Epidemiology and treatment of patients with chronic lymphatic leukemia and mantle cell lymphoma

Abstract

Chronic lymphatic leukemia (CLL) is a malignant, lymphoproliferative disease of B lymphocytes and is therefore classified as a subgroup of B-cell non-Hodgkin's lymphomas (B-NHL). CLL is the most common type of leukemia in adults. However, with around 5,000 incident patients per year in Germany, it is one of the rarer malignant diseases. Originating from blood stem cells and bone marrow, it affects the blood and is characterized by excessive accumulation of abnormal B-lymphocytes. CLL progresses slowly, has a median diagnosis age of 70, and a 5-year survival rate of about 87%. Mantle cell lymphoma (MCL) is a rare subtype of B-cell non-Hodgkin lymphoma. MCL accounts for approximately 5-7% of malignant lymphomas and occurs at an average age of 65 years. Males are predominantly affected. MCL has a high probability for relapses. The aim of this study is to determine the epidemiology of CLL and MCL and to analyse CLL and MCL patients’ disease specific treatment patterns in Germany. The results of the analysis will be used within the benefit assessment according to §35a SGB V. In module 3 (section 3.2.3) information on the prevalence and incidence of the underlying diseases in Germany are requested. Further, information on the number of patients in the target population are required (section 3.2.4). The specific objectives of this study are: 1) to assess the incidence and estimate the prevalence of CLL and MCL for the most current data year, 2) to quantify the target populations by assessing the number of patients receiving a first-line treatment and the number of patients who are relapsed/refractory and, therefore, receive at least second-line treatment for the most current data year, 3) to describe the identified patients in terms of demographic characteristics (age and gender).

A retrospective analysis of ZfKD data will be conducted utilizing data from 2019 to 2023 (provided that data for 2023 are available at the time of data request). The results of the analysis will be used within the benefit assessment according to §35a SGB V. In module 3 (section 3.2.3) information on the prevalence and incidence of the underlying diseases in Germany are requested. Further, information on the number of patients in the target population are required (section 3.2.4).

The study aims to assess the 1-year incidence of CLL and MCL for 2023 and calculate the 5-year point prevalence of CLL and MCL for 2019 to 2023. Further, the number of patients in three different target populations will be assessed for the most recent year with data available in the registry (presumably 2023) and a trend for respective patient counts will be estimated for the upcoming five years. As the target populations include various lines of disease-specific treatment, information on patients’ surgeries and systemic therapy will be analyzed to differentiate between treatment lines.