Titre :

Romidepsin plus chop versus chop in patients with previously untreated peripheral T-Cell lymphoma : final analysis of the ro-chop trial

Auteur(s) :

Camus, V. [Auteur]
Service d'hématologie [CRLCC Henri Becquerel]
Thieblemont, C. [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Gaulard, P. [Auteur]
Département de pathologie [Mondor]
Cheminant, M. [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Casasnovas, R. [Auteur]
Service d'Hématologie Clinique (CHU de Dijon)
Ysebaert, L. [Auteur]
Service Hématologie - IUCT-Oncopole [CHU Toulouse]
Damaj, G. L. [Auteur]
CHU Caen
Guidez, S. [Auteur]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital [CHU de Poitiers [La Milétrie]]
Pica, G. M. [Auteur]
Centre Hospitalier Métropole Savoie [Chambéry]
Kim, W. S. [Auteur]
Samsung Medical Center Sungkyunkwan University School of Medicine
Lim, S. T. [Auteur]
National Cancer Centre Singapore
Andre, M. [Auteur]
CHU UCL Namur
Gutiérrez, N. [Auteur]
Centro de Investigación Biomédica en Red de Cáncer [CIBERONC]
Instituto de Investigación Biomédica de Salamanca [IBSAL]
Penarrubia, M. J. [Auteur]
Rio Hortega University Hospital (Hospital Universitario Río Hortega) [Valladolid, Spain] [RHUH]
Staber, P. B. [Auteur]
Medizinische Universität Wien = Medical University of Vienna
Trotman, J. [Auteur]
The University of Sydney
Hüttmann, A. [Auteur]
West German Cancer Center [Essen, Germany]
Stefoni, V. [Auteur]
Policlinico S. Orsola-malpighi
Rossi, G. [Auteur]
Azienda Socio Sanitaria Territoriale Spedali Civili di Brescia [Brescia]
Delfau-Larue, M. [Auteur]
CHU Henri Mondor [Créteil]
Cottereau, A. [Auteur]
Hôpital Cochin [AP-HP]
Itti, E. [Auteur]
Service de médecine nucléaire [Créteil]
Li, J. [Auteur]
Bristol-Myers Squibb Company
Delarue, R. [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
De Leval, L. [Auteur]
Centre Hospitalier Universitaire Vaudois = Lausanne University Hospital [Lausanne] [CHUV]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Bachy, E. [Auteur]
Hospices Civils de Lyon [HCL]

Titre de la manifestation scientifique :

17th International Conference on Malignant Lymphoma

Ville :

Lugano

Pays :

Suisse

Date de début de la manifestation scientifique :

2023-06-13

Titre de la revue :

Hematological Oncology

Éditeur :

Wiley

Date de publication :

2023-06-09

ISSN :

1099-1069

Mot(s)-clé(s) en anglais :

aggressive T-cell non-Hodgkin lymphoma

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Introduction: The primary analysis of the Ro-CHOP trial (NCT01796002) demonstrated that romidepsine (Ro) plus CHOP did not provide an increased efficacy compared with CHOP alone in patients with previously untreated ...
Lire la suite >Introduction: The primary analysis of the Ro-CHOP trial (NCT01796002) demonstrated that romidepsine (Ro) plus CHOP did not provide an increased efficacy compared with CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL). We report here the final analysis of the Ro-CHOP trial. Methods: The study was an open-label multicenter randomized (1:1) phase III study of Ro-CHOP versus CHOP as frontline treatment of patients 18–80 years with PTCL. The primary endpoint was progression-free survival (PFS) according to IWG 1999 criteria. Overall survival (OS) was a secondary endpoint, relapse patterns and PFS/OS after the first progression (PFS2/OS2) were analyzed post-hoc. The cut-off date was set to 2022/12/13, that is, five years after the last patient was enrolled. Results: 211 and 210 patients were assigned to receive 6 cycles of Ro-CHOP or CHOP in 3-week cycles, respectively. Median age was 65 (25–81) years. With a median follow-up of 71.8 months, 271 patients (64.4%) presented a PFS event by independent RAC assessment. Median PFS was 12 months (95% CI = [9; 25.8]) and 10.2 months ([7.4; 13.2]) for Ro-CHOP and CHOP, respectively (HR = 0.79 [0.62; 1.005], p = 0.054, 2-sided p-value). Based on 229 deaths, median OS was 62.2 months and 43.8 months for Ro-CHOP and CHOP, respectively. The causes of death were the following: lymphoma (n = 165, 72.4%), concurrent illness (n = 30, 13.2%), other reasons (n = 12, 5.3%), toxicity of salvage treatment (n = 8, 3.5%), toxicity of study treatment (n = 4, 1.8%), unknown (n = 9, 3.9%). No new safety signal was observed. A significantly prolonged PFS in the follicular helper T-cell (TFH) lymphoma subgroup (centrally reviewed) was still observed with this longer follow-up. The median PFS was 19.5 months ([11.5; 44.4]) in the Ro-CHOP arm and 10.6 months ([7.4; 14.9) the CHOP arm with a HR of 0.703 ([0.502; 0.985], p = 0.0395). Additional treatment was given to 251 patients after progression (Ro-CHOP = 115, and CHOP = 136), leading to an overall response rate of 35.7% (CR/CRu: 21.7%) and 31.6% (CR/CRu: 22.1%) in the Ro-CHOP and CHOP groups, respectively. Overall, 191 of the 251 patients (76.1%) progressed after second-line therapy, and 20 patients died without a second progression (8.0%). The median PFS2 and OS2 were 3.3 months (95% CI, [2.7; 4.5]) and 11.5 months ([9.6; 15.9]), respectively. Twenty-three patients (9.2%) received an allogeneic stem cell transplantation (median age 51 [29–70] years) and displayed 1-year PFS2 and OS2 rates estimated at 59.7% and 81.8%, respectively. Detailed outcome according to salvage treatment at progression will be presented at the meeting. Conclusion: Five years after randomization of the last patient, outcome of patients treated for PTCL was confirmed to be not significantly different between the Ro-CHOP and CHOP arms, except for PTCL from TFH origin. Second-line treatments led to poor results after disease progression/relapse.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Date de dépôt :

2024-09-06T21:05:51Z
2024-09-25T15:04:22Z
2024-09-26T13:37:14Z