دورية أكاديمية
Autologous Hematopoietic Stem Cell Transplantation vs Intravenous Pulse Cyclophosphamide in Diffuse Cutaneous Systemic Sclerosis
| العنوان: | Autologous Hematopoietic Stem Cell Transplantation vs Intravenous Pulse Cyclophosphamide in Diffuse Cutaneous Systemic Sclerosis |
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| المؤلفون: | van Laar, Jacob, Farge, Dominique, Sont, Jacob, Naraghi, Kamran, Marjanovic, Zora, Larghero, Jérôme, Schuerwegh, Annemie, Marijt, Erik, Vonk, Madelon, Schattenberg, Anton, Matucci-Cerinic, Marco, Voskuyl, Alexandre, van de Loosdrecht, Arjan, Daikeler, Thomas, Kötter, Ina, Schmalzing, Marc, Martin, Thierry, Lioure, Bruno, Weiner, Stefan, Kreuter, Alexander, Deligny, Christophe, Durand, Jean-Marc, Emery, Paul, Machold, Klaus, Sarrot-Reynauld, Françoise, Warnatz, Klaus, Adoue, Daniel, Constans, Joël, Tony, Hans-Peter, del Papa, Nicoletta, Fassas, Athanasios, Himsel, Andrea, Launay, David, Lo Monaco, Andrea, Philippe, Pierre, Quere, Isabelle, Rich, Éric, Westhovens, Rene, Griffiths, Bridget, Saccardi, Riccardo, van den Hoogen, Frank, Fibbe, Willem, Socie, Gérard, Gratwohl, Alois, Tyndall, Alan, Study Group, Ebmt/eular Scleroderma |
| المساهمون: | Service de Médecine Interne Saint-Louis, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal Paris, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Saint-Antoine AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CIC - Biotherapie - Saint Louis ((CIC-BT 301)), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal Paris, Centre Hospitalier Universitaire Strasbourg (CHU Strasbourg), Les Hôpitaux Universitaires de Strasbourg (HUS), Département d'Oncologie et Hématologie Strasbourg, Hôpital Pierre Zobda-Quitman CHU de la Martinique, CHU de la Martinique Fort de France, Médecine interne et immunologie clinique Hôpital de la Conception - APHM, Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception CHU - APHM (LA CONCEPTION), Clinique de médecine interne, Université Joseph Fourier - Grenoble 1 (UJF)-Centre Hospitalier Universitaire CHU Grenoble (CHUGA), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hôpital Saint-André, Service de médecine interne Lille, Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille), CHU Clermont-Ferrand, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Hopital Saint-Louis AP-HP (AP-HP) |
| المصدر: | ISSN: 2168-6165. |
| بيانات النشر: | HAL CCSD American Medical Association |
| سنة النشر: | 2014 |
| مصطلحات موضوعية: | [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| الوصف: | International audience ; IMPORTANCE:High-dose immunosuppressive therapy and autologous hematopoietic stem cell transplantation (HSCT) have shown efficacy in systemic sclerosis in phase 1 and small phase 2 trials.OBJECTIVE:To compare efficacy and safety of HSCT vs 12 successive monthly intravenous pulses of cyclophosphamide.DESIGN, SETTING, AND PARTICIPANTS:The Autologous Stem Cell Transplantation International Scleroderma (ASTIS) trial, a phase 3, multicenter, randomized (1:1), open-label, parallel-group, clinical trial conducted in 10 countries at 29 centers with access to a European Group for Blood and Marrow Transplantation-registered transplant facility. From March 2001 to October 2009, 156 patients with early diffuse cutaneous systemic sclerosis were recruited and followed up until October 31, 2013.INTERVENTIONS:HSCT vs intravenous pulse cyclophosphamide.MAIN OUTCOMES AND MEASURES:The primary end point was event-free survival, defined as time from randomization until the occurrence of death or persistent major organ failure.RESULTS:A total of 156 patients were randomly assigned to receive HSCT (n = 79) or cyclophosphamide (n = 77). During a median follow-up of 5.8 years, 53 events occurred: 22 in the HSCT group (19 deaths and 3 irreversible organ failures) and 31 in the control group (23 deaths and 8 irreversible organ failures). During the first year, there were more events in the HSCT group (13 events [16.5%], including 8 treatment-related deaths) than in the control group (8 events [10.4%], with no treatment-related deaths). At 2 years, 14 events (17.7%) had occurred cumulatively in the HSCT group vs 14 events (18.2%) in the control group; at 4 years, 15 events (19%) had occurred cumulatively in the HSCT group vs 20 events (26%) in the control group. Time-varying hazard ratios (modeled with treatment × time interaction) for event-free survival were 0.35 (95% CI, 0.16-0.74) at 2 years and 0.34 (95% CI, 0.16-0.74) at 4 years.CONCLUSIONS AND RELEVANCE:Among patients with early diffuse cutaneous systemic ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/25058083; hal-01945807; https://hal.umontpellier.fr/hal-01945807Test; PUBMED: 25058083 |
| DOI: | 10.1001/jama.2014.6368 |
| الإتاحة: | https://doi.org/10.1001/jama.2014.6368Test https://hal.umontpellier.fr/hal-01945807Test |
| رقم الانضمام: | edsbas.65D7431F |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jama.2014.6368 |
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