Cabozantinib use in second or subsequent line of treatment in renal cell carcinoma: an analysis of Italian administrative databases.

Background: Cabozantinib use in everyday clinical practice for advanced or metastatic renal cell carcinoma (RCC) is relatively recent, and real-world data on treatment persistence, adherence and sequencing are still limited. Methods: We conducted an analysis based on an integrated administrative database, covering around 6.9 million health-assisted Italian individuals, to explore the use of cabozantinib for RCC. Patients with at least one prescription for cabozantinib during 2017-2020 were searched. These were characterized during all available period (i.e. from 2010 onwards) before the index date and were observed after inclusion. Results: A total of 113 patients treated with cabozantinib in second or subsequent line were included, and their demographic, clinical and treatment characteristics were described. About half of these RCC patients were aged >65 years (47.8%). Sixty patients (53.1%) were highly adherent to cabozantinib therapy, and the median cabozantinib treatment duration of use was 8.7 months (95% confidence interval: 5.8-11.1). During the first year of follow-up, the average total cost per patient was €32,508. Conclusions: We described second or subsequent line cabozantinib treatment for RCC in a real-world setting and the economic burden of disease in Italy, taking advantage of large, integrated administrative databases.

Who are the patients with Crohn's disease unsuitable to receive an anti-TNFα therapy? Results from a survey of Italian physicians and literature review.

OBJECTIVES: Anti-TNFα agents have been a staple of Crohn's disease treatment for 20 years, but they have weaknesses. New treatments have more recently become available. The aim of this paper is to examine the Crohn's disease patient population for whom anti-TNF treatments are not preferred and where new mechanisms of action should be considered. METHODS: A representative sample of 100 Italian physicians with documented expertise with biological treatment of moderate-to-severe Crohn's disease were interviewed. A literature review on Crohn's disease treatment was also conducted to identify patient populations for whom anti-TNFs are unsuitable. RESULTS: On the basis of the interviewed physicians, about 9% of moderate-to-severe Crohn's disease patients were noneligible to anti-TNFα due to contraindication or possible risk of intolerance, while 11% had discontinued anti-TNFα treatment due to complications or intolerance/hypersensitivity. Patients with severe heart disease and at high risk of infections were more frequently considered unsuitable. The proportion of patients considered unsuitable among elderly patients and in those with recurrent infections, cancer, and other comorbidities ranged between 40 and 60%. CONCLUSIONS: We provided additional quantitative and qualitative information to help identify patients who are less suitable to anti-TNF agents, who could benefit from newer biologic agents with different mechanisms of action.

Prevalence of Prostate Cancer at Different Clinical Stages in Italy: Estimated Burden of Disease Based on a Modelling Study.

Understanding the distribution of prostate cancer (PC) at various clinical stages of disease is of utmost importance to quantify the cancer care needs of patients and to adequately plan health services. The aim of this analysis is thus to provide a model-based estimation of the number of prevalent PC patients at different clinical stages in the Italian setting. A simulation model of patient transitions was constructed on a yearly basis using data obtained through a literature review on the incidence, prevalence, progression and mortality of PC, with specific focus on disease stage. A total of 462,570 prevalent PC patients were estimated at 1 January 2019. According to the model, 94.8% of them had non-metastatic PC and 5.2% had metastatic disease. Among the non-metastatic patients, most had T1/T2 PC (85.6%), followed by T3/T4 (10.9%) and T0/Tx PC (3.6%). About 20% of the T3/T4 patients had biochemically recurrent PC. Among the metastatic PC patients, 66.1% had castration-resistant PC and 33.9% had hormone-sensitive PC. This study provided original information on the distribution of PC according to different clinical stages that may be useful to define strategies, understand the PC disease pathway, estimate treatment-related needs and, possibly, plan targeted interventions for public health management of prostate cancer in Italy.

Epidemiology and unmet needs of bladder cancer in Italy: a critical review.

Bladder cancer is one of the most frequent cancers in high-income countries. Information on bladder cancer in Italy is scattered across scientific literature and institutional and educational resources and no attempt has been made yet to organize and summarize this information across various sources of available data. We, therefore, present herein a critical literature review of recent epidemiological and healthcare data, including patients' unmet needs. We undertook a critical review of the scientific and grey literature by exploring several different databases and search browsers. Available official statistics indicate a high burden of bladder cancer in Italy, where this neoplasm has one of the highest incidences worldwide and, in consideration of its relatively high survival, it ranks 4th in cancer prevalence. The limited therapeutic options for muscle-invasive and advanced/metastatic urothelial cancer are one of the major unmet needs for patients with this neoplasm, in Italy and worldwide. Advances in cancer immunotherapy and in understanding molecular biology of bladder cancer are, however, rapidly altering the therapeutic landscape for targeted subgroups of patients with advanced/metastatic disease. Other unmet needs include the low quality of life after radical cystectomy, the lack of widespread clinical pathway schemes to improve and standardize the quality of care and low Italian patients empowerment. Bladder cancer represents a health burden in Italy, with high incidence and prevalence rates, and important unmet needs for patients, including the limited therapeutic options for advanced/metastatic cancers, the low quality of life after radical cystectomy, the lack of widespread clinical pathway schemes, and the low patients empowerment.