estimated 2005)
Clinical cohorts/end pointsPatients with previous hepatoma/liver cancer incidencePatients with CIN III, patients with CIN I, II (sufficiently large lesion)/CIN regressionHigh-risk women (e.g., family history of breast/ovarian cancer, BRCA mutation, Ashkenazi Jewish descent)/biomarker modulation (e.g., spectral karyotyping)High-risk women (e.g., HNPCC syndrome, obesity)/biomarker modulation (e.g., CAH and molecular biomarkers, such as PTEN and microsatellite instability)
Subjects with environmental exposure (e.g., HBV/HCV or carcinogen)/DNA adducts, biomarker modulation, liver cancer incidencePatients with HPV infection but without CIN/CIN incidence, cervical cancer incidence
High-risk subjects/prevention of HPV infection