Rwd Study for Epidemiology and Characteristics of Patients with Multiple Myeloma in Italy

Executive Summary

Objective The aim of this study was to estimate the prevalence, incidence and characteristics (comorbidities, treatments) of patients with multiple myeloma (MM) in Italy based on literature review and on analysis from two Italian registries: a representative regional registry (Lombardy), and the National Cancer Institute in Milan (INT).

Methods

The analysis has been performed using prevalence and incidence information reported in the literature and real-world data from two sources: the Lombardy region registry and the MM database of the INT. Results from this analysis were then compared with national data.

The study has been conducted on the Lombardy population because of its relevance in terms of number of inhabitants, patients' characteristics and data availability. Data collected from these two databases were used to calculate the number of patients with MM and their characteristics at a national level.

The literature review focused on a retrospective study conducted in 2010 from the Lombardy registry (DENALI) that reported the incidence of MM in this region, and on the INT Milan database.

The Lombardy registry compared administrative and clinical data on 436 hospitalized patients diagnosed with MM who received chemotherapy treatment in 2010. The INT database reports clinical and demographic data from 166 patients diagnosed with MM and treated within the period 2010-2015.

Results

In Italy, the literature reports an age-adjusted incidence for MM of 3.7/100,000 for males and 2.7/100,000 for females; the reported prevalence is 0.040%.

The Lombardy registry shows a prevalence of 0.031% and an age-adjusted mortality rate of 1.6/100,000 for males and 1.1/100,000 for females. The percentage of patients with MM beyond first-line therapy is 31%; 28% are in second-line therapy, 2% in third line and 1% in fourth line or more. The type of first-line therapy and baseline comorbidities are summarized below (Table 1).

As reported by the Lombardy registry, 26% of patients with MM have cardiovascular or renal comorbidities, compared with 16% reported in the INT database. According to reports from the INT database, 17% of patients with MM do not receive treatment.

Applying data from the Lombardy registry, it is possible to estimate that in Italy, in 2016, there are 25,800 patients with MM, 8,000 patients beyond first-line therapy and 2,000 patients with cardiovascular or renal comorbidities. The prevalence used in this study is the one from the literature because it is considered more reliable than the data found in the regional registry.

Conclusions

This analysis shows that various sources need to be assessed to obtain valuable clinical information that is not always available in the literature, such as comorbidities and patients not treated, even if prevalence data are not precisely consistent with values for Italy in the literature.

Based on this analysis we were able to extrapolate the results to the entire Italian population.

Table 1

View largeDownload slide

Table 1

View largeDownload slide

Close modal