rubrica

Screening

  • Paolo Giorgi Rossi1

  1. Servizio interaziendale di epidemiologia, AUSL Reggio Emilia

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Ricerca bibliografica periodo dal 31 agosto 2013 al 15 novembre 2013

Per leggere le caratteristiche di questa ROUTINE di ricerca clicca qui

Stringa: ("mass screening"[MeSH Terms] OR cancer[Title/Abstract] AND screening[Title/Abstract] AND ("italy"[MeSH Terms] OR "italy"[All Fields]) AND ("2013/08/31"[PDAT] : "2013/09/15"[PDAT])

Breve commento a cura di P. Giorgi Rossi
In questi due mesi e mezzo sono usciti lavori importanti e molto attesi, non solo dalla comunità scientifica Italiana. L’analisi pooled dei trial europei condotta da Guglielmo Ronco e pubblicata su Lancet è la più chiara dimostrazione dell’efficacia del test HPV nella riduzione dell’incidenza di cancro invasivo della cervice uterina. Sono stati pubblicati su JNCI i dati dello studio PALMS (Ikenberg) che ha coinvolto due centri italiani, confrontando la p16 come biomarcatore nello screening della cervice uterina. Il gruppo dell’ISPO di Firenze (Ventura) ha pubblicato i dati forse più convincenti fra quelli visti fino ad ora di una riduzione di incidenza del cancro del colon retto nella popolazione screenata con FOBT. Sempre dall’ISPO di Firenze (Carozzi) vengono i dati sull’uso del test HPV nel follow up post colposcopia negativa, uno studio che ci ricorda ancora la lungimiranza di Stefano Ciatto che aveva impostato un protocollo di gestione delle donne in colposcopia tale da essere allo stesso tempo ottima pratica e sistematica produzione di evidenze. Sono usciti anche quattro lavori sullo screening del polmone, due sull’uso dei micro RNA come biomarcatori non invasivi (Mazzoni, Cazzoli), un intervento di Pastorino e un lavoro sui risultati di 10 anni di screening del polmone allo IEO (Veronesi), risultati che continuano ad ampliare la forbice fra studi che danno risultati positivi randomizzati e non, come questo, e studi che registrano un eccesso di mortalità. Per il colon retto, oltre allo studio di Ventura, sono stati pubblicati due trial sulla preparazione dell’intestino per la colonscopia di secondo livello (de Leone, Valiante) e i risultati di detection rate in uno screening dei parenti di primo grado di casi (Del Vecchio). Per lo screening mammografico, sono usciti tre lavori: un’analisi ecologica dei dati di GLOBOCAN sulla relazione fra incidenza e reddito, in cui il reddito sembrerebbe un determinante più forte della presenza o meno di screening (Coccia); un lavoro sull’effetto dello screening nel livellare le differenze socioeconomiche in termini di sopravvivenza (Pacelli); un lavoro sulla proporzione di casi screen-detected con amplificazione del gene HER2/neu, che sembra essere minore che nei casi non screen-detected, riducendo così i costi delle terapie. Infine due analisi di costo-efficacia di screening per i quali non ci sono attualmente raccomandazioni: epatite C (Ruggeri) e cancro del fegato (Cucchetti). Il primo conclude che uno screening dell’infezione da HCV per iniziare un trattamento con alfa interferone precocemente avrebbe un buon rapporto di costo efficacia (circa 5000 euro per QALY). Il secondo non arriva a conclusioni ma riporta una panoramica della letteratura. Segnalo, con una certa preoccupazione, che da diverse edizioni di questa rubrica, la ricerca automatica porta alla luce molti lavori sulla diagnosi precoce della tiroide che a vario titolo usano la parola screening. Il più delle volte non rientrano nei criteri d’inclusione della ricerca, ma quel che è certo è che nel mondo clinico la ricerca in soggetti asintomatici più o meno sistematica di noduli tiroidei su cui fare ago aspirato è una pratica molto diffusa, certamente non basata sulle evidenze e ad altissimo rischio di arrecare danno all’individuo e alla popolazione.

1. Ronco G, Dillner J, Elfström KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ; the International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2013 Nov 1. pii: S0140-6736(13)62218-7. doi:10.1016/S0140-6736(13)62218-7. [Epub ahead of print]
Center for Cancer Epidemiology and Prevention, AO City of Health and Science, Turin, Italy. Electronic address: guglielmo.ronco@cpo.it.

Abstract
BACKGROUND: In four randomised trials, human papillomavirus (HPV)-based screening for cervical cancer was compared with cytology-based cervical screening, and precursors of cancer were the endpoint in every trial. However, direct estimates are missing of the relative efficacy of HPV-based versus cytology-based screening for prevention of invasive cancer in women who undergo regular screening, of modifiers (eg, age) of this relative efficacy, and of the duration of protection. We did a follow-up study of the four randomised trials to investigate these outcomes. METHODS: 176 464 women aged 20-64 years were randomly assigned to HPV-based (experimental arm) or cytology-based (control arm) screening in Sweden (Swedescreen), the Netherlands (POBASCAM), England (ARTISTIC), and Italy (NTCC). We followed up these women for a median of 6•5 years (1 214 415 person-years) and identified 107 invasive cervical carcinomas by linkage with screening, pathology, and cancer registries, by masked review of histological specimens, or from reports. Cumulative and study-adjusted rate ratios (experimental vs control) were calculated for incidence of invasive cervical carcinoma. FINDINGS: The rate ratio for invasive cervical carcinoma among all women from recruitment to end of follow-up was 0•60 (95% CI 0•40-0•89), with no heterogeneity between studies (p=0•52). Detection of invasive cervical carcinoma was similar between screening methods during the first 2•5 years of follow-up (0•79, 0•46-1•36) but was significantly lower in the experimental arm thereafter (0•45, 0•25-0•81). In women with a negative screening test at entry, the rate ratio was 0•30 (0•15-0•60). The cumulative incidence of invasive cervical carcinoma in women with negative entry tests was 4•6 per 10(5) (1•1-12•1) and 8•7 per 10(5) (3•3-18•6) at 3•5 and 5•5 years, respectively, in the experimental arm, and 15•4 per 10(5) (7•9-27•0) and 36•0 per 10(5) (23•2-53•5), respectively, in the control arm. Rate ratios did not differ by cancer stage, but were lower for adenocarcinoma (0•31, 0•14-0•69) than for squamous-cell carcinoma (0•78, 0•49-1•25). The rate ratio was lowest in women aged 30-34 years (0•36, 0•14-0•94). INTERPRETATION: HPV-based screening provides 60-70% greater protection against invasive cervical carcinomas compared with cytology. Data of large-scale randomised trials support initiation of HPV-based screening from age 30 years and extension of screening intervals to at least 5 years. FUNDING: European Union, Belgian Foundation Against Cancer, KCE-Centre d'Expertise, IARC, The Netherlands Organisation for Health Research and Development, the Italian Ministry of Health.

2. Pastorino U, Sverzellati N. Lung cancer: CT screening for lung cancer-do we have an answer? Nat Rev Clin Oncol. 2013 Nov 5. doi: 10.1038/nrclinonc.2013.198. [Epub ahead of print]
Director of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale Tumori, Via Venezian 1, 20133 Milan, Italy.
3. Cucchetti A, Cescon M, Erroi V, Pinna AD. Cost-effectiveness of liver cancer screening. Best Pract Res Clin Gastroenterol. 2013 Dec;27(6):961-72. doi: 10.1016/j.bpg.2013.08.021. Epub 2013 Oct 4.
General Surgery and Transplant Unit, Department of Medical and Surgical Sciences - DIMEC, S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Via Massarenti n° 9, 40138 Bologna, Italy. Electronic address: aleqko@libero.it.

Abstract
Screening for primary liver cancer means surveillance for hepatocellular carcinoma (HCC), which is one of the most common cancers worldwide. Detection of HCC for curative treatment is increased by surveillance, but target population, optimal periodicity and cost-effectiveness aspects are still debated issues. The aim of surveillance is to obtain a reduction in HCC-related mortality and this is usually achieved through an early diagnosis that increases both applicability and cost-effectiveness of curative treatments. The aim of the present review is to analyse economic aspects of HCC surveillance. Articles that assessed cost-effectiveness of surveillance for HCC, published between 1996 and February 2013, were reviewed in order to verify the cost-effectiveness of surveillance, its optimal periodicity, the target population and the role of alternative surveillance strategies. International guidelines are currently based on the results of such cost-effectiveness analyses, highlighting the importance of the release of cost-effectiveness-guided guidelines for HCC management.

4. Mozzoni P, Banda I, Goldoni M, Corradi M, Tiseo M, Acampa O, Balestra V, Ampollini L, Casalini A, Carbognani P, Mutti A. Plasma and EBC microRNAs as early biomarkers of non-small-cell lung cancer. Biomarkers. 2013 Oct 8. [Epub ahead of print]
Department of Clinical and Experimental Medicine, University of Parma, Parma, Italy.

Abstract
Abstract Lung cancer is a major cause of death in Western countries. Current screening methods are invasive and still lead to a high percentage of false positives. There is, therefore, a need to find biomarkers that increase the probability of detecting lung cancer early. MicroRNAs (miRNAs) are stable molecules in blood plasma and exhaled breath condensate (EBC). We quantified miRNA-21 and miRNA-486 expression from plasma and EBC samples from patients with a diagnosis of non-small-cell lung cancer (NSCLC) and controls. miRNA-21 was significantly higher in plasma and in EBC of the NSCLC patients and miRNA-486 was significantly lower. This difference indicates a significantly improved diagnostic value, and suggests that these miRNAs could be clinically used as a first-line screening test in high-risk subjects.

5. Veronesi G, Maisonneuve P, Rampinelli C, Bertolotti R, Petrella F, Spaggiari L, Bellomi M. Computed tomography screening for lung cancer: Results of ten years of annual screening and validation of cosmos prediction model. Lung Cancer. 2013 Dec;82(3):426-430. doi: 10.1016/j.lungcan.2013.08.026. Epub 2013 Sep 8.
Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy. Electronic address: giulia.veronesi@ieo.it.

Abstract
INTRODUCTION: It is unclear how long low-dose computed tomographic (LDCT) screening should continue in populations at high risk of lung cancer. We assessed outcomes and the predictive ability of the COSMOS prediction model in volunteers screened for 10 years. MATERIALS AND METHODS: Smokers and former smokers (>20 pack-years), >50 years, were enrolled over one year (2000-2001), receiving annual LDCT for 10 years. The frequency of screening-detected lung cancers was compared with COSMOS and Bach risk model estimates. RESULTS: Among 1035 recruited volunteers (71% men, mean age 58 years) compliance was 65% at study end. Seventy-one (6.95%) lung cancers were diagnosed, 12 at baseline. Disease stage was: IA in 48 (66.6%); IB in 6; IIA in 5; IIB in 2; IIIA in 5; IIIB in 1; IV in 5; and limited small cell cancer in 3. Five- and ten-year survival were 64% and 57%, respectively, 84% and 65% for stage I. Ten (12.1%) received surgery for a benign lesion. The number of lung cancers detected during the first two screening rounds was close to that predicted by the COSMOS model, while the Bach model accurately predicted frequency from the third year on. CONCLUSIONS: Neither cancer frequency nor proportion at stage I decreased over 10 years, indicating that screening should not be discontinued. Most cancers were early stage, and overall survival was high. Only a limited number of invasive procedures for benign disease were performed. The Bach model - designed to predict symptomatic cancers - accurately predicted cancer frequency from the third year, suggesting that overdiagnosis is a minor problem in lung cancer screening. The COSMOS model - designed to estimate screening-detected lung cancers - accurately predicted cancer frequency at baseline and second screening round.

6. Kenberg H, Bergeron C, Schmidt D, Griesser H, Alameda F, Angeloni C, Bogers J, Dachez R, Denton K, Hariri J, Keller T, von Knebel Doeberitz M, Neumann HH, Puig-Tintore LM, Sideri M, Rehm S, Ridder R; PALMS Study Group. Screening for Cervical Cancer Precursors With p16/Ki-67 Dual-Stained Cytology: Results of the PALMS Study. J Natl Cancer Inst. 2013 Oct 16;105(20):1550-7. doi: 10.1093/jnci/djt235. Epub 2013 Oct 4.
Affiliations of authors: Cytomol, Frankfurt, Germany (HI); Laboratoire Cerba, Cergy Pontoise, France (CB); Institute for Pathology, Mannheim, Germany (DS); Center for Pathology and Cytodiagnostics, Cologne, Germany (HG); Hospital del Mar, Barcelona, Spain (FA); Unità Gestionale Screening Regionale, Ospedale Atri, Italy (CA); Labo Lokeren - Campus Riatol, Antwerp, Belgium (JB); Institute Alfred Fournier, Paris, France (RD); North Bristol NHS Trust, Bristol, United Kingdom (KD); Sønderborg Hospital, Sønderborg, Denmark (JH); Acomed statistik, Leipzig, Germany (TK); Institute for Pathology, University of Heidelberg, Heidelberg, Germany (MvkD); Institute for Pathology, Nordhorn, Germany (HHN); University of Barcelona, Barcelona, Spain (LMP-T); European Institute of Oncology, Milan, Italy (MS); Roche mtm laboratories, Mannheim, Germany (SR, RR).

Abstract
BACKGROUND: Pap cytology is known to be more specific but less sensitive than testing for human papillomavirus (HPV) for the detection of high-grade cervical intraepithelial neoplasia (CIN2+). We assessed whether p16/Ki-67 dual-stained cytology, a biomarker combination indicative of transforming HPV infections, can provide high sensitivity for CIN2+ in screening while maintaining high specificity. Results were compared with Pap cytology and HPV testing. METHODS: A total of 27349 women 18 years or older attending routine cervical cancer screening were prospectively enrolled in five European countries. Pap cytology, p16/Ki-67 immunostaining, and HPV testing were performed on all women. Positive test results triggered colposcopy referral, except for women younger than 30 years with only positive HPV test results. Presence of CIN2+ on adjudicated histology was used as the reference standard. Two-sided bias-corrected McNemar P values were determined. RESULTS: The p16/Ki-67 dual-stained cytology positivity rates were comparable with the prevalence of abnormal Pap cytology results and less than 50% of the positivity rates observed for HPV testing. In women of all ages, dual-stained cytology was more sensitive than Pap cytology (86.7% vs 68.5%; P < .001) for detecting CIN2+, with comparable specificity (95.2% vs 95.4%; P = .15). The relative performance of the tests was similar in both groups of women: younger than age 30 and 30 years or older. HPV testing in women 30 years or older was more sensitive than dual-stained cytology (93.3% vs 84.7%; P = .03) but less specific (93.0% vs 96.2%; P < .001). CONCLUSIONS: The p16/Ki-67 dual-stained cytology combines superior sensitivity and noninferior specificity over Pap cytology for detecting CIN2+. It suggests a potential role of dual-stained cytology in screening, especially in younger women where HPV testing has its limitations.

7. de Leone A, Tamayo D, Fiori G, Ravizza D, Trovato C, De Roberto G, Fazzini L, Dal Fante M, Crosta C, Annalisa de Leone, Darina Tamayo, Giancarla Fiori, Davide Ravizza, Cristina Trovato, Giuseppe De Roberto, Cristiano Crosta. Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG: Bowel cleansing for late-morning colonoscopy. World J Gastrointest Endosc. 2013 Sep 16;5(9):433-9. doi: 10.4253/wjge.v5.i9.433.
Division of Endoscopy, European Institute of Oncology, 20141 Milan, Italy.

Abstract
AIM: To evaluate the efficacy, tolerability, acceptability and feasibility of bisacodyl plus low volume polyethyleneglycol-citrate-simeticone (2-L PEG-CS) taken the same day as compared with conventional split-dose 4-L PEG for late morning colonoscopy. METHODS: Randomised, observer-blind, parallel group, comparative trial carried out in 2 centres. Out patients of both sexes, aged between 18 and 85 years, undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up were eligible. The PEG-CS group received 3 bisacodyl tablets (4 tablets for patients with constipation) at bedtime and 2-L PEG-CS in the morning starting 5 h before colonoscopy. The control group received a conventional 4-L PEG formulation given as split regimen; the morning dose was taken with the same schedule of the low volume preparation. The Ottawa Bowel Preparation Scale (OBPS) score was used as the main outcome measure. RESULTS: A total of 164 subjects were enrolled and 154 completed the study; 78 in the PEG-CS group and 76 in the split 4-L PEG group. The two groups were comparable at baseline. The OBPS score in the PEG-CS group (3.09 ± 2.40) and in the PEG group (2.39 ± 2.55) were equivalent (difference +0.70; 95%CI: -0.09-1.48). This was confirmed by the rate of successful bowel cleansing in the PEG-CS group (89.7%) and in the PEG group (92.1%) (difference -2.4%; 95%CI: -11.40- 6.70). PEG-CS was superior in terms of mucosa visibility compared to PEG (85.7% vs 72.4%, P = 0.042). There were no significant differences in caecum intubation rate, time to reach the caecum and withdrawal time between the two groups. The adenoma detection rate was similar (PEG-CS 43.6% vs PEG 44.7%). No serious adverse events occurred. No difference was found in tolerability of the bowel preparations. Compliance was equal in both groups: more than 90% of subjects drunk the whole solution. Willingness to repeat the same bowel preparations was about 90% for both regimes. CONCLUSION: Same-day PEG-CS is feasible, effective as split-dose 4-L PEG for late morning colonoscopy and does not interfere with work and daily activities the day before colonoscopy.

8. Ruggeri M, Coretti S, Gasbarrini A, Cicchetti A. Economic assessment of an anti-HCV screening program in Italy. Value Health. 2013 Sep-Oct;16(6):965-72. doi: 10.1016/j.jval.2013.07.005.
Faculty of Economics, Catholic University of Sacred Heart, Rome, Italy. Electronic address: mruggeri@rm.unicatt.it.

Abstract
BACKGROUND: The progression of hepatitis C virus (HCV) disease usually occurs over a 10-year period. HCV-related complications as well as the highly debilitating effects on patients represent a significant item of expenditure for the National Health Service. Early detection of HCV infection is an excellent opportunity to improve patients' quality of life and to rationalize resource allocation. OBJECTIVE: The aim of this study was to provide a cost-effectiveness evaluation of an anti-HCV screening program in the Italian National Health Service perspective. METHODS: We built a Markov model made up of two arms. The ''Test Strategy'' arm involves a screening program based on the enzyme immunoassay for detection of antibodies as first-level test and the research of HCV RNA as second-level detection; patients with positive test results are treated with peg-interferon alfa in combination with ribavirine. Parameters were derived from the literature and validated through experts' opinion. Costs and benefits were discounted by 3.5%. Results were expressed as cost/quality-adjusted life-year (QALY) gained through the screening program compared with the treatment of symptomatic patients. Deterministic and probabilistic sensitivity analysis was performed. RESULTS: The incremental cost-effectiveness ratio of the ''Test Strategy'' is €5171/QALY, definitively below the cost/QALY of other approved treatments in Italy. Model results turned out as sensitive to the age of the target population, the prevalence of HCV infection, and the time horizon adopted. CONCLUSIONS: The anti-HCV screening program is a valid health-related investment improving patients' quality of life and survival with an acceptable expenditure increase for the National Health Service.

9. Coccia M. The effect of country wealth on incidence of breast cancer. Breast Cancer Res Treat. 2013 Sep;141(2):225-9. doi: 10.1007/s10549-013-2683-y. Epub 2013 Sep 15.
National Research Council of Italy, CERIS-CNR, Via Real Collegio n. 30, 10024, Moncalieri, Turin, Italy, m.coccia@ceris.cnr.it.

Abstract
The aim of this study is to analyze the relationship between the incidence of breast cancer and income per capita across countries. Data on breast cancer incidence in 52 countries were obtained from GLOBOCAN, along with economic indicators of gross domestic product per capita from the World Bank. Number of computed tomography scanners and magnetic resonance imaging (from World Health Organization) were used as a surrogate for technology and access to screening for cancer diagnosis. Statistical analyses for correlation and regression were performed, along with an analysis of variance (ANOVA). A strong positive association between breast cancer incidence and gross domestic product per capita, Pearson's r = 65.4 %, controlling latitude, density of computed tomography scanners and magnetic resonance imaging was found in countries of temperate zones. The estimated relationship suggests that 1 % higher gross domestic product per capita, within the temperate zones (latitudes), increases the expected age-standardized breast cancer incidence by about 35.6 % (p < 0.001). ANOVA confirms these vital results. While some have argued that latitude and seasonality may affect breast cancer incidence, these findings suggest that wealthier nations may have a higher incidence of breast cancer independent of geographic location and screening technology.

10. Valiante F, Bellumat A, De Bona M, De Boni M. Bisacodyl plus split 2-L polyethylene glycol-citrate-simethicone improves quality of bowel preparation before screening colonoscopy. World J Gastroenterol. 2013 Sep 7;19(33):5493-9. doi: 10.3748/wjg.v19.i33.5493.
Department of Gastroenterology and Digestive Endoscopy, S Maria del Prato Hospital, Feltre, 32032 Belluno, Italy.

Abstract
AIM: To compare the bowel cleansing efficacy, tolerability and acceptability of split 2-L polyethylene glycol (PEG)-citrate-simethicone (PEG-CS) plus bisacodyl (BIS) vs 4-L PEG for fecal occult blood test-positive screening colonoscopy. METHODS: This was a randomised, observer-blind comparative study. Two hundred and sixty-four subjects underwent screening colonoscopy (mean age 62.5 ± 7.4 years, male 61.7%). The primary objective of the study was to compare the bowel cleansing efficacy of the two preparations. INTERVENTIONS: BIS plus PEG-CS: 3 tablets of 5-mg BIS at 16:00, PEG-CS 1-L at 19:00 and 1-L at 7:00, 4-L PEG: 3-L at 17:00, and 1-L at 7:00. Colonoscopy was carried out after 11:00, at least 3 h after the completion of bowel preparation. Bowel cleansing was evaluated using the Harefield Cleansing Scale. RESULTS: Bowel preparation was successful for 92.8% of subjects in the PEG-CS group and for 92.1% of subjects in the 4-L PEG (RR = 1.01; 95%CI: 0.94-1.08). BIS + PEG-CS was better tolerated than 4-L PEG. A greater rate of patients in the BIS + PEG-CS group had no difficulty and/or were willing to repeat the same preparation compared to split-dose 4-L PEG group. Subjects in the BIS + PEG-CS group rated the prep as good or satisfactory in 90.6% as compared to 77% in the 4-L PEG (P = 0.003). Subjects receiving BIS + PEG-CS stated they fully adhered to instructions drinking all the 2-L solution in 97.1% compared with 87.3% in the 4-L PEG (P = 0.003). CONCLUSION: BIS plus split 2-L PEG-CS was as effective as but better tolerated and accepted than split 4-L PEG for screening colonoscopy. This new procedure may increase the positive attitude and participation to colorectal cancer screening colonoscopy.

11. Brunelli M, Manfrin E, Bria E, Massari F, Tortora G, Brunello E, Carbognin L, Nottegar A, Furlanetto J, Molino A, Fiorio E, Chilosi M, Jasani B, Vergine M, Marcolini L, Filippini D, Scarpa A, Martignoni G, Bonetti F; Members of Veneto Region - Pathology Screening Group. HER2/neu gene determination in women screened for breast carcinoma: how screening programs reduce the skyrocketing cost of targeted therapy. Anticancer Res. 2013 Sep;33(9):3705-10.
Department of Pathology and Diagnostics, University of Verona, P.le L. Scuro n. 10, 37134 Verona, Italy. matteo.brunelli@univr.it.

Abstract
Few data on Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast carcinomas have been reported for screen-detected breast carcinoma. Assessing the impact of a targeted intervention with anti-HER2 inhibitors on costs is required in order to plan for better strategies in screening programs. A total of 54,472 women were screened and 323 cases were found to be invasive cancer. We performed immunophenotypical-fluorescent in situ hybridization (FISH) analysis. Among 153 evaluable breast carcinomas, tumours displayed a 3+ scoring status 3+ in 16 (10%), 2+ in 12 (8%), 1+ in 29 (19%) and 0 in 96 (63%) of cases, respectively. All 3+ HER2+ cases and 2/12 2+ (17%) cases exhibited HER2/neu gene amplification, the remaining cases did not. In contrast to the higher incidence reported at the population level, 20-30% HER2-positive cases for metastatic carcinomas, and only 11% of the screen-detected breast carcinomas displayed HER2/neu gene amplification. Breast cancer detection by screening programs hijacks the skyrocketing cost of the use of targeted therapy in HER2-positive carcinoma.

12. Ventura L, Mantellini P, Grazzini G, Castiglione G, Buzzoni C, Rubeca T, Sacchettini C, Paci E, Zappa M. The impact of immunochemical faecal occult blood testing on colorectal cancer incidence. Dig Liver Dis. 2013 Sep 3. pii: S1590-8658(13)00280-6. doi: 10.1016/j.dld.2013.07.017. [Epub ahead of print]
Cancer Prevention and Research Institute, Florence, Italy.

Abstract
BACKGROUND: The efficacy of colorectal cancer screening based on faecal immunochemical test, in terms of reduction of colorectal cancer incidence, is under debate. In the district of Florence, an organized screening programme based on faecal immunochemical test has been running since the early 1990s. The aim of this study was to compare the risk of developing colorectal cancer for subjects undergoing faecal immunochemical test with those who did not undergo the test in the same period. METHODS: Two cohorts were analyzed: subjects who underwent an initial faecal immunochemical test between 1993 and 1999 ("attenders"), and unscreened residents in the same municipalities invited to perform the faecal immunochemical test in the same period ("non-attenders"). Kaplan-Meier and Cox regression analysis were performed to evaluate the risk of developing colorectal cancer. RESULTS: The attenders' and non-attenders' cohorts included 6961 and 26,285 subjects, respectively. Cox analysis showed a reduction in colorectal cancer incidence of 22% in the attenders' compared to the non-attenders' cohort (hazard ratio=0.78, 95% Confidence Interval: 0.65-0.93). CONCLUSION: Our results support the hypothesis that screening based on a single faecal immunochemical test every 2 years produces a significant decrease in colorectal cancer incidence after an average follow-up observation period of 11 years.

13. Carozzi F, Visioli CB, Confortini M, Iossa A, Mantellini P, Burroni E, Zappa M. hr-HPV testing in the follow-up of women with cytological abnormalities and negative colposcopy. Br J Cancer. 2013 Oct 1;109(7):1766-74. doi: 10.1038/bjc.2013.519. Epub 2013 Sep 5.
Analytical Cytology and Biomolecular Unit, Istituto per lo Studio e la Prevenzione Oncologica, Florence 50139, Italy.

Abstract
BACKGROUND: The follow-up after abnormal Pap smear and negative colposcopy is not clearly defined. This study aimed at investigating the role of hr-HPV testing in the management of abnormal Pap test and negative colposcopy for Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+). methods: The study enrolled 1029 women with abnormal screening cytology (years 2006-2010) and negative colposcopy for CIN2+, which subsequently performed a hr-HPV test. Incident CIN2+ lesions were identified through linkage with cancer registry, hospital discharge records, neoplastic pathology reports and the archive of screening programme (2006-2011). RESULTS: During the follow-up, the cohort developed 133 CIN2+ lesions; only one among hr-HPV-negative women. The probability of developing CIN2+ on follow-up time was 0.44% (95% confidence interval (CI) 0.1-3.1) and 41.8% (95% CI 31.8-53.5) for hr-HPV-negative women and hr-HPV-positive women, respectively. A woman with a positive hr-HPV test had about 105 times higher probability of developing a CIN2+ lesion than a woman with a negative hr-HPV test (hazard ratio (HR)=104.5, 95% CI 14.5-755.1), adjusted for index Pap test result, age and cervix squamocolumnar junction visualisation. CONCLUSION: Our results confirm that hr-HPV testing is able to select the real group of women at risk of developing CIN2+ lesions in the follow-up of abnormal cytology and first negative colposcopy.

14. Pacelli B, Carretta E, Spadea T, Caranci N, Di Felice E, Stivanello E, Cavuto S, Cisbani L, Candela S, De Palma R, Fantini MP. Does breast cancer screening level health inequalities out? A population-based study in an Italian region. Eur J Public Health. 2013 Sep 5. [Epub ahead of print]
Regional Health and Social Care Agency of Emilia-Romagna, Bologna 40127, Italy.

Abstract
BACKGROUND: Although population-based screening has the potential to reduce inequalities in breast cancer survival, evidence on this topic is controversial. The objective of this study was to evaluate whether the full implementation of a mammography screening programme in Emilia-Romagna in Italy had an impact on variations in breast cancer survival by educational level. METHODS: A cohort study was performed, including all women <70 years and residing in Emilia-Romagna who had infiltrating breast cancer registered in 1997-2000 (transitional screening period) or 2001-03 (consolidation screening period). Cancer cases were retrieved from the regional Breast Cancer Registry and followed up for 5 years. Educational level was determined from census data and allocated to cancer cases by individual record linkage. Age at diagnosis was classified into two groups (30-49, 50-69: screening target population). RESULTS: A total of 9639 cases were analyzed. In the 1997-2000 period, low-educated women had significantly lower survival compared with high-educated women, both in the younger and in the older age-groups. After the full implementation of the screening programme, these differences decreased in both age-groups, until disappearing completely among women in the age-group invited to screening. CONCLUSIONS: Our findings suggest that a fee-free population-based organized mammography screening programme with active invitation of the whole target population could be effective in reducing differences in survival in the population targeted by the screening.

15. Cazzoli R, Buttitta F, Di Nicola M, Malatesta S, Marchetti A, Rom WN, Pass HI. microRNAs derived from circulating exosomes as noninvasive biomarkers for screening and diagnosing lung cancer. J Thorac Oncol. 2013 Sep;8(9):1156-62. doi: 10.1097/JTO.0b013e318299ac32.
Center of Predictive Molecular Medicine, Center of Excellence on Aging, †Oncological and Cardiovascular Molecular Medicine Unit, University-Foundation, Chieti, Italy.

Abstract
INTRODUCTION: Lung cancer is the highest cause of mortality among tumor pathologies worldwide. There are no validated techniques for an early detection of pulmonary cancer lesions other than low-dose helical computed tomography scan. Unfortunately, this method has some negative effects. Recent studies have laid the basis for development of exosomes-based techniques to screen/diagnose lung cancers. As the isolation of circulating exosomes is a minimally invasive procedure, this technique opens new possibilities for diagnostic applications. METHODS: We used a first set of 30 plasma samples from as many patients, including 10 patients affected by lung adenocarcinomas, 10 with lung granulomas, and 10 healthy smokers matched for age and sex as negative controls. Wide-range microRNAs analysis (742 microRNAs) was performed by quantitative real time polymerase chain reaction. Data were compared on the basis of lesion characteristics, using WEKA software for statistics and modeling. Subsequently, selected microRNAs were evaluated on an independent larger group of samples (105 specimens: 50 lung adenocarcinomas, 30 lung granulomas, and 25 healthy smokers). RESULTS: This analysis led to the selection of four microRNAs to perform a screening test (miR-378a, miR-379, miR-139-5p, and miR-200b-5p), useful to divide population into two groups: nodule (lung adenocarcinomas + carcinomas) and non-nodule (healthy former smokers). Six microRNAs (miR-151a-5p, miR-30a-3p, miR-200b-5p, miR-629, miR-100, and miR-154-3p) were selected for a second test on the nodule population to discriminate between lung adenocarcinoma and granuloma. CONCLUSIONS: The screening test showed 97.5% sensitivity, 72.0% specificity, and area under the curve receiver operating characteristic of 90.8%. The diagnostic test had 96.0% sensitivity, 60.0% specificity, and area under the curve receiver operating characteristic of 76.0%. Further evaluation is needed to confirm the predictive power of these models on larger cohorts of samples.

16. Del Vecchio Blanco G, Cretella M, Paoluzi OA, Caruso A, Mannisi E, Servadei F, Romeo S, Grasso E, Sileri P, Giannelli M, Biancone L, Palmieri G, Pallone F. Adenoma, advanced adenoma and colorectal cancer prevalence in asymptomatic 40- to 49-year-old subjects with a first-degree family history of colorectal cancer. Colorectal Dis. 2013 Sep;15(9):1093-9. doi: 10.1111/codi.12263.
Department of Internal Medicine, Gastroenterology Unit, University Tor Vergata, Rome, Italy.

Abstract
AIM: First-degree relatives (FDRs) of patients with colorectal cancer (CRC) have an increased CRC risk. Few studies have addressed if adenoma and advanced adenoma risk is increased among individuals, 40-49 years of age, with a family history of CRC. Therefore, the aim of the study was to define the prevalence and location of adenoma, advanced adenoma and CRC, according to age, in asymptomatic individuals with a family history of CRC. METHOD: Retrospective study of asymptomatic FDRs, 40 to ≥70 years of age undergoing first screening colonoscopy over a 3-year period, of CRC patients. RESULTS: Among 464 individuals studied, the prevalence of adenoma and advanced adenoma was 18.1% and 6.4%, respectively. According to age intervals, the prevalences of adenoma and advanced adenoma were 14% and 3.5%, respectively, in subjects 40-49 years of age; 14.4% and 6.3%, respectively, in subjects 50-59 years of age; 27% and 8%, respectively, in subjects 60-69 years of age; and 25% and 14%, respectively, in subjects ≥70 years of age; no significant difference was found among the four groups. No difference in lesion location was found, with similar numbers of preneoplastic lesions being present in the right colon and the left colon. CRC was diagnosed in three (0.64%) subjects, one of whom was in the 40-49 years age group. CONCLUSION: In our population of FDRs of CRC patients, 40-49 years of age, the prevalences of adenoma and advanced adenoma were similar to those observed in older subjects with the same CRC risk. Our data support the current indication to perform screening colonoscopy earlier than 45 years of age in subjects at high CRC risk.

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