Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

Background and Objectives: Considering the clinical and economic burden of biological drugs in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological drugs for cancer treatment in a general population of Southern Italy in the years 2010–2014. Methods: This was a retrospective, observational study using data from the healthcare administrative databases of Messina Province for the years 2010–2014. In this study, users of biological drugs for cancer treatment were characterized and the prevalence of use and costs were calculated over time. The potential impact of biosimilars on the expenditure was also estimated. Results: Of a population of 653,810 residents in the Messina area during the study years, 2491 (0.4%) patients received at least one study drug. The most frequently used were monoclonal antibodies (mAbs) (n = 1607; 64.5%) and tyrosine kinase inhibitors (TKIs) (n = 609; 24.4%). mAbs were mainly used by females (60.3%) for metastasis due to an unspecified primary tumor, lymphomas, or breast cancer (24.2, 16.7, and 13.7%, respectively). Most users of small molecules were males (56.3%) being treated for multiple myeloma, metastasis due to unspecified primary tumor, leukemia, and lung cancer (13.1, 12.6, 9.5, and 8.9%, respectively). During the study years, the prevalence of use doubled from 0.9 to 1.8 per 1000 inhabitants; likewise, the related expenditure grew from €6.6 to €13.6 million. Based on our forecasts, this expenditure will grow to €25 million in 2020. Assuming a 50% biosimilar uptake (trastuzumab and rituximab), a potential yearly saving of almost €1 million may be achieved. Conclusions: In recent years, the use and costs of biological drugs in cancer patients have increased dramatically in a large population from Southern Italy. This trend may be counterbalanced by adopting biosimilars once they are available. Claims databases represent a valid tool to monitor the uptake of newly marketed biological drugs and biosimilars

Author Correction to: Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

Unfortunately, many errors were identified in the published article. The original article was corrected

Morpho-Tectonic Evolution of the Southern Apennines and Calabrian Arc: Insights From Pollino Range and Surrounding Extensional Intermontane Basins

The evolution of topography in forearc regions results from the complex interplay of crustal and mantle processes. The Southern Apennines represent a well-studied forearc region that experienced several tectonic phases, initially marked by compressional deformation followed by extension and large-scale uplift. We present a new structural, geomorphic and fluvial analysis of the Pollino Massif and surrounding intermontane basins (Mercure, Campotenese and Castrovillari) to unravel their evolution since the Pliocene. We constrain multiple tectonic transport directions, evolution of the drainage, and magnitude and timing of long-term incision following base level falls. Two sets of knickpoints suggest two phases of base level lowering and allow to estimate similar to 500 m of long-term uplift (late Pleistocene), as observed in the Sila Massif. On a smaller spatial scale, the evolution and formation of topographic relief, sedimentation, and opening of intermontane basins is strongly controlled by the recent increase in rock uplift rate and fault activity. At the regional scale, an along-strike, long-wavelength uplift pattern from north to south can be explained by progressive lateral slab tearing and inflow of asthenospheric mantle beneath Pollino and Sila, which in turn may have promoted extensional tectonics. The lower uplift of Le Serre Massif may be explained as result of weak plate coupling due to narrowing of the Calabrian slab. The onset of uplift in the Pollino Massif, ranging from 400 to 800 ka, is consistent with that one proposed in the southern Calabrian forearc, suggesting a possible synchronism of uplift, and lateral tearing of the Calabrian slab.Topographic evolution constrained by structural, geomorphic and river analysis of the Pollino range and surrounding extensional basins At short spatial scale, increase in rock uplift and fault activity controls the endorheic-exorheic transition At regional scale, uplift increases between 400 and 800 ka, due to progressive lateral slab tearing, and inflow asthenospheric mantl

Epidemiology of trauma admissions in a level 1 trauma center in Northern Italy: a nine-year study

The aim of this study was to analyze the results of 9 years of trauma care and data collection in a level 1 urban trauma center in Northern Italy. Overall, 6065 patients have been included in the study; the number of patients managed yearly has doubled between 2011 and 2019. This rise mostly involved patients with injury severity score (ISS) < 16. Most injuries (94%) were blunt. Road traffic accidents, especially involving motorcycles, were the most common cause of injury. Self-inflicted injuries were responsible for less than 5% of trauma but they were severe in 56% of cases. The median age was 38 and it remained constant over the years; 43% of patients had 14–39 years of age. Different characteristics and patterns of injury were observed for each age group and gender. Males were more likely to be injured in the central years of life while females presented a trimodal pattern in the age distribution. Young adults (14–39 years old) were overall at higher risk of self-harm. Overall mortality was equal to 5.2%. Most deceased were male and ≥ 65 years of age

Long-lasting cognitive abnormalities after COVID-19

Considering the mechanisms capable of causing brain alterations in COVID-19, we aimed to study the occurrence of cognitive abnormalities in the months following hospital discharge. We recruited 38 (aged 22-74 years; 27 males) patients hospitalized for complications of SARS-CoV-2 infection in nonintensive COVID units. Participants underwent neuropsychological testing about 5 months after hospital discharge. Of all patients, 42.1% had processing speed deficits, while 26.3% showed delayed verbal recall deficits. Twenty-one percent presented with deficits in both processing speed and verbal memory. Bivariate analysis revealed a positive correlation between the lowest arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) (P/F) ratio during hospitalization and verbal memory consolidation performance (SRT-LTS score, r = 0.404, p = 0.027), as well as a positive correlation between SpO2 levels upon hospital arrival and delayed verbal recall performance (SRT-D score, rs = 0.373, p = 0.042). Acute respiratory distress syndrome (ARDS) during hospitalization was associated with worse verbal memory performance (ARDS vs. no ARDS: SRT-LTS mean score = 30.63 ± 13.33 vs. 44.50 ± 13.16, p = 0.007; SRT-D mean score = 5.95 ± 2.56 vs. 8.10 ± 2.62, p = 0.029). Cognitive abnormalities can frequently be found in COVID-19 patients 5 months after hospital discharge. Increased fatigability, deficits of concentration and memory, and overall decreased cognitive speed months after hospital discharge can interfere with work and daily activities

Abbreviated Versus Multiparametric Prostate MRI in Active Surveillance for Prostate-Cancer Patients: Comparison of Accuracy and Clinical Utility as a Decisional Tool

(1) Purpose: To compare the diagnostic accuracy between full multiparametric contrast-enhanced prostate MRI (mpMRI) and abbreviated dual-sequence prostate MRI (dsMRI) in men with clinically significant prostate cancer (csPCa) who were candidates for active surveillance. (2) Materials and Methods: Fifty-four patients with a diagnosis of low-risk PCa in the previous 6 months had a mpMRI scan prior to a saturation biopsy and a subsequent MRI cognitive transperineal targeted biopsy (for PI-RADS ≥ 3 lesions). The dsMRI images were obtained from the mpMRI protocol. The images were selected by a study coordinator and assigned to two readers blinded to the biopsy results (R1 and R2). Inter-reader agreement for clinically significant cancer was evaluated with Cohen’s kappa. The dsMRI and mpMRI accuracy was calculated for each reader (R1 and R2). The clinical utility of the dsMRI and mpMRI was investigated with a decision-analysis model. (3) Results: The dsMRI sensitivity and specificity were 83.3%, 31.0%, 75.0%, and 23.8%, respectively, for R1 and R2. The mpMRI sensitivity and specificity were 91.7%, 31.0%, 83.3%, and 23.8%, respectively, for R1 and R2. The inter-reader agreement for the detection of csPCa was moderate (k = 0.53) and good (k = 0.63) for dsMRI and mpMRI, respectively. The AUC values for the dsMRI were 0.77 and 0.62 for the R1 and R2, respectively. The AUC values for the mpMRI were 0.79 and 0.66 for R1 and R2, respectively. No AUC differences were found between the two MRI protocols. At any risk threshold, the mpMRI showed a higher net benefit than the dsMRI for both R1 and R2. (4) Conclusions: The dsMRI and mpMRI showed similar diagnostic accuracy for csPCa in male candidates for active surveillance

Generation of a new transgenic mouse model for assessment of tau gene silencing therapies

Abstract Background Targeting the expression of genes has emerged as a potentially viable therapeutic approach to human disease. In Alzheimer’s disease, therapies that silence the expression of tau could be a viable strategy to slow disease progression. Methods We produced a novel strain of transgenic mice that could be used to assess the efficacy of gene knockdown therapies for human tau, in live mice. We designed a tetracycline-regulated transgene construct in which the cDNA for human tau was fused to ubiquitin and to luciferase to create a single fusion polyprotein, termed TUL. Results When expressed in brain, the TUL polyprotein was cleaved by ubiquitin-processing enzymes to release the luciferase as an independent protein, separating the half-life of luciferase from the long-lived tau protein. Treatment of bigenic tTA/TUL mice with doxycycline produced rapid declines in luciferase levels visualized by in vivo imaging and ex vivo enzyme measurement. Conclusions This new mouse model can be used as a discovery tool in optimizing gene targeting therapeutics directed to reduce human tau mRNA levels. </jats:sec

Prostate Cancer Diagnosis and Treatment in Elderly Patients: A Cross-Sectional Survey Exploring Practice Patterns and Preferences of Uro-Oncologists in Northeast Italy

Background: The optimal diagnostic and therapeutic strategies for prostate cancer (PCa) in patients aged ≥75 years (mild-old and oldest-old) are still contentious. Resource allocation and ideal treatment for older patients are challenges, mainly due to their comorbidities and reduced life expectancy. This survey aims to assess current clinical practices and the experiences of healthcare providers in the diagnosis and management of elderly patients with PCa. Materials and Methods: In Northeast Italy, members of the Gruppo Uro-Oncologico del Nord-Est (GUONE) conducted a survey involving 104 physicians of different specialties (Nuclear Medicine, Medical Oncology, Radiation Oncology, Radiology, Urology) between 1 November 2024 and 30 November 2024. The survey encompassed 51 questions, evaluating various diagnostic and therapeutic scenarios. Results: Digital rectal exam (DRE) was recommended by 35.9% of physicians for patients aged 75 or older at risk of PCa. PSA testing was continued in 76.3% of these patients. For 36.5% of the physicians, there should be no age limit for prostate biopsy. Moreover, 42.6% of physicians recommended a magnetic resonance imaging (MRI)-guided prostate biopsy regardless of age. A prostate biopsy was deemed mandatory before initiating any form of hormonal therapy by 57.7% of the participants. For 22.3% and 34.7% of physicians, there should be no age limit for prostate MRI and PET/CT for staging purposes. Interestingly, PET/CT was not recommended in 52% of cases as a staging tool for patients older than 85 years. For patients without comorbidities, the age limit to consider radical prostatectomy (RP) was 75, with 58.6% of physicians in favor. There were no definitive limits for radiotherapy (RT). Chemotherapy had an age limit for 81.6% of the respondents; for 18.4%, 22.5%, and 26.5% of physicians, age limits were 75, 80, and 85 years, respectively. The use of androgen receptor pathway inhibitors (ARPIs) had no definitive age limits for 46.5% of respondents. For patients with no comorbidities and low-volume metastatic PCa, the preferred option was androgen deprivation therapy + ARPIs + RT. The follow-up schedule after RP or RT exhibited heterogeneity with no consensus regarding the frequency of PSA testing or the age at which it should be discontinued. Conclusions: This survey highlights the need for consensus guidelines in diagnosing and managing mild-old and oldest-old elderly PCa patients. With the aging population, standardized protocols are essential to ensure optimal care