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