An Analysis of the Social and Economic Costs of Breast Cancer in Italy.

BACKGROUND: Breast cancer is the most prevalent cancer affecting women and it represents an important economic burden. The aim of this study was to estimate the socio-economic burden of breast cancer (BC) in Italy both from the National Health Service (NHS) and the government perspectives (costs borne by the social security system). METHODS: The economic analysis was based on the costs incurred by the NHS from 2008 to 2016 (direct costs related to hospitalizations) and by the National Social Security Institute (INPS) from 2009 to 2015 (costs of social security benefits) for patients with breast cancer. The analysis was based on the Hospital Information System (HIS) and Disability Insurance Awards databases. For both databases, patients affected by a malignant neoplasm of the female breast, carcinoma in situ, or secondary malignant neoplasm of the breast were considered. RESULTS: Results show that more than 75,000 women were hospitalized for breast cancer every year, with an overall cost for hospitalization of about €300 million per year. From the Social Security analysis, a number of 29,000 beneficiaries each year was estimated. Considering per patient social costs, breast cancer at the primary stage cost €8828 per year, while secondary neoplasms cost €9780, with an average total economic burden of €257 million per year. CONCLUSIONS: This analysis focused on the economic impact of breast cancer in Italy, showing that an advanced stage of the disease was associated with a higher cost.

Multidisciplinary teams for the proper management of patients with genitourinary tumors: When topics set scientific societies' agenda.

INTRODUCTION: The multidisciplinary management of oncologic patients is identified as the bottom line element of quality in tumor care. METHODS: In 2015, 7 Italian scientific societies representing the specialists involved in the diagnosis and treatment of genitourinary tumors joined efforts in the Italian uro-oncologic multidisciplinary teams (MDTs) project. The aims were to promote the reorganization of genitourinary cancer care, switching to a multidisciplinary approach, reach a consensus on the core elements for the setup of MDTs in genitourinary oncology, and support health policy makers and managers in remodeling of the assistance and care of uro-oncologic patients on a national level. RESULTS: The first activity was the setup of 5 working groups, given the task of exploring selected topics: general principles, organization of MDTs, minimal requirements, economic evaluation, and relations with authorities. The groups participated in the writing of a document that was approved by the scientific societies and published on their web sites. Moreover, a few items summarizing the extensive document were approved in the first MDT Consensus Conference held in Milan in December 2015. CONCLUSIONS: The experience of this initial phase led to the opening of the team to other professionals and societies, in line with a correct management of patients with genitourinary tumors, which need a multidisciplinary as well as a multiprofessional approach with emerging techniques and procedures, and with a new project work package on genitourinary paths of care and indicators.

Position paper on management of iron deficiency in adult cancer patients.

INTRODUCTION: Disorders of iron metabolism are commonly seen in onco-hematological clinical practice. Iron-deficiency anemia and cancer-associated anemia are usually treated with supportive therapies. Optimal management of these conditions are discussed in this perspective paper. Areas covered: A position paper discussing a number of hot topics on anemia in cancer patients is presented. The main areas covered by experts in the field are: definitions, prevalence and consequences of anemia and iron deficiency, incidence of anemia resulting from targeted therapies, importance of anemia diagnosis and monitoring, evaluation of iron status before and during treatment, role of transfusions and erythropoiesis-stimulating agents, management of iron deficiency with or without anemia, parenteral iron supplementation, role of new oral iron formulations, safety and cost issues regarding different iron compounds and administration routes. Expert commentary: Despite the availability of newer therapeutic options for its management, anemia still represents a major complication of treatment in cancer patients (surgery, chemotherapy, radiotherapy, targeted therapies), aggravating physical impairment, and negatively affecting general outcome. The view expressed by the panelists, attendees of the 4th Mediterranean Course on Iron Anemia, summarizes what they consider optimal clinical practice for screening, diagnosis, treatment and monitoring of iron deficiency and anemia in cancer patients.

Burden of advanced breast cancer for patients and caregivers in Europe: comparison of two treatment forms of vinorelbine, oral and intravenous.

AIM: To assess the burden of disease associated with advanced breast cancer (ABC) treated with oral (VinO) or intravenous vinorelbine (VinIV) from the perspective of patients and caregivers in five European countries. METHODS: This was an observational, prospective, international, multicenter study. Patients were included in the study at the beginning of their second cycle of chemotherapy with vinorelbine and categorized into two groups depending on whether they received VinO or VinIV. At baseline (V0) and at the end of the second cycle of chemotherapy (V1), patients and caregivers were asked to complete self-administered questionnaires: SF-12 and burden of disease. RESULTS: At baseline, the two groups were well balanced in demographic and clinical characteristics. However, while HER2+ (human epidermal growth factor receptor 2) disease was significantly more frequent in patients receiving VinIV, patients receiving VinO were predominantly treated with single-agent therapy and were older than those treated with VinIV (67.1 years versus 57.7 years [p = 0.05]). As measured with SF-12, patients with VinO had, at end of cycle 1 and end of cycle 2, significantly more favorable outcomes in physical summary score, role physical, role emotional and mental health (all p < 0.05) than those treated with VinIV. Trends for a better caregiver mental score and social functioning were also observed with VinO (cycle 1 and 2; p < 0.10). From a patient perspective, no major difference was reported on the burden of disease between the two groups, however, a trend for a better" overall impact on daily life" was observed in VinO patients. Major significant differences, showing a lower burden of disease with VinO, were also reported from caregivers. In addition, in patients treated with VinO, mental score was almost similar to the one of the general population. CONCLUSION: VinO showed benefits over VinIV for both patients and caregivers, particularly in health related quality of life and burden of disease. Because of its observational design, results are only informative.

H2020 and Beyond: Skip Discrepancy between Theory and Practice of Personalized Medicine. A Position Paper by the Italian Society of Personalized Medicine.

Many unsolved practical issues, from technical and scientific to ethical, legal and economic topics, are slowing down the translation of Personalized Medicine principles into medical practice. The Italian Society of Personalized Medicine exposes here its point of view, based on the real-world practice of precision medicine carried-out in Italian healthcare structures.

Hypercoagulation screening as an innovative tool for risk assessment, early diagnosis and prognosis in cancer: the HYPERCAN study.

The HYPERCAN is a prospective observational Italian multicentre study started in 2012, structured in two main projects (i.e. Projects A and B) that involve both healthy subjects and cancer patients. The HYPERCAN study aims to assess whether the occurrence of a hypercoagulable state may be predictive of cancer diagnosis in healthy individuals, or may be predictive of disease recurrence, clinical progression and thrombosis in cancer patients. Project A involves two different large cohorts of subjects: The first cohort (Project A-1) consists of 10,000 healthy volunteer blood donors to be enrolled and prospectively follow-up for cancer occurrence, while the second cohort (Project A-2) consists of 25,000 people already enrolled in the framework of the general population-based Moli-Sani study. Project B involves 4,000 adult patients with a confirmed diagnosis of four different cancer types (both limited/resected or metastatic diseases), i.e. non-small cell-lung, gastric, colorectal, and breast cancer, to be enrolled and followed up for 5years or death. Blood samples from all enrolled subjects are collected at baseline and then at different time intervals according to specific time schedules set up for either normal subjects, or patients with limited cancers, or patients with metastatic cancers. Samples will be analysed for a panel of hemostatic proteins, clotting activation biomarkers, thrombin generation, procoagulant microparticles, and thrombophilic polymorphisms. As of November 2015, 6,189 healthy blood donors have been enrolled in project A-1 and 2,532 cancer patients in project B. Clinical follow-up and biological assays are ongoing. The HYPERCAN study wants to explore in different subset of individuals, affected and non-affected by malignant disease, the relationship between coagulation and cancer. The prospective design and the involvement of a large number of individuals will definitively clarify whether alterations in circulating thrombotic markers may be predictive of cancer diagnosis in an otherwise healthy subject and/or may be prognostic of cancer outcome, or of disease progression/relapse in cancer-affected individuals. Finally, the proposed screening with relatively simple and non-high-cost laboratory tests and the use of easy-obtainable peripheral blood samples add a very relevant translational value to this study.

The impact of educational materials on compliance and persistence rates with adjuvant aromatase inhibitor treatment: first-year results from the compliance of aromatase inhibitors assessment in daily practice through educational approach (CARIATIDE) study.

The CARIATIDE study was designed to assess the impact of educational materials (EMs) on compliance and persistence rates with aromatase inhibitor (AI) treatment in postmenopausal women with hormone-receptor-positive early breast cancer. Patients were randomized to standard AI treatment (Group A; N = 1379) or standard AI treatment plus EMs containing information on a range of breast-cancer-related topics (Group B; N = 1379). Standardized questionnaires assessed investigator-perceived levels of care and evaluated patient compliance and behavior. At 1 year, there was no significant difference in compliance between Group A and Group B (81% vs. 82%, p = 0.4524). However, higher compliance in patients receiving EMs was observed in Sweden/Finland (p = 0.0246). Compliance with initial AI and persistence rate were not significantly altered by EM. Other factors associated with improved compliance, irrespective of EMs, e.g. administration of chemotherapy were identified.

[Cost-effectiveness of oral ibandronate, i.v. zoledronic acid and i.v. generic pamidronate in the management of metastatic bone disease in breast cancer patients: two parallel studies]. / Analisi costo-efficacia di ibandronato orale, acido zoledronico i.v. e pamidronato i.v. nel trattamento della malattia ossea metastatica in pazienti con carcinoma mammario: due studi paralleli.

Two parallel cost-effectiveness studies comparing oral ibandronate and i.v. zoledronic acid and generic pamidronate have been performed. Two global economic models were adapted to the Italian National Health Service within the management of metastatic osteolysis in breast cancer patients undergoing chemotherapy and hormonal therapy. Total cost was respectively Euro 100 and Euro 418 lower per patient for ibandronate, vs. zoledronic acid and pamidronate in chemotherapy-treated patients, and Euro 337 and Euro 419 lower in patients undergoing hormonal therapy; also, with a small increment in QALYs, ibandronate resulted as the dominant therapeutic option.

Quality of life in breast and colon cancer long-term survivors: an assessment with the EORTC QLQ-C30 and SF-36 questionnaires.

AIMS AND BACKGROUND: Although the long-term survival of cancer patients has risen during the last decades, little is known about their quality of life. Assessment of the long-term effect of disease and treatments on subjective qualitative aspects of life that are related to health may be important for identifying specific long-term sequelae of cancer and treatments. In order to better understand the outcomes on a long-term survivor population, a sample of breast and colon cancer patients was evaluated using state-of-the-art health-related quality of life (HRQoL) approaches and instruments PATIENTS AND METHODS: EORTC OLQ-C30 and SF-36 HS questionnaires were mailed to a sample of subjects with a diagnosis of breast or colon cancer recruited in two randomized clinical trials with a median follow-up of 65 and 100 months, respectively. Data obtained with the SF-36 HS questionnaire were compared with data from a representative sample of the Italian population, whereas the EORTC QLQ-C30 data were evaluated across relevant subgroups. RESULTS: Out of 2208 subjects, 1772 were randomized to receive the different types of questionnaires and 921 answered (52%). According to the findings, if no serious comorbidity or relapse appeared, long-term cancer survivors reported having a substantially satisfying HRQoL, not much different from (age and sex) comparable controls. The most intriguing findings were those obtained from breast cancer patients. They reported a somewhat higher level than comparable Italian women of limitations in activities, when describing their role, as due to physical problems. In addition, breast cancer patients also reported lower scores (worse health perception) in two EORTC scales describing activities of daily living than colon cancer patients. When data were plotted according to the type of medical therapy, hormone therapy versus chemotherapy, a higher HRQoL was reported by the former than the latter group. CONCLUSIONS: Our study supports the hypotheses that the impact of cancer on quality of life over a period of time is not necessarily devastating in survivors. As regards the impact of different medical strategies, although our data are consistent with other research supporting the hypotheses that hormone therapy does not cause a decrease in long-term quality of life, differences we observed between hormone and chemotherapy might be caused by the action of confounds we were not able to control for or by the distortion introduced by the design of the present study.