Publications by authors named "Francesco Barbato"

67 Publications

Clinical Efficacy of Ponatinib in Philadelphia-Positive T-Cell Acute Lymphoblastic Leukemia with Extramedullary Involvement.

Acta Haematol 2021 Jun 15:1-5. Epub 2021 Jun 15.

Istituto di Ematologia "Seràgnoli" IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

T-cell acute lymphoblastic leukemia (T-ALL) is a rare entity in the adult acute leukemia setting. Translocation (9;22)(q34;q11) and BCR-ABL1 rearrangement are occasionally found in T-ALL and have been reported in no more than 100 cases in the literature (most of which are chronic myeloid leukemia blast crisis). Here, we report the remarkable effectiveness of third-generation tyrosine-kinase inhibitor ponatinib in obtaining hematological and metabolic remission, in a patient with Philadelphia chromosome-positive de novo T-ALL and outcomes of a therapeutic strategy containing chemotherapy intensification, nelarabine, and allogeneic hematopoietic stem cell transplantation.
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http://dx.doi.org/10.1159/000516003DOI Listing
June 2021

PSMA-PET for the assessment of metastatic hormone-sensitive prostate cancer volume of disease.

J Nucl Med 2021 May 14. Epub 2021 May 14.

University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Germany.

Conventional imaging low-(LVD) versus high-volume disease (HVD) are associated with survival in metastatic hormone-sensitive prostate cancer (mHSPC) according to CHAARTED and STAMPEDE trials. We propose a compatible quantitative PSMA-PET framework for disease volume assessment in mHSPC. Three PET centers screened their PSMA-PET database for mHSPC patients. CT versus PSMA-PET stage, lesion number, and classification of LVD vs. HVD were determined by one blinded reader; PSMA-positive tumor volume (PSMA-TV) was quantified semi-automatically. 85 CT-based CHAARTED-LVD and 20 CT-based CHAARTED-HVD patients were included. A PSMA-TV of ~40 ml was the optimal cutoff between CT-based CHAARTED-LVD (non-unifocal) and HVD (non-M1c) (AUC 0.86). Stratification into PET-LVD (unifocal or oligometastatic/disseminated <~40 mL) and PET-HVD (oligometastatic/disseminated ≥~40 mL or M1c) had 13% misalignment with CHAARTED criteria. PSMA-PET criteria with volume quantification deliver comparable LVD/HVD discrimination with additional subgroups for unifocal, oligometastatic and disseminated disease, critical for guidance of targeted or multimodal therapy.
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http://dx.doi.org/10.2967/jnumed.121.262120DOI Listing
May 2021

FDG PET/CT to detect bone marrow involvement in the initial staging of patients with aggressive non-Hodgkin lymphoma: results from the prospective, multicenter PETAL and OPTIMAL>60 trials.

Eur J Nucl Med Mol Imaging 2021 Apr 29. Epub 2021 Apr 29.

Department of Nuclear Medicine, University Hospital Regensburg, Regensburg, Germany.

Purpose: Fluorine-18 fluorodeoxyglucose positron emission tomography combined with computed tomography (FDG PET/CT) is the standard for staging aggressive non-Hodgkin lymphoma (NHL). Limited data from prospective studies is available to determine whether initial staging by FDG PET/CT provides treatment-relevant information of bone marrow (BM) involvement (BMI) and thus could spare BM biopsy (BMB).

Methods: Patients from PETAL (NCT00554164) and OPTIMAL>60 (NCT01478542) with aggressive B-cell NHL initially staged by FDG PET/CT and BMB were included in this pooled analysis. The reference standard to confirm BMI included a positive BMB and/or FDG PET/CT confirmed by targeted biopsy, complementary imaging (CT or magnetic resonance imaging), or concurrent disappearance of focal FDG-avid BM lesions with other lymphoma manifestations during immunochemotherapy.

Results: Among 930 patients, BMI was detected by BMB in 85 (prevalence 9%) and by FDG PET/CT in 185 (20%) cases, for a total of 221 cases (24%). All 185 PET-positive cases were true positive, and 709 of 745 PET-negative cases were true negative. For BMB and FDG PET/CT, sensitivity was 38% (95% confidence interval [CI]: 32-45%) and 84% (CI: 78-88%), specificity 100% (CI: 99-100%) and 100% (CI: 99-100%), positive predictive value 100% (CI: 96-100%) and 100% (CI: 98-100%), and negative predictive value 84% (CI: 81-86%) and 95% (CI: 93-97%), respectively. In all of the 36 PET-negative cases with confirmed BMI patients had other adverse factors according to IPI that precluded a change of standard treatment. Thus, the BMB would not have influenced the patient management.

Conclusion: In patients with aggressive B-cell NHL, routine BMB provides no critical staging information compared to FDG PET/CT and could therefore be omitted.

Trial Registration: NCT00554164 and NCT01478542.
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http://dx.doi.org/10.1007/s00259-021-05348-6DOI Listing
April 2021

Incidence, Risk Factors and Complications of Ocular Graft-Versus-Host Disease Following Hematopoietic Stem Cell Transplantation.

Am J Ophthalmol 2021 07 22;227:25-34. Epub 2021 Feb 22.

Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero Universitaria di Bologna (FB, MA), Bologna, Italy.

Purpose: The purpose of this research was to evaluate the incidence, risk factors, and complications of ocular graft-versus-host disease (GVHD) in a large single-center study.

Design: Retrospective observational case series.

Methods: This study included 283 patients who underwent hematopoietic stem cell transplantation (HSCT) between 2005 and 2020. Ocular GVHD was diagnosed according to International Chronic Ocular GVHD Consensus Group criteria. Potential risk factors for ocular GVHD were evaluated using the Cox proportional hazards model.

Results: The cumulative incidence of ocular GVHD was 19.7% at 1 year, 29.3% at 2 years, 40.7% at 3 years, 47.2% at 4 years, and 49.7% at 5 years. Ocular GVHD was significantly associated with recipient age (hazard ratio [HR]: 1.228; 95% confidence interval [CI]: 1.033-1.459; P = .020); female sex (HR: 1.797; 95% CI: 1.195-2.703; P = .005); peripheral blood stem cell use (PBSC) (HR: 2.079; 95% CI: 1.268-3.411; P = .004); and previous acute GVHD (HR: 1.276; 95% CI: 1.073-1.518; P = .006). Ocular complications after HSCT included cataract, corneal ulcer, corneal perforation, lacrimal obstruction, herpetic keratitis, and cytomegalovirus retinitis.

Conclusions: Half of patients developed ocular GVHD in the 5 years following HSCT. Older age, female sex, use of PBSC, and acute GVHD disease were significant predictors of ocular GVHD. Hematologists and ophthalmologists should be aware of its vision threating complications.
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http://dx.doi.org/10.1016/j.ajo.2021.02.022DOI Listing
July 2021

[Ga]Ga-PSMA-11 PET/CT improves tumor detection and impacts management in patients with hepatocellular carcinoma (HCC).

J Nucl Med 2021 Jan 28. Epub 2021 Jan 28.

Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Germany.

Hepatocellular carcinoma (HCC) is the sixth most prevalent cancer and the third most frequent cause of cancer-related death. A growing number of local and systemic therapies are available, and accurate staging is critical for management decisions. We assessed the impact of neovasculature imaging by Ga-Ga-PSMA-11 PET/CT on disease staging, prognostic groups and management of patients with HCC compared to staging with computed tomography (CT). Forty patients who received imaging with Ga-Ga-PSMA-11 PET/CT for HCC staging between September 2018 and September 2019 were retrospectively included. Management pre- and post-PET scan was assessed by standardized surveys. Presence of HCC was evaluated by three blinded readers on a per-patient and per-region basis for PET/CT (PET criteria) and multi-phase contrast-enhanced CT (CT criteria) in separate sessions. Lesions were validated by follow-up imaging or histopathology, and progression-free survival (PFS) was recorded. Endpoints were detection rate and positive predictive value (PPV) for Ga-Ga-PSMA-11 PET vs. CT, inter-reader reproducibility, and changes in stage, prognostic groups and management plans. Median age was 65 years (range, 37-81), median Child-Pugh score was 5 (range, 5-9). Most patients were treatment naïve (27 of 40, 67.5%). The sensitivity of PET vs. CT to identify liver lesions for patients with lesion validation was 31/32 (97%) for both modalities, while it was 6/6 (100%) vs. 4/6 (67%) for extra-hepatic lesions. PET and CT each had a PPV of 100% at the liver level. PET vs. CT stage was congruent in 30/40 (75%) patients; upstaging was seen in 8/40 patients (20%), while 2/40 (5%) had downstaging by PET. Intended management changed in 19/40 patients (47.5%); 9/19 of these patients were found to have detectable distant metastases (47.4%) and assigned stage 4 disease, the majority of whom were shifted to systemic therapy (8 of 9, 89%). Two patients underwent Lu-Lu-PSMA-617 radioligand therapy. Median PFS was 5.2 months for the entire cohort; 5.3 months for PET M0, and 4.7 months for PET M1 patients, respectively. Ga-Ga-PSMA-11 PET demonstrated higher accuracy than CT in the detection of HCC metastases and was associated with management change in about half of the patient cohort.
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http://dx.doi.org/10.2967/jnumed.120.257915DOI Listing
January 2021

COVID-19 impact on neurology training program in Italy.

Neurol Sci 2021 Mar 14;42(3):817-823. Epub 2021 Jan 14.

"Rita Levi Montalcini" Department of Neurology, University of Turin, Turin, Italy.

The ongoing COVID-19 pandemic is having a huge impact on clinical activity of all hospitals, including the ones involved in training of residents. In addition, neurology residents underwent substantial modifications of their training program. Aim of our investigation was to evaluate the impact of COVID-19 pandemic on the educational activities of Italian neurology residents through an online questionnaire delivered to neurology residents. The results obtained showed that almost 30% of the respondents were redistributed to COVID-19 units. Neurology departments underwent substantial modifications of their organization influencing clinical educational activities; lessons and seminars were rescheduled online and research protocols were stopped and transferred to remote working, when feasible. There was a relevant use of telemedicine approach even if most of the respondents had never been trained before. Some of the changes had a North-South gradient, following the epidemiology of the pandemic. The data obtained from our survey highlight those points to address to be prepared for possible future emergencies.
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http://dx.doi.org/10.1007/s10072-020-04991-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807224PMC
March 2021

Small Fibre Involvement in Multifocal Motor Neuropathy Explored with Sudoscan: A Single-Centre Experience.

Diagnostics (Basel) 2020 Sep 26;10(10). Epub 2020 Sep 26.

Università Cattolica del Sacro Cuore, 00168 Rome, Italy.

Objective: Multifocal motor neuropathy (MMN) is a rare inflammatory neuropathy, clinically characterized by exclusive motor involvement. We wished to evaluate the possible presence of sensory dysfunction, including the evaluation of small fibres, after a long-term disease course.

Patients And Methods: seven MMN patients, regularly followed in our Neurology Department, underwent clinical evaluation, neurophysiological examination by nerve conduction studies (NCSs), and Sudoscan. We compared neurophysiological data with a group of patients with other disorders of the peripheral nervous system.

Results: NCSs showed a reduction of sensory nerve action potential amplitude in 2/7 MMN patients. Sudoscan showed borderline electrochemical skin conductance (ESC) values in 3/7 MMN patients (two of them with abnormal sensory NCSs).

Conclusions: Our results confirm that sensory involvement may be found in some MMN after a long-term disease course, and it could also involve the small fibres.
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http://dx.doi.org/10.3390/diagnostics10100755DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7599533PMC
September 2020

Identification of PCWG3 Target Populations Is More Accurate and Reproducible with PSMA PET Than with Conventional Imaging: A Multicenter Retrospective Study.

J Nucl Med 2021 May 11;62(5):675-678. Epub 2020 Sep 11.

Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium-University Hospital Essen, Essen, Germany

Prostate-specific membrane antigen (PSMA)-ligand PET is potentially useful for screening of castration-resistant prostate cancer (CRPC) clinical trial target populations. We investigated the impact of PSMA PET on Prostate Cancer Clinical Trials Working Group 3 (PCWG3) clinical subtype classification when compared with conventional imaging (CI). A multicenter retrospective study enrolled patients who had undergone PSMA PET for CRPC, had prostate-specific antigen values of at least 1 ng/mL, and had undergone CI-that is, CT plus bone scanning or whole-body MRI. The clinical PCWG3 subtype was determined for PET versus CI by 3 masked readers. Sixty-seven patients were included, and PSMA PET led to up-staging in 15% (10/67) of patients; of these, 6 of 10 (60%) had nonmetastatic CRPC on CI. PSMA PET resulted in down-staging in 15% (10/67) of patients. Agreement for PET versus CI PCWG3 clinical subtypes was 0.81 versus 0.51, 0.74 versus 0.47, 0.95 versus 0.72, or 0.59 versus 0.66 for local, nodal, bone, or visceral disease, respectively. Despite 70% concordance with CI, PSMA PET demonstrated superior reproducibility and accuracy especially for non-metastatic CRPC and should be implemented in future clinical trial entry procedures.
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http://dx.doi.org/10.2967/jnumed.120.246603DOI Listing
May 2021

Volumetric PET Response Assessment Outperforms Conventional Criteria in Patients Receiving High-Dose Pembrolizumab for Malignant Mesothelioma.

J Nucl Med 2021 02 12;62(2):191-194. Epub 2020 Jun 12.

Department of Medical Oncology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.

Fixed-dose pembrolizumab (200 mg absolute, day 1, every 3 wk) for the treatment of malignant pleural mesothelioma did not result in survival benefit in the phase 3 PROMISE-meso trial compared with second-line chemotherapy. Because of lack of validated imaging response criteria, responder subgroups with potential survival benefit have not yet been identified. Here, we administered high-dose pembrolizumab (10 mg/kg, day 1, every 2 wk) considering the KEYNOTE-028 trial and assessed the prognostic value of PET metabolic response in patients with chemotherapy-resistant malignant mesothelioma of the pleura or peritoneum. Data from 27 patients with baseline and follow-up F-FDG PET/CT imaging were retrospectively analyzed. RECIST, version 1.1; modified RECIST; and PERCIST using both tumor lesion metabolic activity in a 1 cm spheric region of interest of up to 5 target lesions (PERCIST) and metabolic tumor volume PERCIST (PERCIST) were applied separately to categorize responders in CT and PET imaging studies. Progression-free survival (PFS) and overall survival (OS) were compared between responders and nonresponders using Kaplan-Meier and log-rank analyses. Programmed cell death protein 1 ligand expression status was assessed, and its association with outcome was investigated. Twenty-seven patients had F-FDG PET/CT imaging at baseline and after at least 4 cycles pembrolizumab. Median PFS and OS were 3.4 and 15.1 mo, respectively. Response rates were 7%, 7%, 30%, and 30% based on RECIST, modified RECIST, PERCIST, and PERCIST response criteria, respectively. Response according to PERCIST predicted prolonged OS or PFS ( < 0.01), whereas all other imaging criteria and programmed cell death protein 1 ligand expression did not. F-FDG PET metabolic volume response predicts survival in patients with malignant mesothelioma receiving high-dose pembrolizumab. These results should prompt inclusion of PET response assessment in future phase 3 clinical trials.
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http://dx.doi.org/10.2967/jnumed.120.245803DOI Listing
February 2021

PSMA-Ligand PET for Early Castration-Resistant Prostate Cancer: A Retrospective Single-Center Study.

J Nucl Med 2021 01 22;62(1):88-91. Epub 2020 May 22.

Department of Nuclear Medicine, University of Duisburg-Essen, and German Cancer Consortium-University Hospital Essen, Essen, Germany

The low detection rate of conventional imaging and unspecific fluctuations in prostate-specific antigen can hamper early diagnosis of castration-resistant prostate cancer (CRPC). We thus assessed the value of prostate-specific membrane antigen (PSMA) PET/CT in the detection of early CRPC (prostate-specific antigen ≤ 3 ng/mL). We identified 55 patients with early CRPC from our institutional database. PSMA PET/CT and its CT component were interpreted independently by 3 masked readers. The primary endpoint was the per-patient detection rate; secondary endpoints were interobserver agreement and predictors of PET positivity. PSMA PET/CT was positive in 41 of 55 (75%) patients. Sixteen of 55 (29%) patients had local disease only, and 25 of 55 (45%) had M1 disease. Overall, PSMA PET/CT interobserver agreement was substantial by Landis and Koch criteria (Fleiss κ = 0.77). PSMA PET/CT localized prostate cancer lesions in 75% of patients and M1 disease in 45%. Detection of early CRPC facilitates disease-delaying therapies for local or oligometastatic disease. PSMA PET/CT is of value in early CRPC and should be included in the CRPC entry criteria of the European Association of Urology and Prostate Cancer Working Group 3.
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http://dx.doi.org/10.2967/jnumed.120.245456DOI Listing
January 2021

Diagnosis and Treatment of VOD/SOS After Allogeneic Hematopoietic Stem Cell Transplantation.

Front Immunol 2020 3;11:489. Epub 2020 Apr 3.

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) is a rare complication characterized by hepatomegaly, right-upper quadrant pain, jaundice, and ascites, occurring after high-dose chemotherapy, hematopoietic stem cell transplantation (HSCT) and, less commonly, other conditions. We review pathogenesis, clinical appearance and diagnostic criteria, risk factors, prophylaxis, and treatment of the VOD occurring post-HSCT. The injury of the sinusoidal endothelial cells with loss of wall integrity and sinusoidal obstruction is the basis of development of postsinusoidal portal hypertension responsible for clinical syndrome. Risk factors associated with the onset of VOD and diagnostic tools have been recently updated both in the pediatric and adult settings and here are reported. Treatment includes supportive care, intensive management, and specific drug therapy with defibrotide. Because of its severity, particularly in VOD with associated multiorgan disease, prophylaxis approaches are under investigation. During the last years, decreased mortality associated to VOD/SOS has been reported being it attributable to a better intensive and multidisciplinary approach.
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http://dx.doi.org/10.3389/fimmu.2020.00489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7147118PMC
March 2021

Ultrasound Aspects of Neurotoxicity-Mediated Sciatic Nerve Injury After Intramuscular Ketorolac Injection.

J Ultrasound Med 2020 Sep 7;39(9):1877-1878. Epub 2020 Apr 7.

Fondazione Policlinico Agostino Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

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http://dx.doi.org/10.1002/jum.15277DOI Listing
September 2020

Mapping Prostate Cancer Lesions Before and After Unsuccessful Salvage Lymph Node Dissection Using Repeat PSMA PET.

J Nucl Med 2020 07 5;61(7):1037-1042. Epub 2019 Dec 5.

Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK), University Hospital Essen, Essen, Germany

The aim of this study was to analyze patterns of persistent versus recurrent or new PET lesions in a selected patient cohort with prostate-specific antigen (PSA) persistence after salvage lymph node dissection (SLND) and pre-procedure and post-procedure prostate-specific membrane antigen (PSMA) ligand PET. Sixteen patients were included in this multicenter study. The inclusion criteria were PSMA PET performed for biochemical recurrence before SLND (pre-SLND PET) and repeat PSMA PET performed for a persistently elevated PSA level (≥0.1 ng/mL) at least 6 wk after SLND (post-SLND PET). Image analysis was performed by 3 independent nuclear medicine physicians applying the molecular imaging TNM system PROMISE. Lesions were confirmed by histopathology, presence on correlative CT/MRI/bone scanning, or PSA response after focal therapy. Post-SLND PET identified prostate cancer lesions in 88% (14/16) of patients with PSA persistence after SLND. Median PSA was 1.2 ng/mL (interquartile range, 0.6-2.8 ng/mL). Disease was confined to the pelvis in 56% of patients (9/16), and most of these men had common iliac (6/16, 38%) and internal iliac lymph node metastases (6/16, 38%). Extrapelvic disease was detected in 31% of patients (5/16). In pre- and post-SLND PET comparison, 10 of 16 had at least one lesion already detected at baseline (63% PET persistence), 4 of 16 had new lesions only (25% PET recurrence), and 2 had no disease on post-SLND PET. All validated regions (11 regions in 9 patients) were true-positive. Nine of 14 (64%) patients underwent repeat local therapies after SLND (7/14 radiotherapy, 2/14 surgery). SLND of pelvic nodal metastases was often not complete according to PSMA PET. About two thirds of patients had PET-positive nodal disease after SLND already seen on pre-SLND PSMA PET. Notably, about one quarter of patients had new lesions, not detected by presurgical PSMA PET.
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http://dx.doi.org/10.2967/jnumed.119.235374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383079PMC
July 2020

NAFLD-Associated Comorbidities in Advanced Stage HCC Do Not Alter the Safety and Efficacy of Yttrium-90 Radioembolization.

Liver Cancer 2019 Nov 29;8(6):491-504. Epub 2019 Jul 29.

Department of Gastroenterology and Hepatology, Essen University Hospital, Essen, Germany.

Background: Patients with advanced hepatocellular carcinoma (HCC) arising in nonalcoholic fatty liver disease (NAFLD) may not be suitable for systemic therapy due to metabolic syndrome-related diseases. Recent trials did not show a survival benefit of radioembolization (RE) compared to sorafenib in advanced stage HCC but RE may represent an adequate alternative in patients with contraindications to systemic therapy due to its favorable safety profile.

Aim: To investigate the impact of NAFLD-related comorbidities on safety and efficacy of RE for HCC treatment in a retrospective monocentric cohort study.

Patients And Methods: Safety and efficacy of RE were evaluated in patients with NAFLD-associated HCC. Hepatitis B virus (HBV)-related HCC patients served as controls, exhibiting matching Barcelona Liver Cancer Clinic (BCLC) stages while showing significantly fewer metabolic comorbidities.

Results: Overall, 87 HCC patients with NAFLD (mean age 71.3 ± 6.9 years) and 62 HCC patients with HBV (mean age 58.8 ± 10.9 years) not amenable to surgical or conventional locoregional treatments were included. Patients with HBV-related HCC had a comparable liver function to HCC patients with NAFLD. RE treatment-related toxicity did not differ between the two groups (increase in bilirubin Common Terminology Criteria for Adverse Events grade in 29 [38.7%] NAFLD and 20 [39.2%] HBV patients, = 0.91). Overall survival was similar in HCC patients with NAFLD and HBV (11.1 [interquartile range, IQR, 18.27] vs. 9.3 months [IQR 14.73], = 0.38), also in the subgroup analyses of BCLC B and C stages.

Conclusion: RE showed similar survival outcomes at a comparable toxicity profile in HCC patients with NAFLD and HBV. NAFLD-associated metabolic comorbidities did not exhibit limitations for RE while offering comparable therapeutic efficacy as compared to HBV patients.
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http://dx.doi.org/10.1159/000501484DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6883476PMC
November 2019

Are Canned Beverages Industries Progressively Switching to Bisphenol AF?

J Food Sci 2019 Nov 31;84(11):3303-3311. Epub 2019 Oct 31.

Dept. of Pharmacy, School of Medicine and Surgery, Univ. of Naples Federico II, Via D. Montesano, 49, I-80131, Naples, Italy.

Seven bisphenols, endocrine-disruptor chemicals, were analytically determined for risk assessment in 52 large-consumption beverages collected from the Italian market. The analytes under examination were bisphenol A, bisphenol F, bisphenol E, bisphenol B, bisphenol AF, bisphenol A diglycidyl ether, and bisphenol M. The concentration levels of all bisphenols detected ranged from
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http://dx.doi.org/10.1111/1750-3841.14833DOI Listing
November 2019

Sural nerve biopsy in peripheral neuropathies: 30-year experience from a single center.

Neurol Sci 2020 Feb 24;41(2):341-346. Epub 2019 Oct 24.

Università Cattolica del Sacro Cuore, Rome, Italy.

Introduction: Nerve biopsy has been widely used to investigate patients with peripheral neuropathy, and in many centers, it is still a useful diagnostic tool in this setting. In this study, we reviewed the histopathological spectrum of the nerve biopsies performed in our center in a 30-year period and we analyzed their relevance in the clinical setting.

Materials And Methods: Retrospective analysis of the retrieved data was done for cases of nerve biopsies performed in our institute between 1988 and 2018. Surgical technique and histopathological analysis were done accordingly to standard protocol.

Results: Complete clinical and pathological data were available only for 717 cases. The procedure was generally safe, with only 0.3% superimposed infection. Main pathological results were "unspecific" axonal polyneuropathy (49.8%), vasculitis neuropathy (9.3%), acquired demyelinating neuropathy (8.9%), and Charcot-Marie-Tooth (8.2%). Considering clinical-neurophysiological suspicion of vasculitis, nerve biopsy confirmed the diagnosis in 60.9% of cases.

Discussion: In conclusion, for inherited neuropathies, we do not recommend this invasive procedure, but we strongly suggest a genetic test. Conversely, in vasculitic neuropathies or in dysimmune neuropathies not clearly confirmed by neurophysiological examination, nerve biopsy continues to represent a useful and irreplaceable tool.
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http://dx.doi.org/10.1007/s10072-019-04082-0DOI Listing
February 2020

Clinical utility of measuring Epstein-Barr virus-specific cell-mediated immunity after HSCT in addition to virological monitoring: results from a prospective study.

Med Microbiol Immunol 2019 Dec 9;208(6):825-834. Epub 2019 Jul 9.

Department of Specialized, Experimental, and Diagnostic Medicine, Operative Unit of Clinical Microbiology, St. Orsola-Malpighi Polyclinic, University of Bologna, Via Massarenti 9, 40138, Bologna, Italy.

Lack of virus-specific cell-mediated immunity (CMI) is associated with worse viral infection outcome in hematopoietic stem cell transplantation (HSCT). We aimed to evaluate the role of immunological monitoring of Epstein-Barr virus (EBV) infection in addition to virological one in 33 adult and 18 pediatric allogeneic HSCT recipients. Virological monitoring of infection was performed on whole blood samples by a quantitative real-time PCR assay. Immunological monitoring was performed by Enzyme-linked ImmunoSPOT assay, evaluating EBV-specific CMI, at fixed time-points and when EBV DNAemia was ≥ 10,000 copies/mL. Fifty-one percent of patients developed a post-transplant EBV infection and reduced-intensity conditioning regimen was the only factor associated to infection (P = 0.023). Lack of EBV-specific CMI during active EBV infection was associated with a greater severity of infection. Patients without EBV-specific CMI showed higher median peak level of EBV DNAemia than patients with EBV-specific CMI (P = 0.014), and consequently received more frequently, at EBV DNAemia peak, anti-CD20 therapy (0 versus 54.5%, P = 0.002). No patients with EBV-specific CMI versus 27.2% without EBV-specific CMI developed EBV-related complications (P = 0.063), including two lethal EBV-related post-transplant lymphoproliferative disorders. Combined immunological and virological measurements could improve EBV infection management in HSCT, anticipating the beginning of preemptive treatment from the EBV DNAemia peak to the finding of the lack of EBV-specific CMI.
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http://dx.doi.org/10.1007/s00430-019-00629-2DOI Listing
December 2019

Ga-PSMA-11 Positron Emission Tomography Detects Residual Prostate Cancer after Prostatectomy in a Multicenter Retrospective Study.

J Urol 2019 12 24;202(6):1174-1181. Epub 2019 Jun 24.

Department of Nuclear Medicine, University Hospital Essen, Essen.

Purpose: Prostate specific antigen persistence after radical prostatectomy is associated with adverse outcomes in patients with prostate cancer. We sought to define regions at risk for residual disease as well as the accuracy of prostate specific membrane antigen ligand positron emission tomography in patients with prostate specific antigen persistence.

Materials And Methods: At 6 participating centers a total of 191 patients who underwent Ga-prostate specific membrane antigen-11 positron emission tomography/computerized tomography or positron emission tomography/magnetic resonance imaging for persistently elevated postoperative prostate specific antigen (0.1 ng/ml or greater) were retrospectively included in study. The detection rate and the positive predictive value were determined. In 33 patients with additional prostate specific membrane antigen ligand positron emission tomography before prostatectomy we also determined the rate of positron emission tomography based persistence and recurrence.

Results: Prostate specific membrane antigen ligand positron emission tomography localized prostate cancer in 130 of 191 patients (68%) with prostate specific antigen persistence at a median prostate specific antigen of 1.1 ng/ml. The detection rate significantly increased with prostate specific antigen (p <0.001). Regarding prostate specific membrane antigen positron emission tomography/computerized tomography only 61 of 173 patients (35%) had disease confined to the pelvis while 57 of 173 (33%) had distant lesions. The most frequently affected nodal regions were the obturator in 42% and the presacral/mesorectal region in 40%. In 15 of the 33 patients (45%) with prostate specific membrane antigen ligand positron emission tomography before and after surgery at least 1 lesion was detected at baseline (positron emission tomography persistence), 8 (24%) had new lesions (positron emission tomography recurrence) and 10 (30%) had negative positron emission tomography findings. The positive predictive value of prostate specific membrane antigen ligand positron emission tomography was 91%. Systemic therapy initiation was significantly associated with distant lesions on prostate specific membrane antigen ligand positron emission tomography.

Conclusions: Prostate specific membrane antigen ligand positron emission tomography localized prostate cancer in more than two-thirds of patients with high risk features and prostate specific antigen persistence after prostatectomy. Obturator and presacral/mesorectal nodes are at high risk for persistent metastasis.
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http://dx.doi.org/10.1097/JU.0000000000000417DOI Listing
December 2019

Occurrence of Bisphenol A and its analogues in some foodstuff marketed in Europe.

Food Chem Toxicol 2019 Sep 13;131:110575. Epub 2019 Jun 13.

Pharm-Analysis & Bio-Pharm Laboratory, Department of Pharmacy, School of Medicine and Surgery, University of Naples Federico II, Via D. Montesano, 49, I-80131, Naples, Italy; Consorzio Interuniversitario INBB, Viale Medaglie d'Oro, 305, I-00136, Rome, Italy. Electronic address:

Bisphenol A and its analogues belong to the class of endocrine disrupting chemicals, massively employed by industries to produce polycarbonate and epoxy resins, designed to be in direct contact with foodstuffs. Their leaching from the canned packaging into its content results in food contamination. This review aims at offering a country-specific overview of the occurrence of bisphenols in six main categories of foodstuff marketed in the EU, based on monitoring studies performed in the 27 EU countries for which data are available and prevalently published in the last five years. The general overview of the literature data shows that concentration values of BPs detected into foodstuff is lower in Northern Europe than Southern Europe. A probable daily intake was hypothesized for some countries to provide an EU population exposure assessment. The consumption of canned meat and vegetables is responsible of PDI values higher than those of other food categories. These data emphasize that food and beverage monitoring should deserve greater attention especially by European countries for which no studies are available and especially with regards to bisphenols other than BPA whose limits are not set by the European regulations and whose toxicity has not been fully established.
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http://dx.doi.org/10.1016/j.fct.2019.110575DOI Listing
September 2019

Scrutinizing the interactions between bisphenol analogues and plasma proteins: Insights from biomimetic liquid chromatography, molecular docking simulations and in silico predictions.

Environ Toxicol Pharmacol 2019 May 9;68:148-154. Epub 2019 Mar 9.

Pharm-Analysis & Bio-Pharm Laboratory, Department of Pharmacy, School of Medicine and Surgery, University of Naples Federico II, Via D. Montesano, 49, I-80131, Naples, Italy; Consorzio Interuniversitario INBB, Viale Medaglie d'Oro, 305, I-00136, Rome, Italy. Electronic address:

The interactions between human serum albumin (HSA) and α- acid glycoprotein (AGP), the main plasma proteins binding drugs/xenobiotics, and some endocrine disrupting chemicals (EDCs), such as bisphenol A (BPA) and some of its structural analogues, bisphenol S (BPS), bisphenol F (BPF), bisphenol E (BPE), bisphenol B (BPB), bisphenol AF (BPAF), bisphenol A diglycidyl ether (BADGE) and bisphenol M (BPM), were characterized by biomimetic liquid chromatography (LC). The interactions between bisphenols (BPs) and either HSA or AGP protein was found to be non-specific and essentially lipophilicity-driven. To get more information on the binding of BPs and plasma proteins, in silico predictions and molecular docking simulations were exploited, and the results achieved in silico were compared to those observed in vitro. BPM was the one exhibiting the highest affinity on both plasma proteins according to these data. Our findings clarified the binding of these EDCs to plasma proteins and offered insights into the biodistribution and bioaccumulation processes underlying their toxicity.
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http://dx.doi.org/10.1016/j.etap.2019.02.008DOI Listing
May 2019

Entry of therapeutics into the brain: Influence of exposed polarity calculated in silico and measured in vitro by supercritical fluid chromatography.

Int J Pharm 2019 Apr 14;560:294-305. Epub 2019 Feb 14.

Worldwide Medicinal Chemistry, Pfizer Global Research & Development, Groton Laboratories, Eastern Point Road, Groton, CT 06340, United States. Electronic address:

The present work proposes a novel application of EPSA (not an acronym but found to be referred to by many as Exposed Polar Surface Area), a supercritical fluid chromatography (SFC) polarity readout for assisting in the prediction of the extent of drug permeation through the blood-brain barrier (BBB). For this purpose, EPSA values for 69 structurally unrelated acidic, basic, neutral and amphoteric compounds were determined by a validated SFC method. Additionally, water-accessible surface area (WASA) values for the whole dataset were calculated in silico and compared to experimentally determined EPSA values. All these indexes were used to model the uptake of drugs through the BBB. Highly significant statistical models (r (n-1) = 0.81) were achieved by using WASA and/or EPSA values along with other experimentally determined (e.g. phospholipophilicity) and in silico calculated descriptors.
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http://dx.doi.org/10.1016/j.ijpharm.2019.02.008DOI Listing
April 2019

A case of ultrasound diagnosis of supraorbital neuralgia.

Muscle Nerve 2019 05 21;59(5):E32-E33. Epub 2019 Feb 21.

Institute of Neurology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Sacred Heart, Rome, Italy.

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http://dx.doi.org/10.1002/mus.26440DOI Listing
May 2019

Liver Stiffness Measurement Allows Early Diagnosis of Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome in Adult Patients Who Undergo Hematopoietic Stem Cell Transplantation: Results from a Monocentric Prospective Study.

Biol Blood Marrow Transplant 2019 05 18;25(5):995-1003. Epub 2019 Jan 18.

Institute of Hematology L. and A Seràgnoli, Sant'Orsola Malpighi University Hospital, Bologna, Italy.

Veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a life-threatening complication affecting patients undergoing hematopoietic stem cell transplantation (HSCT). The survival rate is higher when specific therapy is initiated early; thus, improving early, noninvasive diagnosis of VOD/SOS is an important need. In an adult population undergoing HSCT, we aimed to assess the role of liver stiffness measurement (LSM), evaluated by transient elastography (TE), for diagnosing VOD/SOS. Between April 2016 and March 2018, 78 consecutive adult patients with indications for allogeneic HSCT were prospectively included. LSM was performed before HSCT and at days +9/10, +15/17, and +22/24 post-HSCT. New European Society for Blood and Marrow Transplantation criteria were used to establish VOD/SOS diagnosis. Four patients developed VOD/SOS (5.1%) during the study period, with a median time of +17 days post-HSCT. A sudden increase in LSM compared with previously assessed values and pre-HSCT values, was seen in all patients who developed VOD/SOS. LSM increases occurred from 2 to 12 days before clinical SOS/VOD appearance. The VOD/SOS diagnostic performance of increased LSM over pre-HSCT assessment showed an area under the receiver operating characteristic curve of 0.997 (sensitivity 75%; specificity 98.7%). LSM gradually decreased following successful VOD/SOS-specific treatment. Interestingly, LSM values did not increase significantly in patients experiencing hepatobiliary complications (according to the Common Terminology Criteria) other than VOD/SOS. LSM by TE can be considered a promising method to perform an early, preclinical diagnosis and follow-up of VOD/SOS.
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http://dx.doi.org/10.1016/j.bbmt.2019.01.019DOI Listing
May 2019

Sudoscan in the evaluation and follow-up of patients and carriers with TTR mutations: experience from an Italian Centre.

Amyloid 2018 Dec 14;25(4):242-246. Epub 2019 Jan 14.

b Università Cattolica del Sacro Cuore , Roma , Italia.

Objective: To evaluate the utility of Sudoscan as possible marker of disease progression and disease onset in a cohort of hereditary ATTR amyloidosis (hATTR amyloidosis) polyneuropathy patients and carriers.

Patients And Methods: We regularly performed different clinical scales, nerve conductions studies (NCS), and Sudoscan on a cohort of hATTR amyloidosis patients and carriers from a single centre of central Italy, a non-endemic area, in the last 2 years.

Results: About 18 hATTR amyloidosis patients and 8 asymptomatic carriers were enrolled. All patients had a neuropathy affecting large fibres, small fibres or both. Two subjects developed symptoms and neurophysiological alterations during follow-up. Sudoscan data from hand and feet inversely correlated with neuropathy severity and with disease duration. Moreover, global disease status, expressed by Kumamoto scale also inversely correlated with Sudoscan values.

Conclusions: We confirmed that Sudoscan is a reliable marker of disease progression in late-onset hATTR amyloidosis patients and we suggest its possible utility in early detection of disease in this population.
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http://dx.doi.org/10.1080/13506129.2018.1545640DOI Listing
December 2018

Human exposure to bisphenol AF and diethylhexylphthalate increases susceptibility to develop differentiated thyroid cancer in patients with thyroid nodules.

Chemosphere 2019 Mar 17;218:885-894. Epub 2018 Nov 17.

Pharm-Analysis & Bio-Pharm Laboratory, Department of Pharmacy, School of Medicine and Surgery, University of Naples Federico II, Via D. Montesano, 49, I-80131, Naples, Italy; Consorzio Interuniversitario INBB, Viale Medaglie d'Oro, 305, I-00136, Rome, Italy. Electronic address:

Pollutants represent potential threats to the human health, being ubiquitous in the environment and exerting toxicity even at low doses. This study aims at investigating the role of fifteen multiclass organic pollutants, assumed as markers of environmental pollution, most of which exerting endocrine-disrupting activity, in thyroid cancer development. The increasing incidence of differentiated thyroid cancer (DTC) may be related to the rising production and environmental dissemination of pollutants. Fifty-five patients, twenty-seven with diagnosis of benign thyroid nodules and twenty-eight suffering from differentiated thyroid cancer, were enrolled and the concentration levels of seven bisphenols, two phthalates (i.e. di(2-ethylhexyl) phthalate (DEHP) and its main metabolite, mono-(2-ethyl-hexyl) phthalate) (MEHP)), two chlorobenzenes, (1,4-dichlorobenzene and 1,2,4,5-tetrachlorobenzene), and 3 phenol derivatives (2-chlorophenol, 4- nonylphenol, and triclosan) were determined in their serum by using a validated analytical method based on high performance liquid chromatography with ultraviolet tandem fluorescence detection. A significant relationship was found between malignancy and the detection in the serum of both bisphenol AF and DEHP. Indeed, their presence confers a more than fourteen times higher risk of developing differentiated thyroid cancer. Relationship between these two pollutants and the risk of malignancy was dose-independent and not mediated by higher thyroid stimulating hormone levels. Even if a conclusive evidence cannot still be drawn and larger prospective studies are needed, the exposure to low doses of environmental endocrine-disrupting contaminants can be considered consistent with the development of thyroid cancer.
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http://dx.doi.org/10.1016/j.chemosphere.2018.11.084DOI Listing
March 2019

Simultaneous determination of fifteen multiclass organic pollutants in human saliva and serum by liquid chromatography-tandem ultraviolet/fluorescence detection: A validated method.

Biomed Chromatogr 2019 Mar 3;33(3):e4427. Epub 2018 Dec 3.

Pharm-Analysis & Bio-Pharm Laboratory. Department of Pharmacy, School of Medicine and Surgery, University of Naples Federico II, Naples, Italy.

A quick and inexpensive validated method, based on sample treatment by liquid-liquid microextraction followed by liquid chromatography (LC) coupled with ultraviolet tandem fluorescence detection is proposed for the determination of 15 multiclass pollutants both in serum and in saliva, as a simple and easy to draw matrix. The method was set up and validated according to European guidelines. The compounds of interest include some endocrine-disrupting chemicals (i.e. bisphenol A, bisphenol B, bisphenol E, bisphenol F, bisphenol AF, bisphenol A diglycidyl ether, bisphenol M, diethylhexyl phthalate, monoethylhexyl phthalate, triclosan and 4-nonylphenol), as well as other pollutants belonging to the class of volatile organic compounds (2-chlorophenol, 1,2 dichlorobenzene, 1,2,4,5-tetrachlorobenzene). The limits of quantifications ranged from 2.28 × 10  μg mL (bisphenol A diglycidyl ether) to 6.29 μg mL (diethylhexyl phthalate), while those of detection ranged from 0.068 × 10  μg mL (bisphenol A diglycidyl ether) to 1.031 μg mL (diethylhexyl phthalate). To test method suitability, it was applied to real saliva and serum samples of healthy human volunteers and was found to meet the demands of the laboratories handling simple and relatively inexpensive equipment for screening oriented at rapid and reliable contamination assessment of a population.
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http://dx.doi.org/10.1002/bmc.4427DOI Listing
March 2019

Cytotoxicity of seven bisphenol analogues compared to bisphenol A and relationships with membrane affinity data.

Chemosphere 2018 Jun 5;201:432-440. Epub 2018 Mar 5.

Pharm-Analysis & Bio-Pharm Laboratory - Department of Pharmacy, School of Medicine and Surgery, University of Naples Federico II, Via D. Montesano, 49, I-80131 Naples, Italy; Consorzio Interuniversitario INBB, Viale Medaglie d'Oro, 305, I-00136 Rome, Italy. Electronic address:

Bisphenol A (BPA) is a chemical used in numerous industrial applications. Due to its well ascertained toxicity as endocrine disruptor, industries have started to replace it with other bisphenols whose alleged greater safety is scarcely supported by literature studies. In this study, the toxicity of seven BPA analogues was evaluated using both in silico and in vitro techniques, as compared to BPA toxicity. Furthermore, their affinity indexes for phospholipids (i.e. phospholipophilicity) were determined by immobilized artificial membrane liquid chromatography (IAM-LC) and possible relationships with in vitro toxic activity were also investigated. The results on four different cell cultures yielded similar ranking of toxicity for the bisphenols considered, with IC values confirming their poor acute toxicity. As compared to BPA, bisphenol AF, bisphenol B, bisphenol M, and bisphenol A diglycidyl ether resulted more toxic, while bisphenol S, bisphenol F and bisphenol E were found as the less toxic congeners. These results are partly consistent with the scale of phospholipid affinity showing that toxicity increases at increasing membrane affinity. Therefore, phospholipophilicity determination can be assumed as a useful preliminary tool to select less toxic congeners to surrogate BPA in industrial applications.
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http://dx.doi.org/10.1016/j.chemosphere.2018.03.014DOI Listing
June 2018
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