Article Dans Une Revue Journal of Clinical Oncology Année : 2022

Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA)

1 HCL - Hospices Civils de Lyon
2 UCBL - Université Claude Bernard Lyon 1
3 CLCC Henri Becquerel - Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
4 AP-HP - Hopital Saint-Louis [AP-HP]
5 Hôpital Necker - Enfants Malades [AP-HP]
6 Service d'hématologie biologique [CHU de Dijon]
7 CTM - Center for Translational and Molecular medicine [Dijon - UMR1231]
8 Service Hématologie - IUCT-Oncopole [CHU Toulouse]
9 CRCT - Centre de Recherches en Cancérologie de Toulouse
10 CHU Caen
11 NU - Normandie Université
12 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
13 Centre Hospitalier Métropole Savoie [Chambéry]
14 Samsung Medical Center Sungkyunkwan University School of Medicine
15 National Cancer Centre Singapore
16 CHU UCL Namur
17 Universidad de Salamanca [España] = University of Salamanca [Spain]
18 CIBERONC - Centro de Investigación Biomédica en Red de Cáncer
19 HCUV - Hospital Clinico Universitario de Valladolid [Castilla y León, Spain]
20 Medizinische Universität Wien = Medical University of Vienna
21 The University of Sidney
22 CRGH - Concord Repatriation General Hospital [Sydney, Australia]
23 AöR - University Hospital Essen
24 Universität Duisburg-Essen = University of Duisburg-Essen [Essen]
25 Policlinico Sant'Orsola-Malpighi
26 Azienda Socio Sanitaria Territoriale Spedali Civili di Brescia [Brescia]
27 IMRB - Institut Mondor de Recherche Biomédicale
28 Département de pathologie [Mondor]
29 CHU Henri Mondor [Créteil]
30 CHUV - Centre Hospitalier Universitaire Vaudois = Lausanne University Hospital [Lausanne]
31 Hôpital Henri Mondor
32 UPE - Université Paris-Est
33 LYSA-IM - LYSA Imaging (Créteil)
34 Bristol-Myers Squibb Company
35 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
36 GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365
37 Celgene Corporation
Marc Andr
  • Fonction : Auteur

Résumé

PURPOSE Romidepsin, a histone deacetylase inhibitor, has demonstrated activity in relapsed or refractory peripheral T-cell lymphoma (PTCL) as a single agent. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy is widely used as first-line treatment of PTCL; however, it has limited efficacy. Results from a phase Ib and II study showed the feasibility of combining romidepsin with CHOP (Ro-CHOP).

METHODS This study is a randomized phase III study of Ro-CHOP versus CHOP in adult patients with previously untreated PTCL. All patients received CHOP in 3-week cycles for six cycles. Romidepsin, 12 mg/m 2 , was administered intravenously over a 4-hour period on days 1 and 8 of each 3-week cycle for six cycles. The primary end point was progression-free survival (PFS) according to International Working Group 1999 criteria.

RESULTS

Between January 2013 and December 2017, 421 patients were enrolled (Ro-CHOP, n 5 211; CHOP, n 5 210). The median PFS for Ro-CHOP versus CHOP was 12.0 months (95% CI, 9.0 to 25.8) versus 10.2 months (95% CI, 7.4 to 13.2) with a hazard ratio of 0.81 (P 5 .096). In the Ro-CHOP versus CHOP arms, the median overall survival was 51.8 versus 42.9 months and the objective response rate was 63% versus 60% with complete response plus unconfirmed complete response rates of 41% versus 37% (P . .1 in all comparisons), respectively. Grade 3 or 4 treatment-emergent adverse events occurring in $ 30% of patients in the Ro-CHOP arm included thrombocytopenia (50% v 10% in the Ro-CHOP v CHOP arms, respectively), neutropenia (49% v 33%), anemia (47% v 17%), and leukopenia (32% v 20%).

CONCLUSION The addition of romidepsin to CHOP did not improve PFS, response rates, nor overall survival and increased the frequency for grade $ 3 treatment-emergent adverse events. Ro-CHOP does not represent a significant advance in the standard of care for patients with previously untreated PTCL.

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Dates et versions

inserm-04783069 , version 1 (14-11-2024)

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Citer

Emmanuel Bachy, Vincent Camus, Catherine Thieblemont, David Sibon, Ren É-Olivier Casasnovas, et al.. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). Journal of Clinical Oncology, 2022, 40 (3), pp.242-251. ⟨10.1200/JCO.21⟩. ⟨inserm-04783069⟩
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