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.

Abstract

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).

• Authors: Vincent Camus, Catherine Thieblemont, Philippe Gaulard, Morgane Cheminant, Rene-Olivier Casasnovas, Loïc Ysebaert, Gandhi Laurent Damaj, Stéphanie Guidez, Gian Matteo Pica, Won Seog Kim, Soon Thye Lim, Marc Andre, Norma Gutiérrez, Maria Jesus Penarrubia, Philipp B Staber, Judith Trotman, Andreas Hüttmann, Vittorio Stefoni, Alessandra Tucci, Patrick Fogarty, Hassan Farhat, Julie Abraham, Wajed Abarah, Fatiha Belmecheri, Vincent Ribrag, Marie-Helene Delfau-Larue, Anne-Ségolène Cottereau, Emmanuel Itti, Ju Li, Richard Delarue, Laurence de Leval, Franck Morschhauser, Emmanuel Bachy
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 42 Issue 14 Pg. 1612-1618 (May 10 2024) ISSN: 1527-7755 [Electronic] United States
• PMID: 38364196 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase III, Multicenter Study)

Chemical References

• Cyclophosphamide
• Doxorubicin
• Vincristine
• Prednisone
• Depsipeptides
• romidepsin

Topics

• Humans
• Lymphoma, T-Cell, Peripheral (drug therapy, mortality)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Cyclophosphamide (administration & dosage, therapeutic use)
• Doxorubicin (administration & dosage, therapeutic use)
• Vincristine (administration & dosage, therapeutic use)
• Prednisone (administration & dosage, therapeutic use)
• Depsipeptides (administration & dosage, therapeutic use)
• Middle Aged
• Male
• Female
• Aged
• Adult
• Progression-Free Survival