IMMUNOTHERAPY WITH SUBCUTANEOUS LOW-DOSE INTERLEUKIN-2 PLUS MELATONINAS SALVAGE THERAPY OF HEAVILY CHEMOTHERAPY-PRETREATED OVARIAN-CANCER

Preliminary results showed that IL-2 immunotherapy may be effective in the treatment of recurring advanced ovarian cancer. The pineal neuroh ormone melatonin (MLT) has been proven to amplify IL-2 efficacy by cou nteracting macrophage-mediated immunosuppression. On this basis, a pil ot phase II study of low-dose IL-2 plus MLT was performed in advanced ovarian cancer patients progressing after at least 3 previous polychem otherapeutic lines. The study included 12 evaluable patients. IL-2 was injected subcutaneously at 3 million IU/day for 6 days/week for 4 wee ks, by repealing the cycle after a al-day rest period in nonprogressin g patients. MLT was given orally at 40 mg/day. No complete response wa s seen. A partial response was achieved in 2/12 (16%) patients. A stab le disease was obtained in 5 other patients, whereas the remaining 5 p atients progressed. The treatment was well tolerated. This preliminary study suggests that immunotherapy with low-dose IL-2 plus MLT may rep resent a well tolerated and promising therapy of advanced ovarian canc er progressing on standard medical treatments.