Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial. - Université de Lille Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2024

Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial.

Gandhi Laurent Damaj
  • Fonction : Auteur
Won Seog Kim
  • Fonction : Auteur
Soon Thye Lim
  • Fonction : Auteur
Marc Andre
  • Fonction : Auteur
Norma Gutiérrez
  • Fonction : Auteur
Maria Jesus Penarrubia
  • Fonction : Auteur
Philipp B Staber
  • Fonction : Auteur
Judith Trotman
  • Fonction : Auteur
Andreas Hüttmann
  • Fonction : Auteur
Vittorio Stefoni
  • Fonction : Auteur
Alessandra Tucci
  • Fonction : Auteur
Julie Abraham
  • Fonction : Auteur
Ju Li
  • Fonction : Auteur
Laurence de Leval
  • Fonction : Auteur

Résumé

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The primary analysis of the Ro-CHOP phase III randomized controlled trial (ClinicalTrials.gov identifier: NCT01796002) established that romidepsin (Ro) plus cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) did not yield an increased efficacy compared with CHOP alone as first-line treatment of peripheral T-cell lymphoma. We report the planned final analysis 5 years after the last patient enrolled. With a median follow-up of 6 years, median progression-free survival (PFS) was 12.0 months compared with 10.2 months (hazard ratio [HR], 0.79 [95% CI, 0.62 to 1.005]; P = .054), while median overall survival was 62.2 months (35.7-86.6 months) and 43.8 months (30.1-70.2 months; HR, 0.88 [95% CI, 0.68 to 1.14]; P = .324) in the Ro-CHOP and CHOP arms, respectively. In an exploratory analysis, the median PFS in the centrally reviewed follicular helper T-cell lymphoma subgroup was significantly longer in the Ro-CHOP arm (19.5 v 10.6 months, HR, 0.703 [95% CI, 0.502 to 0.985]; P = .039). Second-line treatments were given to 251 patients with a median PFS2 and OS2 after relapse or progression of 3.3 months and 11.5 months, respectively. Within the limits of highly heterogeneous second-line treatments, no specific regimen seemed to provide superior disease control. However, a potential benefit was observed with brentuximab vedotin in association with chemotherapy even after excluding anaplastic large-cell lymphoma subtype or after adjusting for histology and international prognostic index in a multivariate model (HR for PFS, 0.431 [95% CI, 0.238 to 0.779]; P = .005).
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Dates et versions

hal-04604526 , version 1 (07-06-2024)

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Vincent Camus, Catherine Thieblemont, Philippe Gaulard, Morgane Cheminant, Rene-Olivier Casasnovas, et al.. Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial.. Journal of Clinical Oncology, 2024, Journal of Clinical Oncology, 42, pp.1612-1618. ⟨10.1200/JCO.23.01687⟩. ⟨hal-04604526⟩
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