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Recurrence after colorectal cancer resection is rarely documented in the general population while a key clinical determinant for patient survival. We identified 8785 patients with colorectal cancer diagnosed between 2010 and 2013 and clinically followed up to 2020 in 15 cancer registries from seven European countries (Bulgaria, Switzerland, Germany, Estonia, France, Italy, and Spain). We estimated world age-standardized net survival using a flexible cumulative excess hazard model. Recurrence rates were calculated for patients with initially resected stage I, II, or III cancer in six countries, using the actuarial survival method. The proportion of nonmetastatic resected colorectal cancers varied from 58.6% to 78.5% according to countries. The overall 5-year net survival by country ranged between 60.8% and 74.5%. The absolute difference between the 5-year survival extremes was 12.8 points for stage II (Bulgaria vs Switzerland), 19.7 points for stage III (Bulgaria vs. Switzerland) and 14.8 points for Stage IV and unresected cases (Bulgaria vs. Switzerland or France). Five-year cumulative rate of recurrence among resected patients with stage I-III was 17.7%. As compared to the mean of the whole cohort, the risk of developing a recurrence did not differ between countries except a lower risk in Italy for both stage I/II and stage III cancers and a higher risk in Spain for stage III. Survival after colorectal cancer differed across the concerned European countries while there were slight differences in recurrence rates. Population-based collection of cancer recurrence information is crucial to enhance efforts for evidence-based management of colorectal cancer follow up.
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Neoplasias Colorrectales , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Sistema de Registros , Humanos , Neoplasias Colorrectales/mortalidad , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/epidemiología , Sistema de Registros/estadística & datos numéricos , Masculino , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/mortalidad , Femenino , Europa (Continente)/epidemiología , Anciano , Persona de Mediana Edad , Anciano de 80 o más Años , AdultoRESUMEN
OBJECTIVES: To assess the impact of tocilizumab (TCZ) monotherapy after ultra-short-pulse glucocorticoids (GCs) on clinical manifestations, and vessel inflammation and damage in large vessel-GCA (LV-GCA). METHODS: In this prospective observational study, we enrolled patients with active LV-GCA. All patients received 500 mg per day i.v. methylprednisolone for three consecutive days and weekly s.c. TCZ injections from day 4 until week 52. PET/CT was performed on all patients at baseline and at weeks 24 and 52. The primary end points were the reduction in the PET vascular activity score (PETVAS) at weeks 24 and 52 compared with baseline, and the proportion of patients with relapse-free remission at weeks 24 and 52. The secondary end point was the proportion of patients with new aortic dilation at weeks 24 and 52. RESULTS: A total of 18 patients were included (72% female, mean age 68.5 years). Compared with the baseline value, a significant reduction in the PETVAS was observed at weeks 24 and 52, mean (95% CI) reductions -8.6 (-11.5 to -5.7) and -10.4 (-13.6 to -7.2), P = 0.001 and 0.002, respectively. The proportion of patients with relapse-free remission at weeks 24 and 52 was 10/18 (56%, 95% CI 31-78) and 8/17 (47%, 95% CI 23-72), respectively. At weeks 24 and 52, no patient had shown new aortic dilation. However, 4 patients who had shown aortic dilation at baseline showed a significant increase in aortic diameter (≥5 mm) at week 52. CONCLUSION: TCZ monotherapy after ultra-short-pulse GCs controlled the clinical symptoms of GCA and reduced vascular inflammation. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT05394909.
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Arteritis de Células Gigantes , Glucocorticoides , Humanos , Femenino , Anciano , Masculino , Glucocorticoides/uso terapéutico , Arteritis de Células Gigantes/diagnóstico por imagen , Arteritis de Células Gigantes/tratamiento farmacológico , Tomografía Computarizada por Tomografía de Emisión de Positrones , Resultado del Tratamiento , InflamaciónRESUMEN
OBJECTIVES: To assess the maintenance of efficacy of one year of tocilizumab (TCZ) monotherapy after its discontinuation in large vessel-GCA (LV-GCA). METHODS: 17 patients with active LV-GCA were previously treated with 3 boluses of intravenous methylprednisone and weekly subcutaneous TCZ in monotherapy for 52 weeks. Patients in relapse-free clinical remission at week 52 discontinued TCZ and entered part two, which was a 26-week observational follow-up period. PET/CT was performed in all patients at the end of the 26-week observational period (week 78). End points were the variation in PET vascular activity score (PETVAS) at week 78 compared with baseline and with week 52, and the proportion of patients with relapse-free clinical remission at week 78 and at the end of the follow-up. RESULTS: Compared with baseline, a significant reduction in PETVAS was observed at week 78, mean (95% CI) change -6.6 (-9.5 to -3.7). However, compared with week 52, PETVAS significantly increase 6 months after TCZ discontinuation (week 78), mean (95% CI) change 4.6 (0.7-8.5). The proportion of patients with relapse-free clinical remission at weeks 78 and at the end of the follow-up (median time from TCZ discontinuation 148 weeks) was 11/17 (65%, 95% CI 38-86) and 8/17 (47%, 95% CI 23-72), respectively. Age and sex-adjusted HR (95% CI) for each unit increase of PETVAS indicating subsequent relapse was 1.36 (0.92-2.00). CONCLUSIONS: One year of TCZ monotherapy was effective in maintaining drug-free clinical remission in LV-GCA. Changes in PETVAS early after TCZ discontinuation may predict subsequent relapses. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05394909.
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OBJECTIVE AND DESIGN: We aimed to identify cytokines whose concentrations are related to lung damage, radiomic features, and clinical outcomes in COVID-19 patients. MATERIAL OR SUBJECTS: Two hundred twenty-six patients with SARS-CoV-2 infection and chest computed tomography (CT) images were enrolled. METHODS: CCL18, CHI3L1/YKL-40, GAL3, ANG2, IP-10, IL-10, TNFα, IL-6, soluble gp130, soluble IL-6R were quantified in plasma samples using Luminex assays. The Mann-Whitney U test, the Kruskal-Wallis test, correlation and regression analyses were performed. Mediation analyses were used to investigate the possible causal relationships between cytokines, lung damage, and outcomes. AVIEW lung cancer screening software, pyradiomics, and XGBoost classifier were used for radiomic feature analyses. RESULTS: CCL18, CHI3L1, and ANG2 systemic levels mainly reflected the extent of lung injury. Increased levels of every cytokine, but particularly of IL-6, were associated with the three outcomes: hospitalization, mechanical ventilation, and death. Soluble IL-6R showed a slight protective effect on death. The effect of age on COVID-19 outcomes was partially mediated by cytokine levels, while CT scores considerably mediated the effect of cytokine levels on outcomes. Radiomic-feature-based models confirmed the association between lung imaging characteristics and CCL18 and CHI3L1. CONCLUSION: Data suggest a causal link between cytokines (risk factor), lung damage (mediator), and COVID-19 outcomes.
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COVID-19 , Neoplasias Pulmonares , Humanos , Interleucina-6 , SARS-CoV-2 , Proteína 1 Similar a Quitinasa-3 , Detección Precoz del Cáncer , Radiómica , Pulmón/diagnóstico por imagen , Citocinas , Quimiocinas CCRESUMEN
BACKGROUND: Exposure to air pollution has been proposed as one of the potential risk factors for leukaemia. Work-related formaldehyde exposure is suspected to cause leukaemia. METHODS: We conducted a nested register-based case-control study on leukaemia incidence in the Viadana district, an industrial area for particleboard production in Northern Italy. We recruited 115 cases and 496 controls, frequency-matched by age, between 1999 and 2014. We assigned estimated exposures to particulate matter (PM10, PM2.5), nitrogen dioxide (NO2), and formaldehyde at residential addresses, averaged over the susceptibility window 3rd to 10th year prior to the index date. We considered potential confounding by sex, age, nationality, socio-economic status, occupational exposures to benzene and formaldehyde, and prior cancer diagnoses. RESULTS: There was no association of exposures to PM10, PM2.5, and NO2 with leukaemia incidence. However, an indication of increased risk emerged for formaldehyde, despite wide statistical uncertainty (OR 1.46, 95%CI 0.65-3.25 per IQR-difference of 1.2 µg/m3). Estimated associations for formaldehyde were higher for acute (OR 2.07, 95%CI 0.70-6.12) and myeloid subtypes (OR 1.79, 95%CI 0.64-5.01), and in the 4-km buffer around the industrial facilities (OR 2.78, 95%CI 0.48-16.13), although they remained uncertain. CONCLUSIONS: This was the first study investigating the link between ambient formaldehyde exposure and leukaemia incidence in the general population. The evidence presented suggests an association, although it remains inconclusive, and a potential significance of emissions related to industrial activities in the district. Further research is warranted in larger populations incorporating data on other potential risk factors.
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Contaminantes Atmosféricos , Contaminación del Aire , Exposición a Riesgos Ambientales , Formaldehído , Leucemia , Material Particulado , Italia/epidemiología , Humanos , Leucemia/epidemiología , Leucemia/inducido químicamente , Leucemia/etiología , Estudios de Casos y Controles , Masculino , Incidencia , Femenino , Persona de Mediana Edad , Contaminantes Atmosféricos/análisis , Exposición a Riesgos Ambientales/efectos adversos , Adulto , Formaldehído/análisis , Formaldehído/toxicidad , Anciano , Material Particulado/análisis , Contaminación del Aire/efectos adversos , Contaminación del Aire/análisis , Dióxido de Nitrógeno/análisis , Adulto JovenRESUMEN
PURPOSE: This study quantifies the impact on budget and cost per health benefit of implementing digital breast tomosynthesis (DBT) in place of digital mammography (DM) for breast cancer screening among asymptomatic women in Italy. METHODS: A budget impact analysis and a cost consequence analysis were conducted using parameters from the MAITA project and literature. The study considered four scenarios for DBT implementation, i.e., DBT for all women, DBT for women aged 45-49 years, DBT based on breast density (BI-RADS C + D or D only), and compared these to the current DM screening. Healthcare provider's perspective was adopted, including screening, diagnosis, and cancer treatment costs. RESULTS: Introducing DBT for all women would increase overall screening costs by 20%. Targeting DBT to women aged 45-49 years or with dense breasts would result in smaller cost increases (3.2% for age-based and 1.4-10.7% for density-based scenarios). The cost per avoided interval cancer was significantly higher when DBT was applied to all women compared to targeted approaches. The cost per gained early-detected cancer slightly increases in targeted approaches, while the assumptions on the clinical significance and overdiagnosis of cancers detected by DBT and not by DM have a strong impact. CONCLUSIONS: Implementing DBT as a primary breast cancer test in screening programs in Italy would lead to a substantial increase in costs. Tailoring DBT use to women aged 45-49 or with dense breasts could enhance the feasibility and sustainability of the intervention. Further research is needed to clarify the impact of DBT on overdiagnosis and the long-term outcomes.
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PURPOSE: We present a comprehensive investigation into the organizational, social, and ethical impact of implementing digital breast tomosynthesis (DBT) as a primary test for breast cancer screening in Italy. The analyses aimed to assess the feasibility of DBT specifically for all women aged 45-74, women aged 45-49 only, or those with dense breasts only. METHODS: Questions were framed according to the European Network of Health Technology Assessment (EuNetHTA) Screening Core Model to produce evidence for the resources, equity, acceptability, and feasibility domains of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) decision framework. The study integrated evidence from the literature, the MAITA DBT trials, and Italian pilot programs. Structured interviews, surveys, and systematic reviews were conducted to gather data on organizational impact, acceptability among women, reading and acquisition times, and the technical requirements of DBT in screening. RESULTS: Implementing DBT could significantly affect the screening program, primarily due to increased reading times and the need for additional human resources (radiologists and radiographers). Participation rates in DBT screening were similar, if not better, to those observed with standard digital mammography, indicating good acceptability among women. The study also highlighted the necessity for specific training for radiographers. The interviewed key persons unanimously considered feasible tailored screening strategies based on breast density or age, but they require effective communication with the target population. CONCLUSIONS: An increase in radiologists' and radiographers' workload limits the feasibility of DBT screening. Tailored screening strategies may maximize the benefits of DBT while mitigating potential challenges.
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Neoplasias de la Mama , Detección Precoz del Cáncer , Mamografía , Humanos , Femenino , Neoplasias de la Mama/diagnóstico por imagen , Italia , Mamografía/métodos , Persona de Mediana Edad , Anciano , Detección Precoz del Cáncer/métodos , Estudios de FactibilidadRESUMEN
BACKGROUND: Recent studies supported the association between occupational exposure to asbestos and risk of cholangiocarcinoma (CC). Aim of the present study is to investigate this association using an update of mortality data from the Italian pooled asbestos cohort study and to test record linkage to Cancer Registries to distinguish between hepatocellular carcinoma (HCC) and intrahepatic/extrahepatic forms of CC. METHODS: The update of a large cohort study pooling 52 Italian industrial cohorts of workers formerly exposed to asbestos was carried out. Causes of death were coded according to ICD. Linkage was carried out for those subjects who died for liver or bile duct cancer with data on histological subtype provided by Cancer Registries. RESULTS: 47 cohorts took part in the study (57,227 subjects). We identified 639 causes of death for liver and bile duct cancer in the 44 cohorts covered by Cancer Registry. Of these 639, 240 cases were linked to Cancer Registry, namely 14 CC, 83 HCC, 117 cases with unspecified histology, 25 other carcinomas, and one case of cirrhosis (likely precancerous condition). Of the 14 CC, 12 occurred in 2010-2019, two in 2000-2009, and none before 2000. CONCLUSION: Further studies are needed to explore the association between occupational exposure to asbestos and CC. Record linkage was hampered due to incomplete coverage of the study areas and periods by Cancer Registries. The identification of CC among unspecific histology cases is fundamental to establish more effective and targeted liver cancer screening strategies.
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Amianto , Neoplasias de los Conductos Biliares , Colangiocarcinoma , Enfermedades Profesionales , Exposición Profesional , Humanos , Colangiocarcinoma/epidemiología , Colangiocarcinoma/etiología , Exposición Profesional/efectos adversos , Italia/epidemiología , Neoplasias de los Conductos Biliares/epidemiología , Neoplasias de los Conductos Biliares/etiología , Masculino , Amianto/efectos adversos , Estudios de Cohortes , Femenino , Persona de Mediana Edad , Anciano , Enfermedades Profesionales/epidemiología , Enfermedades Profesionales/etiología , Neoplasias Hepáticas/epidemiología , Neoplasias Hepáticas/etiología , Carcinoma Hepatocelular/epidemiología , Carcinoma Hepatocelular/etiología , Sistema de RegistrosRESUMEN
OBJECTIVE: To test the efficacy of self- compared to radiographer-led compression to reduce the average glandular dose without affecting image quality and compliance to follow-up mammography. MATERIALS AND METHODS: Women presenting for mammography for breast cancer follow-up, symptoms, opportunistic screening, or familial risk were asked to participate and, if willing, were randomized to self-compression or radiographer-led compression. Image quality was assessed blindly by two independent radiologists and two radiographers. Pain and discomfort were measured immediately after mammography and their recall was asked when the women participated in the follow-up mammogram, 1 or 2 years later. RESULTS: In total, 495 women (mean age 57 years +/-14) were enrolled, 245 in the self-compression and 250 radiographer-compression arms. Image quality was similar in the two arms (radiologists' judgement p = 0.90; radiographers' judgement p = 0.32). A stronger compression force was reached in the self- than in the radiographer-arm (114.5 vs. 10.25 daN, p < .001), with a 1.7-mm reduction in thickness (p = .14), and almost no impact on dose per exam (1.90 vs. 1.93 mGy, p = .47). Moderate/severe discomfort was reported by 7.8% vs 9.6% (p = .77) and median pain score was 4.0 in both arms (p = .55). Median execution time was 1 min longer with self-compression (10.0 vs. 9.1 min, p < 0.001). No effect on subsequent mammography was detectable (p = 0.47). CONCLUSION: Self-compression achieved stronger compression of the breast, with comparable image quality, but did not substantially reduce glandular dose. The proportion of women who attended follow-up mammography was also similar in the two groups. TRIAL REGISTRATION: clinicaltrials.gov NCT04009278 KEY POINTS: ⢠In mammography, appropriate compression is essential to obtain high image quality and reduce dose. Compression causes pain and discomfort. ⢠Self-compression has been proposed to reach better compression and possibly increase participation in mammography. ⢠In a randomized trial, self-compression reached stronger compression of the breast, with comparable image quality but with no glandular dose reduction or impact on participation in follow-up mammography.
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Neoplasias de la Mama , Mamografía , Femenino , Humanos , Persona de Mediana Edad , Mamografía/métodos , Mama/diagnóstico por imagen , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/complicaciones , Presión , Dolor/etiologíaRESUMEN
BACKGROUND: Despite being at higher risk of severe disease and pregnancy complications, evidence on susceptibility to SARS-CoV-2 infection in pregnancy is still limited. The aim of the study is to compare the likelihood of undergoing a SARS-CoV-2 test and testing positive for COVID-19 in pregnancy and puerperium with that of the general female population of reproductive age. METHODS: This is a retrospective population-based cohort study including 117,606 women of reproductive age (March 2020-September 2021) with 6608 (5.6%) women having ≥ 1 pregnancy. Women were linked to the pregnancy registry to be classified as "non-pregnant", "pregnant", and "puerperium"; then, according to the national case-based integrated COVID-19 surveillance system, all women undergoing a SARS-CoV-2 test during the study period were identified. The Incidence Rate Ratio was calculated to compare the likelihood of being tested for SARS-CoV-2 in pregnant, puerperium and non-pregnant women among all women included. The likelihood of having a COVID-19 diagnosis was calculated using two comparators (not-pregnant women and the person-time before/after pregnancy) by means of Cox proportional hazards models, adjusting for age and with the cluster option to control standard error calculation in repeated pregnancies. Only first infection and swabs before the first one positive were included. RESULTS: The probability of being tested for SARS-CoV-2 was 4.9 (95% CI: 4.8-5.1) and 3.6 times higher (95%CI: 3.4-3.9) in pregnancy (including spontaneous miscarriages) and in the puerperium, respectively. The Hazard Ratio (HR) of covid-19 diagnosis during pregnancy vs. non-pregnancy was 1.17 (95% CI 1.03-1.33) with similar results when comparing the risk during pregnancy with that of the same women outside pregnancy (puerperium excluded), with an HR of 1.13 (95% CI 0.96-1.33); the excess decreased when excluding the test performed at admission for delivery (HR 1.08 (95%CI 0.90-1.30). In the puerperium, the HR was 0.62 (95% CI 0.41-0.92) comparing women with ≥ 1childbirth with all other women and excluding the first two weeks of puerperium. CONCLUSIONS: Women during pregnancy showed a small increase in the risk of infection, compatible with a higher likelihood of being tested. A lower probability of infection during the puerperium was observed during the entire pandemic period, suggesting likely protective behaviors which were effective in reducing their probability of infection.
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COVID-19 , Complicaciones Infecciosas del Embarazo , Embarazo , Femenino , Humanos , Masculino , COVID-19/diagnóstico , COVID-19/epidemiología , SARS-CoV-2 , Incidencia , Prueba de COVID-19 , Estudios Retrospectivos , Estudios de Cohortes , Complicaciones Infecciosas del Embarazo/diagnóstico , Complicaciones Infecciosas del Embarazo/epidemiologíaRESUMEN
BackgroundUnderstanding the epidemiology of reinfections is crucial for SARS-CoV-2 control over a long period.AimTo evaluate the risk of SARS-CoV-2 reinfection by vaccination status, predominant variant and time after first infection.MethodsWe conducted a cohort study including all residents in the Reggio Emilia province on 31 December 2019, followed up until 28 February 2022 for SARS-CoV-2 first infection and reinfection after 90 days. Cox models were used to compare risk of first infection vs reinfection, adjusting for age, sex, vaccine doses and comorbidities.ResultsThe cohort included 538,516 residents, 121,154 with first SARS-CoV-2 infections and 3,739 reinfections, most in the Omicron BA.1 period. In the pre-Omicron period, three doses of vaccine reduced risk of reinfection by 89% (95%â¯CI:â¯87-90), prior infection reduced risk by 90% (95%â¯CI:â¯88-91), while two doses and infection reduced risk by 98% (95%â¯CI:â¯96-99). In the Omicron BA.1 period, protection estimates were 53% (95%â¯CI:â¯52-55), 9% (95%â¯CI:â¯4-14) and 76% (95%â¯CI:â¯74-77). Before Omicron, protection from reinfection remained above 80% for up to 15 months; with Omicron BA.1, protection decreased from 71% (95%â¯CI:â¯65-76) at 5 months to 21% (95%â¯CI:â¯10-30) at 22 months from the first infection. Omicron BA.1 reinfections showed 48% (95%â¯CI:â¯10-57) lower risk of severe disease than first infections.ConclusionsNatural immunity acquired with previous variants showed low protection against Omicron BA.1. Combined vaccination and natural immunity seems to be more protective against reinfection than either alone. Vaccination of people with prior infection reduced the risk of severe disease.
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COVID-19 , SARS-CoV-2 , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Estudios de Cohortes , Reinfección/epidemiología , Reinfección/prevención & control , Italia/epidemiología , VacunaciónRESUMEN
BACKGROUND: Parent self-efficacy (PSE), parents' confidence in their ability to successfully raise their children, has proved to be a powerful direct predictor of specific positive parenting practices. The aim of this study was to validate the Italian version of the Tool to Measure Parenting Self-Efficacy (TOPSE) using data from the questionnaires previously completed in a controlled before-after study conducted in 2015 to evaluate a newsletter programme to help improve parenting. Mothers and fathers of newborns were asked to complete the TOPSE at the child's birth (t0), at 6 months (t1) and at 12 months (t2): 265 TOPSE questionnaires were collected at t0 (43%), 158 at t1 (26%) and 188 at t2 (31%). METHODS: We measured internal reliability using Cronbach's alpha for each of the eight domains of the TOPSE. The intracluster correlation coefficient (ICC) was used to evaluate the external reliability only for parents with more than one child. Responsiveness was measured by testing the ability of the questionnaire to detect differences between groups and times that we expected to be measurable, based on consolidated findings in the literature. Mean scores of PSE improved from t0 to t2 (Hypothesis 1), PSE was lower at baseline for first-time parents than for those with multiple children (Hypothesis 2) and the improvement from t0 to t2 was stronger for first-time parents than for parents with multiple children (Hypothesis 3). RESULTS AND CONCLUSION: Based on our sample of questionnaires, the Italian version of the TOPSE was reliable for almost all of the domains except for Emotion, Self-acceptance and Learning, which could be refined by re-framing or dropping one item. External reliability was moderate, bearing in mind that the questionnaire was repeated at different times over 12 months, during which parents normally change. Responsiveness was good, especially for the Emotion and Empathy domains.
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Responsabilidad Parental , Autoeficacia , Niño , Femenino , Humanos , Recién Nacido , Responsabilidad Parental/psicología , Padres/psicología , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
The new recommendations of the European Council (December 2022) indicate to the Member States to implement mammography screening programs for women aged 45 to 74 and make explicit reference to the European guidelines produced by the ECIBC (European Commission Initiative on Breast Cancer) for operational indications. For women aged 70-74, the ECIBC suggests a three-year interval, rather than two years, and the process of adaptation and adoption of the guidelines in Italy has taken this recommendation as it is. Previous indications for Italian screening programs proposed a two-year interval for all women over 50 years of age. The intervention analyzes the rationale and interpretation of the evidence that led to the formulation of the different recommendations. It discusses whether the new recommendations fit into the perspective of risk-stratified screening that is under evaluation by several studies. it analyzes some of the critical issues of the methodology for developing recommendations in defining the characteristics of complex interventions, in particular the difficulties that the formulation of dichotomous questions finds in answering questions such as what is the best age to stop screening and what is the best interval at any age, which require an analysis of a continuous variable as age or interval duration. Finally, the opportunities and limitations in producing evidence regarding the best interval to adopt in mammography screening are discussed.
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Neoplasias de la Mama , Mamografía , Femenino , Humanos , Persona de Mediana Edad , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/epidemiología , Detección Precoz del Cáncer , Italia/epidemiología , Mamografía/tendencias , Tamizaje Masivo/métodosRESUMEN
How to manage human papillomavirus (HPV)-positive women in cervical cancer screening remains debated. Our study compared different strategies to triage HPV positivity in a large cohort of women participating in a population HPV-based screening program. Women were tested for HPV (Cobas 4800; Roche), and those positive were triaged with cytology; cytology-positives were referred to colposcopy, while negatives were referred to 1-year HPV retesting. All HPV-positive women were also evaluated with p16/ki67 dual staining (Roche). All lesions found within 24 months of follow-up were included in the analyses. Of the 70 146 women tested, 4757 (6.8%) were HPV-positive. Of these, 1090 were cytology-positive and were referred to colposcopy. Of the 2958 HPV-positive/cytology-negative women who presented at 1-year retesting, 1752 (59.9%) still tested positive. Cumulatively, 532 CIN2+ (including 294 CIN3+) were found. The sensitivity of cytology, HPV16/18 and p16/ki67 as triage test for CIN3+ was 67.9%, 56.0% and 85.0%, respectively. The positive predictive value (PPV) for immediate colposcopy referral was 21.0%, 15.8% and 22.9%, respectively. Combining cytology with typing increased sensitivity to 83.9% and lowered PPV to 14.8%, while combining p16/ki67 and typing increased sensitivity to 91.1%, lowering the PPV to 15.9%. Women negative to p16/ki67 triage presented a cumulative 1-year CIN3+ risk of about 1%. In conclusion, when triaging HPV positivity, p16/ki67 performed better than cytology with or without HPV16/18 genotyping. The strategies that included dual staining achieved sensitivity and low 1-year risk for CIN3+ sufficiently high enough to permit considering extending the surveillance interval to 2 to 3 years for HPV-positive/triage-negative women.
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Papillomavirus Humano 16/aislamiento & purificación , Papillomavirus Humano 18/aislamiento & purificación , Triaje , Displasia del Cuello del Útero/virología , Neoplasias del Cuello Uterino/virología , Inhibidor p16 de la Quinasa Dependiente de Ciclina/análisis , Femenino , Genotipo , Pruebas de ADN del Papillomavirus Humano , Papillomavirus Humano 16/genética , Papillomavirus Humano 18/genética , Humanos , Antígeno Ki-67/análisisRESUMEN
As the primary screening test, E6/E7 mRNA has shown similar sensitivity for CIN3+ and lower positivity rate than the HPV DNA test. Nevertheless, the overall mRNA positivity is too high for immediate colposcopy, making a triage test necessary. The aim was to estimate the mRNA performance as a primary test with different triage strategies. All HPV DNA-positives were tested for mRNA, cytology and p16/ki67. A sample of HPV DNA-negatives was also tested for mRNA to estimate test specificity. We included all CIN3+ histologically diagnosed within 24 months since recruitment. Of the 41 127 participants, 7.7% were HPV DNA-positive, of which 66.4% were mRNA-positive. Among the HPV DNA-negatives, 10/1108 (0.9%) were mRNA-positive. Overall, 97 CIN3+ were found. If mRNA was used as the primary test, it would miss about 3% of all CIN3+ with a 22% reduction of positivity compared with HPV DNA. The weighted specificity estimate for Asunto(s)
Infecciones por Papillomavirus
, Neoplasias del Cuello Uterino
, Colposcopía
, Detección Precoz del Cáncer/métodos
, Femenino
, Humanos
, Antígeno Ki-67/genética
, Papillomaviridae/genética
, Embarazo
, ARN Mensajero/genética
, Sensibilidad y Especificidad
, Neoplasias del Cuello Uterino/diagnóstico
, Neoplasias del Cuello Uterino/genética
, Neoplasias del Cuello Uterino/patología
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BACKGROUND: Although mammography screening is recommended in most European countries, the balance between the benefits and harms of different screening intervals is still a matter of debate. This review informed the European Commission Initiative on Breast Cancer (BC) recommendations. METHODS: We searched PubMed, EMBASE, and the Cochrane Library to identify RCTs, observational or modelling studies, comparing desirable (BC deaths averted, QALYs, BC stage, interval cancer) and undesirable (overdiagnosis, false positive related, radiation related) effects from annual, biennial, or triennial mammography screening in women of average risk for BC. We assessed the certainty of the evidence using the GRADE approach. RESULTS: We included one RCT, 13 observational, and 11 modelling studies. In women 50-69, annual compared to biennial screening may have small additional benefits but an important increase in false positive results; triennial compared to biennial screening may have smaller benefits while avoiding some harms. In younger women (aged 45-49), annual compared to biennial screening had a smaller gain in benefits and larger harms, showing a less favourable balance in this age group than in women 50-69. In women 70-74, there were fewer additional harms and similar benefits with shorter screening intervals. The overall certainty of the evidence for each of these comparisons was very low. CONCLUSIONS: In women of average BC risk, screening intervals have different trade-offs for each age group. The balance probably favours biennial screening in women 50-69. In younger women, annual screening may have a less favourable balance, while in women aged 70-74 years longer screening intervals may be more favourable.
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Neoplasias de la Mama/diagnóstico por imagen , Mamografía/estadística & datos numéricos , Adulto , Factores de Edad , Anciano , Detección Precoz del Cáncer , Europa (Continente)/epidemiología , Reacciones Falso Positivas , Femenino , Humanos , Mamografía/efectos adversos , Persona de Mediana Edad , Estudios Observacionales como Asunto , Guías de Práctica Clínica como Asunto , Medición de RiesgoRESUMEN
BACKGROUND: This study aimed to evaluate the effectiveness of a biennial faecal immunochemical test (FIT) screening programme in reducing annual colorectal cancer (CRC) incidence in its dynamic target population. METHODS: The target population included over 1,000,000 persons aged 50-69 living in a region of northern Italy. The average annual response rate to invitation was 51.4%. Each observed annual age-standardised (Europe) rate per 100,000 persons between 2005, the year of introduction of the programme, and 2016 was compared with each expected annual rate as estimated with age-period-cohort (men) and age-period (women) models. RESULTS: For both sexes, the rates observed in 1997-2004 and those expected in 2005-2016 were stable. Observed rates increased in 2005, peaked in 2006 (the first full year of screening), dropped significantly below the expected level in 2009, and continued to decrease until 2013 (the eighth full year), after which no further significant changes occurred. In the pooled years 2013-2016, the observed incidence rate per 100,000 persons was 102.2 [95% CI: 97.4, 107.1] for men, 75.6 [95% CI: 71.6, 79.7] for women and 88.4 [95% CI: 85.3, 91.5] for both sexes combined, with an observed:expected incidence rate ratio of 0.68 [95% CI: 0.65, 0.71], 0.79 [95% CI: 0.76, 0.82] and 0.72 [95% CI: 0.66, 0.81], respectively. DISCUSSION: The study provided multiple consistent proofs of a causal relationship between the introduction of screening and a stable 28% decrease in annual CRC incidence after eight years.
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Neoplasias Colorrectales , Intención , Colonoscopía , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/epidemiología , Detección Precoz del Cáncer , Femenino , Humanos , Incidencia , Masculino , Tamizaje Masivo , Sangre OcultaRESUMEN
BACKGROUND & AIMS: This cohort study compared colorectal cancer (CRC) incidence and mortality between people who participated in an Italian regional biennial fecal immunochemical test (FIT) screening program and people who did not. METHODS: The program started in 2005. The target population included over 1,000,000 people aged 50 to 69 years. The FIT was a one-sample OC-Sensor (Eiken Chemical Co, Tokyo, Japan) (cutoff, ≥20 µg hemoglobin/g feces). The average annual response rate to invitation was 51.4%. The records of people invited up to June 2016 were extracted from the screening data warehouse. Attenders were subjects who responded to the first 2 invitations or to the single invitation sent them before they became ineligible. Non-attenders were subjects who did not respond to any of these invitations. The records were linked with the regional CRC registry. People registered up to December 2016 were identified. Self-selection-adjusted incidence rate ratios (IRRs) and incidence-based CRC mortality rate ratios (MRRs) for attenders to non-attenders, with 95% confidence intervals (CIs), were calculated. RESULTS: The cohort generated 2,622,131 man-years and 2,887,845 woman-years at risk with 4490 and 3309 CRC cases, respectively. The cohort of attenders was associated with an IRR of 0.65 (95% CI, 0.61-0.69) for men, 0.75 (95% CI, 0.70-0.80) for women and 0.69 (95% CI, 0.66-0.72) for both sexes combined. The self-selection-adjusted IRR was 0.67 (95% CI, 0.62-0.72) for men and 0.79 (95% CI, 0.72-0.88) for women. The IRR for stage I, II, III, and IV CRC was 1.35 (95% CI, 1.20-1.50), 0.61 (95% CI, 0.53-0.69), 0.60 (95% CI, 0.53-0.68) and 0.28 (95% CI, 0.24-0.32) for men and 1.64 (95% CI, 1.43-1.89), 0.60 (95% CI, 0.52-0.69), 0.73 (95% CI, 0.63-0.85) and 0.35 (95% CI, 0.30-0.42) for women. The overall incidence-based CRC MRR was 0.32 (95% CI, 0.28-0.37) for men, 0.40 (95% CI, 0.34-0.47) for women and 0.35 (95% CI, 0.31-0.39) for both sexes combined. The adjusted MRR was 0.35 (95% CI, 0.29-0.41) for men and 0.46 (95% CI, 0.37-0.58) for women. CONCLUSIONS: Attendance to a FIT screening program is associated with a CRC incidence reduction of 33% among men and 21% among women, and a CRC mortality reduction of 65% and 54%, respectively.
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Neoplasias Colorrectales , Detección Precoz del Cáncer , Estudios de Cohortes , Colonoscopía , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/epidemiología , Heces/química , Femenino , Hemoglobinas/análisis , Humanos , Masculino , Tamizaje Masivo , Sangre OcultaRESUMEN
Background Adding digital breast tomosynthesis (DBT) to digital mammography (DM) improves breast cancer screening sensitivity, but how this impacts mortality and other end points is unknown. Purpose To compare interval and overall breast cancer incidence after screening with DBT plus DM versus DM alone. Materials and Methods In this prospective trial (RETomo), women attending screening were randomized to one round of DBT plus DM (experimental arm) or to DM (control arm). All were then rescreened with DM after 12 months (women aged 45-49 years) or after 24 months (50-69 years). The primary outcome was interval cancer incidence. Cumulative incidence up to the subsequent screening round plus 9 months (21- and 33-month follow-up for women aged 45-49 and 50-69, respectively) was also reported. Ductal carcinomas in situ are included. Subgroup analyses by age and breast density were conducted; 95% CIs computed according to binomial distribution are reported. Results Baseline cancer detection was higher in the DBT plu DM arm than DM arm (101 of 13 356 women vs 61 of 13 521 women; relative detection, 1.7 [95% CI: 1.2, 2.3]). The mean age ± standard deviation for the women in both arms was 55 years ± 7. Interval cancer incidence was similar in the two arms (21 vs 22 cancers; relative incidence, 0.97 [95% CI: 0.53, 1.8]). Cumulative incidence remained higher in the DBT plus DM arm in women over 50 (153 vs 124 cancers; relative incidence, 1.2 [95% CI: 0.99, 1.6]), while it was similar in the two arms in women aged 45-49 (36 vs 41 cancers; relative incidence, 0.89 [95% CI: 0.57, 1.4]). Conclusion In women younger than 50 years, the benefit of early diagnosis seemed to be appreciable, while for women over age 50, the higher sensitivity of tomosynthesis plus mammography was not matched by a subsequent reduction in cancers at the next screening examination or in the intervening interval. Clinical trial registration no. NCT02698202 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Lee and Ray in this issue.
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Neoplasias de la Mama , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/patología , Femenino , Humanos , Incidencia , Masculino , Mamografía/métodos , Estudios Prospectivos , Sensibilidad y EspecificidadRESUMEN
OBJECTIVES: To evaluate the accuracy of PET/CT and of PET vascular activity score (PETVAS) in assessing disease activity and the ability of PETVAS in predicting relapses in a large single-centre cohort of patients with large vessel vasculitis (LVV). METHODS: We conducted a retrospective cohort study of prospectively collected data of consecutive patients diagnosed with LVV who underwent at least one PET/CT scan between 2007 and 2020. The nuclear medicine physician's interpretation of each PET/CT scan (active/inactive vasculitis) was compared with disease activity clinical judgement (active disease/remission). For each PET/CT scan, the PETVAS score was calculated and its accuracy in assessing disease activity was evaluated. The ability of PETVAS in predicting subsequent relapses was evaluated. RESULTS: A total of 100 consecutive LVV patients (51 large vessel GCA, 49 Takayasu arteritis) underwent a total of 476 PET/CT scans over a mean follow-up period of 97.5 months. Physician-determined PET/CT grading was able to distinguish between clinically active and inactive LVV with a sensitivity of 60% (95% CI 50.9, 68.7) and specificity of 80.1% (95% CI 75.5, 84.1); the area under the curve (AUC )was 0.70 (95% CI 0.65, 0.75). PETVAS was associated with disease activity, with an age and sex-adjusted odds ratio for active disease of 1.15 (95% CI 1.11, 1.19). A PETVAS ≥10 provided 60.8% sensitivity and 80.6% specificity in differentiating between clinically active and inactive LVV; the AUC was 0.73 (95% CI 0.68, 0.79). PETVAS was not associated with subsequent relapses, with an age and sex-adjusted hazard ratio of 1.04 (95% CI 0.97, 1.11). CONCLUSIONS: The visual PET/CT grading scale and PETVAS had moderate accuracy to distinguish active LVV from remission. PETVAS did not predict disease relapses.