Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in ItalyBMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7178.224 (Published 23 January 1999) Cite this as: BMJ 1999;318:224
- Italian Study Group for the Di Bella Multitherapy Trials.
- Correspondence to: Dr Roberto Raschetti, Istituto Superiore di Sanità, Department of Epidemiology and Biostatistics, Viale Regina Elena, 299 00161 Rome, Italy
- Accepted 23 January 1999
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 8different 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 1998and followed to 31October 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 3months, 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: 1of the 32patients with non-Hodgkin's lymphoma; 1of the 33patients with breast cancer; and 1of the 29patients 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.