Title :

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.

Author(s) :

Camus, Vincent [Auteur]
Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen [CLCC Henri Becquerel]
Thieblemont, Catherine [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Gaulard, Philippe [Auteur]
CHU Henri Mondor [Créteil]
Cheminant, Morgane [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Casasnovas, Rene-Olivier [Auteur]
Lipides - Nutrition - Cancer [Dijon - U1231] [LNC]
Ysebaert, Loïc [Auteur]
Institut Universitaire du Cancer de Toulouse - Oncopole [IUCT Oncopole - UMR 1037]
Damaj, Gandhi Laurent [Auteur]
CHU Caen
Guidez, Stéphanie [Auteur]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital [CHU de Poitiers [La Milétrie]]
Pica, Gian Matteo [Auteur]
Centre Hospitalier Métropole Savoie [Chambéry]
Kim, Won Seog [Auteur]
Lim, Soon Thye [Auteur]
Andre, Marc [Auteur]
Gutiérrez, Norma [Auteur]
Penarrubia, Maria Jesus [Auteur]
Staber, Philipp B [Auteur]
Trotman, Judith [Auteur]
Hüttmann, Andreas [Auteur]
Stefoni, Vittorio [Auteur]
Tucci, Alessandra [Auteur]
Fogarty, Patrick [Auteur]
The Lymphoma Academic Research Organisation [Lyon] [LYSARC]
Farhat, Hassan [Auteur]
Centre Hospitalier de Versailles André Mignot [CHV]
Abraham, Julie [Auteur]
CHU Limoges
Abarah, Wajed [Auteur]
Grand Hôpital de l'Est Francilien [GHEF]
Belmecheri, Fatiha [Auteur]
Institut Paoli-Calmettes [IPC]
Ribrag, Vincent [Auteur]
Université Paris-Saclay
Delfau-Larue, Marie-Helene [Auteur]
CHU Henri Mondor [Créteil]
Cottereau, Anne-Segolène [Auteur]
Université Paris Cité [UPCité]
Itti, Emmanuel [Auteur]
CHU Henri Mondor [Créteil]
Li, Ju [Auteur]
Delarue, Richard [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
De Leval, Laurence [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Bachy, Emmanuel [Auteur]
Université Claude Bernard Lyon 1 [UCBL]

Journal title :

Journal of Clinical Oncology

Abbreviated title :

J Clin Oncol

Volume number :

42

Pages :

1612-1618

Publication date :

2024-05-10

ISSN :

1527-7755

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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).Show less >

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

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

Submission date :

2024-05-15T21:09:17Z
2024-06-07T08:32:45Z