Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy

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 non­Hodgkin'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.