Regione Lombardia capo fila nel File F

Ragazzo, Carlos Emmanuel Joppert

doi:10.1007/bf03320727

Cited by 8 publications

(2 citation statements)

References 2 publications

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“…The second database was the File F registry (2004–2012), including all drug and selected novel high-cost drug prescriptions administered both in the outpatient setting and in day hospital, and reimbursed by the National Health Service (NHS) [14]. Each record includes information about the market authorization code of the drug package (Autorizzazione all’Immissione in Commercio, AIC), the date and dosage of drug administration, and information about the hospital and the physician administering the drug.…”

Section: Methodsmentioning

confidence: 99%

Management and Survival of Pleural Mesothelioma: A Record Linkage Study

et al. 2018

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Background: Pleural mesothelioma (PM) is a rare, highly lethal tumor. A definite consensus on its management has yet to be established. Objectives: To assess management, overall survival (OS), and their predictors in a cohort of patients from Lombardy, the largest Italian region (about 10 million inhabitants). Methods: Through a record linkage between Lombardy health care administrative databases, we identified patients diagnosed with PM in 2006–2011 without history of cancer, evaluating their management. OS from PM diagnosis was estimated using the Kaplan-Meier method. Predictors of OS and of treatment were assessed using Cox regression models with time-dependent covariates when appropriate. Results: Out of 1,326 patients, 754 (56.9%) received treatment for PM: 205 (15.5%) underwent surgery, and 696 (52.5%) used chemotherapy. Surgery was spread across several hospitals, and most patients diagnosed in nonspecialized centers (70%) underwent surgery in the same centers. Age at diagnosis was a strong inverse determinant of surgery. Determinants of receiving chemotherapy were younger age, a more recent first diagnosis, and first diagnosis in a specialized center. OS was 45.4% at 1 year, 24.8% at 2 years, and 9.6% at 5 years (median 11 months). OS decreased with age, and was higher for those who underwent surgery, but not for those treated with chemotherapy. Conclusions: Management of PM varied widely in clinical practice, and significant predictors of treatment were younger age and recent diagnosis, though a high proportion of patients were not treated. Patients were treated in various hospitals, indicating the importance of concentrating serious rare neoplasms in Comprehensive Cancer Centers (as recognized by the Italian Health Ministry).

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Section: Methodsmentioning

confidence: 99%

Management and Survival of Pleural Mesothelioma: A Record Linkage Study

et al. 2018

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“…The File F was primarily instituted for reimbursements among different Italian regions and different local health authorities within the same region. It includes all prescriptions of drugs administered directly in the outpatient setting and of selected novel high-cost drugs administered both in the outpatient setting and in the day hospital (DH) in Lombardy and reimbursed by the National Health Service (NHS) [14]. It lists the AIFA input on the market authorization code (Autorizzazione all'Immissione in Commercio [AIC]) of the drug package, the unique identification code of the patient receiving the drug, the date and dosage, and also the hospital and physician administering the drug.…”

Section: Methodsmentioning

confidence: 99%

Trastuzumab-Related Cardiotoxicity in Early Breast Cancer: A Cohort Study

et al. 2013

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Background. Concerns have been raised about the cardiac safety profile of trastuzumab for the adjuvant treatment of early stage breast cancer in clinical practice. We assessed trastuzumab-related cardiotoxicity and its predictors in a large cohort of Italian women. Methods. Through a record linkage between four regional health care databases, we identified the rate of severe cardiac adverse events among women treated with trastuzumab for early breast cancer in Lombardy. The cumulative risk of cardiotoxicity was estimated using the Kaplan-Meier method, and independent predictors were assessed using the Cox model. Results. Of 2,046 trastuzumab users, 53 (2.6%) experienced at least one hospitalization for a cardiac event, and there were two cardiac deaths. The cumulative risk of cardiotoxicity increased up to 2 years after starting treatment, reaching a plateau at 2.8%. The risk was low (0.2%) among young women, whereas the incidence was approximately 10% in women aged Ն70 years, irrespective of cardiovascular risk factors. Age and history of cardiac disease were strong predictors of cardiotoxicity, with a hazard ratio of 11.3 (95% confidence interval [CI]: 3.5-36.6) for women aged Ն70 years as compared with those Ͻ50 years of age. Hazard ratio was 4.4 (95% CI: 2.1-9.5) for women with a history of cardiac disease compared with those without a history of cardiac disease. Conclusions. Cardiotoxicity of trastuzumab varies considerably across subgroups of patients. The long-term safety profile was less favorable than in the largest clinical trial. Strategies to reduce cardiotoxicity in high-risk women should be investigated. The Oncologist 2013;18:795-801 Implications for Practice: Concerns have been raised about the safety profile of trastuzumab for older, less healthy, unselected populationsoutsideofclinicaltrials.Cliniciansneedinformationontheincidenceofcardiotoxicityoftrastuzumab-basedadjuvantregimens in patients with HER-2 positive early invasive breast cancer in clinical practice, according to patient characteristics. This large cohort suggests that the incidence of short-term severe cardiotoxicity (not only congestive heart failure) in clinical practice is higher than that recorded in clinical trials that tested the same regimen. Age and history of cardiac disease are strong predictors of cardiotoxicity. The risk/ benefit profile of trastuzumab should be quantitatively assessed, and strategies to reduce cardiotoxicity-especially in older women (Ն70 years) and women Ͼ50 years of age with several cardiovascular risk factors-should be developed.

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