A PHASE-II STUDY OF TAMOXIFEN PLUS MELATONIN IN METASTATIC SOLID TUMOR PATIENTS

Preliminary data would suggest that the pineal hormone, melatonin (MLT ). may enhance tamoxifen (TMX) anti-tumour efficacy. Both MLT and TMX have been used as single agents in the palliative treatment of metasta tic neoplasms, other than the classical hormone-dependent tumours, wit hout, however, any clear efficacy. On this basis, a phase II study wit h TMX plus MLT has been performed in untreatable metastatic solid tumo ur patients. The study included 25 metastatic solid tumour patients ot her than breast cancer and prostate cancer (six unknown primary tumour ; four melanoma; four uterine cervix carcinoma; five pancreatic cancer ; three hepatocarcinoma; two ovarian cancer; one non-small-cell lung c ancer), for whom no other effective standard therapy was available, be cause of poor clinical conditions, no response to previous chemotherap ies and/or chemotherapy-resistant tumours. Both drugs were given orall y every day until disease progression (TMX, 20 mg day(-1) at noon; MLT , 20 mg day(-1) in the evening). Three patients had a partial response CPR) (12%; 95% confidence limits 2-24%) (one cervix carcinoma: one me lanoma; one unknown primary tumour. A stable disease (SD) was achieved in 13 other patients, whereas the remaining nine patients progressed. Performance status (PS) improved in 9/25 patients, whose median score increased from 50% to 70%. Finally, a survival longer than 1 year was observed in 7/25 (28%) patients. This Phase II study would suggest th at the neuroendocrine combination with TMX plus MLT may have some bene fit in untreatable metastatic solid tumour patients, either in control ling cancer cell proliferation or improving the PS.