Project description:OBJECTIVE: To determine whether the treatment known as Di Bella multitherapy exerts antitumour activity worthy of further controlled clinical evaluation. DESIGN: 11 independent multicentre uncontrolled phase II trials relevant to 8 different types of cancer. SETTING: 26 Italian hospitals specialising in cancer treatment. SUBJECTS: 386 patients with advanced cancer were enrolled in the trials between March and July 1998 and followed to 31 October 1998. INTERVENTIONS: Melatonin, bromocriptine, either somatostatin or octreotide, and retinoid solution, the drugs that constitute Di Bella multitherapy, were given to patients daily. Cyclophosphamide and hydroxyurea were added in some trials. MAIN OUTCOME MEASURES: Responses were assessed every 1, 2, or 3 months, depending on the specific trial, and toxicity was evaluated using criteria developed by the World Health Organisation. RESULTS: No patient showed complete remission. Three patients showed partial remission: 1 of the 32 patients with non-Hodgkin's lymphoma; 1 of the 33 patients with breast cancer; and 1 of the 29 patients with pancreatic cancer. At the second examination, 12% (47) of the patients had stable disease; 52% (199) progressed; and 25% (97) died. CONCLUSIONS: Di Bella multitherapy did not show sufficient efficacy in patients with advanced cancer to warrant further clinical testing.
