Experimentation with Di Bella polychemotherapy in Tuscany

The study reports the experience of Di Bella Treatment (an unconventional treatment for cancer) for advanced cancer patients in Tuscany. A total of (38 + 140 + 463) patients were treated (38 phase II study, 140 observational study and 463 distributional study) and all the case report forms were collected and analyzed in the Regional Coordinator Center of Pisa. No objective response was observed; as of May 31, 1999 63 patients are in stable disease (1 phase II, 3 observational and 59 distributional study). Percentage of interruptions to treatment due to death, refusal and toxicity were similar between patients O and D, while there are significant differences in terms of progressive disease (O = 52% vs D = 18%) and number of losts to follow up (40% in distributional study). The median duration of treatment was 2.31 months (range: 0-15) in the observational study and 3.2 months (range: 0-13) in the distributional study. The median overall survival time (4.5 months) and the median time to disease progression (2.7 months) were calculated by Kaplan-Meier Method and were based on all treated patients (intention to treat population). Follow-up of the study was stopped at 31.05.1999.