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Giuliani J.,Materials Salutis Hospital | Bonetti A.,Materials Salutis Hospital
Clinical Lung Cancer | Year: 2016

Objective: The aim of this study was to estimate the pharmacologic costs for the management of skin toxicity in patients treated with epidermal growth factor receptor (EGFR) inhibitors in our institution in order to value the direct medical economic impact in daily clinical practice. Patients and Methods: We retrospectively analyzed all consecutive patients treated with EGFR inhibitors (cetuximab, panitunumab, and erlotinib) at our institution from January 2008 to December 2014. We evaluated the severity and mean duration of skin rash for each grade, and we identified costs for the different therapeutic interventions. Results: We evaluated 22 patients. The median follow-up time was 21.71 months (range, 5.63-94.41 months). At the last follow-up, 17 (77.3%) patients were deceased and 5 (22.7%) patients were alive with metastases. The median overall survival was 21.07 months (range, 4.24-77.14 months). Twenty-one (95.5%) patients developed skin toxicities: 5 (23.8%) with grade 1, 13 (61.9%) with grade 2, and 3 (14.3%) with grade 3. No grade 4 was observed. The mean duration of grade 1 toxicity was 89 days (no specific treatments were started), the mean duration of grade 2 toxicity was 142 days (cost range, 304.5€-449.5€), and the mean duration of grade 3 toxicity was 96 days (cost range, 232.9€-362.2€). Conclusion: Our experience showed that management of skin toxicities related to EGFR inhibitors is not expensive, especially for low-grade toxicities; therefore, we also recommend that clinicians pay particular attention to patients with low grades of toxicities to reduce progression to higher-grade toxicities and the consequent risk of hospitalization, a situation that may seriously impact costs. © 2016 Elsevier Inc.


Giuliani J.,Materials Salutis Hospital | Bonetti A.,Materials Salutis Hospital
Journal of Gastrointestinal Cancer | Year: 2015

Purpose: Gastrointestinal stromal tumor (GIST) is the most common mesenchymal malignancy of the gastrointestinal tract. GISTs may coexist with different types of cancer, either synchronous or metachronous. The frequency of this association and the spectrum of neoplasms involved have not been sufficiently analyzed; most of publications describe a single case report and rare case series. In the absence of definitive data, it could be interesting to compare the frequency of the occurrence of GIST and second malignancies in literature. Methods: A review of all case series that reported the frequency of the occurrence of GIST and synchronous second malignancies were considered. Results: Six retrospective case series were considered, including 440 GIST patients; of these, there were 64 (14.5 %) patients with other synchronous second malignancies. Median age was 67 years, median GIST size was 3.91 cm (range 3.0–4.79 cm), and all cases (100.0 %) were CD117 and CD34 positive. According to the risk categories, 35.2 % of patients had a very low risk, 24.0 % a low risk, 27.6 % an intermediate risk, and 13.2 % a high risk. Conclusions: Regarding the occurrence of GISTs and synchronous second malignancies, we can consider it as more common than it has been considered. Differently, concerning the topic of the incidence of second primary malignancies (SPMs) and metachronous second malignancies in pre-imatinib and after-imatinib era, we can consider it as a clinically relevant topic; according to the present knowledge, the main cause for the increased incidence of SPMs in the imatinib era is explained by the increased survival of patients with metastatic GISTs and therefore more time available to develop SPMs. © 2015, Springer Science+Business Media New York.


Giuliani J.,Materials Salutis Hospital | Marzola M.,University of Ferrara
Central European Journal of Medicine | Year: 2014

Introduction. In the absence of a published head-to-head trial between concomitant cisplatin-radiotherapy vs cetuximab-radiotherapy, we compared results of cetuximab vs cisplatin in unresectable HNSCC in our daily clinical practice. Materials and methods. We retrospectively analyzed all consecutive patients with unresectable HNSCC treated at Clinical Oncology Unit of the University Hospital of Ferrara (Italy) from October 2008 to February 2010. Results. We evaluated 21 patients: at last follow-up, 6 patients (28.6%) were deceased, 15 patients (71.4%) were alive and, among these, 13 (61.9%) were alive without evidence of disease (NED). Median follow-up time was 9.74 months. Median OS was 10.95 months. General characteristics were similar in the two subgroups, except for median age (low in cisplatin-subgroup: 55 vs 72) and the type of response (with a high numbers of complete response in cisplatin-subgroup). By the univariate analysis there was no statistical significance difference in OS (p= 0.898) between the two subgroups. Conclusions. Based on state-of-the-art, it was not possible to identify either treatment regimen is as superior in prolonging either locoregional control or OS: our results seem to indicate that the two treatments may be equally efficacious and deferring the choice of treatment on the toxicity profile. Head-to-head trials are needed. © 2014 Versita and Springer-Verlag.


Pancione M.,University of Sannio | Remo A.,Materials Salutis Hospital | Colantuoni V.,University of Sannio
Pathology Research International | Year: 2012

Colorectal cancer (CRC) is one of the most common causes of death, despite decades of research. Initially considered as a disease due to genetic mutations, it is now viewed as a complex malignancy because of the involvement of epigenetic abnormalities. A functional equivalence between genetic and epigenetic mechanisms has been suggested in CRC initiation and progression. A hallmark of CRC is its pathogenetic heterogeneity attained through at least three distinct pathways: a traditional (adenoma-carcinoma sequence), an alternative, and more recently the so-called serrated pathway. While the alternative pathway is more heterogeneous and less characterized, the traditional and serrated pathways appear to be more homogeneous and clearly distinct. One unsolved question in colon cancer biology concerns the cells of origin and from which crypt compartment the different pathways originate. Based on molecular and pathological evidences, we propose that the traditional and serrated pathways originate from different crypt compartments explaining their genetic/epigenetic and clinicopathological differences. In this paper, we will discuss the current knowledge of CRC pathogenesis and, specifically, summarize the role of genetic/epigenetic changes in the origin and progression of the multiple CRC pathways. Elucidation of the link between the molecular and clinico-pathological aspects of CRC would improve our understanding of its etiology and impact both prevention and treatment. © 2012 Massimo Pancione et al.


Roggeri A.,ProCure Solutions | Micheletto C.,Materials Salutis Hospital | Roggeri D.P.,ProCure Solutions
International Journal of COPD | Year: 2014

Purpose: Fixed-dose combinations of inhaled corticosteroids and long-acting β2-agonists have proven to prevent and reduce chronic obstructive pulmonary disease (COPD) exacerbations. The aim of this analysis was to explore the clinical consequences and direct health care costs of applying the findings of the PATHOS (An Investigation of the Past 10 Years Health Care for Primary Care Patients with Chronic Obstructive Pulmonary Disease) study to the Italian context. Patients and methods: Effectiveness data from the PATHOS study, a population-based, retrospective, observational registry study conducted in Sweden, in terms of reduction in COPD and pneumonia-related hospitalizations, were considered, in order to estimate the differences in resource consumption between patients treated with budesonide/formoterol and fluticasone/salmeterol. The base case considers the average dosages of the two drugs reported in the PATHOS study and the actual public price in charges to the Italian National Health Service, while the difference in hospitalization rates reported in the PATHOS study was costed based on Italian real-world data. Results: The PATHOS study demonstrated a significant reduction in COPD hospitalizations and pneumonia-related hospitalizations in patients treated with budesonide/formoterol versus fluticasone/salmeterol (-29.1% and -42%, respectively). In the base case, the treatment of a patient for 1 year with budesonide/formoterol led to a saving of €499.90 (€195.10 for drugs, €193.10 for COPD hospitalizations, and €111.70 for pneumonia hospitalizations) corresponding to a -27.6% difference compared with fluticasone/salmeterol treatment. Conclusion: Treatment of COPD with budesonide/formoterol compared with fluticasone/salmeterol could lead to a reduction in direct health care costs, with relevant improvement in clinical outcomes. © 2014 Roggeri et al.


Giuliani J.,Materials Salutis Hospital | Marzola M.,University of Ferrara
Archives of Dermatological Research | Year: 2013

The aim of this study was to evaluate the intensity and the duration of acneiform skin rash in young and elderly patients, to define a possible relationship between age and skin rash. We retrospectively analyzed all consecutive patients with advanced NSCLC who developed acneiform skin rash during erlotinib treatment at our Clinical Oncology Unit from June 2006 to May 2011. We divided the general case study into two subgroups: young and elderly patients (≥65 years) and we compared clinical, pathological and therapeutical characteristics of both subgroups. Among 25 patients affected by advanced NSCLC treated with erlotinib during the reference period, 19 patients (76.0 %) developed acneiform skin rash. Fourteen (73.7 %) of 19 patients were elderly. The majority of elderly patients has developed acneiform skin rash (82.4 vs 62.5 %). In addition, in elderly patients, acneiform skin rash has a higher intensity (for mild rash 7.1 vs 20.0 %, for moderate rash 57.1 vs 60.0 %, for severe rash 35.7 vs 20.0 %) and longer duration, especially for mild and moderate rash (for mild rash 154 vs 40 days, for moderate rash 120 vs 76 days, for severe rash 31 vs 85 days). The univariate analysis showed no statistical significant difference in OS between young and elderly patients (p = 0.191), such as age, does not seem to influence the appearance (p = 0.386), duration (p = 0.455) and grade of acneiform skin rash (p = 0.765). In conclusion, we can affirm that age is an insufficient predictor of acneiform skin rash during erlotinib treatment in advanced NSCLC and does not seem to statistically influence the appearance, duration and grade of skin rash. © 2013 Springer-Verlag Berlin Heidelberg.


Giuliani J.,Materials Salutis Hospital | Marzola M.,University of Ferrara
Journal of Gastrointestinal Cancer | Year: 2013

Purpose The aim of this study is to evaluate the intensity and the duration of skin rash in young and elderly patients treated with cetuximab for advanced colorectal cancer, in order to define a possible relationship between age and skin toxicity. Methods We retrospectively analyzed all consecutive patients with advanced colorectal cancer who developed skin rash during cetuximab treatment at the Clinical Oncology Unit from June 2006 to May 2011. We divided the general case study into two subgroups: young and elderly patients (≥65 years old), and we compared clinical, pathological, and therapeutical characteristics of both subgroups. Results Among the 31 patients affected by advanced colorectal cancer (64.5 % with colon cancer and 35.5 % with rectal cancer) treated with cetuximab, 19 patients (61.3 %) developed skin toxicities: seven patients (36.8 %) had grade 1 skin rash, nine patients (47.4 %) had grade 2, three patients (15.8 %) had grade 3, and no grade 4 was found. Ten (52.6 %) out of 19 patients were elderly (>65 years). Concerning skin rash, grading was substantially comparable between the two subgroups, but median duration of skin rash was higher in the first subgroup for all grades. The univariate analysis showed no statistical significant difference in overall survival between young and elderly patients (p=0.171), such as age that does not seem to statistically influence the appearance (p=0.386), duration (p=0.455), and grade of skin rash (p=0.765). Conclusions Age is an insufficient predictor of skin toxicity during cetuximab treatment in advanced colorectal cancer and does not seem to statistically influence the appearance, duration, and grade of skin rash. © Springer Science+Business Media New York 2013.


Remo A.,Materials Salutis Hospital | Pancione M.,University of Sannio | Zanella C.,Materials Salutis Hospital | Vendraminelli R.,Materials Salutis Hospital
Pathologica | Year: 2012

Colorectal carcinoma (CRC) is the second most frequent malignant disease in developed countries. Many aetiological factors have been reported in CRC development including genetic or non-genetic (environmental) elements. Independently of these, three groups of alterations have been implicated: 1) chromosomal instability (CIN); 2) microsatellite instability (MSI); 3) CpG island methylator phenotype (CIMP). A different multistep association between these alterations contributes to determine three distinct developmental pathways: traditional, alternative and serrated. Each genotypic CRC assessment is associated with specific morphologic or clinical features. Pathologists have to consider the morphologic and clinical features of each CRC when study tumours with molecular tests. Chromatin remodelling is extremely dynamic and depends on several DNA-based processes, such as transcription, DNA repair and replication. The recent results with whole genome sequencing in a vast array of cancers have provided a catalogue of genetic lesions in chromatin modifiers that were previously unappreciated. It has revealed surprising facts about mutations in several SWI/ SNF complex members in many malignancies including CRC. The loss of INI1 expression is detected at a low rate in CRC and may be associated with differentiation grade and survival. Accumulating evidence suggests a critical role of the epithelial mesenchymal transition (EMT) in cancer progression. Some results support the existence of crosstalk between EMT and epigenetic modifications in the MSI-CRC group. We have summarized the role of genetic/epigenetic changes in the origin of the multiple CRC pathway, taking into account current knowledge of pathogenesis and feasibility of designing novel therapeutic approaches.


Bonetti A.,Materials Salutis Hospital | Giuliani J.,Materials Salutis Hospital | Muggia F.,New York University
Anticancer Research | Year: 2014

Oxaliplatin and fluoropyrimidines are synergic combinations very active for the treatment of advanced colorectal cancer and for the adjuvant treatment of stage III colon cancer. Oxaliplatin-based regimens can be further strengthened by the addition of a third component, either a traditional drug such as irinotecan or targeted agents such as anti-vascular endothelial growth factor (VEGF) drugs, bevacizumab and aflibercept, or the anti-epidermal growth factor receptor (EGFR), cetuximab and panitumumab. The availabilty of all these active agents prompted several clinical trials on different lines of treatment of advanced colorectal cancer patients and in the adjuvant setting. Clinical studies involving the administration of anti-EGFR drugs also helped identify mutations in KRAS as a negative marker for the activity of these agents. However, positive selection criteria for targeted agents have not been identified. The results of oxaliplatin-containing regimens are critically presented and discussed in this review. © 2014, International Institute of Anticancer Research. All rights reserved.


Ricci R.P.,San Filippo Neri Hospital | Morichelli L.,San Filippo Neri Hospital | D'Onofrio A.,Vincenzo Monaldi Hospital | Calo L.,Casilino Hospital | And 5 more authors.
Europace | Year: 2013

AimsThe HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management.Methods and resultsThe workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5-86.0%] and 97.4% (CI, 96.5-98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1-14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53-0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0-107.0) min × health personnel/100 patients.ConclusionHome Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption. © 2013 The Author.

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