Evaluation of the safety and efficacy of the first-line treatment with somatostatin combined with melatonin, retinoids, vitamin D3, and low doses of cyclophosphamide in 20 cases of breast cancer: A preliminary report

Giuseppe Di Bella, Fabrizio Mascia, Alessandro Ricchi, Biagio Colori

Research output: Contribution to journalArticle


OBJECTIVE: The current strategies for the treatment of breast cancer are essentially based on surgery, preceded and/or followed by chemotherapy often supplemented by radiotherapy and/or the administration of hormonal therapy and monoclonal antibodies. Their combined use has made it possible to increase an overall survival but they are still penalized by adverse effects and toxicity. The marked anti-cancer effects of biological molecule such as somatostatin, melatonin, retinoid, vitamin D3 and prolactin inhibitors have been studied and documented for several decades. Their integrated and synergic action have been demonstrated, but only a few studies have as yet been carried out on their combined application in humans. The aim of the present investigation was to evaluate both the objective clinical response and toxicity of the biological multimodal treatment named Di Bella Method (DBM). MATHERIAL AND METHODS: The clinical data from a total of 20 women with a certified diagnosis of breast cancer,defined disease stage, and who independently decided to follow the DBM as first-line treatment, were retrospectively reviewed. RESULTS: The mean age of the patients was 51 years (min 30; max 73). Twelve (12) patients (60%) presented an early stage disease, while the other 40% had a locally advanced/metastatic stage. An overall clinical benefit was achieved in 75% of cases, with 55% of complete response and 20% of partial response. For metastatic patients, the overall survival rate was 71%. The main toxicity effects included leukopenia, gastrointestinal phenomena and drowsiness. CONLUSIONS: The preliminary results of this report confirm the positive action of the biological treatment in terms of efficacy and survival, showing a more than favorable profile of tolerability.

Original languageEnglish
Pages (from-to)660-668
Number of pages9
JournalNeuroendocrinology Letters
Issue number7
Publication statusPublished - 2013



  • Biological therapy
  • Breast cancer
  • Di bella method
  • First-line treatment
  • Growth factors
  • Melatonin
  • Retinoids
  • Somatostatin
  • Vitamin D3

ASJC Scopus subject areas

  • Endocrinology
  • Endocrine and Autonomic Systems
  • Endocrinology, Diabetes and Metabolism
  • Clinical Neurology
  • Psychiatry and Mental health
  • Neurology

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