Table 1.

US FDA approved agents for cancer risk reduction

DrugCancer typeMechanismTargeted cohort
TamoxifenBreastSERM: Selective estrogen receptor modulatorWomen with DCIS (ductal carcinoma in situ) after breast surgery and radiation
Women at high risk for breast cancera
RaloxifeneBreastSERMPostmenopausal women at high risk for invasiveb breast cancer
Porfimer sodium + photodynamic therapy (PDT) & omeprazoleEsophagealProduction of oxygen-free radicals kills nearby cancer cells of precancerous tissues after exposure to lightMales and females with high-grade dysplasia in Barrett esophagus
AspirinColorectalInduces apoptosis and interrupts prostaglandin production through inhibition of cyclooxygenase enzymesAdults ages 50–59 yearsc
CelecoxibColorectalInduces apoptosis and interrupts prostaglandin production through selective inhibition of the cyclooxygenase-2 enzymeMales and females ≥18 years with FAP (Familial adenomatous polyposis)
Bacillus Calmette-Guerin (BCG)BladderMechanism unknown; induces local immune reaction against tumorMales and females with CIS (carcinoma in situ) of the urinary bladder
ValrubicinBladderInterferes with DNA synthesis and leads to cell deathMales and females with BCG-refractory CIS
FluorouracilSkinInterferes with DNA synthesis and leads to cell deathMales and females with multiple actinic keratoses
Diclofenac sodium 3%SkinMechanism unknownMales and females with actinic keratoses
5-aminolevulinic acid + PDTSkinSolution kills precancerous cell when exposed to lightMales and females with actinic keratoses of the face or scalp
ImiquimodSkinEnhances immune response and promotes apoptosisImmunocompetent males and females with actinic keratoses of the face or scalp
Ingenol mebutateSkinInduces primary necrosisMales and females with actinic keratoses on the face, scalp, trunk and extremities
  • a"High risk" defined as women at least age 35 years with a 5-year predicted risk of breast cancer ≥ 1.67% as calculated by the Gail model.

  • b“High risk” defined as at least one breast biopsy showing lobular carcinoma in situ (CIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥ 1.66% (based on the modified Gail model).

  • cLow-dose aspirin use for the primary prevention of cardiovascular disease and colorectal cancer in adults ages 50–59 years who have a 10% or greater 10-year CVD risk, are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years.