Dondi Letizia, Ronconi Giulia, Dondi Leonardo, Calabria Silvia, Dell'Anno Irene, Piccinni Carlo, Addesi Alice, Esposito Immacolata, Martini Nello
Fondazione ReS (Ricerca e Salute), Roma.
Drugs & Health Srl, Roma.
Recenti Prog Med. 2024 Sep;115(9):404-414. doi: 10.1701/4334.43182.
The diffuse large B-cell lymphoma (Dlbcl) is the most common non-Hodgkin lymphoma and at highest incidence among the elderly. Despite the improved outcomes of patients treated with the first-line (1L) standard of care until the end of 2022, composed by rituximab and polychemotherapy (R-Chop), during the last 20 years, the rate of relapsed and refractory Dlbcl (rrDlbcl) remains elevated. This study has identified and analyzed patients newly diagnosed with Dlbcl and treated with 1L, from the perspective of the Italian National Health Service (Ssn).
From the administrative database of Fondazione Ricerca e Salute (ReS) including ~5.5 million inhabitants/year in Italy, adults with a new in-hospital Dlbcl diagnosis (index date) and treated with 1L in 2018, 2019, 2020 and 2021 were identified and characterized in terms of demographics and comorbidities during a period (from 4 to 8 years) preceding index date. From 1 to 4 years following index date (follow-up), overall survival (Kaplan-Meier curves), percentage distribution of patients by line of therapy including dispensation/administration of chemo-immunotherapy, hemopoietic stem cell transplantation (Hsct), and direct healthcare costs charge to the Ssn, were evaluated.
Overall, from the ReS database, 206 patients newly diagnosed with Dlbcl and treated with 1L from 2018 to 2021 in Italy (incidence from 0.9 to 1.7 x100,000 adult inhabitants) were identified. They were mainly older (median age 68 [56; 75] years), males (56%) and affected by ≥2 comorbidities (52%), mostly cardiometabolic. During 4 years of follow-up, 56% of cases in 2018 survived. During the first follow-up year: 73%, 80%, 100% and 35% of cases in 2018, 2019, 2020 and 2021, respectively, received a 2L; 42% and 64% of cases in 2018 and 2020, respectively, received a 3L. At least one Hsct was found as a 2L among cases in 2018, 2020 and 2021. On average, each patient newly diagnosed with Dlbcl and treated with 1L from 2018 to 2021 caused a total expenditure directly charged to the Ssn ranging from € 20,000 to € 30,000 during the first follow-up year (chemo-immunotherapy accounted for 40-53%), which reduced with time in favor of other drugs and Hsct.
This analysis confirms the high rate of rrDlbcl and the high economic impact charged to the SSN to support first the chemo-immunotherapy, then the chronic care and the absence of standardized further lines of therapy for patients with rrDlbcl.
弥漫性大B细胞淋巴瘤（Dlbcl）是最常见的非霍奇金淋巴瘤，在老年人中发病率最高。尽管截至2022年底，接受一线（1L）标准治疗（由利妥昔单抗和多药化疗组成，即R-Chop方案）的患者预后有所改善，但在过去20年中，复发难治性Dlbcl（rrDlbcl）的发生率仍然很高。本研究从意大利国家卫生服务局（Ssn）的角度，对新诊断为Dlbcl并接受1L治疗的患者进行了识别和分析。
从Fondazione Ricerca e Salute（ReS）的行政数据库中（该数据库涵盖意大利每年约550万居民），识别出2018年、2019年、2020年和2021年新入院诊断为Dlbcl并接受1L治疗的成年人，并对其在索引日期之前（4至8年）的人口统计学和合并症进行了特征描述。在索引日期之后的1至4年（随访期），评估了总生存期（Kaplan-Meier曲线）、按治疗线划分的患者百分比分布，包括化疗免疫治疗的配药/给药、造血干细胞移植（Hsct），以及向Ssn收取的直接医疗费用。
总体而言，从ReS数据库中识别出2018年至2021年在意大利新诊断为Dlbcl并接受1L治疗的206名患者（发病率为每10万成年居民0.9至1.7例）。他们主要为老年人（中位年龄68[56；75]岁），男性（56%），且患有≥2种合并症（52%），主要是心脏代谢方面的合并症。在4年的随访中，2018年的病例中有56%存活。在首次随访年：2018年、2019年、2020年和2021年的病例中，分别有73%、80%、100%和35%接受了二线（2L）治疗；2018年和2020年的病例中，分别有42%和64%接受了三线（3L）治疗。在2018年、2020年和2021年的病例中，至少有1例Hsct被用作二线治疗。平均而言，2018年至2021年新诊断为Dlbcl并接受1L治疗的每名患者在首次随访年直接向Ssn收取的总费用在20,000欧元至30,000欧元之间（化疗免疫治疗占40-53%），随着时间推移，费用减少，有利于其他药物和Hsct。
该分析证实了rrDlbcl的高发生率以及向SSN收取的高昂经济影响，首先用于支持化疗免疫治疗，然后用于长期护理，并且rrDlbcl患者缺乏标准化的后续治疗方案。
