Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study

倾向得分匹配 医学 移植 造血干细胞移植 内科学 人口 蕈样真菌病 前瞻性队列研究 外科 淋巴瘤 环境卫生
作者
Adèle de Masson,M. Beylot‐Barry,C. Ram‐Wolff,Jean-Baptiste Mear,Stéphane Dalle,M. D’Incan,S. Oro,Corentin Orvain,Julie Abraham,O. Dereure,Amandine Charbonnier,Jérôme Cornillon,Christine Longvert,Stéphane Barète,S. Boulinguez,E. Wierzbicka-Hainaut,F. Aubin,Marie‐Thérèse Rubio,Marc Bernard,Aline Schmidt-Tanguy,Roch Houot,Anne Pham‐Ledard,David Michonneau,Pauline Brice,Hélène Labussiere‐Wallet,Jean-David Bouaziz,Florent Grange,Hélène Moins-Teisserenc,Katayoun Jondeau,Laurence Michel,Samia Mourah,Maxime Battistella,Etienne Daguindau,Michael Loschi,Alexandra Picard,Nathalie Franck,Natacha Maillard,Anne Huynh,Stéphanie Nguyen,Ambroise Marçais,G. Chaby,Patrice Céballos,Y. Le Corre,Sébastien Maury,Jacques-Olivier Bay,Henri Adamski,Emmanuel Bachy,Edouard Forcade,Gérard Socié,Martine Bagot,Sylvie Chevret,Emmanuel Bachy,Adèle de Masson,M. Beylot‐Barry,Caroline Ram-Wolff,Jean-Baptiste Mear,Stéphane Dalle,M. D’Incan,Olivier Dereure,Corentin Orvain,Julie Abraham,O. Dereure,Amandine Charbonnier,Jérôme Cornillon,Christine Longvert,Stéphane Barète,S. Boulinguez,E. Wierzbicka-Hainaut,François Aubin,Marie-Thérèse Rubio,Marc Bernard,Aline Schmidt-Tanguy,Roch Houot,Anne Pham‐Ledard,David Michonneau,Pauline Brice,Hélène Labussiere‐Wallet,Jean-David Bouaziz,Florent Grange,Hélène Moins-Teisserenc,Katayoun Jondeau,Laurence Michel,Samia Mourah,Maxime Battistella,Etienne Daguindau,Michael Loschi,Alexandra Picard,Nathalie Franck,Natacha Maillard,Anne Huynh,Stéphanie Nguyen,Ambroise Marçais,G. Chaby,Patrice Céballos,Y. Le Corre,Sébastien Maury,Jacques-Olivier Bay,Henri Adamski,Emmanuel Bachy,Edouard Forcade,Gérard Socié,Martine Bagot,Sylvie Chevret,Emmanuel Bachy,Adèle de Masson,M. Beylot‐Barry,Caroline Ram-Wolff,Stéphane Dalle,M. D’Incan,S. Oro,O. Dereure,Christine Longvert,Stéphane Barète,S. Boulinguez,E. Wierzbicka-Hainaut,François Aubin,Anne Pham‐Ledard,Florent Grange,Alexandra Picard,Nathalie Franck,G. Chaby,Y. Le Corre,Henri Adamski,Maxime Battistella,Sylvie Chevret,Jean-Baptiste Mear,Corentin Orvain,Julie Abraham,Amandine Charbonnier,Jérôme Cornillon,Marie-Thérèse Rubio,Marc Bernard,Aline Schmidt-Tanguy,Roch Houot,David Michonneau,Pauline Brice,Hélène Labussiere‐Wallet,Katayoun Jondeau,Etienne Daguindau,Michael Loschi,Natacha Maillard,Anne Huynh,Stéphanie Nguyen,Ambroise Marçais,Patrice Céballos,Régis Peffault de Latour,Emmanuel Bachy,Edouard Forcade,Gérard Socié,Sébastien Maury,Jacques-Olivier Bay
出处
期刊:The Lancet [Elsevier BV]
卷期号:401 (10392): 1941-1950 被引量:24
标识
DOI:10.1016/s0140-6736(23)00329-x
摘要

Advanced-stage cutaneous T-cell lymphomas (CTCLs) are rare, usually refractory, and fatal diseases. Case series have suggested that allogeneic haematopoietic stem cell transplantation (HSCT) might improve the prognosis of advanced-stage CTCLs. The objective of this study was to investigate the effect of allogeneic HSCT compared with non-HSCT therapy on the outcome of individuals with advanced-stage CTCLs.In this prospective, multicentre, matched controlled trial, conducted at 30 hospitals, participants with advanced CTCLs were allocated treatment: if they had an available compatible related donor they were assigned to allogeneic HSCT, or if not they were allocated to non-allogeneic HSCT therapy. Key inclusion criteria were participants aged 18-70 years, with advanced stage mycosis fungoides or Sézary syndrome, and at least one poor prognostic criteria. Participants were excluded if they were not in complete or partial remission of the disease. Propensity score 1:1 matching with replacement (ie, that each participant treated with HSCT was matched to the participant with the closest propensity score treated with non-HSCT therapy, even if they had already been matched) was used to handle confounding factors, with the balance of covariate distribution between HSCT and non-HSCT groups assessed using standardised mean differences. The primary endpoint was progression-free survival in the matched intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02520908), and is currently active but not recruiting.From June 1, 2016, to March 3, 2022, total of 99 participants were enrolled at 17 centres in France. Participants with a sibling or matched unrelated donor were assigned to allogeneic HSCT (HSCT group, n=55 [56%]) and participants without a donor were assigned to non-allogeneic HSCT treatment (non-HSCT group, n=44 [44%]). The median follow-up among survivors was 12·6 months (IQR 11·0-35·2). In the HSCT group, 51 participants (93%) were 1:1 matched to participants from the non-HSCT group. In the intention-to-treat analysis, median progression-free survival was significantly longer in the HSCT group (9·0 months [95% CI 6·6-30·5]) than in the non-HSCT group (3·0 months [2·0-6·3]), with a hazard ratio of 0·38 (95% CI 0·21-0·69; p<0·0001). In the per-protocol population, 40 participants (78%) in the HSCT group had 101 serious events and 29 participants (67%) in the non-HSCT group had 70 serious adverse events. The most common serious adverse event other than graft-versus-host disease in both groups was infections, occurring in 30 participants (59%) in the HSCT group and in 19 participants (44%) in the non-HSCT group.Allogeneic HSCT was associated with significantly longer progression-free survival in participants with advanced-stage CTCLs. These results indicate that allogeneic HSCT treatment should be made available to individuals with high-risk, advanced-stage mycosis fungoides or Sézary syndrome who achieve pre-transplant disease remission.French Ministry of Health, National Cancer Institute, Programme Hospitalier de Recherche Clinique en Cancérologie.
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