Real-life efficacy of immunotherapy for Sézary syndrome: a multicenter observational cohort study.

IF 9.6 1区医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-06-21 eCollection Date: 2024-07-01 DOI:10.1016/j.eclinm.2024.102679

Alizée Bozonnat, Marie Beylot-Barry, Olivier Dereure, Michel D'Incan, Gaëlle Quereux, Emmanuella Guenova, Marie Perier-Muzet, Stephane Dalle, Florent Grange, Manuelle-Anne Viguier, Caroline Ram-Wolff, Laurence Feldmeyer, Helmut Beltraminelli, Nathalie Bonnet, Florent Amatore, Eve Maubec, Nathalie Franck, Laurent Machet, François Chasset, Florence Brunet-Possenti, Jean-David Bouaziz, Maxime Battistella, Marie Donzel, Anne Pham-Ledard, Claudia Bejar, Hélène Moins-Teisserenc, Samia Mourah, Philippe Saiag, Ewa Hainaut, Catherine Michel, Guido Bens, Henri Adamski, François Aubin, Serge Boulinguez, Pascal Joly, Billal Tedbirt, Isabelle Templier, Laura Troin, Henri Montaudié, Saskia Ingen-Housz-Oro, Sarah Faiz, Laurent Mortier, Gabor Dobos, Martine Bagot, Matthieu Resche-Rigon, Claire Montlahuc, Arnaud Serret-Larmande, Adèle de Masson

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Abstract

Background: Sézary syndrome is an extremely rare and fatal cutaneous T-cell lymphoma (CTCL). Mogamulizumab, an anti-CCR4 monoclonal antibody, has recently been associated with increased progression-free survival in a randomized clinical trial in CTCL. We aimed to evaluate OS and prognostic factors in Sézary syndrome, including treatment with mogamulizumab, in a real-life setting.

Methods: Data from patients with Sézary (ISCL/EORTC stage IV) and pre-Sézary (stage IIIB) syndrome diagnosed from 2000 to 2020 were obtained from 24 centers in Europe. Age, disease stage, plasma lactate dehydrogenases levels, blood eosinophilia at diagnosis, large-cell transformation and treatment received were analyzed in a multivariable Cox proportional hazard ratio model. This study has been registered in ClinicalTrials (SURPASSe01 study: NCT05206045).

Findings: Three hundred and thirty-nine patients were included (58% men, median age at diagnosis of 70 years, Q1-Q3, 61-79): 33 pre-Sézary (9.7% of 339), 296 Sézary syndrome (87.3%), of whom 10 (2.9%) had large-cell transformation. One hundred and ten patients received mogamulizumab. Median follow-up was 58 months (95% confidence interval [CI], 53-68). OS was 46.5% (95% CI, 40.6%-53.3%) at 5 years. Multivariable analysis showed that age ≥ 80 versus <50 (HR: 4.9, 95% CI, 2.1-11.2, p = 0.001), and large-cell transformation (HR: 2.8, 95% CI, 1.6-5.1, p = 0.001) were independent and significant factors associated with reduced OS. Mogamulizumab treatment was significantly associated with decreased mortality (HR: 0.34, 95% CI, 0.15-0.80, p = 0.013).

Interpretation: Treatment with mogamulizumab was significantly and independently associated with decreased mortality in Sézary syndrome.

Funding: French Society of Dermatology, Swiss National Science Foundation (IZLIZ3_200253/1) and SKINTEGRITY.CH collaborative research program.

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塞扎里综合征免疫疗法的实际疗效：一项多中心观察性队列研究。

背景介绍塞扎里综合征是一种极其罕见的致命性皮肤T细胞淋巴瘤（CTCL）。最近，在一项CTCL随机临床试验中，抗CCR4单克隆抗体莫加单抗（Mogamulizumab）与无进展生存期延长有关。我们的目的是在现实生活中评估塞扎里综合征的OS和预后因素，包括使用莫干单抗的治疗：方法：我们从欧洲 24 个中心获得了 2000 年至 2020 年期间确诊的塞扎里（ISCL/EORTC IV 期）和塞扎里综合征前期（IIIB 期）患者的数据。在多变量考克斯比例危险比模型中对年龄、疾病分期、血浆乳酸脱氢酶水平、诊断时血液嗜酸性粒细胞增多、大细胞转化和接受的治疗进行了分析。该研究已在 ClinicalTrials（SURPASSe01 研究：NCT05206045）上注册：共纳入 339 名患者（58% 为男性，诊断时的中位年龄为 70 岁，Q1-Q3，61-79 岁）：33名塞扎里前期患者（339人中占9.7%），296名塞扎里综合征患者（87.3%），其中10名患者（2.9%）发生了大细胞转化。110名患者接受了莫干单抗治疗。中位随访时间为58个月（95%置信区间[CI]，53-68）。5年后的OS为46.5%（95% 置信区间为40.6%-53.3%）。多变量分析表明，年龄≥80岁与释义：使用莫干单抗治疗与塞扎里综合征患者死亡率的降低有显著的独立相关性：法国皮肤病学会、瑞士国家科学基金会（IZLIZ3_200253/1）和SKINTEGRITY.CH合作研究项目。

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

期刊介绍： eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.