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Mariangela Boccardi,1 Savino Cilla,2 Mara Fanelli,3 Carmela Romano,2 Paolo Bonome,1 Milena Ferro,1 Donato Pezzulla,1 Roberto Di Marco,4 Francesco Deodato,1,5,* Gabriella Macchia1,* 1Radiation Oncology Unit, Responsible Research Hospital, Campobasso, Italy; 2Medical Physics Unit, Responsible Research Hospital, Campobasso, Italy; 3Research Laboratories, Responsible Research Hospital, Campobasso, Italy; 4Department of Medicina e Scienze della Salute “V. Tiberio”, Università degli Studi del Molise, Campobasso, Italy; 5Istituto di Radiologia, Università Cattolica del Sacro Cuore, Roma, Italy*These authors contributed equally to this workCorrespondence: Milena Ferro, Responsible Research Hospital, L.go Gemelli, 1, Campobasso, 86100, Italy, Email milena.ferro@responsible.hospitalPurpose: The most prevalent treatment-related side effect related to adjuvant radiotherapy (RT) for breast cancer is acute skin toxicity in the irradiated area. The purpose of this single-institution pilot study is to provide preliminary clinical results on the feasibility and safety of a breast ultra-hypofractionated radiation treatment delivered using an automated hybrid-VMAT technique. Skin damage was assessed both with clinical examination and objectively using a Cutometer equipment.Patients and Methods: Patients received 26 Gy to the whole breast and 30 Gy to the tumoral bed in 5 fractions using an automated hybrid-VMAT approach with the option for the breath hold technique if necessary. Acute and late toxicities were clinically evaluated at baseline, 1- and 6-months after treatment using the CTC-AE v.5.0 scale. An instrumental evaluation of the skin elasticity was performed using a Cutometer® Dual MP580. Two parameters per patient, R0 (the total skin firmness) and Q1 (the elastic recovery), were registered at the different timelines.Results: From June 2022 to January 2024, 30 patients, stage T1-T2, N0 were enrolled in the study. Four out of 30 (13.3%) patients reported G2 acute skin toxicities. At 6 months, G2 late toxicity was registered in 3 patients (10%). A total of 2160 measures of R0 and Q1 were recorded. At 1 month after treatment, no correlation was found between measured values of R0 and Q1 and clinical evaluation. At 6 months after treatment, clinical late toxicity ≥ 1 was strongly associated with decreased R0 and Q1 values ≥ 24% (p = 0.003) and ≥ 18% (p = 0.022), respectively.Conclusion: Ultra-hypofractionated whole-breast radiotherapy, when supported by advanced treatment techniques, is both feasible and safe. No severe adverse effects were observed at any of the different timeframes. Acute and late skin toxicities were shown to be lower in contrast to data presented in the literature.Keywords: breast cancer, ultra-hypofractionated radiotherapy, Cutometer, hybrid-VMAT technique

Valeria Dipasquale, Ugo Cucinotta, Claudio Romano Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood “G. Barresi”, University of Messina, Messina, ItalyCorrespondence: Valeria Dipasquale, Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood “G. Barresi”, University of Messina, Via Consolare Valeria 1, Messina, 98124, Italy, Tel +390902212918, Email dipasquale.va@gmail.comAbstract: Biologic drugs have significantly modified the pharmacological management of several chronic conditions, including inflammatory bowel diseases (IBD). By contrast, in the last two decades, biologics have been associated with increased direct medical costs. As patents for the reference drugs have expired, the development and commercialization of biosimilars through abbreviated licensing pathways represented an affordable alternative in patients fulfilling the indication for biologics. A growing body of evidence, first in adults and then in the pediatric age group too, has provided reassuring data in terms of efficacy and safety of biosimilars both in naïve patients and in those previously on reference drugs who had to switch to the biosimilar. This review summarizes the currently available evidence for biosimilar use in IBD, with a focus on pediatric IBD. The most common practical approaches to biosimilar use in the pediatric clinical settings are also discussed.Keywords: anti-TNF, CT-P13, Crohn’s disease, ulcerative colitis, inflammatory bowel disease, children

Augusto Lombardi,1 Elena Pastore,1 Stefano Maggi,1 Gianluca Stanzani,2 Valeria Vitale,2 Camilla Romano,1 Laura Bersigotti,1 Andrea Vecchione,3 Claudio Amanti11Breast Surgery, Università La Sapienza, Ospedale Sant’Andrea, Rome, Italy; 2Breast Surgery, Ospedale Sant’Andrea, Rome, Italy; 3Department of Pathology, Università La Sapienza, Ospedale Sant’Andrea, Rome, ItalyBackground: The primary goal in conservative breast cancer surgery is the complete excision of the tumor, but at the same time attempting to obtain a satisfactory postoperative esthetic result. The notion of “No Ink on Tumor” that indicates exclusively the presence of tumor cells on the inked surface of the surgical specimen is now the gold standard; however, the problem of the free margin is still a fundamental topic of debate that has not yet found a definitive solution.Methods: Our retrospective analysis takes into account 1440 patients undergoing breast conservative surgery, from October 2004 to November 2018, all treated at the breast unit of our institution.Results: Positive margins (R1) rate was 10.2% (147 cases out of 1440). Overall survival was 95% at 5 years and 89% at 10 years. No differences in mortality and local recurrence rate between R0 and R1 patients were found. Half of the R1 patients underwent secondary surgery with enlargement of margins, while in the other half we performed direct mastectomy. Among the analyzed variables, age, histological size, histological type, grading, multifocality, lympho-vascular invasion and lymph node status were significantly correlated with the R1 status. The multivariate analysis shows the association of age and surgical technique (oncoplastic) with R1 status.Conclusion: Further studies will allow the creation of a statistical model, for better pre-operative prediction of patients with higher risk of R1 and better selection of patients to be candidates for conservative surgery.Keywords: breast-conserving therapy, margin status, age, oncoplastic surgery

Patrizia Alvisi,1 Serena Arrigo,2 Salvatore Cucchiara,3 Paolo Lionetti,4 Erasmo Miele,5 Claudio Romano,6 Alberto Ravelli,7 Daniela Knafelz,8 Stefano Martelossi,9 Graziella Guariso,10 Salvatore Accomando,11 Giovanna Zuin,12 Costantino De Giacomo,13 Lucio Balzani,14 Monia Gennari,15 Marina Aloi3 On behalf of the SIGENP IBD Working Group 1Pediatric Gastroenterology Unit, Pediatric Department, Maggiore Hospital, Bologna, Italy; 2Pediatric Gastroenterology and Endoscopy Unit, G Gaslini Children’s Hospital, Genoa, Italy; 3Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy; 4Gastroenterology and Nutrition Unit, Meyer Children’s Hospital, Florence, Italy; 5Pediatric Department, Federico II University of Naples, Naples, Italy; 6Pediatric Gastroenterology, University of Messina, Messina, Italy; 7Gastroenterology and GI Endoscopy Unit, University Department of Pediatrics, Children’s Hospital, Brescia, Italy; 8Hepatology and Gastroenterology Unit, Bambino Gesù Hospital, Rome, Italy; 9Department of Pediatrics, Institute of Child Health, IRCSS Burlo Garofolo, Trieste, Italy; 10University of Padua, Padua, Italy; 11Pediatric Department, University of Palermo, G di Cristina Children’s Hospital, Palermo, Italy; 12Pediatric Unit, Buzzi Hospital, Milan, Italy; 13Pediatric Unit, Niguarda Hospital, Milan, Italy; 14Morgagni Hospital, Forlì, Italy; 15Emergency Pediatric Department, S Orsola Hospital, Bologna, Italy Background: Adalimumab (Ada) treatment is an available option for pediatric Crohn’s disease (CD) and the published experience as rescue therapy is limited.Objectives: We investigated Ada efficacy in a retrospective, pediatric CD cohort who had failed previous infliximab treatment, with a minimum follow-up of 6 months.Methods: In this multicenter study, data on demographics, clinical activity, growth, laboratory values (CRP) and adverse events were collected from CD patients during follow-up. Clinical remission (CR) and response were defined with Pediatric CD Activity Index (PCDAI) score ≤10 and a decrease in PCDAI score of ≥12.5 from baseline, respectively.Results: A total of 44 patients were consecutively recruited (mean age 14.8 years): 34 of 44 (77%) had active disease (mean PCDAI score 24.5) at the time of Ada administration, with a mean disease duration of 3.4 (range 0.3–11.2) years. At 6, 12, and 18 months, out of the total of the enrolled population, CR rates were 55%, 78%, and 52%, respectively, with a significant decrease in PCDAI scores (P2 years was negatively correlated with final PCDAI score (P

M Cascella,1 CA Forte,1 S Bimonte,1 G Esposito,1 C Romano,2 R Costanzo,2 A Morabito,2 A Cuomo1 1Department of Anesthesia and Pain Medicine, Istituto Nazionale Tumori, IRCCS – Fondazione G Pascale, Naples, Italy; 2Thoracic Medical Oncology, Istituto Nazionale Tumori, IRCCS – Fondazione G Pascale, Naples, Italy Background: Previous studies have shown the efficacy of tapentadol (TP) for chronic cancer pain. We evaluated multiple effectiveness aspects of TP prolonged release on moderate–severe cancer-related pain, neuropathic pain (NeP), patient satisfaction, and quality of life. Methods: An observational prospective study was conducted on 80 cancer patients. Opioid-naïve patients received a starting dose of prolonged-release TP 50 mg twice daily, and opioid-experienced patients were switched to TP, not to exceed 500 mg/day. Treatment response was evaluated at 3, 6, 30–40, and 60–70 days through response rate, numeric rating-scale scoring, survival analysis (time to event for response), pain-intensity difference, TP escalation-index percentage, and effects on NeP. The drug-sparing effect on concomitant therapies was evaluated. Results: Seventy of 80 patients (88%) were responders to treatment (95% CI 78%–94%). Compared to T0, pain-intensity reductions were statistically significant for all intervals (P

Pancreatic cancer (pancreatic ductal adenocarcinoma (PDAC/PC)) has been an aggressive disease that is associated with early metastases. It is characterized by dense and collagenous desmoplasia/stroma, predominantly produced by pancreatic stellate cells (PSCs). PSCs interact with cancer cells as well as other stromal cells, facilitating disease progression. A candidate growth factor pathway that may mediate this interaction is the hepatocyte growth factor (HGF)/c-MET pathway. HGF is produced by PSCs and its receptor c-MET is expressed on pancreatic cancer cells and endothelial cells. The current review discusses the role of the MET/HGF axis in tumour progression and dissemination of pancreatic cancer. Therapeutic approaches that were developed targeting either the ligand (HGF) or the receptor (c-MET) have not been shown to translate well into clinical settings. We discuss a two-pronged approach of targeting both the components of this pathway to interrupt the stromal–tumour interactions, which may represent a potential therapeutic strategy to improve outcomes in PC.

Carlotta Bianco,1 Sanja Kezic,2 Matteo Crosera,1 Vesna Svetličić,3 Suzana Šegota,3 Giovanni Maina,4 Canzio Romano,5 Francesca Larese,6,7 Gianpiero Adami11Department of Chemical and Pharmaceutical Sciences, University of Trieste, Trieste, Italy; 2Academic Medical Center, Coronel Institute, University of Amsterdam, Amsterdam, the Netherlands; 3Laboratory for Bioelectrochemistry and Surface Imaging, Division for Marine and Environmental Research, Ruder Boškovic Institute, Zagreb, Croatia; 4Department of Clinical and Biological Sciences, University of Turin, Turin, Italy; 5Department of Public and Pediatric Health Sciences, University of Turin, Turin, Italy; 6Unit of Occupational Medicine, University of Trieste, Trieste, Italy; 7Department of Medical Sciences, University of Trieste, Trieste, ItalyAbstract: The objective of this study was to determine the in vitro percutaneous penetration of silver and characterize the silver species released from textiles in different layers of full thickness human skin. For this purpose, two different wound dressings and a garment soaked in artificial sweat were placed in the donor compartments of Franz cells for 24 hours. The concentration of silver in the donor phase and in the skin was determined by an electrothermal atomic absorption spectrometer (ET-AAS) and by inductively coupled plasma mass spectrometer (ICP-MS). The characterization of silver species in the textiles and in the skin layers was made by scanning electron microscopy with integrated energy dispersive X-ray spectroscopy (SEM-EDX). Additionally, the size distribution of silver nanoparticles in the textiles was performed by atomic force microscopy (AFM). On the surface of all investigated materials, silver nanoparticles of different size and morphology were found. Released silver concentrations in the soaking solutions (ie, exposure concentration) ranged from 0.7 to 4.7 µg/mL (0.6–4.0 µg/cm2), fitting the bactericidal range. Silver and silver chloride aggregates at sizes of up to 1 µm were identified both in the epidermis and dermis. The large size of these particles suggests that the aggregation occurred in the skin. The formation of these aggregates likely slowed down the systemic absorption of silver. Conversely, these aggregates may form a reservoir enabling prolonged release of silver ions, which might lead to local effects.Keywords: silver textile, silver release, skin

Claudio Amanti,1 Valeria Vitale,1 Augusto Lombardi,1 Stefano Maggi,1 Laura Bersigotti,1 Gianni Lazzarin,1 Emiliano Nuccetelli,1 Camilla Romano,1 Laura Campanella,1 Lara Cristiano,2 Alessandra Bartoloni,2 Giuseppe Argento2 1Breast Surgery Unit, 2Radiology Unit, University of Roma, La Sapienza Sant'Andrea Hospital, Rome, Italy Background: Nipple-sparing mastectomy (NSM), understood as an oncologically valid procedure, is relatively new, and is an evolution of traditional mastectomy, particularly in relation to breast-conserving surgery. The anterior perforating branches are responsible for the cutaneous vascularization of the breast skin, and their preservation is a fundamental step to avoid possible postoperative necrosis. Therefore, evaluating the potential complications of cancer-related reconstructive surgical procedures such as NSM, both the distance of the tumoral lesion from the skin and the surgical incision site should be carefully considered. The preferred site of incision corresponds to the inframammary fold or possibly the periareolar area.Methods: We retrospectively reviewed 113 patients who underwent NSM from January 2005 to October 2012 to evaluate skin complications. The anatomical study was performed by magnetic resonance imaging of the breast.Results: Only one of the 113 women who had undergone a NSM procedure had total necrosis (0.9%) and six patients had partial necrosis (5.8%) of the nipple-areola complex. Keywords: nipple-sparing mastectomy, breast, magnetic resonance imaging, breast perforating vessels, breast anatomy

Sabrina Cardile, Claudio RomanoDepartment of Pediatrics, University of Messina, ItalyAbstract: Gastroesophageal reflux is a common condition in the pediatric population, with an increasing incidence in the last few years. It can be defined as an effortless retrograde movement of gastric contents into the esophagus related to complex multifactorial pathogenesis, involving anatomical, hormonal, environmental, and genetic factors. In some cases, it may be associated with esophageal or extraesophageal symptoms (heartburn and regurgitation), and is defined as gastroesophageal reflux disease (GERD). The therapeutic approach to gastroesophageal reflux in infants and children is often conservative, including changes in lifestyle (eg, posture and thickening of meals). If these children remain symptomatic after lifestyle changes (nutrition, feeding, and positional modification), or present with clinical red flags (poor weight gain, recurrent respiratory symptoms, or hematemesis) and complications of GERD (esophagitis, bleeding, stricture, Barrett's esophagus, or adenocarcinoma) it may be necessary to set up a proper diagnostic protocol. Proton pump inhibitors have been recommended as the most effective acid suppression therapy for adults and pediatric patients. Esomeprazole, the S-isomer of omeprazole, is the only single-isomer proton pump inhibitor available. The paper assesses the safety and tolerability of esomeprazole in pediatric and adolescent patients.Keywords: esomeprazole, gastroesophageal reflux disease, pump proton inhibitors

In August 2013 drilling triggered the eruption of mud near the international airport of Fiumicino (Rome, Italy). We monitored the evolution of the eruption and collected samples for laboratory characterization of physicochemical and rheological properties. Over time, muds show a progressive dilution with water; the rheology is typical of pseudoplastic fluids, with a small yield stress that decreases as mud density decreases. The eruption, while not naturally triggered, shares several similarities with natural mud volcanoes, including mud componentry, grain-size distribution, gas discharge, and mud rheology. We use the size of large ballistic fragments ejected from the vent along with mud rheology to compute a minimum ascent velocity of the mud. Computed values are consistent with in situ measurements of gas phase velocities, confirming that the stratigraphic record of mud eruptions can be quantitatively used to infer eruption history and ascent rates and hence to assess (or reassess) mud eruption hazards.