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Background Physical activity may increase the risk of cardiotoxicity (myocardial ischemia, major arrhythmias) of 5-Fluorouracil, but this risk has never been investigated for its prodrug capecitabine. Patients and Methods One hundred and ninety-two consecutive patients undergoing capecitabine chemotherapy from December 1, 2010 through July 31, 2016 were prospectively evaluated. The baseline evaluation included electrocardiography (ECG) and echocardiography (2DE); a follow-up evaluation, including ECG and exercise stress testing (2DE in case of ECG abnormalities), was done after ≥10 days of treatment. Cardiotoxicity was suspected from ischemic ECG changes, new kinetic abnormalities at 2DE, Lown classification ≥2 ventricular arrhythmia, symptomatic arrhythmias, or positive stress test, and confirmed by a negative stress test after capecitabine washout. Results Cardiotoxicity was diagnosed in 32 patients (16.7%): six at rest and 26 during exercise. All 32 patients had ECG abnormalities: ST-segment changes (24 patients), negative T-waves (2) and/or arrhythmias: ventricular arrhythmias (14 cases), supraventricular tachycardia (2), complete heart block (1). Eight patients had typical symptoms, 6 had atypical symptoms, 1 had syncope, 17 (53%) were asymptomatic. Cardiotoxicity was more common in patients with atypical symptoms during daily life (OR = 15.7) and in those on a therapeutic schedule of 5 days/week (OR = 9.44). Conclusion Capecitabine cardiotoxicity is frequent, and often elicited by physical effort. Oncologists, cardiologists, and general practitioners should be aware of this risk. Active cardiotoxicity surveillance with ECG (and echocardiogram and/or stress testing in suspected cases) during therapy is recommended. Clinical Trials registration number CRO-2010-17.

Objective: To describe the practice of prostate-specific antigen (PSA) testing over more than 20 years in Friuli Venezia Giulia (FVG), North-Eastern Italy. Methods: A population-based, ecological study was conducted using information derived from regional administrative health-related databases. Data on PSA and prostate biopsies performed on resident men aged ⩾45 years from 1998 to 2019 were retrieved. PSA and biopsy rates were calculated as the number of men who had at least one such procedure in each calendar year over the mean resident male population of the same year. Temporal trends were analyzed using joinpoint regression (annual percentage change –APC). Results: A total of 2,502,670 PSA were made between 1998 to 2019 in men aged ⩾45 years. The number of PSA steadily increased from 51,055 in 1998-1999 to 134,504 in 2010-2011, then dropped to 122,080 in 2018-2019. Significant changes in the slopes of PSA rates emerged in 2002 and 2009: the largest increase occurred during 1998-2002 (APC 18.4), followed by a smaller increase in 2002-2009 (APC 3.4) and a subsequent reduction (APC -2.5). Similar patterns emerged for all ages, but the decrease since 2009 was smaller for men aged ⩾65 years. An upward trend emerged in biopsy rate from 1998 to 2001 (APC 13.0), followed by a smaller increase until 2007 (APC 5.7) and a subsequent decrease. Biopsies as percentage of PSA decreased from 3.2% to 2.2%, particularly in those aged ⩾75 years. Conclusions: Although overall declining PSA rates have been observed in FVG since 2009, rates remained higher in the ⩾65-year-old group than in the 45-64–year-old group.

Background: The age-standardized rate of breast cancer (BC) increased nearly nine-fold in the last 30 years in Setif, Algeria. A case-control study was carried out to investigate the role of sociodemographic characteristics and reproductive factors in the etiology of BC in this young Arab/Berber population of Setif. Methods: Cases were 612 women with incident BC admitted to major teaching and general hospitals of Setif during 2012–2017. Controls were 615 women admitted for acute, non-neoplastic conditions to the same hospital network of cases. Information was elicited using a standardized questionnaire. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed after allowance for age and education. Results: Significant associations with BC risk emerged for family history of BC (OR= 4.15 for yes vs. no; 95%CI: 2.22-7.77), for the generation of oral contraceptive used (OR=1.57 for II-generation vs. III-generation; 95%CI:1.01-2.44), and education (OR=0.63 for >11 years vs. no schooling; 95%CI: 0.46-0.86). Conversely, parity and body mass index were not associated with BC risk, whereas a late age at menarche was linked with a non statistically significant BC risk (OR=1.20 for >15 vs.

Health misinformation can severely affect human behaviour, especially in controversial areas such as that of complementary medicine. A cross-sectional observational study was conducted on 16 web pages to identify different kinds of falsehoods, to estimate the risk of running into deceptive information, and to observe the differences among experts' and one layperson's assessments. Almost all analyzed claims were unfounded. Unexpectedly, the experts agreed more often on considering analyzed scientific statements to be correct rather than incorrect. However, half of the time, the experts did not agree, so that the correctness of some claims remained undefined. A statistically significant risk of running into unfounded information and incorrect or undefined claims was found. There was a low agreement between the expert and layperson evaluation. The results of this study can help consumer health librarians to interpret cues of potentially misleading information about controversial issues and thereby improve their information and communication services.

This Monograph aims to provide the scientific community and the Regional Healthcare Service an up-to-date Atlas of mortality for the Campania Region (Southern Italy). The Atlas shows an overview of mortality through comparisons with national data and with intraregional macroareas. Maps presenting risk measures with municipal details are also provided.Both overall and cause-specific mortality data for the period 2006-2014 referred to people residing in Campania Region are analysed in this Atlas. Twenty-nine death causes (major causes and specific cancers) are studied; for each of them, it has been provided: • direct standardised rates (standard population EU 2013) referred to Italy, Campania Region, and the seven regional Local Health Units (LHUs); • standardised mortality ratios (SMRs), estimated on a regional basis, referred to every LHU; • years of life lost (number and rate) both on a regional and on LHU basis; • mortality rate trends for the period 2006-2014, including annual percentage changes (APCs) for Italy, Campania Region, and every LHU; • for every death cause, regional maps are provided also with municipal details for Relative Risks (RRs) and risk posterior probabilities (PPs) estimated through a Bayesian hierarchical model. Risk estimates are presented both crude and adjusted by socioeconomic deprivation index resulted from the 2011 Census of the Italian National Institute fo Statistics.In Campania Region, standardised mortality ratios (per 100,000; IC95%) higher than the national average have been recorded for the following causes: all causes of death: M: 1,233.3 (IC95% 1,227.9-1,238.9) vs 1,093.8 (IC95% 1,092.5-1,095.1); F: 826.1 (IC95% 822.6-829.7) vs 722.8 (IC95% 721.9-732.6); digestive system diseases: M: 51.2 (IC95% 50.2-52.3) vs 44.2 (IC95% 44.0-44.5); F: 35.8 (IC95% 35.1-36.6) vs 29,2 (IC95% 29.0-29.4); circulatory system diseases: M: 493.1 (IC95% 489.6-496.8) vs 404.3 (IC95% 403.5-405.1); F: 388.5 (IC95% 386.1-390.9) vs 296.5 (IC95% 295.9-297.0); genitourinary system diseases: M: 27.2 (IC95% 26.4-28.1) vs 21.9- (IC95% 21.7-22.1); F: 18.2 (IC95% 17.7-18.7) vs 13.7- (IC95% 13.5-13.8); endocrine and metabolic diseases: M: 60.0 (IC95% 58.8-61.2) vs 43.8 (IC95% 43.5-44.0); F: 60.7 (IC95% 59.8-61.7) vs 36.6 (IC95% 36.4-36.8); myocardial infarction: M: 71.1 (IC95% 69.8-72.4) vs 60.9 (IC95% 60.6-61.2); F: 38.2 (IC95% 37.4-39.0) vs 30.2-(IC95% 30.0-30.4); diabetes: M: 52.6 (IC95% 51.5-53.8) vs 35.1 (IC95% 34.9-35.3); F: 53.8 (IC95% 52.9-54.7) vs 28.6 (IC95% 28.4-28.8). On the other hand, mortality rates comparable to or lower than the national average are observed for the remaining causes of death, with different differences for gender. Mortality for cancer causes in Campania Region presents rates higher than the rates observed at national level in males for the following causes: all cancers: 380.4 (IC95% 377.5-383.3) vs 356.5 (IC95% 355.8-357.2); lung cancer: 112.5 (IC95% 110.9/114.0) vs 93.0 (IC95% 92.6-93.3);larynx cancer: 7.6 (IC95% 7.2-8.0) vs 5.5 (IC95% 5.4-5.6);bladder cancer: 25.1 (IC95% 24.4-25.9) vs 17.3 (IC95% 17.1-17.4); in females for the following causes: liver cancer: 3.8 (IC95% 3.6-4.1) vs 3.3 (IC95% 3.2-3.4);bladder cancer:: 3.5 (IC95% 3.3-3.7) vs 3.0 (IC95% 2.9-3.0). In Campania Region, mortality rates comparable to or lower than the national average are observed for the remaining cancer causes both in females and in males. For almost all the death causes, the highest mortality rates are observed in the three LHUs of Naples (Naples centre, Naples 2 North, Naples 3 South); for some death causes, also the Province of Caserta presents the highest mortality rates. It is worth noting that these areas are characterised by the highest urbanisation and regional population density, and by exposures to possible environmental risks. Time trend analyses highlight that regional and national trends are similar for almost all the examined death causes. In Campania Region, males present decreasing trends for all-cause mortality; for respiratory system, circulatory system, and digestive system diseases; for all malignant cancers; for lung, prostate, and stomach cancers; for leukaemias. On the other hand, an increasing trend is shown for liver cancer. Trends for genitourinary system and nervous system diseases are almost unchanged; the same is for blood diseases and haemolymphopoietic system cancers. In females, there is a decreasing mortality trend for all causes, for circulatory system and digestive system diseases; for haemolymphopoietic system and stomach cancers; on the contrary, an increasing trend is highlighted for communicable diseases and lung and liver cancer, mirroring the national situation. Trends for respiratory system, genitourinary system, nervous system diseases; blood diseases; all malignant cancers; kidney and breast cancers; leukaemias are almost unchanged. The analysis of mortality data on municipal basis reported that the most excesses in mortality risk occur in the municipalities included in the area with the highest urban development of Naples and, partly, in the municipalities of the Caserta Province. The distribution of the excesses at municipal level is not homogeneous in Campania Region, but there are relevant intermunicipal differences related to the considered causes of death. This heterogeneity in the distribution of excess risk is a characteristic also of the area called Terra di fuochi (Land of fires), both for overall mortality and for mortality by gender.Mortality data are a valuable support to the analysis of the population health conditions. Excesses in general mortality and for some specific causes found in Campania Region vs Italy in 2006-2014 suggest that in this region there is a need to implement more strict intervention in terms both of primary prevention (for individuals and the environment) and of management of the whole care and clinical pathway of some pathologies, bearing in mind the burden of regional structural and economic factors on these excesses. The highest excesses in mortality in Campania Region have been found in the areas with the highest degree of urbanisation: this confirms the national data of a different distribution of diseases - and mortality - in the areas characterised by high urban development compared to rural areas. Finally, cause-specific mortality maps at municipal level, extended to the whole region, could enable to identify possible critical issues which may need epidemiological studies focused on possible local factors of environmental pressure.

Background The linear association between median age at cancer onset and median age of the underlying population has been described only for breast cancer. We quantified the shape and strength of such association for 20 cancer types using data from all population-based cancer registries (CRs) worldwide. Methods The patients’ median age at cancer onset and of the underlying population were extracted from all CRs listed in volumes VI (1983–1987 years) and XI (2008–2012 years) of Cancer Incidence in Five Continents. The association was assessed at cross-sectional level by linear regression models and longitudinally considering only the long-standing CRs active throughout the study period (i.e., 25-year span). Results During 2008–2012, each one-year increase in median population ageing was associated in men with a nearly half year increase of median age at onset of all cancers, but skin, and a 2/3 year increase in women. Variance explained by linear model was around 60%. In long-standing CRs a decrease in median age at cancer onset was observed for prostate and cervical cancers throughout the 25-year span. Conclusions Population ageing reflected 60% of the median age at cancer onset. Misinterpretation of peaks of cancer incidence in specific age groups may be avoided by examining population pyramids.

To evaluate the impact of time to treatment initiation (TTI) on overall survival in patients with head-and-neck squamous cell carcinoma (HNSCC).In the period 2003-2009, 1616 HNSCC patients were diagnosed in Friuli Venezia Giulia Region, Northeastern Italy, including 462 oral, 346 oropharyngeal, 212 hypopharyngeal, and 596 laryngeal cancers. Clinical information, including date and type of first treatment, and follow-up were retrieved from the regional Cancer Registry and a population-based health database collecting comprehensive health information on people living in the Region. Multivariate hazard ratio (HR) and confidence intervals (CI) were calculated through Cox model.Overall, the median TTI was 28days, (Q1-Q3: 13-45days), but significant variations emerged according to anatomical site, cancer stage, treatment approach, and care transition to specialized centers. Five-year overall survival decreased with increasing treatment delay from 62% for TTI30days to 39% for TTI≥90days (p0.01). HR of death was 1.13 (95% CI: 0.92-1.39) for TTI between 45-89days, and 1.47 (1.05-2.05) for TTI≥90days. The association between TTI and poor prognosis was stronger for laryngeal cancers and early-stage HNSCCs. Further, care transition from community hospitals to specialized centers was associated to a better prognosis (HR=0.73; 95% CI: 0.60-0.88).Our study findings suggest that HNSCC patients treated within 45days from diagnosis have increased survival probabilities and that early-stage patients suffered the most from treatment delay. Furthermore, care transition to specialized centers -though competitive to timely treatment- improves survival by providing the most innovative technologies and treatment approaches.

Cancers diagnosed in children below the age of 15 years represent 1.2% of all cancer cases, and survival after a childhood cancer has greatly improved over the past 40 years in all high income countries. This study aims to estimate the number of people living in Italy after a childhood cancer for all cancers combined and for a selection of cancer types. We computed 15-year prevalence using data from 15 Italian population-based cancer registries (covering 19% of Italian population) and estimated complete prevalence for Italy by using the CHILDPREV method, implemented in the COMPREV software. A total of 44,135 persons were alive at January 1st, 2010 after a cancer diagnosed during childhood. This number corresponds to a proportion of 73 per 100,000 Italians and to about 2% of all prevalent cases. Among them, 54% were males and 64% had survived after being diagnosed before 1995, the start of the observation period. A quarter of all childhood prevalent cases were diagnosed with brain and central nervous system tumors, a quarter with acute lymphoid leukemia, and 7% with Hodgkin lymphoma. Nearly a quarter of prevalent patients were aged 40 years and older. Information about the number of people living after a childhood cancer in Italy by cancer type and their specific health care needs may be helpful to health-care planners and clinicians in the development of guidelines aimed to reduce the burden of late effect of treatments during childhood.

A higher frequency of early onset female breast cancers (BC) has been observed in low/middle income countries than in high income countries. We quantified the role of population ageing to this pattern using data from all population-based cancer registries (CRs) worldwide. Patients’ median age at BC onset and that of the general population were extracted for CRs listed in volumes VI (1983–1987 years) through XI (2008–2012 years) of Cancer Incidence in Five Continents. Their association was assessed at cross-sectional level by linear regression model and longitudinally considering 25-year ageing of the population in long-standing CRs listed at the beginning and at the end of the study. During 2008–2012, each one-year increase of population ageing was associated with a nearly ½ year increase of age at BC diagnosis. Population demographics explained forty-two percent of the age variance for BC. In 1983–1987, long-standing CRs with a median age at BC below age 61.8 years showed an increase of age at BC after 25-years. Worldwide, age at BC diagnosis essentially reflected the median age of the population. Changes in BC detection methodology likely lessened this association. Nevertheless, the elevated absolute number of BCs in young populations deserves strategies of BC prevention.

The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire designed to screen anxious and depressive states in patients in non-psychiatric settings. In spite of its large use, no agreement exists in literature on HADS accuracy in case finding. The present research addresses the issue of HADS accuracy in cancer patients, comparing its two subscales (HADS-A and HADS-D) against tools not in use in psychiatry, which are able to detect prolonged negative emotional states. 2121 consecutive adult cancer inpatients were administered the HADS together with the State Anxiety subscale of State-Trait Anxiety Inventory and the Center for Epidemiologic Studies Scale on Depression. Receiver operating characteristic (ROC) curves were computed to identify a cut-off for anxious and depressive states in cancer patients. All indicators were computed together with their corresponding 95% confidence interval (95% CI). Data of 1628 and 1035 participants were used to assess the accuracy in case finding of HADS-A and HADS-D, respectively. According to the ROC analysis, the optimal cut-off was > 9 units for the HADS-A and > 7 units for the HADS-D. The area under the ROC curve was 0.90 for HADS-A (95% CI 0.88–0.91) and 0.84 for HADS-D (95% CI 0.81–0.86). This study suggested that risk scores of anxious and depressive states above specific HADS cut-offs are useful in identifying anxious and depressive states in cancer patients, and they may thus be applicable in clinical practice.

Background: Incidence rates of thyroid cancer (TC) increased in the last decades worldwide. This study aimed to describe TC incidence in the Friuli Venezia Giulia (FVG) region, to estimate the quota of overdiagnosis, and to investigate the impact of surgery on long-term survival after TC diagnosis. Methods: TC cases reported to the FVG population-based cancer registry during 2002–2013, aged Results: During 2002–2013, 1701 TC cases were reported to the FVG cancer registry, with papillary TC (78.2%) as the most frequent histologic type. ASR increased from 12.4 to 16.5 in women and from 4.3 to 6.2 in men (+33.1% and +44.2%, respectively). Overdiagnosis was estimated as 79% of TC cases in women and 64% in men. Almost all TC cases (97.1%) underwent surgery, including 84.6% of women and 78.9% of men who underwent total thyroidectomy. Up to 10 years after TC diagnosis, the type of surgery did not appear to influence survival. Conclusions: This study documented an increase in TC incidence in FVG in the last decade, with overdiagnosis accounting for a large proportion of TC diagnoses and total thyroidectomy in more than 80% of cases. These findings suggest reconsidering thyroid screening practice and aggressive therapeutic strategies, as recommended by new TC guidelines.

Patient education and empowerment (PEE) is aimed at improving competence of patients during their clinical path and enabling healthcare providers with specific communication strategies. We investigated the interest of Italian Cancer Research & Care Centers (CRCI) users (patients and caregivers) in being involved in PEE activities. An anonymous questionnaire addressed to users was distributed between June 2013 and February 2014. The questionnaire gathered information on the following: health-related topics; 13 different PEE initiatives/modalities of learning already active at CRCI; personal demographic data; the willingness to be more involved in the organization of health services provided and in which context; and five preferred info-educational activities. Frequency distribution and chi-square analysis were computed. Statistical significance (p value) was set at

Diabetes mellitus (DM) is associated with an elevated risk of cancer. The aim of this study was to assess cancer risk and survival in individuals with type 2 DM (T2DM) in Friuli Venezia Giulia, Italy. A retrospective population-based cohort study of 32,247 T2DM patients aged 40-84 years was conducted through a record linkage of local healthcare databases and cancer registry for the period 2002-2009. Standardized incidence ratios (SIRs) with 95% confidence intervals (95%CIs) and 5-year survival probabilities after T2DM and cancer diagnosis were computed. The SIRs for all cancers (n=2069) was 1.28 (95%CI: 1.23-1.34). The highest SIRs were observed for cancers of the liver, female genital organs, small intestine, and pancreas. After 3 years from T2DM diagnosis, a reduced risk of prostate cancer (SIR=0.73, 95%CI: 0.54-0.96) was found in men aged 65-74 years, and a higher risk for breast cancer (SIR=1.24, 95%CI: 1.00-1.52) was found among T2DM female patients. The overall 5-year survival after T2DM was 88.7%. Furthermore, T2DM appeared to have a negative effect on survival of women with breast cancer. This population-based study confirmed that T2DM patients are at increased risk of several cancers, and of premature death in women with breast cancer.

ObjectiveTo define the accuracy of administrative datasets to identify primary diagnoses of breast cancer based on the International Classification of Diseases (ICD) 9th or 10th revision codes.DesignSystematic review.Data sources: MEDLINE, EMBASE, Web of Science and the Cochrane Library (April 2017).Eligibility criteriaThe inclusion criteria were: (a) the presence of a reference standard; (b) the presence of at least one accuracy test measure (eg, sensitivity) and (c) the use of an administrative database.Data extractionEligible studies were selected and data extracted independently by two reviewers; quality was assessed using the Standards for Reporting of Diagnostic accuracy criteria.Data analysisExtracted data were synthesised using a narrative approach.ResultsFrom 2929 records screened 21 studies were included (data collection period between 1977 and 2011). Eighteen studies evaluated ICD-9 codes (11 of which assessed both invasive breast cancer (code 174.x) and carcinoma in situ (ICD-9 233.0)); three studies evaluated invasive breast cancer-related ICD-10 codes. All studies except one considered incident cases.The initial algorithm results were: sensitivity ≥80% in 11 of 17 studies (range 57%–99%); positive predictive value was ≥83% in 14 of 19 studies (range 15%–98%) and specificity ≥98% in 8 studies. The combination of the breast cancer diagnosis with surgical procedures, chemoradiation or radiation therapy, outpatient data or physician claim may enhance the accuracy of the algorithms in some but not all circumstances. Accuracy for breast cancer based on outpatient or physician’s data only or breast cancer diagnosis in secondary position diagnosis resulted low.ConclusionBased on the retrieved evidence, administrative databases can be employed to identify primary breast cancer. The best algorithm suggested is ICD-9 or ICD-10 codes located in primary position.Trial registration numberCRD42015026881.

ObjectivesTo assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying patients diagnosed with incident carcinoma in situ and invasive breast cancer in three Italian administrative databases.DesignA diagnostic accuracy study comparing ICD-9-CM codes for carcinoma in situ (233.0) and for invasive breast cancer (174.x) with medical chart (as a reference standard). Case definition: (1) presence of a primary nodular lesion in the breast and (2) cytological or histological documentation of cancer from a primary or metastatic site.SettingAdministrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli VeneziaGiulia (FVG) Region.ParticipantsWomen with breast carcinoma in situ (n=246) or invasive breast cancer (n=384) diagnosed (in primary position) between 2012 and 2014.Outcome measuresSensitivity and specificity for codes 233.0 and 174.x.ResultsFor invasive breast cancer the sensitivities were 98% (95% CI 93% to 99%) for Umbria, 96% (95% CI 91% to 99%) for NA and 100% (95% CI 97% to 100%) for FVG. Specificities were 90% (95% CI 82% to 95%) for Umbria, 91% (95% CI 83% to 96%) for NA and 91% (95% CI 84% to 96%) for FVG.For carcinoma in situ the sensitivities were 100% (95% CI 93% to 100%) for Umbria, 100% (95% CI 95% to 100%) for NA and 100% (95% CI 96% to 100%) for FVG. Specificities were 98% (95% CI 93% to 100%) for Umbria, 86% (95% CI 78% to 92%) for NA and 90% (95% CI 82% to 95%) for FVG.ConclusionsAdministrative healthcare databases from Umbria, NA and FVG are accurate in identifying hospitalised news cases of carcinoma of the breast. The proposed case definition is a powerful tool to perform research on large populations of newly diagnosed patients with breast cancer.

ObjectivesTo assess the accuracy ofInternational Classification of Diseases, Ninth Revision – Clinical Modification(ICD-9-CM) codes in identifying subjects with colorectal cancer.DesignA diagnostic accuracy study comparing ICD-9-CM codes (index test) for colorectal cancers with medical chart (as a reference standard). Case ascertainment based on neoplastic lesion(s) within the colon/rectum and histological documentation from a primary or metastatic site positive for colorectal cancer.SettingAdministrative databases from the Umbria region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) region and Friuli Venezia Giulia (FVG) region.ParticipantsWe randomly selected 130 incident patients from each hospital discharge database, admitted between 2012 and 2014, having colorectal cancer ICD-9 codes located in primary position, and 94 non-cases, that is, patients having a diagnosis of cancer (ICD-9 140–239) other than colorectal cancer in primary position.Outcome measuresSensitivity, specificity and predictive values for 153.x code (colon cancer) and for 154.x code (rectal cancer).ResultsThe positive predictive value (PPV) for colon cancer diagnoses was 80% for Umbria (95% CI 73% to 87%), 81% for NA (95% CI 73% to 88%) and 80% for FVG (95% CI 72% to 87%).The sensitivity ranged from 98% to 99%, while the specificity ranged from 78% to 80% in the three units.For rectal cancer, the PPV was 84% for Umbria (95% CI 77% to 90%), 80% for NA (95% CI 72% to 87%) and 81% for FVG (95% CI 73% to 87%). The sensitivities ranged from 98% to 100%, while the specificity estimates from 79% to 82%.ConclusionsAdministrative databases in Italy can be a valuable tool for cancer surveillance as well as monitoring geographical and temporal variation of cancer practice.

Lynch syndrome (LS) and familial adenomatous polyposis (FAP) are autosomal dominant hereditary diseases caused by germline mutations leading to the development of colorectal cancer. Moreover, these mutations result in the development of a spectrum of different tumors, including gastric cancers (GCs). Since the clinical characteristics of GCs associated with LS and FAP are not well known, we investigated clinical and molecular features of GCs occurring in patients with LS and FAP attending our Institution. The Hereditary Tumor Registry was established in 1994 at the Department of Oncologic Gastroenterology, CRO Aviano National Cancer Institute, Italy. It includes 139 patients with LS and 86 patients with FAP. Patients were recruited locally for prospective surveillance. Out of 139 LS patients, 4 developed GC&mdash, 3 in the presence of helicobacter pylori infection and 1 on the background of autoimmune diseases. All GCs displayed a high microsatellite instability (MSI-H) and loss of related mismatch repair (MMR) protein. One of the FAP patients developed a flat adenoma, displaying low-grade dysplasia at the gastric body, and another poorly differentiated adenocarcinoma with signet ring cells like Krukenberg without HP infection. LS carriers displayed a risk of GC. The recognition of HP infection and autoimmune diseases would indicate those at higher risk for an endoscopic surveillance. Regarding FAP, the data suggested the need of suitable endoscopic surveillance in long survivals with diffuse fundic gland polyps.

The aim of this study is to compare the prevalence of sleep disorders (SD) between children treated for brain tumors and healthy children, and to define the type of SD. A case-control study was performed from October 2014 to April 2015. Inclusion criteria were patients between 2 and 16 years with “cases” defined as children affected by central nervous system tumors at least 3 months after the end of treatment (surgery and/or radiotherapy and/or chemotherapy) at the time of evaluation and “controls” as healthy children. Children’s sleep quality was assessed with a questionnaire administered to parents (Child’s Sleep Habits Questionnaire, CSHQ). A total score greater than 41 is suggestive for the presence of disturbed sleep. The risk of SD was estimated by the odds ratio (OR) and their 95% confidence intervals (95% CI) through logistic regression models. Twenty-nine cases and 87 controls (in a 1:3 model) were enrolled, for a total of 116 subjects. The prevalence of SD resulted of 82.8% among cases and 64.4% in controls. A statistically significant difference between the two groups (OR 2.65; 95% CI 0.92–7.65) was not reached. Analyzing singular disturbances, parasomnias and night awakenings showed a statistically significant difference between the two groups (OR 4.32; 95% CI 1.08–17.34). Our study revealed a trend toward SD in children with brain tumor when compared to healthy population. Hovewer, analyzing specific subtypes of SD some significant differences were obtained. A significant difference was obtained only for specific subtypes of SD. Further investigations could better define the real burden of SD.

Objectives To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying subjects with melanoma. Design A diagnostic accuracy study comparing melanoma ICD-9-CM codes (index test) with medical chart (reference standard). Case ascertainment was based on neoplastic lesion of the skin and a histological diagnosis from a primary or metastatic site positive for melanoma. Setting Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli Venezia Giulia (FVG) Region. Participants 112, 130 and 130 cases (subjects with melanoma) were randomly selected from Umbria, NA and FVG, respectively; 94 non-cases (subjects without melanoma) were randomly selected from each unit. Outcome measures Sensitivity and specificity for ICD-9-CM code 172.x located in primary position. Results The most common melanoma subtype was malignant melanoma of skin of trunk, except scrotum (ICD-9-CM code: 172.5), followed by malignant melanoma of skin of lower limb, including hip (ICD-9-CM code: 172.7). The mean age of the patients ranged from 60 to 61 years. Most of the diagnoses were performed in surgical departments. The sensitivities were 100% (95% CI 96% to 100%) for Umbria, 99% (95% CI 94% to 100%) for NA and 98% (95% CI 93% to 100%) for FVG. The specificities were 88% (95% CI 80% to 93%) for Umbria, 77% (95% CI 69% to 85%) for NA and 79% (95% CI 71% to 86%) for FVG. Conclusions The case definition for melanoma based on clinical or instrumental diagnosis, confirmed by histological examination, showed excellent sensitivities and good specificities in the three operative units. Administrative databases from the three operative units can be used for epidemiological and outcome research of melanoma.

Objective: To evaluate whether plasma cell-free DNA (cfDNA) was related to clinical outcome in inoperable stage I non-small cell lung cancer (NSCLC) patients undergoing stereotactic body radiotherapy (SBRT).Materials and methods: Plasma cfDNA was assessed at baseline, before the last day and 45 days after the end of SBRT, in 22 NSCLC patients. Twenty-two healthy controls were also evaluated.Results: Plasma cfDNA was higher in patients than in controls. An association with unfavourable disease-free survival was found for continuous baseline cfDNA increments (HR = 5.9, 95%CI: 1.7–19.8, p = 0.04).Conclusion: Plasma cfDNA may be a promising prognostic biomarker in high-risk NSCLC patients.

This study aimed to evaluate plasma concentration of selected cancer-associated inflammatory and immune-modulated cytokines in HIV+ patients with advanced Kaposi sarcoma (KS), and to explore candidate biomarkers capable of predicting clinical outcome in response to chemotherapy (CT) plus combination antiretroviral therapy (cART). Thirty-seven plasma cytokines/chemokines were assessed by Luminex technology in 27 consecutive HIV+ KS patients, followed-up during CT and cART of maintanence (m-cART). Associations between plasma concentration of biomarkers and patient clinical response to m-cART were evaluated by means of Hazard Ratios (HRs) and corresponding 95% Confidence Intervals (CIs). Plasma baseline concentration of Granulocyte colony-stimulating factor (G-CSF), Hepatocyte growth factor (HGF) and endoglin were found to be associated with m-cART clinical response (HR:1.56, 95%CI:1.09–2.22, p = 0.01; HR:0.32, 95% CI:0.10–0.99, p = 0.05; HR:0.72, 95% CI:0.54–0.96, p = 0.03, respectively). The multivariate analysis confirmed the associations of baseline plasma G-CSF and HGF concentration with m-cART clinical complete remission response (HR:1.78, 95% CI:1.15–2.74, p = 0.009; HR:0.19, 95% CI:0.04–0.95, p = 0.04). Our exploratory study suggested that plasma G-CSF, HGF and endoglin may be novel predictors of clinical response during m-cART in HIV+ KS patients. Nonetheless, these findings should be further validated in an independent population study.

BACKGROUND: Some components of the Mediterranean diet have favourable effects on endometrial cancer, and the Mediterranean diet as a whole has been shown to have a beneficial role on various neoplasms. METHODS: We analysed this issue pooling data from three case-control studies carried out between 1983 and 2006 in various Italian areas and in the Swiss Canton of Vaud. Cases were 1411 women with incident, histologically confirmed endometrial cancer, and controls were 3668 patients in hospital for acute diseases. We measured the adherence to the Mediterranean diet using a Mediterranean Diet Score (MDS), based on the nine dietary components characteristics of this diet, that is, high intake of vegetables, fruits/nuts, cereals, legumes, fish; low intake of dairy products and meat; high monounsaturated to saturated fatty acid ratio; and moderate alcohol intake. We estimated the odds ratios (OR) and the corresponding 95% confidence intervals (CI) for increasing levels of the MDS (varying from 0, no adherence, to 9, maximum adherence) using multiple logistic regression models, adjusted for major confounding factors. RESULTS: The adjusted OR for a 6-9 components of the MDS (high adherence) compared with 0-3 (low adherence) was 0.43 (95% CI 0.34-0.56). The OR for an increment of one component of MDS diet was 0.84 (95% CI 0.80-0.88). The association was consistent in strata of various covariates, although somewhat stronger in older women, in never oral contraceptive users and in hormone-replacement therapy users. CONCLUSIONS: Our study provides evidence for a beneficial role of the Mediterranean diet on endometrial cancer risk, suggesting a favourable effect of a combination of foods rich in antioxidants, fibres, phytochemicals, and unsaturated fatty acids.

Background The RARECAREnet project has updated the estimates of the burden of the 198 rare cancers in each European country. Suspecting that scant data could affect the reliability of statistical analysis, we employed a Bayesian approach to estimate the incidence of these cancers. Methods We analyzed about 2,000,000 rare cancers diagnosed in 2000–2007 provided by 83 population-based cancer registries from 27 European countries. We considered European incidence rates (IRs), calculated over all the data available in RARECAREnet, as a valid a priori to merge with country-specific observed data. Therefore we provided (1) Bayesian estimates of IRs and the yearly numbers of cases of rare cancers in each country; (2) the expected time (T) in years needed to observe one new case; and (3) practical criteria to decide when to use the Bayesian approach. Results Bayesian and classical estimates did not differ much; substantial differences (>10%) ranged from 77 rare cancers in Iceland to 14 in England. The smaller the population the larger the number of rare cancers needing a Bayesian approach. Bayesian estimates were useful for cancers with fewer than 150 observed cases in a country during the study period; this occurred mostly when the population of the country is small. Conclusion For the first time the Bayesian estimates of IRs and the yearly expected numbers of cases for each rare cancer in each individual European country were calculated. Moreover, the indicator T is useful to convey incidence estimates for exceptionally rare cancers and in small countries; it far exceeds the professional lifespan of a medical doctor.

This study investigated the risk of lung and bladder cancers in people residing in proximity of a coal-oil-fired thermal power plant in an area of north-eastern Italy, covered by a population-based cancer registry. Incidence rate ratios (IRR) by sex, age, and histology were computed according to tertiles of residential exposure to benzene, nitrogen dioxide (NO2), particular matter, and sulfur dioxide (SO2) among 1076 incident cases of lung and 650 cases of bladder cancers. In men of all ages and in women under 75 years of age, no significant associations were observed. Conversely, in women aged ≥75 years significantly increased risks of lung and bladder cancers were related to high exposure to benzene (IRR for highest vs. lowest tertile: 2.00 for lung cancer and 1.94 for bladder cancer) and NO2 (IRR: 1.72 for lung cancer; and 1.94 for bladder cancer). In these women, a 1.71-fold higher risk of lung cancer was also related to a high exposure to SO2. Acknowledging the limitations of our study, in particular that we did not have information regarding cigarette smoking habits, the findings of this study indicate that air pollution exposure may have had a role with regard to the risk of lung and bladder cancers limited to women aged ≥75 years. Such increased risk warrants further analytical investigations.

We assessed lung and bladder cancer risk in people living near a coal-oil-fired thermal power plant in an area of north-eastern Italy covered by a population-based cancer registry. Incidence rate ratios (IRR) by sex, age, and histology were computed according to tertiles of residential exposure to benzene, nitrogen dioxide (NO2), particular matter (PM10), and sulfur dioxide (SO2) among 1076 incident cases of lung and 650 cases of bladder cancers. In men of all ages and in women under 75 years of age, no significant associations were observed. Conversely, in women aged ≥ 75 years significantly increased risks of lung and bladder cancer were related to high exposure to benzene (IRR for highest vs. lowest tertile: 2.00 for lung cancer and 1.94 for bladder cancer) and NO2 (IRR: 1.72 for lung cancer; and 1.94 for bladder cancer). In these women, a 1.71-fold higher risk of lung cancer was also related to high exposure to SO2. The findings of this descriptive study indicate that air pollution may have a role with regard to the risk of lung and bladder cancers, limited to women aged ≥ 75 years. Such increased risk warrants further analytical investigations.

Background Mechanisms influencing breast cancer (BC) development and recurrence include hyperglycemia, hyperinsulinemia, high insulin-like growth factor-1, high circulating estrogen, inflammation and impaired cellular differentiation/apoptosis. A lifestyle program that targets all the above mechanisms may be warranted. Low glycemic index (GI) foods produce lower post-prandial glucose and insulin responses and have been associated with lower BC risk. Moderate physical activity post-diagnosis reduces BC recurrence and mortality, partly explained by reduced insulin and estrogen levels. Vitamin D increases cell differentiation/apoptosis and high serum vitamin D levels improve BC survival. Yet no trial has evaluated the combined effect of a low GI diet, moderate physical activity and vitamin D supplementation on BC recurrence in the context of a Mediterranean lifestyle setting. Methods Women (30-74 yr) who had undergone surgery for primary histologically confirmed BC (stages I-III) within the previous 12 months, in cancer centres in Italy, will be randomized to follow, for a maximum of 33 months, either a high intensity treatment (HIT) composed of low GI diet + exercise + vitamin D (60 ng/mL serum concentration) or a lower intensity treatment (LITE) with general advice to follow a healthy diet and exercise pattern + vitamin D to avoid insufficiency. Both interventions are on a background of a Mediterranean diet. Considering a 20% recurrence rate within 3 years for BC cases and a predicted rate of 10% in the HIT group, with power of 80% and two-sided alpha of 0.05, the subject number required will be 506 (n = 253 in each arm). Clinic visits will be scheduled every 3 months. Dietary and exercise counselling and vitamin D supplements will be given at each clinic visit when blood samples, anthropometric measures and 7-day food records will be collected. Discussion DEDiCa study aims to reduce BC recurrence in women with BC using a lifestyle approach with additional vitamin D and to investigate possible cardio-metabolic benefits as well as epigenetic modifications according to lifestyle changes. Given the supporting evidence and safety of the components of our intervention we believe it is feasible and urgent to test it in cancer patients. Trial registration May 11, 2016; NCT02786875. EudraCT Number 2015-005147-14

Geographically, Europe consists of 40 countries, some of them are members of the European Union. We examined the estimates of cancer incidence, mortality and 5-year survival for the four most frequent cancers representing about 50% of cancer burden in the European countries. The cancer burden and the increasing trends in incidence of the most common cancers in Europe are of concern, in particular those at younger ages. The differences in survival of patients with cancer are wide for patients diagnosed up to 2002, with the highest survival in northern and central Europe and the lowest survival in the UK and eastern Europe. The pattern observed suggests that further improvements could be made by applying proven treatment protocols and ensuring that all cancer patients have access to early diagnosis and high quality treatment. As a final point, we reported the 4th edition of the European Code against Cancer.

Although a role of glycemic index (GI) and glycemic load (GL) in age-related cataract development is plausible, a few studies, all conducted in USA or Australia, provided results on this issue. The aim of the present study was to provide new original data from a Mediterranean population. We analyzed data from an Italian case–control study including 761 cases with cataract extraction and 1,522 hospital controls, frequency-matched with cases by center, sex, and age. Multivariate odds ratios (ORs) for GI and GL intakes were obtained from logistic regression models after allowance for major confounding factors, including non carbohydrate energy intake, smoking, and diabetes. The ORs of cataract extraction for the highest versus the lowest tertile were 1.20 (95 % confidence interval, CI 0.91–1.57) for GI and 1.57 (95 % CI 1.16–2.13) for GL, with a statistically significant trend in risk for GL (p

Helicobacter pylori (H. pylori) represents an independent risk factor for Gastric Cancer (GC). First Degree Relatives (FDR) of GC subjects and Autoimmune Gastritis (AG) patients are both at increased risk for GC. H. pylori genetic heterogeneity within the gastric niche of FDR and AG individuals has been little explored. To understand whether they exploit an increased H. pylori stability and virulence, 14 AG, 25 FDR, 39 GC and 13 dyspeptic patients (D) were investigated by a cultural PCR-based approach characterizing single colonies-forming-units. We chose three loci within the Cytotoxin-associated gene-A Pathogenicity Island (CagPAI) (cagA,cagE,virB11), vacA, homA and homB as markers of virulence with reported association to GC. Inflammatory/precancerous lesions were staged according to Sydney System. When compared to D, FDR, similarly to GC patients, were associated to higher atrophy (OR = 6.29, 95% CI):1.23&ndash, 31.96 in FDR, OR = 7.50, 95% CI:1.67&ndash, 33.72 in GC) and a lower frequency of mixed infections (OR = 0.16, 95% CI:0.03&ndash, 0.81 in FDR, OR = 0.10, 95% CI:0.02&ndash, 0.48 in GC). FDR presented also an increased neutrophil infiltration (OR = 7.19, 95% CI:1.16&ndash, 44.65). Both FDR and GC carried a higher proportion of CagPAI+vacAs1i1mx+homB+ profiles (OR = 2.71, 95% CI: 1.66&ndash, 4.41 and OR = 3.43, 95% CI: 2.16&ndash, 5.44, respectively). Conversely, AG patients presented a lower frequency of subtypes carrying a stable CagPAI and vacAs1i1mx. These results underline different H. pylori plasticity in FDR and AG individuals, and thus, a different host-bacterium interaction capacity that should be considered in the context of eradication therapies.

Background Organ preservation strategies are under investigation for patients with locally advanced rectal cancer (LARC) who achieve a complete pathologic response in the primary tumor (ypT0) after neoadjuvant chemoradiation therapy (CRT). This study explored the value of this approach for cN+ patients. Methods Data were retrieved from our institutional prospective rectal cancer database. Tumors with mesorectal lymph nodes larger than 5 mm shown on endorectal ultrasonography, pelvic magnetic resonance imaging, or both were staged as cN+. Results The study population comprised 226 patients (142 men and 84 women; median age, 64 years) with LARC who underwent CRT followed by surgery including total mesorectal excision (TME) (n = 179) and full-thickness local excision (LE) (n = 47) between 1996 and 2013. At staging, 123 patients (54.4 %) were cN+. In 65 cases (28.7 %), ypCR was observed. Metastatic mesorectal lymph nodes (ypN+) were detected in 41.6 % of the cN+ patients and in 2.8 % of the cN0 patients (P

Introduction Administrative healthcare databases are useful tools to study healthcare outcomes and to monitor the health status of a population. Patients with cancer can be identified through disease-specific codes, prescriptions and physician claims, but prior validation is required to achieve an accurate case definition. The objective of this protocol is to assess the accuracy of International Classification of Diseases Ninth Revision—Clinical Modification (ICD-9-CM) codes for breast, lung and colorectal cancers in identifying patients diagnosed with the relative disease in three Italian administrative databases. Methods and analysis Data from the administrative databases of Umbria Region (910 000 residents), Local Health Unit 3 of Napoli (1 170 000 residents) and Friuli-Venezia Giulia Region (1 227 000 residents) will be considered. In each administrative database, patients with the first occurrence of diagnosis of breast, lung or colorectal cancer between 2012 and 2014 will be identified using the following groups of ICD-9-CM codes in primary position: (1) 233.0 and (2) 174.x for breast cancer; (3) 162.x for lung cancer; (4) 153.x for colon cancer and (5) 154.0–154.1 and 154.8 for rectal cancer. Only incident cases will be considered, that is, excluding cases that have the same diagnosis in the 5 years (2007–2011) before the period of interest. A random sample of cases and non-cases will be selected from each administrative database and the corresponding medical charts will be assessed for validation by pairs of trained, independent reviewers. Case ascertainment within the medical charts will be based on (1) the presence of a primary nodular lesion in the breast, lung or colon–rectum, documented with imaging or endoscopy and (2) a cytological or histological documentation of cancer from a primary or metastatic site. Sensitivity and specificity with 95% CIs will be calculated. Dissemination Study results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences.

Background Recent studies suggest a powerful prognostic value for blood cytokine levels in different diseases. Non-Hodgkin lymphoma (NHL) still represents one of the main causes of death in the HIV setting, with a wide variation in outcome and survival among patients. We measured blood concentrations of 11 cytokines from HIV–NHL patients at diagnosis and correlated these with the patient outcome to evaluate the prognostic value. Methods Luminex technology was used to simultaneously measure serum levels of interleukin IL-2/5/6/7/8/10/13/15, INF-γ, TNF-α and VEGF. Eighty-one consecutive HIV–NHL patients, at diagnosis, were studied. Hazard Ratios (HRs) and corresponding 95% confidence intervals (CIs) of disease-free survival (DFS) and overall survival (OS) were computed according to cytokine levels. HRs were also calculated for continuous variation of IL-7. Results In the multivariate analysis, statistically significant associations to both DFS and OS were found for IL-7 serum levels ⩾3.2 pg/mL (HR = 5.55, 95%CI:2.38–12.95; HR = 3.53, 95%CI:1.60–7.77, respectively), IL-8 ⩾ 18 pg/mL (HR = 2.69, 95%CI:1.15–6.30; HR = 2.35, 95%CI:1.01–5.51, respectively) and IL-10 ⩾ 13 pg/mL (HR = 2.82, 95%CI: 1.19–6.71; HR = 2.98, 95%CI:1.21–7.30, respectively). When the multivariate analyses were mutually adjusted for INF-γ, IL-7, IL-8, IL-10 and IL-15, serum IL-7 ⩾ 3.2 pg/mL emerged as factor independently associated to increased risk of DFS (HR = 3.63, 95%CI:1.47–8.93) and OS (HR = 3.97, 95%CI:1.49–10.57). Conclusions IL-7, measured at NHL diagnosis, was the only cytokine strongly and independently associated to both DFS and OS. The multiplex analysis of different blood cytokines’ concentration might be useful in defining additive predictive markers in HIV–NHL management and ascertainment of their outcome.

Background Scanty and inconsistent studies are available on the relation between dietary fiber intake and pancreatic cancer. A case–control study was carried out in northern Italy to further investigate the role of various types of dietary fibers in the etiology of pancreatic cancer. Patients and methods Cases were 326 patients with incident pancreatic cancer, excluding neuroendocrine tumors, admitted to major teaching and general hospitals during 1991–2008. Controls were 652 patients admitted for acute, nonneoplastic conditions to the same hospital network of cases. Information was elicited using a validated food frequency questionnaire. Odds ratios (ORs) and the corresponding 95% confidence intervals (CIs) were estimated for intake quintiles of different types of fiber after allowance for total energy intake and other potential confounding factors. Results Total fiber intake was inversely related to risk of pancreatic cancer (OR = 0.4 for highest versus lowest quintile of intake; 95% CI 0.2–0.7). An inverse association emerged between pancreatic cancer and both soluble (OR = 0.4; 95% CI 0.2–0.7) and total insoluble fiber (OR = 0.5; 95% CI 0.3–0.8), particularly cellulose (OR = 0.4; 95% CI 0.3–0.7) and lignin (OR = 0.5; 95% CI 0.3–0.9). Fruit fiber intake was inversely associated with pancreatic cancer (OR = 0.5; 95% CI 0.3–0.8), whereas grain fiber was not (OR = 1.2; 95% CI 0.7–2.0). Conclusions This study suggests that selected types of fiber and total fiber are inversely related to pancreatic cancer.

To evaluate the disease control rate (DCR) in heavily pretreated and relapsed ovarian cancer patients re-challenged with a weekly paclitaxel schedule and to establish whether a correlation between dose intensity, progression-free interval (PFI) and overall survival (OS) exists.Retrospective data were collected from 30 heavily pretreated metastatic ovarian cancer patients who received 80 mg/m(2)/week paclitaxel regimen.The treatment was well tolerated and showed a DCR in 70% of the patients, with only one case of grade 3 hematological toxicity. One patient (3%) showed a complete response, 15 patients (50%) a partial response and five patients (17%) a stabilization of their disease. The regimen was mostly used as a fourth-line chemotherapy (range 2-7). The median dose intensity in responding patients was 57.5 mg/m(2)/week and in those with progressive disease 49.7 mg/m(2)/week. (p = 0.20). PFI and OS were increased in the responder patient groups with a log-rank test of 25.64 (p0.001) and 15.10 (p = 0.0001), respectively.Weekly administration of paclitaxel was active and well tolerated as a salvage therapy for heavily pretreated ovarian cancer patients.