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Article ; Online: Rethinking the Relationship between Insulin and Cancer.

Vigneri, R / Sciacca, L / Vigneri, P

Trends in endocrinology and metabolism: TEM

2020 Volume 31, Issue 8, Page(s) 551–560

Abstract: In addition to being a major metabolic hormone, insulin is also a growth factor with a mitogenic effect on all cells, more marked in malignant cells that often overexpress the insulin receptor. In patients with metabolic diseases characterized by ... ...

Abstract	In addition to being a major metabolic hormone, insulin is also a growth factor with a mitogenic effect on all cells, more marked in malignant cells that often overexpress the insulin receptor. In patients with metabolic diseases characterized by hyperinsulinemia (obesity, type 2 diabetes, and metabolic syndrome), the incidence of several types of cancer is increased, as is cancer-related mortality. Because of the worldwide growing prevalence of metabolic diseases and the diffuse use of insulin and its analogs for treating diabetes, the relationship between insulin and cancer has become a clinically relevant issue. Clinical studies have not clarified the degree to which hyperinsulinemia can influence cancer occurrence and prognosis. To better understand this issue, an improved scientific approach is required, with more careful consideration of the mechanisms related to hyperinsulinemia and carcinogenesis.
MeSH term(s)	Animals ; Diabetes Mellitus, Type 2/physiopathology ; Humans ; Hyperinsulinism/metabolism ; Insulin/metabolism ; Insulin Resistance/physiology ; Neoplasms/metabolism ; Obesity/metabolism
Chemical Substances	Insulin
Language	English
Publishing date	2020-06-26
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1042384-9
ISSN	1879-3061 ; 1043-2760
ISSN (online)	1879-3061
ISSN	1043-2760
DOI	10.1016/j.tem.2020.05.004
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Article: The other side of the coin: dissecting molecular mechanisms behind hereditary breast cancer in search of therapeutic opportunities.

Stella, Stefania / Martorana, Federica / Manzella, Livia / Vigneri, Paolo

Translational oncology

2021 Volume 14, Issue 8, Page(s) 101104

Abstract: Over the last quarter century several genetic alterations have been implicated in hereditary breast cancer (HBC). Two papers recently published in the New England Journal of Medicine explored the mutation prevalence in breast cancer predisposition genes ... ...

Abstract	Over the last quarter century several genetic alterations have been implicated in hereditary breast cancer (HBC). Two papers recently published in the New England Journal of Medicine explored the mutation prevalence in breast cancer predisposition genes across a large population of affected and unaffected subjects. These analyses designated ATM, BARD1, BRCA1, BRCA2, CHEK2, PALB2, RAD51C and RAD51D as the core set of genes associated with a significantly increased risk of developing breast cancer. A deeper understanding of the biological role of these genes unearths an intricate mechanism involving DNA repair and cell cycle regulation. Exploiting these inherited alterations for targeted treatments, as is currently the case with PARP inhibitors, may provide additional therapeutic opportunities for HBC patients.
Language	English
Publishing date	2021-05-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2443840-6
ISSN	1936-5233
ISSN	1936-5233
DOI	10.1016/j.tranon.2021.101104
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Article ; Online: Letter to the Editor: statistics and clinical perception of patients' reported outcomes for palbociclib and abemaciclib: a sliding doors story.

Gebbia, Vittorio / Valerio, Maria Rosaria / Martorana, Federica / Sanò, Maria Vita / Vigneri, Paolo

Journal of comparative effectiveness research

2023 Volume 12, Issue 6, Page(s) e220212

MeSH term(s)	Humans ; Female ; Aminopyridines/therapeutic use ; Pyridines/therapeutic use ; Perception ; Breast Neoplasms ; Antineoplastic Combined Chemotherapy Protocols
Chemical Substances	abemaciclib (60UAB198HK) ; palbociclib (G9ZF61LE7G) ; Aminopyridines ; Pyridines
Language	English
Publishing date	2023-04-28
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	2669725-7
ISSN	2042-6313 ; 2042-6305
ISSN (online)	2042-6313
ISSN	2042-6305
DOI	10.57264/cer-2022-0212
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Article: Potential Therapeutic Targets for Luminal Androgen Receptor Breast Cancer: What We Know so Far.

Stella, Stefania / Martorana, Federica / Massimino, Michele / Vitale, Silvia Rita / Manzella, Livia / Vigneri, Paolo

OncoTargets and therapy

2023 Volume 16, Page(s) 235–247

Abstract: Luminal Androgen Receptor Breast Cancers (LAR BCs) are characterized by a triple negative phenotype and by the expression of Androgen Receptor (AR), coupled with luminal-like genomic features. This unique BC subtype, accounting for about 10% of all ... ...

Abstract	Luminal Androgen Receptor Breast Cancers (LAR BCs) are characterized by a triple negative phenotype and by the expression of Androgen Receptor (AR), coupled with luminal-like genomic features. This unique BC subtype, accounting for about 10% of all triple negative BC, has raised considerable interest given its ill-defined clinical behavior and the chance to exploit AR as a therapeutic target. The complexity of AR activity in BC cells, as revealed by decades of mechanistic studies, holds promise to offer additional therapeutic options beyond mere AR inhibition. Indeed, preclinical and translational evidence showed that several pathways and mediators, including PI3K/mToR, HER2, BRCA1, cell cycle and immune modulation, can be tackled in LAR BCs. Moving from bench to bedside, several clinical trials tested anti-androgen therapies in LAR BCs, but their results are inconsistent and often disappointing. More recently, studies exploring combinations of anti-androgen agents with other targeted therapies have been designed and are currently ongoing. While the results from these trials are awaited, a concerted effort will be needed to find the biological vulnerabilities of LAR BCs which may disclose new and effective therapeutic targets, eventually improving patients' outcomes.
Language	English
Publishing date	2023-04-07
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	2495130-4
ISSN	1178-6930
ISSN	1178-6930
DOI	10.2147/OTT.S379867
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Article: Abemaciclib pharmacology and interactions in the treatment of HR+/HER2- breast cancer: a critical review.

Martorana, Federica / Sanò, Maria Vita / Valerio, Maria Rosaria / Fogli, Stefano / Vigneri, Paolo / Danesi, Romano / Gebbia, Vittorio

Therapeutic advances in drug safety

2024 Volume 15, Page(s) 20420986231224214

Abstract: Abemaciclib (ABE) in combination with endocrine therapy represents the mainstay treatment for either endocrine-resistant metastatic or high-risk early-stage HR+/HER2- breast cancer patients. Hence, an adequate knowledge of this agent pharmacodynamic, ... ...

Abstract	Abemaciclib (ABE) in combination with endocrine therapy represents the mainstay treatment for either endocrine-resistant metastatic or high-risk early-stage HR+/HER2- breast cancer patients. Hence, an adequate knowledge of this agent pharmacodynamic, pharmacokinetic, and of its drug-drug interactions (DDIs) is crucial for an optimal patients management. Additionally, ABE interference with food and complementary/alternative medicines should be taken into account in the clinical practice. Several online tools allow to freely check DDIs and can be easily consulted before prescribing ABE. According to one of this instruments, ABE display the lowest number of interactions among the available cyclin-dependent kinase 4/6 inhibitors. Still, clinicians should be aware that online tools cannot replace the technical datasheet of the drug as well as a comprehensive clinical assessment for each patient. Here we critically review the main pharmacological features of ABE, then focusing on its potential interactions with drugs, food, and alternative medicine, in order to provide a guide for its optimal use in the treatment of HR+/HER2- breast cancer patients.
Language	English
Publishing date	2024-04-25
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2583589-0
ISSN	2042-0994 ; 2042-0986
ISSN (online)	2042-0994
ISSN	2042-0986
DOI	10.1177/20420986231224214
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Article ; Online: The optimal timing between neoadjuvant therapy and surgery of breast cancer: A brief systematic review of the literature.

Lorenzo, Rossi / Meani, Francesco / Longhitano, Claudio / Carciotto, Rosaria / Lanzafame, Katia / Inzerilli, Nicola / Vigneri, Paolo

Critical reviews in oncology/hematology

2023 Volume 183, Page(s) 103921

Abstract: Neoadjuvant therapy is a cornerstone of some early and locally advanced breast cancer treatment. The use of neoadjuvant chemotherapy, in fact, allows to obtain numerous advantages, including allowing a more conservative intervention, evaluating the in ... ...

Abstract	Neoadjuvant therapy is a cornerstone of some early and locally advanced breast cancer treatment. The use of neoadjuvant chemotherapy, in fact, allows to obtain numerous advantages, including allowing a more conservative intervention, evaluating the in vivo response to therapy, modulating the intensity of subsequent treatments based on the degree of response to therapy and allowing to surgery with information on genetics. However, at the end of neoadjuvant cytotoxic therapy it is not possible to carry out surgery immediately, as a certain amount of time is required for recovery from toxicity, especially haematological, due to the systemic therapy itself. At the same time, it is intuitive that too much time must not pass between the end of neoadjuvant therapy and surgery. The goal of this systematic literature review is to summarize the most relevant literature data on this topic, selected and extracted according to the methodology of systematic reviews.
MeSH term(s)	Female ; Humans ; Antineoplastic Agents/therapeutic use ; Breast Neoplasms/drug therapy ; Chemotherapy, Adjuvant ; Neoadjuvant Therapy
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2023-02-04
Publishing country	Netherlands
Document type	Journal Article ; Systematic Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2023.103921
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Zs.A 1931: Show issues

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Article ; Online: Current strategies incorporating immune checkpoint inhibitors for the treatment of advanced or metastatic non-small-cell lung cancers.

Motta, Gianmarco / Vigneri, Paolo

Future oncology (London, England)

2019 Volume 15, Issue 27, Page(s) 3097–3101

MeSH term(s)	Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Agents, Immunological/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/etiology ; Carcinoma, Non-Small-Cell Lung/pathology ; Humans ; Immunomodulation/drug effects ; Lung Neoplasms/drug therapy ; Lung Neoplasms/etiology ; Lung Neoplasms/pathology ; Neoplasm Metastasis ; Neoplasm Staging ; Treatment Outcome
Chemical Substances	Antineoplastic Agents, Immunological
Language	English
Publishing date	2019-10-21
Publishing country	England
Document type	Editorial ; Letter
ZDB-ID	2274956-1
ISSN	1744-8301 ; 1479-6694
ISSN (online)	1744-8301
ISSN	1479-6694
DOI	10.2217/fon-2018-0119
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Zs.A 6478: Show issues

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Article ; Online: A New Kid on the Block: Sacituzumab Govitecan for the Treatment of Breast Cancer and Other Solid Tumors.

Pavone, Giuliana / Motta, Lucia / Martorana, Federica / Motta, Gianmarco / Vigneri, Paolo

Molecules (Basel, Switzerland)

2021 Volume 26, Issue 23

Abstract: Human trophoblast cell-surface antigen-2 (Trop-2) is a membrane glycoprotein involved in cell proliferation and motility, frequently overexpressed in epithelial tumors. Thus, it represents an attractive target for anticancer therapies. Sacituzumab ... ...

Abstract	Human trophoblast cell-surface antigen-2 (Trop-2) is a membrane glycoprotein involved in cell proliferation and motility, frequently overexpressed in epithelial tumors. Thus, it represents an attractive target for anticancer therapies. Sacituzumab govitecan (SG) is a third-generation antibody-drug conjugate, consisting of an anti-Trop-2 monoclonal antibody (hRS7), a hydrolyzable linker, and a cytotoxin (SN38), which inhibits topoisomerase 1. Specific pharmacological features, such as the high antibody to payload ratio, the ultra-toxic nature of SN38, and the capacity to kill surrounding tumor cells (the bystander effect), make SG a very promising drug for cancer treatment. Indeed, unprecedented results have been observed with SG in patients with heavily pretreated advanced triple-negative breast cancer and urothelial carcinomas, and the drug has already received approval for these indications. These results are coupled with a manageable toxicity profile, with neutropenia and diarrhea as the most frequent adverse events, mainly of grades 1-2. While several trials are exploring SG activity in different tumor types and settings, potential biomarkers of response are under investigation. Among these, Trop-2 overexpression and the presence of
MeSH term(s)	Animals ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/pharmacology ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Agents, Immunological/pharmacology ; Antineoplastic Agents, Immunological/therapeutic use ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Camptothecin/adverse effects ; Camptothecin/analogs & derivatives ; Camptothecin/pharmacology ; Camptothecin/therapeutic use ; Female ; Humans ; Immunoconjugates/adverse effects ; Immunoconjugates/pharmacology ; Immunoconjugates/therapeutic use ; Neoplasms/drug therapy ; Neoplasms/pathology
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antineoplastic Agents, Immunological ; Immunoconjugates ; sacituzumab govitecan (M9BYU8XDQ6) ; Camptothecin (XT3Z54Z28A)
Language	English
Publishing date	2021-12-01
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	1413402-0
ISSN	1420-3049 ; 1431-5165 ; 1420-3049
ISSN (online)	1420-3049
ISSN	1431-5165 ; 1420-3049
DOI	10.3390/molecules26237294
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Article ; Online: Outcomes of Sentinel Lymph Node Biopsy for Patients With Node-positive Breast Cancer Treated With Neoadjuvant Chemotherapy.

Cipolla, Calogero / Vieni, Salvatore / D'Agati, Eleonora / Grassi, Nello / Genova, Pietro / Graceffa, Giuseppa / Vigneri, Paolo / Gebbia, Vittorio / Valerio, Maria Rosaria

Anticancer research

2023 Volume 43, Issue 10, Page(s) 4643–4649

Abstract: Background/aim: Clinical trials have shown that the sentinel lymph node biopsy (SLNB) is feasible for patients with cN1 breast carcinoma treated with neoadjuvant chemotherapy (NAC). This study aimed to evaluate the technical outcomes of SLNB by ... ...

Abstract	Background/aim: Clinical trials have shown that the sentinel lymph node biopsy (SLNB) is feasible for patients with cN1 breast carcinoma treated with neoadjuvant chemotherapy (NAC). This study aimed to evaluate the technical outcomes of SLNB by assessing the volume of residual nodal disease. Patients and methods: All patients with cT1-3 cN1 breast cancer undergoing NAC from January 2018 to December 2021 were retrospectively identified from our institutional database. We assessed the outcomes of preoperative clinical examination, ultrasonography, and other imaging to predict the axillary nodal status after NAC for patients converted to cN0 and undergoing SLNB; both adequate mapping and false-negative rate (FNR) at intraoperative evaluation of SLN were assessed. Results: Overall 160 patients were included in the study; 98 were converted to cN0 and underwent SLNB. No difference was found in the adequate mapping rate nor in the mean number of SLNs retrieved compared to the residual LN burden. The intraoperative SLN FNR was 38.2%, with smaller nodal volume being associated with lower FNR (p<0.01). The positive predictive values of physical examination and imaging-based nodal assessment post-NAC were 87.1% and 68.2%, respectively. Conclusion: In a significant percentage of patients with cN1 disease converted to cN0 after NAC, it was possible to recover three or more SLNs. The residual volume of LN disease did not impact the SLN mapping rate. However, we found a high FNR for intraoperative SLN evaluation, particularly for patients with small residual nodal disease. It seems that only a small proportion of patients eligible for SLNB after NAC can be spared ALND.
Language	English
Publishing date	2023-07-17
Publishing country	Greece
Document type	Journal Article
ZDB-ID	604549-2
ISSN	1791-7530 ; 0250-7005
ISSN (online)	1791-7530
ISSN	0250-7005
DOI	10.21873/anticanres.16659
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Article ; Online: Abemaciclib-associated Diarrhea: An Exploratory Analysis of Real-life Data.

Gebbia, Vittorio / Martorana, Federica / Sanò, Maria Vita / Valerio, Maria Rosaria / Giotta, Francesco / Spada, Massimiliano / Piazza, Dario / Caruso, Michele / Vigneri, Paolo

Anticancer research

2023 Volume 43, Issue 3, Page(s) 1291–1299

Abstract: Background/aim: Abemaciclib is a cyclin-dependent kinase 4/6 inhibitor approved in combination with endocrine therapy for treating hormone receptor-positive and human epidermal growth factor receptor 2-negative early and advanced breast cancer patients. ...

Abstract	Background/aim: Abemaciclib is a cyclin-dependent kinase 4/6 inhibitor approved in combination with endocrine therapy for treating hormone receptor-positive and human epidermal growth factor receptor 2-negative early and advanced breast cancer patients. The safety profile of abemaciclib is characterized by frequent gastrointestinal toxicity, especially diarrhea. Therefore, we performed an exploratory analysis of clinical factors that may be potentially associated with diarrhea in patients treated with abemaciclib plus endocrine therapy. Patients and methods: Factors potentially predisposing to diarrhea were selected, such as age ≥70 years, concomitant medications and diseases, diet, and use of laxatives. These variables were correlated with the onset of grade 2/3 diarrhea in a cohort of patients treated with abemaciclib from advanced breast cancer. Univariate and multivariate analysis was performed. Sensitivity and specificity were tested using the ROC curve. Results: Eighty women with advanced breast cancer were included in the study. The univariate analysis found a statistically significant correlation between grade 2/3 diarrhea and age ≥70 years, polypharmacy, and concomitant gastrointestinal diseases (p<0.05). In the multivariate analysis, the number of risk factors significantly correlated with the outcome of interest (p<0.0001). ROC analysis showed our model's 82% sensitivity and 75% specificity. Conclusion: Taking into account specific pre-existing factors, it is possible to estimate the risk of diarrhea in hormone receptor-positive and human epidermal growth factor receptor 2-negative - advanced breast cancer patients, candidates for abemaciclib plus endocrine therapy. In these subjects, implementing proactive prevention and adopting a dose-escalation strategy may represent practical approaches to decrease the abemaciclib toxicity burden.
MeSH term(s)	Humans ; Female ; Aged ; Diarrhea/chemically induced ; Aminopyridines/adverse effects ; Benzimidazoles/adverse effects ; Breast Neoplasms/drug therapy
Chemical Substances	abemaciclib (60UAB198HK) ; Aminopyridines ; Benzimidazoles
Language	English
Publishing date	2023-02-28
Publishing country	Greece
Document type	Journal Article
ZDB-ID	604549-2
ISSN	1791-7530 ; 0250-7005
ISSN (online)	1791-7530
ISSN	0250-7005
DOI	10.21873/anticanres.16276
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