Publications by authors named "Elisa Carretta"

53 Publications

Whole Lung Irradiation after High-Dose Busulfan/Melphalan in Ewing Sarcoma with Lung Metastases: An Italian Sarcoma Group and Associazione Italiana Ematologia Oncologia Pediatrica Joint Study.

Cancers (Basel) 2021 Jun 3;13(11). Epub 2021 Jun 3.

Paediatric Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.

Purpose: To analyze toxicity and outcome predictors in Ewing sarcoma patients with lung metastases treated with busulfan and melphalan (BU-MEL) followed by whole-lung irradiation (WLI).

Methods: This retrospective study included 68 lung metastatic Ewing Sarcoma patients who underwent WLI after BU-MEL with autologous stem cell transplantation, as part of two prospective and consecutive treatment protocols. WLI 12 Gy for <14 years old and 15 Gy for ≥14 years old patients were applied at least eight weeks after BU-MEL. Toxicity, overall survival (OS), event-free survival (EFS) and pulmonary relapse-free survival (PRFS) were estimated and analyzed.

Results: After WLI, grade 1-2 and grade 3 clinical toxicity was reported in 16.2% and 5.9% patients, respectively. The five-year OS, EFS and PRFS with 95% confidence interval (CI) were 69.8% (57.1-79.3), 61.2% (48.4-71.7) and 70.5% (56.3-80.8), respectively. Patients with good histological necrosis of the primary tumor after neoadjuvant chemotherapy showed a significant decreased risk of pulmonary relapse or death compared to patients with poor histological necrosis.

Conclusions: WLI at recommended doses and time interval after BU-MEL is feasible and might contribute to the disease control in Ewing sarcoma with lung metastases and responsive disease. Further studies are needed to explore the treatment stratification based on the histological response of the primary tumor.
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http://dx.doi.org/10.3390/cancers13112789DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8199967PMC
June 2021

Complementary and alternative medicine in sarcoma patients treated in an Italian sarcoma center.

J Cancer Res Ther 2021 Apr-Jun;17(2):516-522

Statistical Service, IRCCS, Istituto Ortopedico Rizzoli, Bologna, Italy.

Background: Bone and soft-tissue sarcoma are rare tumors. Complementary and alternative medicine (CAM) is often used in cancer patients however limited data are available in sarcoma patients. The aim of the present study is to explore the use of CAM in patients with bone and soft-tissue sarcoma.

Methods: Patients in follow-up visit for high grade bone or soft-tissue sarcoma at the Rizzoli outpatient clinic from September 1, 2014, to December 31, 2015, were asked, after written consent, to fill out a questionnaire with items pertaining to sociodemographic factors and their use of CAM before, during, or after chemotherapy.

Results: Four hundred and sixty-nine participated to the survey: 409 were adults and 60 were <18 years old. The percentage of use of CAM in adults was 44.7% and in minors 38.3%. The most common type of CAM was vitamins and minerals, followed by phytotherapy and homeopathy. The majority of patients used CAM after the sarcoma diagnosis. None used CAM alone instead of conventional chemotherapy. Benefits from use of CAM were reported by 75% of patients (some benefit in 53% plus high benefit in others 22%) and side effects in 6.7%. A significant correlation was found with CAM use and female gender, young age (18-44) and higher education. Disclosure to the oncologist was 56% and 69% to their family doctors.

Conclusions: This study shows that CAM use is frequent among adults and pediatric patients with bone and soft tissue sarcoma as in other cancer patients. Moreover, the profile of these Italian CAM consumers in sarcoma patients is similar to other studies. Patients disclosure to their oncologist or physician about the use of CAM was similar to other Italian studies, but higher compared to other international studies.
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http://dx.doi.org/10.4103/jcrt.JCRT_348_20DOI Listing
June 2021

Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Retrospective, Multicenter Study of the Italian Sarcoma Group.

Cancers (Basel) 2021 Mar 2;13(5). Epub 2021 Mar 2.

Chemotherapy Unit, IRCCS Istituto Ortopedico Rizzoli, 1 Via Pupilli, 40136 Bologna, Italy.

The Italian Sarcoma Group performed this retrospective analysis of patients with advanced soft tissue sarcoma, pretreated with ≥1 anthracycline-based treatment, and treated with trabectedin every three weeks. Primary endpoint was to describe real-life use of trabectedin across Italy. Secondary endpoints included objective response rate (ORR) and safety. Overall, 512 patients from 20 Italian centers were evaluated. Leiomyosarcoma (37.7%)/liposarcoma (30.3%) were the most prevalent histological types (abbreviated as L-sarcoma). Patients received a median of four trabectedin cycles (range: 1-40), mostly as a second-line treatment (~60% of patients). The ORR was 13.7% superior ( < 0.0001) in patients with L-sarcoma compared with patients with non-L-sarcoma (16.6% vs. 9.0%). Median progression-free survival (PFS) was 5.1 months, whereas median overall survival (OS) was 21.6 months. Significantly better PFS and OS were observed in patients with L-sarcoma, those with objective responses and/or disease stabilization, treated in an early line and treated with reduced dose. Bone marrow toxicity (61.4%) and transaminase increases (21.9%) were the most common grade 3/4 adverse events. The results of this real-life study suggest that trabectedin is an active treatment, which is mostly given as a second-line treatment to patients with a good performance status and high-grade, metastatic L-sarcoma (clinical trial information: NCT02793050).
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http://dx.doi.org/10.3390/cancers13051053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7958606PMC
March 2021

Histological response to neoadjuvant chemotherapy in localized Ewing sarcoma of the bone: A retrospective analysis of available scoring tools.

Eur J Surg Oncol 2021 Jul 16;47(7):1778-1783. Epub 2021 Feb 16.

Department of Pathology, Azienda Ospedaliera di Padova, Padua, Italy.

Aim: The aim is to evaluate which of the existing scoring systems of histological response to neoadjuvant chemotherapy best stratifies the clinical outcome of patients with localized Ewing sarcoma of bone.

Methods: 474 patients with diagnosis of localized Ewing sarcoma of bone were included. The median follow-up was 13.5 years.

Results: The overall survival and the disease-free survival (DFS) were 70.8% and 63.9% at 5 years. The percentage of histological response to neoadjuvant chemotherapy ranged between 5% and 100% (mean 83%). The agreement between Bologna System and the different percentual cut-offs of histological response to neoadjuvant chemotherapy was high, with kappa statistics of 0.83 for a cut-off of ≥90%; 0.86 for a cut-off of ≥95%; 0.79 for a cut-off of ≥96% and 0.61 for a cut-off of 100%. Statistically higher DFS rates for good responders compared to poor responders were found when using each given system. Model performance indicators showed that Bologna system had a lower AIC score and a higher c-statistics to predict DFS. When the patients classified as good responders using the different percentual cut-offs of histological response to neoadjuvant chemotherapy, were instead re-classified using the Bologna system, statistical differences were noted in DFS within each specific group.

Conclusions: All scoring tools to evaluate histological response to neoadjuvant chemotherapy offer good predictive value for DFS in localized Ewing's sarcoma of bone. The Bologna system better stratifies those patients with histological response to neoadjuvant chemotherapy between 90 and 99%, representing a more reliable scoring tool in this subset.
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http://dx.doi.org/10.1016/j.ejso.2021.02.009DOI Listing
July 2021

Trefoil factor-1 upregulation in estrogen-receptor positive breast cancer correlates with an increased risk of bone metastasis.

Bone 2021 03 27;144:115775. Epub 2020 Nov 27.

Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.

Bone is one of the most preferred sites of metastatic spread from different cancer types, including breast cancer. However, different breast cancer subtypes exhibit distinct metastatic behavior in terms of kinetics and anatomic sites of relapse. Despite advances in the diagnosis, the identification of patients at high-risk of bone recurrence is still an unmet clinical need. We conducted a retrospective analysis, by gene expression and immunohistochemical assays, on 90 surgically resected breast cancer samples collected from patients who experienced no evidence of distant metastasis, bone or visceral metastasis in order to identify a primary tumor-derived marker of bone recurrence. We identified trefoil factor-1 (pS2 or TFF1) as strictly correlated to bone metastasis from ER+ breast cancer. In silico analysis was carried out to confirm this observation, linking gene expression data with clinical characteristics available from public clinical datasets. Then, we investigated TFF1 function in ER+ breast cancer tumorigenesis and bone metastasis through xenograft in vivo models of MCF 7 breast cancer with gain and loss of function of TFF1. As a response to microenvironmental features in primary tumors, TFF1 expression could modulate ER+ breast cancer growth, leading to a less proliferative phenotype. Our results showed it may not play a role in late stages of bone metastasis, however further studies are warranted to understand whether it could contribute in the early-stages of the metastatic cascade. In conclusion, TFF1 upregulation in primary ER+ breast cancer could be useful to identify patients at high-risk of bone metastasis. This could help clinicians in the identification of patients who likely can develop bone metastasis and who could benefit from personalized treatments and follow-up strategies to prevent metastatic disease.
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http://dx.doi.org/10.1016/j.bone.2020.115775DOI Listing
March 2021

Breast cancer spinal metastases: Prognostic factors affecting survival after surgery. A retrospective study.

J Clin Neurosci 2020 Aug 26;78:73-78. Epub 2020 Jun 26.

Department of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Breast cancer spinal metastases (BCSM) are common and require proper treatment that leads to an improvement of the quality of life and contributes to the quod vitam prognosis. Surgical treatment is often required for intractable pain, spinal cord compression or spinal instability. The aim of this retrospective study is to identify which prognostic factors could affect postoperative overall survival in patients affected by BCSM. We report a retrospective cohort study of patients with BCSM, surgically treated from September 2009 to May 2018. Demographic and clinical data were collected. Kaplan-Meier method was used to estimate overall survival, and the log-rank test was used to compare survival curves. A total of 77 patients were studied. The median age at the time of surgery was 54 years. The median follow-up was 49 months. The 3-year and 5-year overall survival rates were 61% (95%CI: 47.5-72.1) and 43.3% (95%CI: 28.8-57.1). Metastatic bone disease (p = 0.0196), preoperative neurological impairment (p = 0.0029), Karnofsky status <70 (p = 0.0241) reduce survival. With multivariate analysis, the effect of Karnofsky score loses statistical significance. The presence of concurrent bone metastases and a preoperative neurological deficit are independent prognostic factors. Therapeutic choices are based on a multidisciplinary assessment that takes into consideration several factors, including an accurate study of prognostic factors.
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http://dx.doi.org/10.1016/j.jocn.2020.06.010DOI Listing
August 2020

Synovial chondrosarcoma: a single-institution experience with molecular investigations and review of the literature.

Histopathology 2020 Sep 28;77(3):391-401. Epub 2020 Jul 28.

Department of Pathology, IRCCS, Istituto Ortopedico Rizzoli, Bologna, Italy.

Aims: To evaluate the available diagnostic histological criteria for synovial chondrosarcoma and to screen for the presence of IDH1/IDH2 mutations in a series of cases of this malignant cartilaginous neoplasm.

Methods And Results: Ten cases of synovial chondrosarcoma diagnosed at our institute were reviewed. At presentation, all tumours occurred in adults (median age, 62 years). The most common location was the knee joint (five cases), and the size at diagnosis ranged from 30 mm to 170 mm. Eight patients had secondary synovial chondrosarcomas associated with pre-existing/recurrent or concomitant synovial chondromatosis. Five patients had local recurrences and three had lung metastases. All patients with intralesional excisions developed local recurrences, whereas those who underwent wide resections did not. At last follow-up (mean, 91 months), available for nine patients, seven patients were alive and disease-free, one patient had died of disease, and one was alive with paravertebral metastases. Frequent histological features observed included loss of clustering of chondrocytes (nine cases), the presence of variable amounts of myxoid matrix (eight cases), peripheral hypercellularity (eight cases), tumour necrosis (six cases), and spindling of chondrocytes (four cases). Of the seven cases for which it was possible to evaluate bone permeation, six showed infiltration of bone marrow. All seven cases screened for mutations of exon 4 of IDH1 and IDH2 were found to be wild-type.

Conclusions: Histological criteria in correlation with clinical and radiological features allow the recognition of synovial chondrosarcoma. IDH1/IDH2 mutations were not present in synovial chondrosarcoma. Adequate surgical margins are important for disease control.
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http://dx.doi.org/10.1111/his.14170DOI Listing
September 2020

Time evolution of restless legs syndrome in haemodialysis patients.

Clin Kidney J 2021 Jan 16;14(1):341-347. Epub 2019 Dec 16.

Department of Experimental, Diagnostic and Specialty Medicine, Nephrology, Dialysis and Transplantation Unit, St Orsola Hospital, University of Bologna, Bologna, Italy.

Background: Restless legs syndrome (RLS) is characterized by an urge to move the extremities, accompanied by paraesthesiae, in the evening and at night. Uraemic RLS, a type of secondary RLS, occurs commonly in chronic kidney disease and end-stage renal disease. Progression of uraemic RLS over time is unclear. Therefore we investigated the prevalence, progression over time, risk factors and impact on survival of uraemic RLS in a cohort of dialysis patients.

Methods: We reviewed at the 7-year follow-up a cohort of haemodialysis (HD) patients we had previously investigated for RLS, through interviews, validated questionnaires and analysis of demographic and clinical data.

Results: At the 7-year follow-up, RLS was present in 16% of patients, with a persistence rate of 33%. A correlation was obtained between RLS and older age, diabetes, low albumin and low body mass index. RLS was associated with reduced overall survival (median survival of 3.3 versus 3.7 years), particularly with the continuous form of RLS (1.61 years). There was a higher incidence of myocardial infarction and peripheral vascular disease, although not reaching statistical significance. RLS patients had absolute higher scores in all quality of life domains. A large majority of study patients (96%) reported being symptom-free within a few days or weeks following kidney transplantation.

Conclusions: The development of RLS, especially the continuous form, in patients undergoing HD has important consequences associated with decreased survival. Our results indicated an association between uraemic RLS and ageing, diabetes and malnutrition. Considerable efforts should be focused on the treatment of RLS, since it significantly and persistently impacts the quality of life of HD patients. Kidney transplantation could represent an effective treatment option for that RLS impacts on dialysis patients' quality of life, thus confirming the secondary nature of RLS in most HD patients.
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http://dx.doi.org/10.1093/ckj/sfz148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7857816PMC
January 2021

Sinusoidal obstruction syndrome/veno-occlusive disease after high-dose intravenous busulfan/melphalan conditioning therapy in high-risk Ewing Sarcoma.

Bone Marrow Transplant 2018 05 15;53(5):591-599. Epub 2018 Jan 15.

Unit of Internal Medicine, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

This mono-institutional observational study was conducted to determine incidence, severity, risk factors, and outcome of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) in high-risk Ewing sarcoma (ES) patients treated with intravenous busulfan and melphalan (BU-MEL) followed by autologous stem cell transplantation (ASCT). During the past 10 years, 75 consecutive ES patients resulted evaluable for the analysis. After diagnosis of SOS/VOD, defibrotide therapy was started as soon as the medication was available. The variables analyzed as potential risk factors were: gender, patient's age at diagnosis, primary tumor site, disease stage, and prior radiation therapy (RT) given, focusing on RT liver exposure. The median age at diagnosis was 18.8 years. Five patients developed moderate to severe SOS/VOD (cumulative incidence, 6.67%). None of 32 pediatric patients (≤17 years) developed SOS/VOD (p = 0.0674). In univariate analysis, prior RT liver exposure resulted statistically significant (p = 0.0496). There was one death due to severe SOS/VOD. This study reports the largest series of high-risk ES patients treated with intravenous BU-MEL before ASCT. The incidence of SOS/VOD was lower when compared with other studies that used oral busulfan. Any prior RT liver exposure should be avoided. Earlier defibrotide treatment confirms to be effective.
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http://dx.doi.org/10.1038/s41409-017-0066-4DOI Listing
May 2018

Looking Through the Patients' Eyes: Measuring Patient Satisfaction in a Public Hospital.

J Patient Exp 2017 Sep 15;4(3):121-128. Epub 2017 May 15.

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Objective: Patient satisfaction is a personal evaluation of health-care services that is often used as an indicator of quality of care. The aim of this study was to identify aspects of hospital care that affect patient satisfaction by examining the structural and convergent validity of an in-house questionnaire.

Methods: The sample consisted of 3320 patients discharged from an Italian public hospital. The questionnaire included items exploring communication with nurses and physicians, pain management, quality of accommodation, and discharge information. Data were analyzed using the Rasch model.

Results: From the patients' perspective, the number of response options was excessive and the questionnaire proved to have both medical and accommodation dimensions. Patients, on average, gave higher satisfaction scores to the medical dimension over the accommodation dimension. Higher satisfaction was associated with kindness and courtesy of the nursing staff, doctors' courtesy, and the quality of bed linen.

Conclusion: The results support the administration of the questionnaire but suggest change in the hospital's analytical procedures in order to match the drivers of satisfaction as seen by the patients.
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http://dx.doi.org/10.1177/2374373517706614DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5593263PMC
September 2017

Survey of Knowledge and Attitudes about Obstructive Sleep Apnoea Among Italian Anaesthetists.

Turk J Anaesthesiol Reanim 2017 Jun 1;45(3):146-152. Epub 2017 Feb 1.

SIAARTI Airway Management Task Force.

Objective: As the care of Obstructive Sleep Apnoea (OSA) patients remains heterogeneous, we hypothesized that it may reflect insufficient OSA knowledge/awareness among clinicians.

Methods: OSA Knowledge/Attitude Questionnaire (OSAKA) was translated into Italian and distributed to anaesthetists attending SIAARTI National Congress and Airways courses and Hands-on Workshops from October 2012 to June 2013.

Results: In total, 370 anaesthetists returned the questionnaires (response rate, 62%); the median (interquartile range [IQR]) knowledge score was 12 (10-14), and the range was 1-17 with no difference by gender, age, professional title or years of practice. The knowledge items achieved a mean rate of corrected response of 66%±0.14%. With regard to attitude items, median (IQR) score was 15 (13-17) and range was 0-20. Females and anaesthetists with >15 years of practice reached higher scores, while anaesthesia residents showed a lower attitude score. Gender and professional title were statistically associated with the attitude score (gender: F=14.6, p=0.0002; professional title: F=4.72, p=0.0099), whereas a weak association was observed within years in practice and attitude score (F=2.6, p=0.0519). Knowledge score correlated positively with attitude score (r=0.4, p<0.0001). For knowledge domains, there was a positive correlation between pathophysiology (mid-grade: r=0.3, p<0.0001), symptoms (low grade: r=0.2, p<0.0001), diagnosis (mid grade: r=0.3, p<0.0001) and the attitude score. Correlation close to zero was observed for epidemiology and treatment domains (r=0.09, p=0.06; r=-0.01, p=0.78, respectively).

Conclusion: The results of our survey demonstrate lack of knowledge about OSA and its treatment, revealing the need to update the syllabus of teaching in medical practice and in national health care policies to improve perioperative care.
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http://dx.doi.org/10.5152/TJAR.2017.51423DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5512392PMC
June 2017

Psychotherapy Alone and Combined With Medication as Treatments for Bipolar II Depression: A Randomized Controlled Trial.

J Clin Psychiatry 2018 Mar/Apr;79(2)

Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

Objective: Bipolar II disorder (BP-II) is associated with marked morbidity and mortality. Quetiapine, the treatment with greatest evidence for efficacy in BP-II depression, is associated with metabolic burden. Psychotherapy, a treatment with few side effects, has not been systematically evaluated in BP-II. This study compared psychotherapy plus placebo to psychotherapy plus pharmacotherapy as treatments for BP-II depression.

Methods: From 2010 to 2015, unmedicated adults (n = 92) with DSM-IV-TR BP-II depression were randomly assigned to weekly sessions of Interpersonal and Social Rhythm Therapy (IPSRT) plus placebo or IPSRT plus quetiapine and followed for 20 weeks.

Results: For primary outcomes, IPSRT + quetiapine yielded significantly faster improvement on 17-item Hamilton Depression Rating Scale (F₁,₁₁₅.₄ = 3.924, P = .048) and greater improvement on Young Mania Rating Scale (F₅₈.₅ = 4.242, P = .044) scores. Both groups, however, improved significantly over time with comparable response rates (≥ 50% reduction in depression scores): 67.4% (62/92) in the entire sample, with no between-group differences. Those randomly assigned to their preferred treatment were 4.5 times more likely to respond (OR = 4.48, 95% CI = 1.20-16.77, P = .026). IPSRT + quetiapine assignment was associated with significantly higher body mass index over time (F₆₇.₉₆ = 6.671, P = .012) and rates of dry mouth (79% v. 58%; χ² = 4.0, P = .046) and a trend toward more complaints of oversedation (100% vs 92%; χ² = 3.4, P = .063).

Conclusions: IPSRT plus quetiapine resulted in greater symptomatic improvement but also more side effects than IPSRT alone. A subset of participants improved with IPSRT alone, although absence of an inactive comparator limits interpretation of this finding. Receipt of preferred treatment was associated with better outcomes. Harms, benefits, and preferences should be considered when recommending treatments for BP-II depression.

Trial Registration: ClinicalTrials.gov identifier: NCT01133821.
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http://dx.doi.org/10.4088/JCP.16m11027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5823786PMC
June 2019

Incidence of interval cancers in faecal immunochemical test colorectal screening programmes in Italy.

J Med Screen 2018 03 14;25(1):32-39. Epub 2017 Feb 14.

3 Registro Tumori del Veneto, Regione Veneto, Padova, Italy.

Objective In Italy, colorectal screening programmes using the faecal immunochemical test from ages 50 to 69 every two years have been in place since 2005. We aimed to measure the incidence of interval cancers in the two years after a negative faecal immunochemical test, and compare this with the pre-screening incidence of colorectal cancer. Methods Using data on colorectal cancers diagnosed in Italy from 2000 to 2008 collected by cancer registries in areas with active screening programmes, we identified cases that occurred within 24 months of negative screening tests. We used the number of tests with a negative result as a denominator, grouped by age and sex. Proportional incidence was calculated for the first and second year after screening. Results Among 579,176 and 226,738 persons with negative test results followed up at 12 and 24 months, respectively, we identified 100 interval cancers in the first year and 70 in the second year. The proportional incidence was 13% (95% confidence interval 10-15) and 23% (95% confidence interval 18-25), respectively. The estimate for the two-year incidence is 18%, which was slightly higher in females (22%; 95% confidence interval 17-26), and for proximal colon (22%; 95% confidence interval 16-28). Conclusion The incidence of interval cancers in the two years after a negative faecal immunochemical test in routine population-based colorectal cancer screening was less than one-fifth of the expected incidence. This is direct evidence that the faecal immunochemical test-based screening programme protocol has high sensitivity for cancers that will become symptomatic.
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http://dx.doi.org/10.1177/0969141316686391DOI Listing
March 2018

Cognitive Clusters in Specific Learning Disorder.

J Learn Disabil 2018 Jan/Feb;51(1):32-42. Epub 2016 Nov 17.

2 Inter-Institutional Epidemiological Unit, AUSL of Reggio Emilia, Italy.

The heterogeneity among children with learning disabilities still represents a barrier and a challenge in their conceptualization. Although a dimensional approach has been gaining support, the categorical approach is still the most adopted, as in the recent fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. The introduction of the single overarching diagnostic category of specific learning disorder (SLD) could underemphasize interindividual clinical differences regarding intracategory cognitive functioning and learning proficiency, according to current models of multiple cognitive deficits at the basis of neurodevelopmental disorders. The characterization of specific cognitive profiles associated with an already manifest SLD could help identify possible early cognitive markers of SLD risk and distinct trajectories of atypical cognitive development leading to SLD. In this perspective, we applied a cluster analysis to identify groups of children with a Diagnostic and Statistical Manual-based diagnosis of SLD with similar cognitive profiles and to describe the association between clusters and SLD subtypes. A sample of 205 children with a diagnosis of SLD were enrolled. Cluster analyses (agglomerative hierarchical and nonhierarchical iterative clustering technique) were used successively on 10 core subtests of the Wechsler Intelligence Scale for Children-Fourth Edition. The 4-cluster solution was adopted, and external validation found differences in terms of SLD subtype frequencies and learning proficiency among clusters. Clinical implications of these findings are discussed, tracing directions for further studies.
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http://dx.doi.org/10.1177/0022219416678407DOI Listing
August 2018

Evaluating patient safety indicators in orthopedic surgery between Italy and the USA.

Int J Qual Health Care 2016 Sep 6;28(4):486-91. Epub 2016 Jun 6.

Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum - University of Bologna, Via San Giacomo, 12, 40126 Bologna, Italy.

Objective: To compare patient safety in major orthopedic procedures between an orthopedic hospital in Italy, and 26 US hospitals of similar size.

Design: Retrospective analysis of administrative data from hospital discharge records in Italy and Florida, USA, 2011-13. Patient Safety Indicators (PSIs) developed by the Agency for Healthcare Quality and Research were used to identify inpatient adverse events (AEs). We examined the factors associated with the development of each different PSI, taking into account known confounders, using logistic regression.

Setting: One Italian orthopedic hospital and 26 hospitals in Florida with ≥ 1000 major orthopedic procedures per year.

Participants: Patients ≥ 18 years who underwent 1 of the 17 major orthopedic procedures, and with a length of stay (LOS) > 1 day.

Intervention: Patient Safety management between Italy and the USA.

Main Outcome Measure: Patient Safety Indicators.

Results: A total of 14 393 patients in Italy (mean age = 59.8 years) and 131 371 in the USA (mean age = 65.4 years) were included. US patients had lower adjusted odds of developing a PSI compared to Italy for pressure ulcers (odds ratio [OR]: 0.21; 95% confidence interval [CI]: 0.10-0.45), hemorrhage or hematoma (OR: 0.42; CI 0.23-0.78), physiologic and metabolic derangement (OR: 0.08; CI 0.02-0.37). Italian patients had lower odds of pulmonary embolism/deep vein thrombosis (OR: 3.17; CI 2.16-4.67) compared to US patients.

Conclusions: Important differences in patient safety events were identified across countries using US developed PSIs. Though caution about potential coding differences is wise when comparing PSIs internationally, other differences may explain AEs, and offer opportunities for cross-country learning about safe practices.
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http://dx.doi.org/10.1093/intqhc/mzw053DOI Listing
September 2016

Post analysis simulated correlation of the El-Ganzouri airway difficulty score with difficult airway.

Braz J Anesthesiol 2016 May-Jun;66(3):298-303. Epub 2014 Nov 27.

Department of Emergency, Anaesthesia and Intensive Care Section, "G.B. Morgagni-Pierantoni" Hospital, Forlì, Italy.

Background: Difficult airway (DA) occurs frequently (5-15%) in clinical practice. The El-Ganzouri Risk Index (EGRI) has a high sensitivity for predicting a difficult intubation (DI). However difficult mask ventilation (DMV) was never included in the EGRI. Since DMV was not included in the EGRI assessment, and obstructive sleep apnea (OSA) is also correlated with DMV, a study correlating the prediction of DA and OSA (identified by STOP-Bang questionnaire, SB) seemed important.

Methods: We accessed a database previously collected for a post analysis simulation of the airway difficulty predictivity of the EGRI, associated with normal and difficult airway, particularly DMV. As secondary aim, we measured the correlation between the SB prediction system and DA, compared to the EGRI.

Results: A total of 2747 patients were included in the study. The proportion of patients with DI was 14.7% (95% CI 13.4-16) and the proportion of patients with DMV was 3.42% (95% CI 2.7-4.1). The incidence of DMV combined with DI was (2.3%). The optimal cutoff value of EGRI was 3. EGRI registered also an higher ability to predict DMV (AUC=0.76 (95% CI 0.71-0.81)). Adding the SB variables in the logistic model, the AUC increases with the inclusion of "observed apnea" variable (0.83 vs. 0.81, p=0.03). The area under the ROC curve for the patients with DI and DMV was 0.77 (95% CI 0.72-0.83).

Conclusions: This study confirms that the incidence of DA is not negligible and suggests the use of the EGRI as simple bedside predictive score to improve patient safety.
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http://dx.doi.org/10.1016/j.bjane.2014.09.003DOI Listing
May 2017

[Post analysis simulated correlation of the El-Ganzouri airway difficulty score with difficult airway].

Rev Bras Anestesiol 2016 May-Jun;66(3):298-303. Epub 2016 Mar 15.

Setor de Emergência, Anestesia e Tratamento Intensivo, G.B. Morgagni-Pierantoni Hospital, Forlì, Itália.

Background: Difficult airway (DA) occurs frequently (5-15%) in clinical practice. The El-Ganzouri Risk Index (EGRI) has a high sensitivity for predicting a difficult intubation (DI). However difficult mask ventilation (DMV) was never included in the EGRI. Since DMV was not included in the EGRI assessment, and obstructive sleep apnea (OSA) is also correlated with DMV, a study correlating the prediction of DA and OSA (identified by STOP-Bang questionnaire, SB) seemed important.

Methods: We accessed a database previously collected for a post analysis simulation of the airway difficulty predictivity of the EGRI, associated with normal and difficult airway, particularly DMV. As secondary aim, we measured the correlation between the SB prediction system and DA, compared to the EGRI.

Results: A total of 2747 patients were included in the study. The proportion of patients with DI was 14.7% (95% CI 13.4-16) and the proportion of patients with DMV was 3.42% (95% CI 2.7-4.1). The incidence of DMV combined with DI was (2.3%). The optimal cutoff value of EGRI was 3. EGRI registered also an higher ability to predict DMV (AUC=0.76 (95% CI 0.71-0.81)). Adding the SB variables in the logistic model, the AUC increases with the inclusion of "observed apnea" variable (0.83 vs. 0.81, p=0.03). The area under the ROC curve for the patients with DI and DMV was 0.77 (95% CI 0.72-0.83).

Conclusions: This study confirms that the incidence of DA is not negligible and suggests the use of the EGRI as simple bedside predictive score to improve patient safety.
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http://dx.doi.org/10.1016/j.bjan.2016.02.007DOI Listing
April 2016

CYP17A1 polymorphisms and clinical outcome of castration-resistant prostate cancer patients treated with abiraterone.

Int J Biol Markers 2016 Jul 30;31(3):e264-9. Epub 2016 Jul 30.

Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola (Forlì-Cesena) - Italy.

Background: We evaluated the role of single nucleotide polymorphisms in the CYP17A1 gene for predicting clinical outcome in castration-resistant prostate cancer (CRPC) patients treated with abiraterone.

Methods: Sixty-four patients were genotyped for the selected polymorphisms (rs743572, rs10883783, rs17115100 and rs284849) in CYP17A1. We hypothesized that different genotypes could be associated with progression-free survival (PFS) and overall survival (OS).

Results: Statistical analyses highlighted no significant associations between these polymorphisms and clinical outcome. However, individuals with the most common TT genotype for rs10883783 had a 3 months' longer PFS than individuals with the TA + AA genotype.

Conclusions: With the limitation of the retrospective study design and the small sample size, the analyzed polymorphisms do not seem to be correlated with clinical outcome of CRPC patients treated with abiraterone.
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http://dx.doi.org/10.5301/jbm.5000197DOI Listing
July 2016

The relationship between integrated care and cancer patient experience: A scoping review of the evidence.

Health Policy 2016 Jan 13;120(1):55-63. Epub 2015 Dec 13.

Institute of Health Policy Management and Evaluation (IHPME), University of Toronto, 155 College Street, Suite 425, Toronto, ON, Canada M5T 3M6.

Background: Health policy documents underscore the need to develop organizational models to optimize the integration of cancer care pathways around patient needs. Still, there is a lack of clarity about the meaning of integrated care as perceived by patients. The purpose of this study is to explore the relationship between the integration of cancer services and patients' experience.

Materials And Methods: We completed a scoping review of the available literature searching PubMed, Embase and Scopus from the earliest date available in each database to February 2013.

Results: From 1760 bibliographic records, we identified 30 articles relevant for this analysis. Based on the qualitative conventional content analysis, we defined three integrated care approaches: "individual care provider", "team care providers", "mixed approach", that impact on the following patient experience dimensions: patient satisfaction, quality of life, psychological and physical outcomes, continuity of care and empowerment.

Conclusions: This scoping review identifies important aspects of integration from patients' perspective and suggests that policy makers should consider how to best include patients' experience into the patient care pathway. Future perspectives include engaging patients, family members, caregivers and clinicians in an on-going dialogue and have them participate actively in developing, implementing and evaluating policies, services and programmes.
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http://dx.doi.org/10.1016/j.healthpol.2015.12.004DOI Listing
January 2016

Bronchoscopic Lung Cryobiopsy Increases Diagnostic Confidence in the Multidisciplinary Diagnosis of Idiopathic Pulmonary Fibrosis.

Am J Respir Crit Care Med 2016 Apr;193(7):745-52

1 Department of Diseases of the Thorax.

Rationale: Surgical lung biopsy is often required for a confident multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF). Alternative, less-invasive biopsy methods, such as bronchoscopic lung cryobiopsy (BLC), are highly desirable.

Objectives: To address the impact of BLC on diagnostic confidence in the multidisciplinary diagnosis of IPF.

Methods: In this cross-sectional study we selected 117 patients with fibrotic interstitial lung disease without a typical usual interstitial pneumonia pattern on high-resolution computed tomography. All cases underwent lung biopsies: 58 were BLC, and 59 were surgical lung biopsy (SLB). Two clinicians, two radiologists, and two pathologists sequentially reviewed clinical-radiologic findings and biopsy results, recording at each step in the process their diagnostic impressions and confidence levels.

Measurements And Main Results: We observed a major increase in diagnostic confidence after the addition of BLC, similar to SLB (from 29 to 63%, P = 0.0003 and from 30 to 65%, P = 0.0016 of high confidence IPF diagnosis, in the BLC group and SLB group, respectively). The overall interobserver agreement in IPF diagnosis was similar for both approaches (BLC overall kappa, 0.96; SLB overall kappa, 0.93). IPF was the most frequent diagnosis (50 and 39% in the BLC and SLB group, respectively; P = 0.23). After the addition of histopathologic information, 17% of cases in the BLC group and 19% of cases in the SLB group, mostly idiopathic nonspecific interstitial pneumonia and hypersensitivity pneumonitis, were reclassified as IPF.

Conclusions: BLC is a new biopsy method that has a meaningful impact on diagnostic confidence in the multidisciplinary diagnosis of interstitial lung disease and may prove useful in the diagnosis of IPF. This study provides a robust rationale for future studies investigating the diagnostic accuracy of BLC compared with SLB.
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http://dx.doi.org/10.1164/rccm.201504-0711OCDOI Listing
April 2016

Lymph node pick up by separate stations: Option or necessity.

World J Gastrointest Surg 2015 May;7(5):71-7

Paolo Morgagni, Domenico Garcea, Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy.

Aim: To evaluate whether lymph node pick up by separate stations could be an indicator of patients submitted to appropriate surgical treatment.

Methods: One thousand two hundred and three consecutive gastric cancer patients submitted to radical resection in 7 general hospitals and for whom no information was available on the extension of lymphatic dissection were included in this retrospective study.

Results: Patients were divided into 2 groups: group A, where the stomach specimen was directly formalin-fixed and sent to the pathologist, and group B, where lymph nodes were picked up after surgery and fixed for separate stations. Sixty-two point three percent of group A patients showed < 16 retrieved lymph nodes compared to 19.4% of group B (P < 0.0001). Group B (separate stations) patients had significantly higher survival rates than those in group A [46.1 mo (95%CI: 36.5-56.0) vs 27.7 mo (95%CI: 21.3-31.9); P = 0.0001], independently of T or N stage. In multivariate analysis, group A also showed a higher risk of death than group B (HR = 1.24; 95%CI: 1.05-1.46).

Conclusion: Separate lymphatic station dissection increases the number of retrieved nodes, leads to better tumor staging, and permits verification of the surgical dissection. The number of dissected stations could potentially be used as an index to evaluate the quality of treatment received.
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http://dx.doi.org/10.4240/wjgs.v7.i5.71DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4438450PMC
May 2015

Efficacy of endocrine therapy in relation to progesterone receptor and Ki67 expression in advanced breast cancer.

Breast Cancer Res Treat 2015 Jul 27;152(1):57-65. Epub 2015 May 27.

Department of Medical Oncology, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via Piero Maroncelli 40, 47014, Meldola, Italy.

We assessed whether progesterone receptor (PgR) and Ki67 in primary tumors and/or matched metastases are predictors of clinical benefit from first-line endocrine therapy (ET) in advanced breast cancer. We evaluated patients treated at our institute with first-line ET (2002-2011), excluding those receiving concomitant chemotherapy or trastuzumab or pretreated with >2 lines of chemotherapy. A cut-off of 20 % immunostained cells was used for PgR and Ki67. The main endpoint was time-to-progression (TTP). Groups were compared by the log-rank test and Cox multivariate analysis. In the 135 assessable patients (93 % were receiving an aromatase inhibitor; biomarker assessment had been performed on primary tumors in 77 cases, on metastases in 23 and on both in 35), median TTP was 16 months (median follow-up 43 months). The overall discordance rate between primary tumors and metastases was 23 % for Ki67 and 31 % for PgR. A longer median TTP (24 vs. 12 months, P = 0.012) was seen for PgR >20 % in metastases. Ki67 showed a trend for TTP prediction in the entire case series (P = 0.062). Patients with high Ki67 and low PgR in metastases had a median TTP of only 5 months. High Ki67 in primary tumors (P = 0.026) or metastases (P = 0.01) predicted disease progression at the first evaluation. PgR in metastases remained a significant independent predictor of TTP at multivariate analysis (HR 2.45). In an ER-high population, PgR >20 % in metastases identified patients with a long TTP on endocrine treatment, while Ki67 >20 % was associated with an increased risk of non-response.
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http://dx.doi.org/10.1007/s10549-015-3423-2DOI Listing
July 2015

Early outcome prediction on 18F-fluorocholine PET/CT in metastatic castration-resistant prostate cancer patients treated with abiraterone.

Oncotarget 2014 Dec;5(23):12448-58

Department of Nuclear Medicine, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS, Meldola, Italy.

Objective: We investigated the role of 18F-fluorocholine positron emission tomography/computed tomography (FCH-PET/CT) in the early evaluation of abiraterone and outcome prediction in patients with metastatic castration-resistant prostate cancer (CRPC).

Patient And Methods: Forty-three patients with metastatic CRPC progressing after docetaxel received abiraterone 1,000 mg daily with prednisone 5 mg twice daily. Patients were evaluated monthly for serological PSA response and safety. FCH-PET/CT was done at baseline and after 3 to 6 weeks. Univariate and multivariate Cox regression models addressed potential predictors of progression-free survival (PFS) and overall survival (OS).

Results: Declines in PSA level of ≥50% were seen in 21 of 43 (49%) patients. Forty-two patients were evaluable for FCH-PET/CT response. FCH-PET/CT bone flare was observed in 4 of 42 (10%) evaluable patients. In univariate analysis, PSA decline and FCH-PET/CT response predicted PFS, while PSA decline and FCH-PET/CT (progression vs non progression) predicted OS. In multivariate analysis, only FCH-PET/CT (progression vs nonprogression) remained significant for PFS and OS (p = 0.022 and p = 0.027, respectively).

Conclusion: Early FCH-PET/CT can predict clinical outcome in CRPC beyond PSA response. These data support further studies on FCH-PET/CT for abiraterone monitoring and outcome prediction in patients with CRPC.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322993PMC
http://dx.doi.org/10.18632/oncotarget.2558DOI Listing
December 2014

Does the time between CT scan and chemotherapy increase the risk of acute adverse reactions to iodinated contrast media in cancer patients?

BMC Cancer 2014 Oct 31;14:792. Epub 2014 Oct 31.

Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, via Piero Maroncelli 40, Meldola 47014, Italy.

Background: Cancer patients undergo routine computed-tomography (CT) scans and, therefore, iodinated contrast media (ICM) administration. It is not known whether a time-dependent correlation exists between chemotherapy administration, contrast enhanced CT and onset of acute ICM-related adverse reactions (ARs).

Methods: All consecutive contrast-enhanced CTs performed from 1 January 2010 to 31 December 2012 within 30 days of the last chemotherapy administration were retrospectively reviewed. Episodes of acute ICM-related ARs were reported to the pharmacovigilance officer. We analyzed time to CT evaluation calculated as the time elapsed from the date of the CT performed to the date of the last chemotherapy administration. Patients were classified into 4 groups based on the antineoplastic treatment: platinum-based, taxane-based, platinum plus taxane and other group.

Results: Out of 10,472 contrast-enhanced CTs performed, 3,945 carried out on 1,878 patients were considered for the study. Forty acute ICM-related ARs (1.01%; 95% CI, 0.70-1.33) were reported. No differences were seen among immediate (within 10 days of the last chemotherapy administration), early (11-20 days) and delayed (21-30 days) CTs. Median time to CT in patients who experienced an acute ICM-related AR by treatment group was not statistically different: 20 days (range 6-30), 17 days (range 5-22), 13 days (range 8-17), 13 days (range (2-29) for the platinum, taxane, platinum plus taxane and other group, respectively (P =0.251).

Conclusions: Our results did not reveal any correlation between time to CT and risk of acute ICM-related ARs in cancer patients.
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http://dx.doi.org/10.1186/1471-2407-14-792DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4223747PMC
October 2014

Chromogranin A is a potential prognostic marker in prostate cancer patients treated with enzalutamide.

Prostate 2014 Dec 27;74(16):1691-6. Epub 2014 Sep 27.

Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)-IRCCS, Meldola, Italy.

Background: In this retrospective study, we assessed chromogranin A (CgA) baseline value as a possible factor associated with poor prognosis in metastatic castration-resistant prostate cancer (CRPC).

Methods: Thirty-five patients with metastatic CRPC progressing after docetaxel chemotherapy treated with enzalutamide are subdivided into three groups: serum CgA level was normal when <120 ng/ml (group A, n = 10), within three times the upper normal value (UNV) when between 120 and 360 (group B, n = 17), more than three times the UNV when ≥360 ng/ml (group C, n = 8).

Results: No correlation was observed in three groups among CgA baseline values and PSA response rates (RR) (P = 0.4648), whereas a significative difference was associated with median progression-free survival (PFS) and overall survival (OS) among three CgA groups (P = 0.0301 and P = 0.0011, respectively). In the multivariate analysis, PSA RR (nonresponsive vs. responsive) and CgA levels (group 3 vs. groups 1 + 2) were predictors of OS (P = 0.0029 and P = 0.0025, respectively), whereas they only were not significantly correlated with PFS, even had a borderline significance (P = 0.0628 and P = 0.0772, respectively).

Conclusions: In CRPC patients treated with enzalutamide, the evaluation of serum CgA levels could be an useful prognostic factor because of the strong association between CgA value more than three times the UNV and clinical outcome, independently from PSA response.
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http://dx.doi.org/10.1002/pros.22890DOI Listing
December 2014

Taxanes as a risk factor for acute adverse reactions to iodinated contrast media in cancer patients.

Oncologist 2014 Aug 25;19(8):823-8. Epub 2014 Jul 25.

Department of Medical Oncology, Oncology Pharmacy Unit, Biostatistics and Clinical Trials Unit, IT Unit, Anesthesiology Unit, Cardiology Unit, and Radiology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

Background: The impact of cytotoxic agents on the risk of acute allergy-like adverse reactions (ARs) to intravenous iodinated contrast media (ICM) injections is unknown.

Methods: We retrospectively reviewed 13,565 computed tomography (CT) scans performed in a consecutive cohort of cancer patients from January 1, 2010 to December 31, 2012. Episodes of acute ICM-related ARs were reported to the pharmacovigilance officer. The following matched comparisons were made: tax code, gender, primary tumor, antineoplastic therapy, and date of last cycle. Concomitant antineoplastic treatment was classified into five groups: platinum, taxane, platinum plus taxane, other, and no treatment group (no therapy had been administered in the previous 24 months). Logistic regression was used to estimate odds ratio (OR) and 95% confidence interval (CI) to evaluate the risk of acute ICM-related ARs.

Results: Of 10,472 contrast-enhanced CT scans, 97 (0.93%; 95% CI: 0.74-1.11) ICM-related ARs were reported, 11 of which (0.1%) were severe, including one fatality. The overall incidence was significantly higher in patients aged <65 years (p = .0062) and in the platinum plus taxane and taxane groups (p = .007), whereas no correlation was found with gender, number of previous CT scans, site of disease, or treatment setting. Multivariate analysis confirmed an increased risk for patients aged <65 years (OR: 1.73; 95% CI: 1.14-2.63) and for the taxane group (in comparison with the no treatment group; OR: 2.06; 95% CI: 1.02-4.16).

Conclusion: Among cancer patients, concomitant treatment with taxanes and younger age would seem to be risk factors for ICM-related ARs.
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http://dx.doi.org/10.1634/theoncologist.2013-0470DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4122472PMC
August 2014

Copy number analysis of 24 oncogenes: MDM4 identified as a putative marker for low recurrence risk in non muscle invasive bladder cancer.

Int J Mol Sci 2014 Jul 14;15(7):12458-68. Epub 2014 Jul 14.

Biosciences Laboratory, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola 47014, Italy.

Patients with non-muscle invasive bladder cancer (NMIBC) generally have a high risk of relapsing locally after primary tumor resection. The search for new predictive markers of local recurrence thus represents an important goal for the management of this disease. We studied the copy number variations (CNVs) of 24 oncogenes (MDM4, MYCN, ALK, PDGFRA, KIT, KDR, DHFR, EGFR, MET, SMO, FGFR1, MYC, ABL1, RET, CCND1, CCND2, CDK4, MDM2, AURKB, ERBB2, TOP2A, AURKA, AR and BRAF) using multiplex ligation probe amplification technique to verify their role as predictive markers of recurrence. Formalin-fixed paraffin-embedded tissue samples from 43 patients who underwent transurethral resection of the bladder (TURB) were used; 23 patients had relapsed and 20 were disease-free after 5 years. Amplification frequencies were analyzed for all genes and MDM4 was the only gene that showed significantly higher amplification in non recurrent patients than in recurrent ones (0.65 vs. 0.3; Fisher's test p=0.023). Recurrence-free survival analysis confirmed the predictive role of MDM4 (log-rank test p=0.041). Our preliminary results indicate a putative role for the MDM4 gene in predicting local recurrence of bladder cancer. Confirmation of this hypothesis is needed in a larger cohort of NMIBC patients.
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http://dx.doi.org/10.3390/ijms150712458DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4139853PMC
July 2014

PSA flare with abiraterone in patients with metastatic castration-resistant prostate cancer.

Clin Genitourin Cancer 2015 Feb 12;13(1):39-43. Epub 2014 Jun 12.

Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. Electronic address:

Background: The aim of this study was to assess early serum prostate-specific antigen (PSA) changes in patients treated with abiraterone and to correlate those changes with clinical outcome.

Patients And Methods: We retrospectively evaluated 103 patients with castrate-resistant prostate cancer (CRPC) treated with compassionate use of abiraterone in Romagna, Italy. In these patients, serum PSA levels were monitored every 4 weeks, and a time course of serum PSA levels was obtained. The PSA flare phenomenon was evaluated. The log-rank test was applied to compare survival between groups of patients according to early PSA level changes.

Results: Of 103 patients, 43 (41.7%) had an immediate PSA response, whereas 9 (8.7%) had an initial PSA flare. Of the 9 patients with PSA flare, 5 attained a subsequent PSA response. The temporary PSA flare exceeded baseline values by a median of 19.7% (range, 5%-62.9%). The median PFS of the 9 patients in the PSA-flare group was higher compared with patients without the PSA flare (10.5 vs. 6.4 months; P = .0999) but was similar to the subgroup of patients with immediate PSA response (10.5 vs. 10.7 months; P = .7019). In the multivariate analysis, only the PSA response remained as a predictor of progression-free survival (PFS) (P < .0001) and overall survival (OS) (P = .0003), respectively.

Conclusion: PSA flare occurs not infrequently in patients with CRPC who respond to abiraterone. Patients should be informed of this possible PSA flare phenomenon.
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http://dx.doi.org/10.1016/j.clgc.2014.06.010DOI Listing
February 2015

Chromogranin A predicts outcome in prostate cancer patients treated with abiraterone.

Endocr Relat Cancer 2014 Jun 8;21(3):487-93. Epub 2014 May 8.

Medical Oncology Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - IRCCS, Via Maroncelli 40, 47014 Meldola (FC), Italy.

In this retrospective study, we evaluated the chromogranin A (CgA) baseline value as a predictor of clinical outcome in patients with metastatic castration-resistant prostate cancer (CRPC) treated with abiraterone 1000 mg per day, whose disease progressed after docetaxel chemotherapy. In the 48 evaluable patients, serum CgA level was normal when <120  ng/ml (group A, n=16), within three times the upper normal value (UNV) when between 120 and 360 (group B, n=16), more than three times the UNV when ≥360  ng/ml (group C, n=16). Decline in PSA level ≥50% or more (PSA RR) was observed in 26 of 48 (54%) patients. PSA response rate did not correlate with the CgA groups. CgA levels more than three times the UNV predicted an early radiological progressive disease in eight of 11 cases (73%). The median progression-free survival (PFS) among the CgA groups A, B, and C was 9.2, 9.2, and 4.8 months respectively, P=0.0459. The median overall survival (OS) among the CgA groups was 19.0, 18.8, and 10.8 months respectively, P=0.2092. In the multivariate analysis, PSA RR (nonresponsive vs responsive) and CgA levels (group 3 vs groups 1+2) were predictors of PFS (P=0.0002 and P=0.0047 respectively), whereas PSA RR only was significantly associated with OS (P=0.0024), while CgA levels remained of borderline significance (P=0.0919). A serum CGA level more than three times the UNV predicted PFS and showed a trend vs OS prediction, independently from PSA response, in CRPC patients treated with abiraterone.
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http://dx.doi.org/10.1530/ERC-14-0071DOI Listing
June 2014
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