A retrospective observational clinical study of triple negative breast cancer cases treated with Di Bella Method: A preliminary data.

Objectives: Triple negative breast cancer (TNBC) is a distinct subtype of breast cancer that has a poor prognosis due to the lack of effective therapeutic agents. Since a significant proportion of human surgical samples of TNBC expressed mRNA for the growth hormone (GH), growth hormone-releasing hormone (GHRH), and gonadotropin-releasing hormone (GnRH) receptors, and the mitogenic proliferative activity of GH, GHRH, and GnRH, have been identified as effective therapeutic targets for somatostatin and its analogs and GnRH analogs, Di Bella Method (DBM), a combination of hormonal analogs and vitamins, was introduced to target and inhibit solid tumors. The present study aimed to improve the prognosis of TNBC using DBM in women with TNBC.

Sinonasal Outcomes Obtained after 2 Years of Treatment with Benralizumab in Patients with Severe Eosinophilic Asthma and CRSwNP: A "Real-Life" Observational Study.

Background/objectives: Benralizumab is a monoclonal antibody that targets the interleukin-5 receptor (IL-5Rα), leading to the rapid depletion of blood eosinophils. RCTs have demonstrated efficacy in patients with severe eosinophilic asthma (SEA). The aim of this study was to assess the efficacy of benralizumab on sinonasal outcomes in a real-life setting in patients with SEA and concomitant chronic rhinosinusitis with nasal polyps (CRSwNP).

Comparative real-world outcomes of dupilumab versus endoscopic sinus surgery in the treatment of severe CRSwNP patients.

Introduction: Management of severe chronic rhinosinusitis with nasal polyps (CRSwNP) has changed significantly in recent years, with different treatments now available including biologics and endoscopic sinus surgery (ESS), although there are still few comparative studies. We aimed to compare 1-year outcomes of patients with severe CRSwNP treated with dupilumab or ESS plus intranasal corticosteroids (INCS).

Methods: In this retrospective, real-life, observational, cohort study, we enrolled 101 patients with severe CRSwNP who were treated with INCS and either ESS (n = 49) or dupilumab (n = 52).

How to manage recurrences after surgery in CRSwNP patients in the biologic era: a narrative review.

Objective: This narrative review analyses factors affecting recurrence of Chronic rhinosinusitis with nasal polyps (CRSwNP) after surgery, such as type, extension and completeness of endoscopic sinus surgery (ESS). We also described new implications in the management of recurrences after the advent of biologics.

Methods: We identified four topics: definition of disease state; factors linked to recurrence of polyps; evaluation and management of recurrence in clinical practice.

A retrospective observational study on cases of osteosarcomas treated with a multitherapy: The rationale and effectiveness.

Backgrounds: The prognosis of patients with osteosarcoma in many cases remains poor, and life expectancy with lung metastases is around 12 months. Chemotherapy and radiotherapy can only temporarily control neoplastic progression, followed by developing chemo and radioresistant tumours.

Methods: This is a retrospective observational study on 15 patients diagnosed with osteosarcoma and treated by a multitherapy approach.

Sinonasal Biomarkers Defining Type 2-High and Type 2-Low Inflammation in Chronic Rhinosinusitis with Nasal Polyps.

The complex pathophysiology of chronic rhinosinusitis with nasal polyps (CRSwNP) generates a spectrum of phenotypes with a wide variety of inflammatory states. We enrolled 44 very-likely-to-be type 2 CRSwNP patients in order to evaluate the load of inflammation and to analyze human interleukins in nasal secretion. Clinical data were collected to evaluate the severity of the disease.

Effectiveness of Dupilumab in the Treatment of Patients with Severe Uncontrolled CRSwNP: A "Real-Life" Observational Study in the First Year of Treatment.

The aim of this study was to evaluate the efficacy of dupilumab in the treatment of severe uncontrolled Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), with or without asthma as add-on therapy with intra-nasal corticosteroids in a real-life setting over the first year of treatment. Our data demonstrated that subcutaneous 300 mg dupilumab administered at home via a pre-filled auto-injector every two weeks, based on indications set by the Italian Medicines Agency, was rapidly effective in reducing the size of polyps, decreasing symptoms of disease, improving quality of life, and recovering olfaction. Significant improvement was observed after only 15 days of treatment, and it progressively increased at 6 and 12 months.

A retrospective observational study on cases of anaplastic brain tumors treated with the Di Bella Method: A rationale and effectiveness.

Despite all the new developments in cancer therapy, the life expectancy of patients with malignant anaplastic brain tumors and glioblastoma multiform (GBM) remains short. Since the establishment of the Di Bella Method (DBM) in cancer therapy, DBM was able to increase the survival rate and life quality, without overt toxicity, in comparison to what is described in the literature related to the analogous brain tumors, with the same immunohistochemical, histologic and clinical features. Therefore, we treated seven patients with malignant anaplastic brain tumors using the DBM protocol.

Effects of Somatostatin and Vitamin C on the Fatty Acid Profile of Breast Cancer Cell Membranes.

Background: Vitamin C (Vit C) is an important physiological antioxidant with growing applications in cancer. Somatostatin (SST) is a natural peptide with growth inhibitory effect in several mammary cancer models.

Objective: The combined effects of SST and Vit C supplementation have never been studied in breast cancer cells so far.

Effects of somatostatin, curcumin, and quercetin on the fatty acid profile of breast cancer cell membranes.

Breast cancer is a worldwide commonly found malignancy in women and effective treatment is regarded as a huge clinical challenge even in the presence of several treatment options. Extensive literature is available demonstrating polyphenols as phytopharmaceutical anticancer agents. Among the polyphenols, quercetin and curcumin have been reported to have a strong potential against breast cancer.

The Entrapment of Somatostatin in a Lipid Formulation: Retarded Release and Free Radical Reactivity.

The natural peptide somatostatin has hormonal and cytostatic effects exerted by the binding to specific receptors in various tissues. Therapeutic uses are strongly prevented by its very short biological half-life of 1-2 min due to enzymatic hydrolysis, therefore encapsulation methodologies are explored to overcome the need for continuous infusion regimes. Multilamellar liposomes made of natural phosphatidylcholine were used for the incorporation of a mixture of somatostatin and sorbitol dissolved in citrate buffer at pH = 5.

The over-expression of GH/GHR in tumour tissues with respect to healthy ones confirms its oncogenic role and the consequent oncosuppressor role of its physiological inhibitor, somatostatin: a review of the literature.

The interaction between pituitary hormones, GH - PRL, and Growth Factors, GF, plays a fundamental role in the physiological and neoplastic mechanisms of growth, the latter using these factors to a much greater extent compared to the former, with a direct dose-dependent effect on the speed of local or metastatic expansion. In hormone-dependent tumours, the respective male and female sex hormones interact with GH - PRL - GF to sustain the expansion of the tumour. We carried out a review of the literature on the relationship between the expression of GH and GHR in tumour tissues compared to healthy tissues, and on the correlation between this expression and tumour aggressiveness.

Melatonin with adenosine solubilized in water and stabilized with glycine for oncological treatment - technical preparation, effectivity and clinical findings.

Melatonin has shown the potential to inhibit growth of different tumors, both in vitro and in vivo. There is clear evidence that the administration of melatonin alone or in combination with chemo and radiotherapy in cancer patients with advanced solid tumors has been associated with improved outcomes of tumor regression and survival. Moreover, chemotherapy has been shown to be better tolerated in patients treated with melatonin.

Complete objective response, stable for 5 years, with the Di Bella Method, of multiple-metastatic carcinoma of the breast.

Breast cancer is the most common cancer and the leading cause of cancer death among women. Despite all efforts, about 11,939 deaths and 50,000 new diagnoses for breast cancer were estimated among Italian women in 2016. Therefore new approaches are needed to improve the survival and higher remission rates.

Congenital fibrosarcoma in complete remission with Somatostatin, Bromocriptine, Retinoids, Vitamin D3, Vitamin E, Vitamin C, Melatonin, Calcium, Chondroitin sulfate associated with low doses of Cyclophosphamide in a 14-year Follow up.

At birth, a male child presented a 6 cm tumour in the right leg. The tumour was partially removed after just 12 days. Histology showed a congenital fibrosarcoma associated with reactive lymphadenitis.

Solution of retinoids in vitamin E in the Di Bella Method biological multitherapy.

Objective: The aim of the liposoluble vitamin solution in the DBM formulation is to enhance the biovailability, the stability, the half-life and the therapeutic efficacy of the components without resorting to excessive or toxic doses.

Method: The DBM vitamin solution contains 0.5 grams of vitamin A palmitate ester, 0.

Recurrent Glioblastoma Multiforme (grade IV - WHO 2007): a case of complete objective response - concomitant administration of Somatostatin / Octreotide, Retinoids, Vit E, Vit D3, Vit C, Melatonin, D2 R agonists (Di Bella Method.

In a 41 year old man, with Glioblastoma Multiforme (Grade IV - WHO 2007) and loco-regional recurrence, treated conventionally with surgery, radio-therapy and Temolozomide, a complete objective response was subsequently achieved by means of the well-tolerated concomitant administration of Somatostatin + slow-release Octreotide, Melatonin, Retinoids solubilized in Vitamin E, Vit D3, Vit C, D2 R agonists, and Temolozomide. In addition to the positive and previously unreported therapeutic finding, this result allowed the patient to avoid further surgical trauma and the correlated risks, achieving an excellent quality of life and working capacity.

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.

The Di Bella Method (DBM) in the treatment of prostate cancer: a preliminary retrospective study of 16 patients and a review of the literature.

Objective: To evaluate the objective clinical response and the safety of the combined administration of somatostatin, melatonin, retinoids, vitamin D3, dopamine subtype 2 receptor (D2R) agonists and low doses of cyclophosphamide, associated with androgen ablation, in patients with a histological diagnosis of prostate adenocarcinoma (Pac).

Materials And Methods: The clinical data of 30 patients with non-invasive and metastatic prostate cancer, who attended our institution over a period of more than 5 years, were retrospectively reviewed.

Results: 16 patients satisfied the evaluation criteria.

The Di Bella Method (DBM) improved survival, objective response and performance status in a retrospective observational clinical study on 55 cases of lymphomas.

Objectives: Lymphomas are the main form of haematological neoplasms, representing 55.6% of all tumours of the blood. Overall, they account for 5.

Melatonin anticancer effects: review.

Melatonin (N-acetyl-5-methoxytryptamine, MLT), the main hormone produced by the pineal gland, not only regulates circadian rhythm, but also has antioxidant, anti-ageing and immunomodulatory properties. MLT plays an important role in blood composition, medullary dynamics, platelet genesis, vessel endothelia, and in platelet aggregation, leukocyte formula regulation and hemoglobin synthesis. Its significant atoxic, apoptotic, oncostatic, angiogenetic, differentiating and antiproliferative properties against all solid and liquid tumors have also been documented.

The Di Bella Method (DBM) improved survival, objective response and performance status in a retrospective observational clinical study on 23 tumours of the head and neck.

In 23 cases of carcinoma of the head and neck, the combined use of Somatostatin and/or its analogue Octreotide, prolactin inhibitors, Melatonin, Retinoids, Vitamin E, Vitamin D3, Vitamin C, Calcium, chondroitin-sulphate, and minimal oral doses of cyclophosphamide (50-100 mg/day) led to a decided increase in survival with respect to the median values reported in the literature for the same tumours and stages, together with an evident improvement in the quality of life, partial or complete objective responses and, in some cases, complete and stable cure with functional recovery. The rationale and the mechanisms of molecular biology of the treatment are discussed, showing that the treatment has a differentiating, apoptotic, antiproliferative, antiangiogenic and antimetastatic effect, and, unlike chemo- and/or radiotherapy, preserves and enhances the trophism and functionality of organs, tissues and immunitary and antitumoral homeostasis. This result, achieved without toxicity, demonstrates the efficacy of this biological multitherapy (Prof.

Laudatio for centenary of the birth of Luigi Di Bella, MD, PhD.

On the centennial of the birth of Luigi Di Bella, the desire to memorialise, at least in part, his thoughts has prompted us to write this tribute, in the hope that one day his dreams may come true. Throughout his research for a treatment of cancer, he deemed it necessary to employ a complex array of substances that, by acting centripetally on neoplastic cells, could in turn be capable of affecting, either simultaneously or sequentially, the myriad of biological reactions supporting their lives. Hence, not a substance but a method (Di Bella Method, DBM).

The Di Bella Method (DBM) improved survival, objective response and performance status in a retrospective observational clinical study on 122 cases of breast cancer.

Objectives: To increase the efficacy and reduce the toxicity of cancer therapy.

Method: The DBM with MLT (melatonin), Retinoids, vitamins E, D3, and C has a differentiating, cytostatic, antiangiogenic, immunomodulating, factorially synergic effect, at the same time reinforcing those functions that Physiology considers essential for life. With Somatostatin and/or its analogues, the DBM has an antiproliferative effect, negatively regulating the most powerful mitogenic molecule (GH), receptorially co-expressed and interactive with Prolactin, inhibited by Cabergoline and/or Bromocriptin.

The Di Bella Method (DBM).

Aims: the aim of the Di Bella Method (DBM) is to try to overcome the high toxicity level and the limited efficacy of the current medical treatments for cancer.

Method: using Melatonin, Retinoids, and vitamins E, D3, and C, components of the extracellular matrix, the DBM reinforces those means that Physiology considers essential for life. Acting together, these differentiating molecules also have an antiangiogenic and antiproliferative effect.