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Article ; Online: Biomarkers for Antibody-Drug Conjugates in Solid Tumors.

Katrini, Jalissa / Boldrini, Laura / Santoro, Celeste / Valenza, Carmine / Trapani, Dario / Curigliano, Giuseppe

2024 Volume 23, Issue 4, Page(s) 436–446

Abstract: The clinical development and then the progressive entry in clinical practice of antibody-drug conjugates (ADC) have marked a transformative advancement in the overall cancer treatment. ADCs have been extensively tested for a large number of tumors, ... ...

Abstract	The clinical development and then the progressive entry in clinical practice of antibody-drug conjugates (ADC) have marked a transformative advancement in the overall cancer treatment. ADCs have been extensively tested for a large number of tumors, reporting heterogeneous clinical efficacy and safety results. In some diseases, the advent of ADCs has yielded significant changes in the prognostic trajectory, portending an improvement of the survival and/or quality of life. ADCs are targeted agents, capable of delivering highly cytotoxic payloads selectively to antigen-expressing cancer cells. As such, they have been intended as perfect "bullets" to enable the promise of precision medicine, toward high-efficacy and limited-toxicity treatment options. However, only some approved ADCs are intended for the use in biomarker-selected patient populations, restricting potentially the opportunity to be more precise. Yet, key characteristics of modern ADCs might allow the activity of ADCs in tumors with heterogeneous or low expression of cancer antigens, resulting in a clinical activity that could sublimate the classic paradigm of a drug-to-target perfect match. In our review, we portrayed the current landscape of approved ADCs, reporting data of activity as related to the expression of the cancer antigens, and elucidating possible determinants of the safety and efficacy, including when used in a therapeutic sequence.
MeSH term(s)	Humans ; Immunoconjugates/pharmacology ; Immunoconjugates/therapeutic use ; Quality of Life ; Neoplasms ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Biomarkers
Chemical Substances	Immunoconjugates ; Antineoplastic Agents ; Biomarkers
Language	English
Publishing date	2024-02-16
Publishing country	United States
Document type	Review ; Journal Article
ZDB-ID	2063563-1
ISSN	1538-8514 ; 1535-7163
ISSN (online)	1538-8514
ISSN	1535-7163
DOI	10.1158/1535-7163.MCT-23-0482
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Article ; Online: Unaccompanied foreign minors and mental health: Implementation and evaluation of the RHS-15 screening procedure for unaccompanied foreign minors.

Fontana, Marco / Fattori, Francesco / Trezzi, Sofia / Conte, Massimo / Bernardini, Laura / Marando, Laura / Michelini, Giovanni / Trapani, Andrea / Costantino, Maria Antonella

Journal of migration and health

2023 Volume 7, Page(s) 100177

Abstract: Background and objective: The recent notable increase in refugees' flows, with refugee children and adolescents relocating worldwide, posed severe challenges to the different national healthcare systems. Social groups such as refugees fleeing from their ...

Abstract	Background and objective: The recent notable increase in refugees' flows, with refugee children and adolescents relocating worldwide, posed severe challenges to the different national healthcare systems. Social groups such as refugees fleeing from their countries because of persecution, wars and violence are considered at high risk of developing mental health-related problems. Despite international and national policies legally regulating the reception process and protecting health-related rights, including the mental well-being of refugee migrants, there is a theoretical and applied need for evidence-based instruments and procedures to support mental health within this population. Recent evidence refers to the Refugee Health Screener-15 (RHS-15) as a reliable and valid instrument for the early detection of trauma-related mental health problems. In this scenario, this study aimed to test the RHS screening process within a multidisciplinary first intervention reception context for unaccompanied refugee minors. Design: The RHS-15 was administered with the support of cultural-linguistic mediators to 81 unaccompanied minor residents in a first intervention facility in Milan, Italy. This study aimed to assess psychometric characteristics, such as reliability, sensitivity and specificity feasibility and its implementation within a first intervention reception process. Results: The analysis resulted in the validation of the RHS in its 13-item format. The results highlighted and confirmed an efficient delivery, excellent reliability and a positive predictive and convergent validity of the 13-item version. Further analysis showed an excellent ability to avoid false negatives, although there was a clear tendency to identify false positives. Conclusions: The early identification of vulnerabilities among refugee minors is recommended to promote their long-term overall well-being. Integrating the screening results with additional observational elements and more specific diagnostic tools is recommended to gain a comprehensive perspective of the minors' well-being.
Language	English
Publishing date	2023-03-17
Publishing country	England
Document type	Journal Article
ISSN	2666-6235
ISSN (online)	2666-6235
DOI	10.1016/j.jmh.2023.100177
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Article: Evolving treatment landscape of immunotherapy in breast cancer: current issues and future perspectives.

Valenza, Carmine / Rizzo, Graziella / Passalacqua, Maria Ilenia / Boldrini, Laura / Corti, Chiara / Trapani, Dario / Curigliano, Giuseppe

Therapeutic advances in medical oncology

2023 Volume 15, Page(s) 17588359221146129

Abstract: Immune checkpoint inhibitors (ICIs) deeply changed the treatment landscape of breast cancer (BC). In particular, anti-programmed-death (ligand) 1 antibodies were approved for the treatment of triple-negative breast cancer (TNBC), both in first line for ... ...

Abstract	Immune checkpoint inhibitors (ICIs) deeply changed the treatment landscape of breast cancer (BC). In particular, anti-programmed-death (ligand) 1 antibodies were approved for the treatment of triple-negative breast cancer (TNBC), both in first line for metastatic disease and in neoadjuvant setting, on the basis of a demonstrated improvement of the survival outcomes. In light of these results, current clinical trials aim at improving this benefit investigating novel combinations and strategies, at exploring the role of ICIs beyond TNBC, and at better selecting the patients in order to spare non-responders from avoidable toxicities. This narrative review aims at summarizing and discussing the evolving landscape of immunotherapeutic treatments for BC, highlighting the current challenges and the future perspectives.
Language	English
Publishing date	2023-01-19
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2503443-1
ISSN	1758-8359 ; 1758-8340
ISSN (online)	1758-8359
ISSN	1758-8340
DOI	10.1177/17588359221146129
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Article ; Online: Neoadjuvant therapy in hormone Receptor-Positive/HER2-Negative breast cancer.

Cantini, Luca / Trapani, Dario / Guidi, Lorenzo / Boscolo Bielo, Luca / Scafetta, Roberta / Koziej, Marcin / Vidal, Laura / Saini, Kamal S / Curigliano, Giuseppe

Cancer treatment reviews

2023 Volume 123, Page(s) 102669

Abstract: Neoadjuvant therapy is commonly used in patients with locally advanced or inoperable breast cancer (BC). Neoadjuvant chemotherapy (NACT) represents an established treatment modality able to downstage tumours, facilitate breast-conserving surgery, yet ... ...

Abstract	Neoadjuvant therapy is commonly used in patients with locally advanced or inoperable breast cancer (BC). Neoadjuvant chemotherapy (NACT) represents an established treatment modality able to downstage tumours, facilitate breast-conserving surgery, yet also achieve considerable pathologic complete response (pCR) rates in HER2-positive and triple-negative BC. For patients with HR+/HER2- BC, the choice between NACT and neoadjuvant endocrine therapy (NET) is still based on clinical and pathological features and not guided by biomarkers of defined clinical utility, differently from the adjuvant setting where gene-expression signatures have been widely adopted to drive decision-making. In this review, we summarize the evidence supporting the choice of NACT vs NET in HR+/HER2- BC, discussing the issues surrounding clinical trial design and proper selection of patients for every treatment. It is time to question the binary paradigm of responder vs non-responders as well as the "one size fits all" approach in luminal BC, supporting the utilization of continuous endpoints and the adoption of tissue and plasma-based biomarkers at multiple timepoints. This will eventually unleash the full potential of neoadjuvant therapy which is to modulate patient treatment based on treatment sensitivity and surgical outcomes. We also reviewed the current landscape of neoadjuvant studies for HR+/HER2- BC, focusing on antibody-drug conjugates (ADCs) and immunotherapy combinations. Finally, we proposed a roadmap for future neoadjuvant approaches in HR+/HER2- BC, which should be based on a staggered biomarker-driven treatment selection aiming at impacting long-term relevant endpoints.
MeSH term(s)	Female ; Humans ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Breast Neoplasms/therapy ; Chemotherapy, Adjuvant ; Mastectomy, Segmental ; Neoadjuvant Therapy ; Patient Selection ; Receptor, ErbB-2/analysis ; Triple Negative Breast Neoplasms/drug therapy
Chemical Substances	Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2023-12-10
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	125102-8
ISSN	1532-1967 ; 0305-7372
ISSN (online)	1532-1967
ISSN	0305-7372
DOI	10.1016/j.ctrv.2023.102669
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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)
Zs.MO 611: Show issues

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Article: Identifying and costing common gaps in Central and West Africa pharmaceutical regulation.

Alfonso, Claudia P / N'Jambong, Guy B / Magdy, Alaa / Di Trapani, Laura / Kuwana, Rutendo / Kahsay, Abraham G / Maïga, Diadié / Ossei-Agyeman-Yeboah, Sybil N A / Djitafo Fah, Aimé B / Ndomondo-Sigonda, Margareth

Frontiers in medicine

2024 Volume 11, Page(s) 1362253

Abstract: Background: Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be ... ...

Abstract	Background: Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrumental for the newly incepted African Medicine Agency. Aims: This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally. Objectives: The study used NRA self-assessment outcomes to identify common gaps in four critical regulatory pillars and estimate the cost of addressing them from regional perspectives that aimed at raising the maturity level of regulatory institutions. Methods: A cross-sectional study, using the WHO Global Benchmarking Tool (GBT), was conducted between 2020 and 2021 with five NRAs from ECCAS and ECOWAS member states that use French and Spanish as Results: The 10 NRAs operated in a non-formal-to-reactive approach (ML1-2), which hinders their ability to ensure the quality of MPHT and respond appropriately to public health emergencies. Common gaps were identified in four critical regulatory pillars-good regulatory practices, preparedness for public health emergencies, quality management systems, and substandard and falsified medical products-with overall cost to address gaps estimated at US$3.3 million. Contribution: We elaborated a reproducible method to strengthen regulatory systems at a regional level to improve equitable access to assured-quality MPHT. Our bottom-up approach could be utilized by RECs to address common gaps through common efforts.
Language	English
Publishing date	2024-04-05
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2024.1362253
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Article: Durable responses in patients with HER2+ breast cancer and leptomeningeal metastases treated with trastuzumab deruxtecan.

Alder, Laura / Trapani, Dario / Bradbury, Claire / Van Swearingen, Amanda E D / Tolaney, Sara M / Khasraw, Mustafa / Anders, Carey K / Lascola, Christopher D / Hsu, Liangge / Lin, Nancy U / Sammons, Sarah

NPJ breast cancer

2023 Volume 9, Issue 1, Page(s) 19

Abstract: Leptomeningeal metastases (LM) are a devastating complication of HER2 + metastatic breast cancer (MBC), with no effective treatments. In a case series of 8 patients with heavily pretreated HER2 + MBC and progressing LM, all 8 patients (100%) derived ... ...

Abstract	Leptomeningeal metastases (LM) are a devastating complication of HER2 + metastatic breast cancer (MBC), with no effective treatments. In a case series of 8 patients with heavily pretreated HER2 + MBC and progressing LM, all 8 patients (100%) derived clinical benefit from Trastuzumab deruxtecan (TDXd), and 4 patients (50%) had an objective partial response based on formal neuroradiology MRI reads using the EORTC/RANO-LM Revised-Scorecard. T-DXd warrants further study in LM in HER2 + MBC and solid tumors where T-DXd may be active.
Language	English
Publishing date	2023-03-30
Publishing country	United States
Document type	Journal Article
ISSN	2374-4677
ISSN	2374-4677
DOI	10.1038/s41523-023-00519-0
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Article ; Online: In vitro investigations on dopamine loaded Solid Lipid Nanoparticles.

Cometa, Stefania / Bonifacio, Maria Addolorata / Trapani, Giuseppe / Di Gioia, Sante / Dazzi, Laura / De Giglio, Elvira / Trapani, Adriana

Journal of pharmaceutical and biomedical analysis

2020 Volume 185, Page(s) 113257

Abstract: The progressive degeneration of nigrostriatal neurons leads to depletion of the neurotransmitter dopamine (DA) in Parkinson's disease (PD). The hydrophilicity of DA, hindering its cross of the Blood Brain Barrier, makes impossible its therapeutic ... ...

Abstract	The progressive degeneration of nigrostriatal neurons leads to depletion of the neurotransmitter dopamine (DA) in Parkinson's disease (PD). The hydrophilicity of DA, hindering its cross of the Blood Brain Barrier, makes impossible its therapeutic administration. This work aims at investigating some physicochemical features of novel Solid Lipid Nanoparticles (SLN) intended to enhance DA brain delivery for PD patients by intranasal administration. For this aim, novel SLN were formulated in the presence of Glycol Chitosan (GCS), and it was found that SLN containing GCS and DA were smaller than DA-loaded SLN, endowed with a slightly positive zeta potential value and, remarkably, incorporated 81 % of the initial DA content. The formulated SLN were accurately characterized by Infrared Spectroscopy in Attenuated Total Reflectance mode (FT-IT/ATR) and Thermogravimetric Analysis (TGA) to highlight SLN solid-state properties as a preliminary step forward biological assay. Overall, in vitro characterization shows that SLN are promising for DA incorporation and stable from a thermal viewpoint. Further studies are in due course to test their potential for PD treatment.
MeSH term(s)	Administration, Intranasal ; Antiparkinson Agents/administration & dosage ; Antiparkinson Agents/chemistry ; Antiparkinson Agents/pharmacokinetics ; Chitosan/chemistry ; Dopamine/administration & dosage ; Dopamine/chemistry ; Dopamine/pharmacokinetics ; Drug Carriers/chemistry ; Drug Compounding/methods ; Drug Liberation ; Drug Stability ; Fats/chemistry ; Humans ; Nanoparticles/chemistry ; Oils/chemistry ; Parkinson Disease/drug therapy ; Spectroscopy, Fourier Transform Infrared ; Thermogravimetry
Chemical Substances	Antiparkinson Agents ; Drug Carriers ; Fats ; Oils ; glycol-chitosan ; Gelucire 50-13 (121548-05-8) ; Chitosan (9012-76-4) ; Dopamine (VTD58H1Z2X)
Language	English
Publishing date	2020-03-12
Publishing country	England
Document type	Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2020.113257
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Article ; Online: Supramolecular assemblies based on polymeric cyclodextrin nanosponges and a cationic porphyrin with antimicrobial photodynamic therapy action.

Zagami, Roberto / Rubin Pedrazzo, Alberto / Franco, Domenico / Caldera, Fabrizio / De Plano, Laura M / Trapani, Mariachiara / Patanè, Salvatore / Trotta, Francesco / Mazzaglia, Antonino

International journal of pharmaceutics

2023 Volume 637, Page(s) 122883

Abstract: Within of the increasing requirement of alternative approaches to fight emerging infections, nano-photosensitisers (nanoPS) are currently designed with the aim to optimize the antimicrobial photodynamic (aPDT) efficacy. The utilize of less expensive ... ...

Abstract	Within of the increasing requirement of alternative approaches to fight emerging infections, nano-photosensitisers (nanoPS) are currently designed with the aim to optimize the antimicrobial photodynamic (aPDT) efficacy. The utilize of less expensive nanocarriers prepared by simple and eco-friendly methodologies and commercial photosensitisers are highly desiderable. In this direction, here we propose a novel nanoassembly composed of water soluble anionic polyester β-CD nanosponges (β-CD-PYRO hereafter named βNS) and the cationic 5,10,15,20-tetrakis(1-methylpyridinium-4- yl)porphine (TMPyP). Nanoassemblies were prepared in ultrapure water by mixing PS and βNS, by exploiting their mutual electrostatic interaction, and characterized by various spectroscopic techniques such as UV/Vis, Steady-State and Time Resolved Fluorescence, Dynamic Light Scattering and ζ-potential. NanoPS produce appreciable amount of single oxygen similar to free porphyrin and a prolonged stability after 6 days of incubations in physiological conditions and following photoirradiation. Antimicrobial photodynamic action against fatal hospital-acquired infections such as P. aeruginosa and S. aureus was investigated by pointing out the ability of cationic porphyrin loaded- CD nanosponges to photo-kill bacterial cells at prolonged time of incubation and following irradiation (MBC
MeSH term(s)	Cyclodextrins/chemistry ; Staphylococcus aureus ; Photochemotherapy ; Porphyrins/pharmacology ; Porphyrins/chemistry ; Water/chemistry ; Anti-Infective Agents ; Photosensitizing Agents/pharmacology ; Photosensitizing Agents/chemistry
Chemical Substances	Cyclodextrins ; Porphyrins ; Water (059QF0KO0R) ; Anti-Infective Agents ; Photosensitizing Agents
Language	English
Publishing date	2023-03-25
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	428962-6
ISSN	1873-3476 ; 0378-5173
ISSN (online)	1873-3476
ISSN	0378-5173
DOI	10.1016/j.ijpharm.2023.122883
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Zs.A 1409: Show issues

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Article ; Online: Childbirth, Puerperium and Abortion Care Protocol during the COVID-19 Pandemic.

Trapani Júnior, Alberto / Vanhoni, Laura Rassi / Silveira, Sheila Koettker / Marcolin, Alessandra Cristina

Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia

2020 Volume 42, Issue 6, Page(s) 349–355

Abstract: The new coronavirus (severe acute respiratory syndrome-related coronavirus 2, SARS-CoV-2) is a virus that causes a potentially serious respiratory disease that has spread in several countries, reaching humans in all age groups, including pregnant women. ... ...

Title translation	Protocolo de cuidados no parto, no puerpério e no abortamento durante a pandemia de Covid-19.
Abstract	The new coronavirus (severe acute respiratory syndrome-related coronavirus 2, SARS-CoV-2) is a virus that causes a potentially serious respiratory disease that has spread in several countries, reaching humans in all age groups, including pregnant women. The purpose of this protocol is to provide technical and scientific support to Brazilian obstetricians regarding childbirth, postpartum and abortion care during the pandemic.
MeSH term(s)	Abortion, Legal/methods ; Betacoronavirus/isolation & purification ; Brazil ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques/methods ; Comorbidity ; Coronavirus Infections/diagnosis ; Coronavirus Infections/drug therapy ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Coronavirus Infections/therapy ; Delivery, Obstetric/methods ; Disease Transmission, Infectious/prevention & control ; Female ; Humans ; Infection Control/methods ; Infection Control/organization & administration ; Pandemics/prevention & control ; Perinatal Care/methods ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/prevention & control ; Pneumonia, Viral/therapy ; Pregnancy ; Pregnancy Complications, Infectious/diagnosis ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/prevention & control ; Pregnancy Complications, Infectious/therapy ; Risk Assessment/methods ; SARS-CoV-2 ; COVID-19 Drug Treatment
Keywords	covid19
Language	English
Publishing date	2020-06-30
Publishing country	Brazil
Document type	Journal Article ; Practice Guideline
ZDB-ID	2105176-8
ISSN	1806-9339 ; 0100-7203
ISSN (online)	1806-9339
ISSN	0100-7203
DOI	10.1055/s-0040-1713587
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Article ; Online: Degradation of 1,2-dichloroethane in real polluted groundwater by using enriched bacterial consortia in aerobic and anaerobic laboratory-scale conditions

De Marines, Federica / Cruciata, Ilenia / Di Bella, Gaetano / Di Trapani, Daniele / Giustra, Maria Gabriella / Scirè Calabrisotto, Laura / Greco Lucchina, Pietro / Quatrini, Paola / Viviani, Gaspare

International Biodeterioration & Biodegradation. 2023 Sept., v. 183 p.105644-

2023

Abstract: The aim of this work was to gain insights about the feasibility of chlorinated solvents removal through biostimulated and bioaugmented biological processes in laboratory-scale permeable reactive barriers (PRBs) under anaerobic and aerobic conditions. The ...

Abstract	The aim of this work was to gain insights about the feasibility of chlorinated solvents removal through biostimulated and bioaugmented biological processes in laboratory-scale permeable reactive barriers (PRBs) under anaerobic and aerobic conditions. The experimental plant consisted of two Plexiglas cylindrical columns filled with silica sand and fed with real groundwater contaminated by chlorinated solvents (mainly 1,2-dichloroethane, 1,2-DCA, at a concentration of 20 mg l⁻¹). Column A simulated a PRB containing poly-β-hydroxybutyrate (PHB) powder as electron donor and worked under anaerobic conditions; in Column B an inlet air flow rate ensured aerobic conditions. Both columns were inoculated with dechlorinating bacterial consortia obtained by enrichment cultures from the same contaminated groundwater. Results from Column A showed that PHB can be fermented and used as a slow-releasing carbon source for sustaining reductive dechlorination, as revealed by acetate production up to 267 mg l⁻¹ and 100% 1,2-DCA removal. The microbial community detected in Column A at the end of the experimental period was mainly enriched in sulfate reducing bacteria that could act as both fermenting and dechlorinating agents. Column B showed a slight lower 1,2-DCA removal efficiency (98%) likely related to the establishment of aerobic (co)metabolic processes.
Keywords	acetates ; air flow ; biodegradation ; carbon ; dechlorination ; ethylene dichloride ; groundwater ; groundwater contamination ; microbial communities ; polymethylmethacrylate ; quartz ; sulfates ; Chlorinated solvents ; Permeable reactive barrier ; Poly-β-hydroxybutyrate ; Biological reductive dechlorination ; Direct or cometabolic aerobic oxidation ; Metagenomics
Language	English
Dates of publication	2023-09
Publishing place	Elsevier Ltd
Document type	Article ; Online
ISSN	0964-8305
DOI	10.1016/j.ibiod.2023.105644
Database	NAL-Catalogue (AGRICOLA)

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