Titre
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).
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Bachy, E.
Auteure/Auteur
Camus, V.
Auteure/Auteur
Thieblemont, C.
Auteure/Auteur
Sibon, D.
Auteure/Auteur
Casasnovas, R.O.
Auteure/Auteur
Ysebaert, L.
Auteure/Auteur
Damaj, G.
Auteure/Auteur
Guidez, S.
Auteure/Auteur
Pica, G.M.
Auteure/Auteur
Kim, W.S.
Auteure/Auteur
Lim, S.T.
Auteure/Auteur
André, M.
Auteure/Auteur
García-Sancho, A.M.
Auteure/Auteur
Penarrubia, M.J.
Auteure/Auteur
Staber, P.B.
Auteure/Auteur
Trotman, J.
Auteure/Auteur
Hüttmann, A.
Auteure/Auteur
Stefoni, V.
Auteure/Auteur
Re, A.
Auteure/Auteur
Gaulard, P.
Auteure/Auteur
Delfau-Larue, M.H.
Auteure/Auteur
de Leval, L.
Auteure/Auteur
Meignan, M.
Auteure/Auteur
Li, J.
Auteure/Auteur
Morschhauser, F.
Auteure/Auteur
Delarue, R.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1527-7755
Statut éditorial
Publié
Date de publication
2022-01-20
Volume
40
Numéro
3
Première page
242
Dernière page/numéro d’article
251
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
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).
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 <sup>2</sup> , 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.
Between January 2013 and December 2017, 421 patients were enrolled (Ro-CHOP, n = 211; CHOP, n = 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 = .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%).
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.
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 <sup>2</sup> , 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.
Between January 2013 and December 2017, 421 patients were enrolled (Ro-CHOP, n = 211; CHOP, n = 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 = .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%).
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.
Sujets
PID Serval
serval:BIB_176EB32E5BC5
PMID
Date de création
2021-11-30T14:45:49.103Z
Date de création dans IRIS
2025-05-20T17:40:41Z