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
{"title":"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。","authors":"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","doi":"10.1016/j.eclinm.2024.102679","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Findings: </strong>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).</p><p><strong>Interpretation: </strong>Treatment with mogamulizumab was significantly and independently associated with decreased mortality in Sézary syndrome.</p><p><strong>Funding: </strong>French Society of Dermatology, Swiss National Science Foundation (IZLIZ3_200253/1) and SKINTEGRITY.CH collaborative research program.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6000,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11245986/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-life efficacy of immunotherapy for Sézary syndrome: a multicenter observational cohort study.\",\"authors\":\"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\",\"doi\":\"10.1016/j.eclinm.2024.102679\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Sézary syndrome is an extremely rare and fatal cutaneous T-cell lymphoma (CTCL). 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This study has been registered in ClinicalTrials (SURPASSe01 study: NCT05206045).</p><p><strong>Findings: </strong>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. 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Real-life efficacy of immunotherapy for Sézary syndrome: a multicenter observational cohort study.
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.
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.
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