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Article ; Online: Pharmacological insights on novel oral selective estrogen receptor degraders in breast cancer.

Guglielmi, Giorgio / Del Re, Marzia / Gol, Leila Sadeghi / Bengala, Carmelo / Danesi, Romano / Fogli, Stefano

2024 Volume 969, Page(s) 176424

Abstract: The therapeutic landscape of estrogen receptor (ER)-positive breast cancer includes endocrine treatments with aromatase inhibitors (AIs), selective estrogen receptor modulators (SERMs), and selective estrogen receptor degraders (SERDs). Fulvestrant is ... ...

Abstract	The therapeutic landscape of estrogen receptor (ER)-positive breast cancer includes endocrine treatments with aromatase inhibitors (AIs), selective estrogen receptor modulators (SERMs), and selective estrogen receptor degraders (SERDs). Fulvestrant is the first approved SERD with proven efficacy and good tolerability in clinical practice. However, drug resistance, low receptor affinity, and parental administration stimulated the search for new oral SERDs opening a new therapeutic era in ER + breast cancer. Elacestrant is an orally bioavailable SERD that has been recently approved by the FDA for postmenopausal women with ER+, human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Other molecules of the same class currently tested in clinical trials are amcenestrant, giredestrant, camizestrant, and imlunestrant. The current review article offers a detailed pharmacological perspective of this emerging drug class, which may help with their possible future clinical applications.
MeSH term(s)	Female ; Humans ; Breast Neoplasms/pathology ; Fulvestrant ; Selective Estrogen Receptor Modulators/pharmacology ; Selective Estrogen Receptor Modulators/therapeutic use ; Breast/pathology ; Estrogen Receptor alpha/metabolism ; Mouth Neoplasms/drug therapy
Chemical Substances	Fulvestrant (22X328QOC4) ; Selective Estrogen Receptor Modulators ; Estrogen Receptor alpha
Language	English
Publishing date	2024-02-23
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	80121-5
ISSN	1879-0712 ; 0014-2999
ISSN (online)	1879-0712
ISSN	0014-2999
DOI	10.1016/j.ejphar.2024.176424
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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: Cost-Effectiveness of Treatment Optimisation with Biomarkers for Immunotherapy in Solid Tumours: A Systematic Review.

Mucherino, Sara / Lorenzoni, Valentina / Triulzi, Isotta / Del Re, Marzia / Orlando, Valentina / Capuano, Annalisa / Danesi, Romano / Turchetti, Giuseppe / Menditto, Enrica

Cancers

2024 Volume 16, Issue 5

Abstract: This study investigated the health economic evaluations of predictive biomarker testing in solid tumours treated with immune checkpoint inhibitors (ICIs). Searching PubMed, EMBASE, and Web of Science from June 2010 to February 2022, 58 relevant articles ... ...

Abstract	This study investigated the health economic evaluations of predictive biomarker testing in solid tumours treated with immune checkpoint inhibitors (ICIs). Searching PubMed, EMBASE, and Web of Science from June 2010 to February 2022, 58 relevant articles were reviewed out of the 730 screened. The focus was predominantly on non-small cell lung cancer (NSCLC) (65%) and other solid tumours (40%). Among the NSCLC studies, 21 out of 35 demonstrated cost-effectiveness, notably for pembrolizumab as first-line treatment when preceded by PD-L1 assessment, cost-effective at a threshold of $100,000/QALY compared to the standard of care. However, for bladder, cervical, and triple-negative breast cancers (TNBCs), no economic evaluations met the affordability threshold of $100,000/QALY. Overall, the review highlights a certain degree of uncertainty about the cost-effectiveness of ICI. In particular, we found PD-L1 expression associated with ICI treatment to be a cost-effective strategy, particularly in NSCLC, urothelial, and renal cell carcinoma. The findings suggest the potential value of predictive biomarker testing, specifically with pembrolizumab in NSCLC, while indicating challenges in achieving cost-effectiveness for certain other solid tumours.
Language	English
Publishing date	2024-02-29
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers16050995
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Article ; Online: Applicazioni cliniche di bevacizumab nel trattamento del tumore del colon-retto e dell’ovaio.

Danesi, Romano / Cremolini, Chiara / Ciccarone, Francesca / Lorusso, Domenica

Recenti progressi in medicina

2021 Volume 112, Issue 6, Page(s) 444–453

Abstract: The development of biological drugs, which began in the 1980s, has revolutionized the treatment of numerous oncological diseases and severely disabling autoimmune diseases, with widely demonstrated evidence of benefit. Today, biological drugs represent ... ...

Title translation	Clinical applications of bevacizumab in the treatment of colorectal and ovarian cancer.
Abstract	The development of biological drugs, which began in the 1980s, has revolutionized the treatment of numerous oncological diseases and severely disabling autoimmune diseases, with widely demonstrated evidence of benefit. Today, biological drugs represent an important and continuously developing category and are used both as a support therapy in onco-hematology and as molecules with their own therapeutic activity, such as monoclonal antibodies. Among these, bevacizumab represents a drug of relevant clinical value, used as antiangiogenic therapy in numerous cancers, in particular colorectal and ovarian cancers. The expiry of the patent period of monoclonal antibodies, including bevacizumab, has opened up to the development of biosimilar drugs, represented by structurally similar molecules with pharmacokinetic, pharmacodynamic and clinical characteristics equivalent to a biological drug already present in clinical use (originator biologic). The development process of these drugs is contained in the guidelines of the major regulatory bodies (FDA/EMA) and is faster than that provided for the originator biologic. Since biosimilars have a lower cost than reference drugs, their use represents a possibility of containing health care costs and of satifying the growing demand in terms of efficacy and personalization of pharmacological therapies. Considering the particular severity of the diseases treated, including colorectal and ovarian cancers, biosimilar drugs must be used with full awareness, in terms of efficacy and safety, since their approval is based on a rigorous analytical process, as well as preclinical and clinical evaluation.
MeSH term(s)	Antibodies, Monoclonal ; Antineoplastic Agents, Immunological/therapeutic use ; Bevacizumab ; Biosimilar Pharmaceuticals/pharmacokinetics ; Biosimilar Pharmaceuticals/therapeutic use ; Colorectal Neoplasms/drug therapy ; Drug Approval ; Female ; Humans ; Ovarian Neoplasms/drug therapy
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents, Immunological ; Biosimilar Pharmaceuticals ; Bevacizumab (2S9ZZM9Q9V)
Language	Italian
Publishing date	2021-06-15
Publishing country	Italy
Document type	Journal Article
ZDB-ID	138266-4
ISSN	2038-1840 ; 0034-1193
ISSN (online)	2038-1840
ISSN	0034-1193
DOI	10.1701/3620.36027
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Article ; Online: Corrigendum to "Breaking barriers in triple negative breast cancer (TNBC) - Unleashing the power of antibody-drug conjugates (ADCs)" [Cancer Treatment Reviews 123 (2024) 102672].

Dri, Arianna / Arpino, Grazia / Bianchini, Giampaolo / Curigliano, Giuseppe / Danesi, Romano / De Laurentiis, Michelino / Del Mastro, Lucia / Fabi, Alessandra / Generali, Daniele / Gennari, Alessandra / Guarneri, Valentina / Santini, Daniele / Simoncini, Edda / Zamagni, Claudio / Puglisi, Fabio

Cancer treatment reviews

2024 Volume 125, Page(s) 102714

Language	English
Publishing date	2024-03-16
Publishing country	Netherlands
Document type	Published Erratum
ZDB-ID	125102-8
ISSN	1532-1967 ; 0305-7372
ISSN (online)	1532-1967
ISSN	0305-7372
DOI	10.1016/j.ctrv.2024.102714
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Zs.A 1022: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article: TGF-β mRNA levels in circulating extracellular vesicles are associated with response to anti-PD1 treatment in metastatic melanoma.

Crucitta, Stefania / Cucchiara, Federico / Marconcini, Riccardo / Bulleri, Alessandra / Manacorda, Simona / Capuano, Annalisa / Cioni, Dania / Nuzzo, Amedeo / de Jonge, Evert / Mathjissen, Ron H J / Neri, Emanuele / van Schaik, Ron H N / Fogli, Stefano / Danesi, Romano / Del Re, Marzia

Frontiers in molecular biosciences

2024 Volume 11, Page(s) 1288677

Abstract: Introduction: ...

Abstract	Introduction:
Language	English
Publishing date	2024-04-03
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2814330-9
ISSN	2296-889X
ISSN	2296-889X
DOI	10.3389/fmolb.2024.1288677
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Article ; Online: Post-translational modifications and antioxidant properties of different therapeutic human serum albumins.

Mori, Filippo / Natali, Letizia / Danesi, Romano / Nannizzi, Silvia / Farina, Claudio

International journal of biological macromolecules

2021 Volume 183, Page(s) 927–935

Abstract: Human serum albumin (HSA) is widely used for the treatment of diverse clinical conditions to restore plasma volume, manage burns and treat hypoproteinemia.Although the HSA preparations should ideally preserve its functionality, the structural integrity ... ...

Abstract	Human serum albumin (HSA) is widely used for the treatment of diverse clinical conditions to restore plasma volume, manage burns and treat hypoproteinemia.Although the HSA preparations should ideally preserve its functionality, the structural integrity and antioxidant properties of HSA may be compromised as a result of the manufacturing process. The present study examined seven commercially available HSA preparations for clinical use to investigate their post-translational modifications (PTMs) and antioxidant activity, including DPPH radical-scavenging, peroxyl radical antioxidant and metal binding activities, by means of mass spectrometry and Ellman's assay. The results confirmed that most of the PTMs of HSA and especially the oxidation of the free thiol residue varied between the different commercial albumins and the percentage of these PTMs were higher than those of physiological HSA. Moreover, HSA-DA isoform was increased at the end of the stability time and new oxidative modifications occurred in these samples. In conclusion, the bioprocesses for production of commercial albumins are responsible of their wide heterogeneity, being the ethanol fractionation and their storage conditions the more critical phases. Nonetheless, the Kedrion albumin shows a high content of free thiol and a lower concentration of PTMs than other commercial albumins.
MeSH term(s)	Antioxidants/metabolism ; Biphenyl Compounds/metabolism ; Humans ; Oxidation-Reduction ; Peroxides/metabolism ; Picrates/metabolism ; Protein Processing, Post-Translational ; Serum Albumin, Human/metabolism
Chemical Substances	Antioxidants ; Biphenyl Compounds ; Peroxides ; Picrates ; perhydroxyl radical (3170-83-0) ; 1,1-diphenyl-2-picrylhydrazyl (DFD3H4VGDH) ; Serum Albumin, Human (ZIF514RVZR)
Language	English
Publishing date	2021-05-07
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	282732-3
ISSN	1879-0003 ; 0141-8130
ISSN (online)	1879-0003
ISSN	0141-8130
DOI	10.1016/j.ijbiomac.2021.05.046
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Article ; Online: IDH1 mutation is detectable in plasma cell-free DNA and is associated with survival outcome in glioma patients.

Crucitta, Stefania / Pasqualetti, Francesco / Gonnelli, Alessandra / Ruglioni, Martina / Luculli, Giovanna Irene / Cantarella, Martina / Ortenzi, Valerio / Scatena, Cristian / Paiar, Fabiola / Naccarato, Antonio Giuseppe / Danesi, Romano / Del Re, Marzia

BMC cancer

2024 Volume 24, Issue 1, Page(s) 31

Abstract: Background: Circulating cell-free DNA (cfDNA, liquid biopsy) is a powerful tool to detect molecular alterations. However, depending on tumor characteristics, biology and anatomic localization, cfDNA detection and analysis may be challenging. Gliomas are ...

Abstract	Background: Circulating cell-free DNA (cfDNA, liquid biopsy) is a powerful tool to detect molecular alterations. However, depending on tumor characteristics, biology and anatomic localization, cfDNA detection and analysis may be challenging. Gliomas are enclosed into an anatomic sanctuary, which obstacles the release of cfDNA into the peripheral blood. Therefore, the advantages of using liquid biopsy for brain tumors is still to be confirmed. The present study evaluates the ability of liquid biopsy to detect IDH1 mutations and its correlation with survival and clinical characteristics of glioma patients. Methods: Blood samples obtained from glioma patients were collected after surgery prior to the adjuvant therapy. cfDNA was extracted from plasma and IDH1 p.R132H mutation analysis was performed on a digital droplet PCR. χ2-test and Cohen k were used to assess the correlation between plasma and tissue IDH1 status, while Kaplan Meier curve and Cox regression analysis were applied to survival analysis. Statistical calculations were performed by MedCalc and GraphPad Prism software. Results: A total of 67 samples were collected. A concordance between IDH1 status in tissue and in plasma was found (p = 0.0024), and the presence of the IDH1 mutation both in tissue (138.8 months vs 24.4, p < 0.0001) and cfDNA (116.3 months vs 35.8, p = 0.016) was associated with longer median OS. A significant association between IDH1 mutation both in tissue and cfDNA, age, tumor grade and OS was demonstrated by univariate Cox regression analysis. No statistically significant association between IDH1 mutation and tumor grade was found (p = 0.10). Conclusions: The present study demonstrates that liquid biopsy may be used in brain tumors to detect IDH1 mutation which represents an important prognostic biomarker in patients with different types of gliomas, being associated to OS.
MeSH term(s)	Humans ; Glioma/pathology ; Mutation ; Brain Neoplasms/pathology ; Polymerase Chain Reaction ; Cell-Free Nucleic Acids/genetics ; Isocitrate Dehydrogenase/genetics
Chemical Substances	Cell-Free Nucleic Acids ; Isocitrate Dehydrogenase (EC 1.1.1.41) ; IDH1 protein, human (EC 1.1.1.42.)
Language	English
Publishing date	2024-01-03
Publishing country	England
Document type	Journal Article
ZDB-ID	2041352-X
ISSN	1471-2407 ; 1471-2407
ISSN (online)	1471-2407
ISSN	1471-2407
DOI	10.1186/s12885-023-11726-0
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Article: Corrigendum: Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma.

Lorusso, Domenica / Danesi, Romano / Locati, Laura Deborah / Masi, Gianluca / De Giorgi, Ugo / Gadducci, Angiolo / Pignata, Sandro / Sabbatini, Roberto / Savarese, Antonella / Valabrega, Giorgio / Zamagni, Claudio / Colombo, Nicoletta

Frontiers in oncology

2023 Volume 13, Page(s) 1232476

Abstract: This corrects the article DOI: 10.3389/fonc.2022.979519.]. ...

Abstract	[This corrects the article DOI: 10.3389/fonc.2022.979519.].
Language	English
Publishing date	2023-08-07
Publishing country	Switzerland
Document type	Published Erratum
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2023.1232476
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Article ; Online: Management of Adverse Events Associated with Cabozantinib Therapy in Renal Cell Carcinoma.

Schmidinger, Manuela / Danesi, Romano

The oncologist

2017 Volume 23, Issue 3, Page(s) 306–315

Abstract: Cabozantinib was recently approved for the treatment of advanced renal cell carcinoma (RCC) after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. Cabozantinib is a multikinase inhibitor targeting VEGF receptor (VEGFR) 2, ... ...

Abstract	Cabozantinib was recently approved for the treatment of advanced renal cell carcinoma (RCC) after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. Cabozantinib is a multikinase inhibitor targeting VEGF receptor (VEGFR) 2, mesenchymal-epithelial transition receptor, and "anexelekto" receptor tyrosine kinase. A 60-mg daily dose led to improved overall survival and progression-free survival (PFS) versus everolimus in advanced RCC patients as a second- or later-line treatment in the METEOR trial. Improved PFS with cabozantinib versus sunitinib has also been demonstrated in the first-line setting in CABOSUN. However, cabozantinib, like other VEGFR inhibitors, is associated with toxicity that may affect the patient's quality of life. The most frequent adverse events (AEs) are diarrhea, fatigue, hypertension, hand-foot syndrome, weight loss, nausea, and stomatitis. This article summarizes the safety profile of cabozantinib in RCC patients and offers guidance for the management of these AEs. We discuss the underlying mechanisms of these AEs and, based on our experiences with cabozantinib and other multikinase inhibitors, we present approaches to manage toxicity. Prophylactic and therapeutic solutions are available to help with the management of toxicity associated with cabozantinib, and adequate interventions can ensure optimum adherence and maximize patient outcomes. Implications for practice: Cabozantinib leads to improved survival outcomes in renal cell carcinoma patients compared with everolimus. However, management of the adverse event profile is crucial to achieve optimum adherence and outcomes with the use of cabozantinib. This review aims to provide appropriate guidance that will minimize the impact of adverse events and help to maximize the utility of this agent in patients with advanced renal cell carcinoma.
MeSH term(s)	Anilides/adverse effects ; Anilides/pharmacokinetics ; Anilides/therapeutic use ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/pharmacokinetics ; Antineoplastic Agents/therapeutic use ; Carcinoma, Renal Cell/drug therapy ; Drug-Related Side Effects and Adverse Reactions/pathology ; Drug-Related Side Effects and Adverse Reactions/physiopathology ; Drug-Related Side Effects and Adverse Reactions/prevention & control ; Drug-Related Side Effects and Adverse Reactions/therapy ; Humans ; Kidney Neoplasms/drug therapy ; Medication Adherence ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/pharmacokinetics ; Protein Kinase Inhibitors/therapeutic use ; Pyridines/adverse effects ; Pyridines/pharmacokinetics ; Pyridines/therapeutic use ; Quality of Life ; Vascular Endothelial Growth Factor Receptor-2/antagonists & inhibitors
Chemical Substances	Anilides ; Antineoplastic Agents ; Protein Kinase Inhibitors ; Pyridines ; cabozantinib (1C39JW444G) ; Vascular Endothelial Growth Factor Receptor-2 (EC 2.7.10.1)
Language	English
Publishing date	2017-11-16
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1634/theoncologist.2017-0335
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