Eugenio Paci

Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between patients, relatives and professional caregivers about patients’ values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control, and improve their quality of life. We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised. In the intervention sites, patients will be offered interviews with a trained facilitator. In the control sites, patients will receive care as usual. In total, 1360 patients will be included. All participating patients will be asked to complete questionnaires at inclusion, and again after 2.5 and 4.5 months. If a patient dies within a year after inclusion, a relative will be asked to complete a questionnaire on end-of-life care. Use of medical care will be assessed by checking medical files. The primary endpoint is patients’ quality of life at 2.5 months post-inclusion. Secondary endpoints are the extent to which care as received is aligned with patients’ preferences, patients’ evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making. International Standard Randomised Controlled Trial Number: ISRCTN63110516 . Date of registration: 10/3/2014.

A recent comprehensive review has been carried out to quantify the benefits and harms of the European population-based mammographic screening programs. Five literature reviews were conducted on the basis of the observational published studies evaluating breast cancer mortality reduction, breast cancer overdiagnosis, and false-positive results. On the basis of the studies reviewed, the authors present a first estimate of the benefit and harm balance sheet. For every 1,000 women screened biennially from ages 50 to 51 years until ages 68 to 69 years and followed up until age 79 years, an estimated seven to nine breast cancer deaths are avoided, four cases are overdiagnosed, 170 women have at least one recall followed by noninvasive assessment with a negative result, and 30 women have at least one recall followed by invasive procedures yielding a negative result. The chance of a breast cancer death being avoided by population-based mammography screening of appropriate quality is more than that of overdiagnosis by screening. These outcomes should be communicated to women offered service screening in Europe. Cancer Epidemiol Biomarkers Prev; 23(7); 1159–63. ©2014 AACR.

Mammography screening in premenopausal women is still the object of controversy and the cost and harms-benefit balance is lower than the one observed for women aged 50 years or more. The reasons are the lower screening sensitivity and the lower risk of occurrence of breast cancer at younger ages. For these reasons, an annual interval is suggested for this age group, and a lower positive predictive value of the recall rate is observed in screening practice. Harms of screening are false positive rates and overdiagnosis (that is an exceeding number of cases over the women's lifetime ascribable to early diagnosis). A tailored approach to screening could both contribute to a reduction of possible harms and reduce the costs of the service screening programmes, which started to offer screening mammography to 45- 49-year-old women also in Italy, according with the suggestions of the Italian Group for Mammography Screening. Higher breast density is considered a marker of risk and, at the same time, it brings about a masking effect that decreases the screening mammography sensitivity at younger ages. the Tailored Breast Screening Trial (TBST) is a population-based, non-inferiority randomised trial aimed at evaluating the impact of a change in the screening protocol in a service screening practice. "Tailored" means that the use of a breast density classification allocates women to a longer interval, decreasing the number of screening rounds in the 45- 50-year age range. Density of the breast at the baseline is considered as an indicator of risk and also as a masking factor. The aim of this study is to assess the impact of a longer interval and the reduction of side effects for women allocated to the intervention group. In this study, any further intervention is offered to high-density women who are followed-up according to the usual care interval, since the study aimed at decreasing the screening burden. 45-year-old women resident in the screening centre catchment area will be invited to attend for mammography screening and will be asked for informed consent in order to be included in the study. After the enrolment, they will receive a high quality digital mammography; two views and breast density will be classified according with the BI-RADS classification. Women are randomly allocated either to an usual care group or to the intervention group. In the intervention group, women with a dense breast (3-4 categories in BI-RADS)will be invited again after 1 year, while the lower-density group in the intervention arm will be invited after 2 years. After the age of 50, all women will continue to be screened in the usual service screening programme. Density of the breast will be read by 2 readers, and controversies will be solved by a consensus. Allocation of women is blinded to the mammography readers. the outcomes are: A. cumulative incidence of interval-cancer cases by intention to treat (ITT) grouping and by density group, aimed at assessing the non inferiority of screening performance; B. cumulative incidence of T2+/node-positive status breast cancer cases between arms and by protocol. Screening performance parameters will be evaluated at each screening round. Interim and outcome analysis are expected at 3 and 6 years average follow- up, respectively, starting from the beginning of the screening. the non-inferiority limit is derived from the accepted level of interval cancers in women 50-69 years, which was considered acceptable by the European Community Guidelines. Assuming a 70%BI-RADS 1-2 at the baseline on the basis of the digital mammography experience, the estimated sample size with a power of 90% is 16,596 women per arm. the background of the study, that uses data from cancer registries and screening centres, describes the most relevant characteristics of breast cancer occurring in the Italian regions where the study will be conducted. The description of stage distribution in the 40-54-year-old group and the coverage by spontaneous screening, as available by outpatient current data, showed the modification of stage at presentation, according with the implementation of service screening in women 50-54 years. In Emilia-Romagna and Piedmont Regions, service screening is already active for women aged 45 years and more, even though different invitation protocols were used. In Tuscany Region the extension of screening has already been planned for the next few years. Performance data are reported: they show the recall and the detection rates at first and at repeated screening rounds in Emilia-Romagna Region. In order to assess the feasibility and the interobserver reproducibility of breast density visual classification by BI-RADS, two testing sets of 80 digital mammograms for screened women aged 50-52 years were made available by the ISPO (Institute for oncological study and prevention) service screening tests. The test was performed by 11 radiologists, which are members of the working group. Concordance was moderate with a BI-RADS classification in 4 categories (kappa=0.46;95%CI 0.41-0.53), and substantial using 1-2 vs.3-4 (kappa=0.68;95%CI 0.59-0.79). The retest performed using the second mammography test did not change the results. the TBST was authorised by the Ethical Committee in Florence (Tuscany Region, Central Italy) and the recruitment is still in progress through the invitation of the target population in the participating screening centres. In Florence and Veneto Region, the first round is almost completed and it confirmed the feasibility of the study and of the randomisation process.

The Tuscan cancer registry has been operating since 1985, providing cancer incidence and survival data in Tuscany; it covers about 33% of the regional population. The purpose of this paper is to provide incidence, prevalence and mortality estimates for the major cancers in the whole Tuscany region for the period 1970-2015. The estimated figures were obtained by applying the MIAMOD method. Starting from mortality and survival data, incidence and prevalence were derived using a statistical back-calculation approach. Survival was modeled on the basis of published data from the Italian cancer registries. According to the estimates, the most frequent cancer sites were colon-rectum in both genders, prostate in men and breast in women, with 4,188, 3,082 and 3,092 new diagnoses, respectively, in 2012. The incidence rates were steadily increasing for lung cancer in women and melanoma in both sexes, while they were decreasing for uterine cervix cancer in women, lung cancer in men and stomach cancer in both sexes. For colorectal cancer a small reduction in incidence was estimated for both sexes in recent years. The incidence rates for prostate cancer, after a steep increase and subsequent stabilization, were estimated to increase slightly in the last years. The breast cancer incidence was estimated to stabilize in the last 10 years. The mortality trends were decreasing for all considered cancers except female lung cancer. Prevalence increased for most of the studied cancers except stomach cancer in both sexes, lung cancer in men and cervix cancer in women. The highest prevalence was estimated for breast cancer, with over 42,000 cases in 2012. This paper provides an updated description of the cancer burden in Tuscany until 2015. These trends will have a significant impact on the regional health services and it is therefore important to enhance both primary prevention, for reducing the cancer incidence, and oncological surveillance, for evaluating the care and assistance of cancer patients.

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Background Due to changes in cancer-related risk factors, improvements in diagnostic procedures and treatments, and the aging of the population, in most developed countries cancer accounts for an increasing proportion of health care expenditures. The analysis of cancer-related costs is a topic of several economic and epidemiological studies and represents a research area of great interest to public health planners and policy makers. In Italy studies are limited either to some specific types of expenditures or to specific groups of cancer patients. Aim of the paper is to estimate the distribution of cancer survivors and associated health care expenditures according to a disease pathway which identifies three clinically relevant phases: initial (one year following diagnosis), continuing (between initial and final) and final (one year before death). Methods The methodology proposed is based on the reconstruction of patterns of care at individual level by combining different data sources, surveillance data and administrative data, in areas covered by cancer registration. Results A total colorectal cancer-related expenditure of 77.8 million Euros for 18012 patients (corresponding to about 4300 Euros per capita) is estimated in 2006 in two Italian areas located in Tuscany and Veneto regions, respectively. Cost of care varies according to the care pathway: 11% of patients were in the initial phase, and consumed 34% of total expenditure; patients in the final (6%) and in the continuing (83%) phase consumed 23% and 43% of the budget, respectively. There is an association between patterns of care/costs and patients characteristics such as stage and age at diagnosis. Conclusions This paper represents the first attempt to attribute health care expenditures in Italy to specific phases of disease, according to varying treatment approaches, surveillance strategies and management of relapses, palliative care. The association between stage at diagnosis, profile of therapies and costs supports the idea that primary prevention and early detection play an important role in a public health perspective. Results from this pilot study encourage the use of such analyses in a public health perspective, to increase understanding of patient outcomes and economic consequences of differences in policies related to cancer screening, treatment, and programs of care.

The national meeting of the National Centre for Screening Monitoring (ONS) was given the title "The screening during the crisis" as we realize that the severe economical crisis of our country influences all the health policies and, as a consequence, screening programs. Within this global scenario, the results of 2010 concerning screening programs can be considered as still positive even if the gap between the North and the Central Regions as compared to the South remains. In short, in 2010 almost 9.5 millions people were invited to undergo a screening examination (3,450,000; 2,496,000 and 3,464,000 for cervical, mammographic and colorectal cancer respectively). As compared to the previous year, a large increase was observed for colorectal screening.Whereas a slight decrease was observed both for cervical and for mammographic screening. The latter trend was partially due to the overload consequent to the extension of the programme to women younger than fifty in a couple of regions (Emilia-Romagna and Piemonte). More than 4.3 millions of subjects actually complied to the invitation (1,375,000; 1,382,000 and 1,582,000 for cervical, mammographic and colorectal cancer, respectively). As a consequence of these activities were identified 6,015 breast cancers (31% of annual occurring breast cancers in Italy in the age group 50-69 years according to the most update estimates of breast cancer occurrence), 4,597 CIN2 or more severe cervical lesions, 2,916 colorectal cancers (15% of annual occurring CRC cancer in Italy in the age group 50-69 years) and 15,049 advanced adenomas.

This report is an update of similar previous papers that have been published by the ONS (Osservatorio nazionale screening, National Centre for Screening Monitoring) since 2002. Data for the survey come from several different programmes that may have changed over time, and may have different settings of organisation and management. During 2010, the first slight decrease in theoretical extension was recorded. Currently, all Italian regions have implemented screening programmes. In 2010, almost 2,496,000 women aged 50-69 years were invited to have a screening mammogram, and more than 1,382,000 were screened. Theoretical extension was 91.7%, while actual extension was 69.1%. An imbalance in extension is still present when comparing northern and central Italy to southern Italy, which only has a 75% coverage by organised screening. The Italian mean value (69%) of two-year extension (period 2009-2010) suggests that, at full capacity, Italian programmes are able to invite only three quarters of the target population. The percentage of women screened during 2010 was 36.7% of the national target population. During the last few years, participation rates were substantially stable, around 55-57% for crude rate, and 59-61% for adjusted rate, respectively. A decreasing trend towards the South of Italy is evident for this parameter, too. Many programmes work with low volumes of activity (below 10,000 or even 5,000 examinations per year), and only one region surpassed the desirable level of at least 20,000 examinations for each programme. Referral rates of 8.8% at first screening and 4.6% at repeat screening were recorded. Direct standardised detection rate was 6.2x1,000 at first screening and 4.3x1,000 at repeat screening, while benign to malignant ratio for first and repeat screening was 0.26 and 0.12, respectively. Detection rate of invasive cancers ≤10 mm was 1.36x1,000 at first screening and 1.49x1,000 at repeat screening; the proportion of in situ carcinomas was 13.9% and 13.4% for first and repeat screening, respectively. Indicators by 5-year age group confirm greater diagnostic problems at younger ages (50-54 years), with higher referral rates, higher frequency of surgical procedures with benign outcome (B/M ratio), and a substantially lower detection rate as compared to older age groups.