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利用健康保险数据对弥漫性大B细胞淋巴瘤一线和二线治疗进行真实世界评估:一项基于比利时人群的研究

Real-World Estimation of First- and Second-Line Treatments for Diffuse Large B-Cell Lymphoma Using Health Insurance Data: A Belgian Population-Based Study.

作者信息

Daneels Willem, Rosskamp Michael, Macq Gilles, Saadoon Estabraq Ismael, De Geyndt Anke, Offner Fritz, Poirel Hélène A

机构信息

Department of Hematology, Ghent University Hospital, Ghent, Belgium.

Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.

出版信息

Front Oncol. 2022 Feb 28;12:824704. doi: 10.3389/fonc.2022.824704. eCollection 2022.

Abstract

We determined first- and second-line regimens, including hematopoietic stem cell transplantations, in all diffuse large B cell lymphoma (DLBCL) patients aged ≥20 yr (n = 1,888), registered at the Belgian Cancer Registry (2013-2015). Treatments were inferred from reimbursed drugs, and procedures registered in national health insurance databases. This real-world population-based study allows to assess patients usually excluded from clinical trials such as those with comorbidities, other malignancies (12%), and advanced age (28% are ≥80 yr old). Our data show that the majority of older patients are still started on first-line regimens with curative intent and a substantial proportion of them benefit from this approach. First-line treatments included full R-CHOP (44%), "incomplete" (R-)CHOP (18%), other anthracycline (14%), non-anthracycline (9%), only radiotherapy (3%), and no chemo-/radiotherapy (13%), with significant variation between age groups. The 5-year overall survival (OS) of all patients was 56% with a clear influence of age (78% [20-59 yr] versus 16% [≥85 yr]) and of the type of first-line treatments: full R-CHOP (72%), other anthracycline (58%), "incomplete" (R-)CHOP (47%), non-anthracycline (30%), only radiotherapy (30%), and no chemo-/radiotherapy (9%). Second-line therapy, presumed for refractory (7%) or relapsed disease (9%), was initiated in 252 patients (16%) and was predominantly (71%) platinum-based. The 5-year OS after second-line treatment without autologous stem cell transplantation (ASCT) was generally poor (11% in ≥70 yr versus 17% in <70 yr). An ASCT was performed in 5% of treated patients (n = 82). The 5-year OS after first- or second-line ASCT was similar (69% versus 66%). After adjustment, multivariable OS analyses indicated a significant hazard ratio (HR) for, among others, age (HR 1.81 to 5.95 for increasing age), performance status (PS) (HR 4.56 for PS >1 within 3 months from incidence), subsequent malignancies (HR 2.50), prior malignancies (HR 1.34), respiratory and diabetic comorbidity (HR 1.41 and 1.24), gender (HR 1.25 for males), and first-line treatment with full R-CHOP (HR 0.41) or other anthracycline-containing regimens (HR 0.72). Despite inherent limitations, patterns of care in DLBCL could be determined using an innovative approach based on Belgian health insurance data.

摘要

我们确定了比利时癌症登记处(2013 - 2015年)登记的所有年龄≥20岁的弥漫性大B细胞淋巴瘤(DLBCL)患者(n = 1888)的一线和二线治疗方案,包括造血干细胞移植。治疗方案根据报销药物以及国家健康保险数据库中登记的程序推断得出。这项基于真实世界人群的研究能够评估那些通常被排除在临床试验之外的患者,比如患有合并症、其他恶性肿瘤(12%)以及高龄(28%年龄≥80岁)的患者。我们的数据显示,大多数老年患者仍开始接受具有治愈意图的一线治疗方案,并且其中很大一部分患者从中获益。一线治疗包括完整的R - CHOP方案(44%)、“不完整”(R -)CHOP方案(18%)、其他蒽环类药物方案(14%)、非蒽环类药物方案(9%)、仅放疗(3%)以及未进行化疗/放疗(13%),各年龄组之间存在显著差异。所有患者的5年总生存率(OS)为56%,年龄(20 - 59岁为78%,≥85岁为16%)以及一线治疗类型对此有明显影响:完整的R - CHOP方案(72%)、其他蒽环类药物方案(58%)、“不完整”(R -)CHOP方案(47%)、非蒽环类药物方案(30%)、仅放疗(30%)以及未进行化疗/放疗(9%)。二线治疗针对难治性疾病(7%)或复发性疾病(9%),252例患者(16%)开始接受二线治疗,且主要(71%)为铂类为基础的治疗方案。未进行自体干细胞移植(ASCT)的患者二线治疗后的5年总生存率普遍较差(≥70岁患者为11%,<70岁患者为17%)。5%的接受治疗患者(n = 82)进行了ASCT。一线或二线ASCT后的5年总生存率相似(分别为69%和66%)。调整后,多变量总生存分析表明,除其他因素外,年龄(年龄每增加,风险比[HR]为1.81至5.95)、体能状态(PS)(发病后3个月内PS>1时HR为4.56)、后续恶性肿瘤(HR为2.50)、既往恶性肿瘤(HR为1.34)、呼吸和糖尿病合并症(HR分别为1.41和1.24)、性别(男性HR为1.25)以及采用完整R - CHOP方案(HR为0.41)或其他含蒽环类药物方案(HR为0.72)进行一线治疗均具有显著的风险比。尽管存在固有局限性,但基于比利时健康保险数据,可采用创新方法确定DLBCL的治疗模式。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e97a/8922541/41335d9e6b93/fonc-12-824704-g001.jpg

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