Background: Breast cancer is still the leading cause of death in women worldwide.
Study question:Our purpose is to improve survival, objective response and quality of life with a non-toxic biological therapy.
Study design:The DBM (Di Bella Method) with MLT (Melatonin), Retinoids, solubilized in vitamin E, D3, and C, Folates, proteoglycans and calcium, has a differentiating, cytostatic, anti-angiogenic, immune-modulating, factorially synergic effect, simultaneously reinforcing the functions which physiology considers to be essential for life. With Somatostatin/Octreotide, prolactin and estrogen inhibitors, DBM has an antiproliferative, antiangiogenic and antimetastatic effect. These molecules govern negatively pituitary secretions like GH-PRL, whose mitogenic properties are enhanced by the combination of ovarian hormones such as estrogen. The negative regulation of GH extends to IGF-1, EGF (Epidermal Growth Factor), VEGF (Vascular Endothelial Growth Factor), and GHdependent growth factors. The DBM (Di Bella Method) uses minimal metronomic apoptotic, non-cytotoxic and non-mutagenic doses of cyclophosphamide. The tolerability of which is enhanced by MLT and by the vitamins included in the DBM. We report a retrospective observational study with 5-year follow-up, carried out on 297 patients affected by breast cancer and treated with the Di Bella Method biological therapy.Results and conclusion: complete and stable objective responses without cytolytic chemotherapy, in some cases even without surgery or radiotherapy, with a generalized improvement in quality of life and no significant and/or prolonged toxicity. The most important 5-year survival rate was 69.4% at stage IV cancer versus 26.3% reported by the National Cancer Institute.
Background:The interaction between pituitary hormones (Growth Hormone-Prolactin), ovarian hormones (Estradiol) and growth factors forms the basis of the mechanisms underlying the growth of tumors of the breast. The literature contains reports of the increased expression of the mitogenic GH (Growth Hormone)/IGF1 (Insulin-Like Growth Factor) axis in tumor tissues compared to healthy tissues, with a directly proportional dose-dependent relationship between GH/IGF1, proliferative index and invasive ability in numerous types of tumors.
Methods and Findings:We carried out this experimental research on the mitogenic role of GH and consequently on the rationale of the anticancer use of its inhibition. The levels of expression of several genes, GH and GHR, were evaluated in 39 cases of breast cancer, divided according to different risk levels on the basis of immunohistochemical and histological tests with nuclear grade.
Conclusion:Research showed that breast cancers with a high and intermediate risk of recurrence are characterized by over-expression of GH and of its receptor (GHR). The expression was limited in cases with a low risk. The overexpression of GH-GHR in breast cancer with a ratio proportional to the level of aggressiveness is a rationale that can encourage a therapeutic intervention with inhibition of the mitogenic GH-IGF1-PRL axis and estrogen.
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