MANHASSET, NY--High-risk individuals are being enrolled in four multicenter clinical trials aimed at preventing lung, breast, colorectal and prostate cancers. These cancers together account for more than half of all cancer deaths, Laura Donahue, MD, said as she recruited participants at North Shore University Hospital's Don Monti Cancer Center Screening and Education Day.
The National Cancer Institute (NCI) is funding these double-blind, placebo-controlled prospective trials, which will be conducted in collaboration with hundreds of hospitals and medical centers in the United States and Canada.
Patients who had stage I non-small-cell lung cancer with no more than one primary tumor at a time are eligible to enter the Lung Cancer Prevention Trial if they underwent complete surgical resection within the past 3 years and are no longer receiving cancer therapy.
"Despite the early stage of diagnosis, 5-year survival is still poor in this population, ranging between 50% and 60%, Dr. Donahue said. Moreover, she added, in long-term survivors of the initial surgery, the incidence of second primary tumors can range up to 12%.
More than 1,000 patients will be randomized to receive either 30 mg of 13-cis-retinoic acid or a placebo daily for 3 years, with 4-year follow-up.
Retinoids have been shown to halt the progress of premalignant lesions of the oral cavity, cervix, and skin, Dr. Donahue noted, and to prevent second primary tumors in head, neck, and lung cancer patients. This trial will assess the qualitative and quantitative toxicity of daily use.
The Breast Cancer Prevention Trial will examine whether tamoxifen(Drug information on tamoxifen) (Nol-vadex) can reduce the incidence of and mortality from breast cancer in 13,000 healthy women considered at high risk, based on an NCI model. This study was undertaken because tamoxifen has proven effective in preventing recurrent disease in breast cancer patients.