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ObjectivesTo assess the accuracy of International Classification of Diseases 9th Revision–Clinical Modification (ICD-9-CM) codes in identifying subjects with lung cancer.DesignA cross-sectional diagnostic accuracy study comparing ICD-9-CM 162.x code (index test) in primary position with medical chart (reference standard). Case ascertainment was based on the presence of a primary nodular lesion in the lung and cytological or histological documentation of cancer from a primary or metastatic site.SettingThree operative units: administrative databases from Umbria Region (890 000 residents), ASL Napoli 3 Sud (NA) (1 170 000 residents) and Friuli Venezia Giulia (FVG) Region (1 227 000 residents).ParticipantsIncident subjects with lung cancer (n=386) diagnosed in primary position between 2012 and 2014 and a population of non-cases (n=280).Outcome measuresSensitivity, specificity and positive predictive value (PPV) for 162.x code.Results130 cases and 94 non-cases were randomly selected from each database and the corresponding medical charts were reviewed. Most of the diagnoses for lung cancer were performed in medical departments.True positive rates were high for all the three units. Sensitivity was 99% (95% CI 95% to 100%) for Umbria, 97% (95% CI 91% to 100%) for NA, and 99% (95% CI 95% to 100%) for FVG. The false positive rates were 24%, 37% and 23% for Umbria, NA and FVG, respectively. PPVs were 79% (73% to 83%)%) for Umbria, 58% (53% to 63%)%) for NA and 79% (73% to 84%)%) for FVG.ConclusionsCase ascertainment for lung cancer based on imaging or endoscopy associated with histological examination yielded an excellent sensitivity in all the three administrative databases. PPV was moderate for Umbria and FVG but lower for NA.

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.

Italy, home to one of the world’s oldest populations, has traditionally shown geographic differences in cancer incidence, with rates decreasing from north to south. The cancer registries that have been accredited by the Italian Cancer Registry Network (AIRTUM), during the last 20 years altogether cover the 90 % of the Italian population, aiming to improve data quality, standardize procedures, and promote research. This study presents the methodological approaches used for data collection, quality control, and analysis to describe current patterns of cancer incidence, mortality, and survival across Italy's three macro-areas (North, Central, South). Estimates of incidence rates and case numbers for 2025 were also produced. Data from 34 accredited cancer registries were analyzed, comprising over 4.6 million cases from 1981 to 2020, with a detailed focus on the 2008–2017 period, which includes over 3 million cases. Cancer incidence and mortality data were collected according to ICD-O-3 and ICD-10 classifications and processed for statistical analysis using tools such as SEERPrep, SEERStat, and the Joinpoint Regression Program. Age-standardized rates were calculated, and incidence and mortality trends from 2013 to 2017 were modeled. Five-year cumulative net survival was estimated using the Pohar-Perme method to adjust for competing risks. Survival trends were analyzed by geographic areas and cancer sites, revealing regional disparities in cancer outcomes. •Cancer registries provide affordable population-based statistics on cancer epidemiology.•Incidence, mortality and survival are the main indicators used for cancer surveillance.•Appropriate methodologic approaches make comparisons intelligible.•In Italy there are historical differences in cancer figures by macro-areas.•There is a need to provide cancer statistics updated to the pre-Covid-19 era in Italy.

Cancer incidence and mortality trends represent epidemiological indicators of fundamental importance for public health systems. The study's aim is to present recent (2013–2017) short-term cancer incidence and mortality trends in Italy, including 80 % of the Italian population, for different cancer sites by sex, age group, and areas. Joinpoint Regression models were employed. A significantly decreasing trend in the incidence of all cancers was observed for men in Italy (-1.9 % per year), particularly for cancers of the lung (-2.5 %), liver (-3.9 %), stomach (-2.8 %), colorectal (-2.2 %), prostate (-3.4 %), and leukaemias (-3.2 %). The only significant increase was seen for skin melanoma (+5.2 % per year). Among women, overall cancer incidence remained stable, with a decrease in the North (-0.6 %) and an increase in the South and Islands (+0.9 %). Decreasing trends were observed for colorectal (-1.9 %), stomach (-3.5 %), liver (-4.0 %%), and leukaemias (-2.0 %) cancers, while incidence increased for skin melanoma (+6.0 % per year), and lung cancer (2.3 %). Cancer mortality declined consistently in both sexes (-1.8 % per year in men and −0.6 % in women), across different areas, and age groups. The observed trends in men and women partly reflect the impact of risk factors affecting both sexes at different times, mainly in the case of tobacco and lung cancer. Also, some trends may be linked to organized screening initiatives (e.g. colorectal) or the decrease in opportunistic screening (e.g. prostate). The snapshot of cancer trends in Italy may highlight new opportunities for strengthening prevention activities and advancing research on early detection and target treatments. [Display omitted] •We observed decreasing incidence and mortality trends in men and stable incidence and decreasing mortality trends in women.•Skin melanoma incidence increased in both sexes, while lung cancer increased in women and decreased in men.•Stomach, colorectal, liver and leukaemias incidence decreased in both sexes.•We highlighted the need to improve cancer prevention initiatives and research in diagnostic and treatments in Italy

Background/Objectives: The increasing incidence of cancer during pregnancy is a growing public health concern, driven by delayed parenthood and rising maternal age. Pregnancy-associated cancer (PAC) presents complex clinical challenges, necessitating a balance between maternal cancer treatment and fetal safety. Historically considered incompatible with favorable pregnancy outcomes, evidence now suggests that pregnancy can often proceed without affecting cancer prognosis. A 2022 study in Italy provided the first population-based PAC estimates by linking cancer registries (CRs) and hospital discharge records (HDRs). This study aimed to update PAC estimates to 2019, covering 30% of the Italian population and addressing prior data limitations. Methods: A retrospective longitudinal analysis was conducted on women aged 15–49 diagnosed with malignant cancers between 2003 and 2019. Data from 21 Italian CRs were linked with HDRs to identify PAC cases, defined as obstetric hospitalizations occurring for women diagnosed with cancer in our study cohort in the period spanning from one year before to two years after a cancer diagnosis. All malignant cancers, excluding non-melanoma skin cancers, were analyzed. PAC rates were calculated per 1000 pregnancies, and trends were assessed using log-linear and JoinPoint regression models. Results: Among 131,774 women diagnosed with cancer, 6329 PAC cases were identified, with a PAC rate of 1.43 per 1000 pregnancies, consistent with global estimates. Thyroid (24.4%) and breast cancer (23.2%) were the most common. Analyzing the PAC rate by pregnancy outcome, in the period 2015–2019, this increased for both childbirths and miscarriages but decreased for voluntary terminations. Most hospitalizations (54%) occurred pre-diagnosis, peaking at diagnosis, especially for breast cancer (69%). Conclusions: PAC incidence is rising, particularly for live births and miscarriages, underscoring the need for multidisciplinary care and robust epidemiological insights to guide clinical management.

The aim of this study is to describe the frequency and trend of pregnancy-associated cancer (PAC) in Italy, an increasingly relevant phenomenon due to postponing age at childbirth. To this purpose, a population-based retrospective longitudinal study design based on cohorts of women aged 15–49 diagnosed with cancer and concomitant pregnancy is proposed. The study uses 19 population-based Cancer Registries, covering about 22% of Italy, and linked at an individual level with Hospital Discharge Records. A total of 2,861,437 pregnancies and 3559 PAC are identified from 74,165 women of the cohort with a rate of 1.24 PAC per 1000 pregnancies. The most frequent cancer site is breast (24.3%), followed by thyroid (23.9%) and melanoma (14.3%). The most frequent outcome is delivery (53.1%), followed by voluntary termination of pregnancy and spontaneous abortion (both 12.0%). The trend of PAC increased from 2003 to 2015, especially when the outcome is delivery, thus confirming a new attitude of clinicians to manage cancer throughout pregnancy. This represents the first attempt in Italy to describe PAC from Cancer Registries data; the methodology is applicable to other areas with the same data availability. Evidence from this study is addressed to clinicians for improving clinical management of women with PAC.

Objectives To assess the accuracy of International 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.

ObjectivesTo assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying subjects with melanoma.DesignA 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.SettingAdministrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli Venezia Giulia (FVG) Region.Participants112, 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 measuresSensitivity and specificity for ICD-9-CM code 172.x located in primary position.ResultsThe 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.ConclusionsThe 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.

IntroductionAdministrative 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 analysisData 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.DisseminationStudy results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences.

ObjectiveCancer stem cells (CSCs) are responsible for tumour formation and spreading, and their targeting is required for tumour eradication. There are limited therapeutic options for advanced colorectal cancer (CRC), particularly for tumours carrying RAS-activating mutations. The aim of this study was to identify novel CSC-targeting strategies.DesignTo discover potential therapeutics to be clinically investigated as single agent, we performed a screening with a panel of FDA-approved or investigational drugs on primary CRC cells enriched for CSCs (CRC-SCs) isolated from 27 patients. Candidate predictive biomarkers of efficacy were identified by integrating genomic, reverse-phase protein microarray (RPPA) and cytogenetic analyses, and validated by immunostainings. DNA replication stress (RS) was increased by employing DNA replication-perturbing or polyploidising agents.ResultsThe drug-library screening led to the identification of LY2606368 as a potent anti-CSC agent acting in vitro and in vivo in tumour cells from a considerable number of patients (∼36%). By inhibiting checkpoint kinase (CHK)1, LY2606368 affected DNA replication in most CRC-SCs, including RAS-mutated ones, forcing them into premature, lethal mitoses. Parallel genomic, RPPA and cytogenetic analyses indicated that CRC-SCs sensitive to LY2606368 displayed signs of ongoing RS response, including the phosphorylation of RPA32 and ataxia telangiectasia mutated serine/threonine kinase (ATM). This was associated with mutation(s) in TP53 and hyperdiploidy, and made these CRC-SCs exquisitely dependent on CHK1 function. Accordingly, experimental increase of RS sensitised resistant CRC-SCs to LY2606368.ConclusionsLY2606368 selectively eliminates replication-stressed, p53-deficient and hyperdiploid CRC-SCs independently of RAS mutational status. These results provide a strong rationale for biomarker-driven clinical trials with LY2606368 in patients with CRC.