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.
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).


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.


CONCLUSIONS
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.
Di Bella Foundation, Via G. Marconi 51, Bologna 40122, Italy. posta@giuseppedibella.it.
Giuseppe
G
Di Bella
Di Bella Foundation, Via G. Marconi 51, Bologna 40122, Italy.
Fabrizio
F
Mascia
Di Bella Foundation, Via G. Marconi 51, Bologna 40122, Italy.
Alessandro
A
Ricchi
Rizzoli Institute, Scientific Research and Care Institute, Bologna, Italy.
Biagio
B
Colori
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008550:Melatonin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010865:Pilot Projects; D012176:Retinoids / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D013004:Somatostatin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D012176:Retinoids; D002762:Cholecalciferol; D013004:Somatostatin; D003520:Cyclophosphamide; D008550:Melatonin