Detection of early stage cancers and assessment of proliferative potensitals of cancers through measurement of urinary diacetylsperime

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Excretion of N^1,N^<12>-diacetylspermine (DiAcSpm) in the urine is increased in patients with various neoplastic diseases. We developed an ELISA system for easy determination of urinary DiAcSpm level using a highly specific antibody against DiAcSpm, and analyzed DiAcSpm in the urine of a number of cancer patients. The sensitivity of urinary DiAcSpm for colon cancer patients was 75.8% (with 0.25μmol/g creatinine, that represents mean + 2S.D. for 52 healthy controls, as a cut-off value), which was markedly higher than that of serum CEA (39.5%), and CA19-9 (14.1%). The sensitivity of urinary DiAcSpm for 83 breast cancer patients (60.2%) was higher than that of CEA (37.3%) and CA15-3 (37.3%). We further demonstrated that DiAcSpm was elevated above the cut-off value in 60% of colorectal cancer patients at earlier clinical stages, namely stage 0 and stage I. Patients whose DiAcSpm was lower than the cut-off value before surgery (25% of the total patients) rarely died of cancer within 1.5 year period after surgery, during which about 10% of the total patients died. Prognosis of patients whose DiAcSpm value was higher than 3 times the cut-off value was significantly poorer than patients with lower DiAcSpm value. This indicate that DiAcSpm value before operation is well correlated with the prognosis of a patient. DiAcSpm recovered to a normal level after a successful treatment of cancer patients including prostate cancer, colon cancer and brain tumor, while the prognosis was poor when DiAcSpm level remained far above the normal limit after apparently effective treatment. Urinary DiAcSpm may thus be considered a novel high performance tumor marker useful in tumor diagnosis, in judging the effectiveness of a treatment and in foreseeing prognosis of patients.