Romidepsin Plus CHOP vs CHOP Alone for Previously Untreated Peripheral T-Cell Lymphoma

Findings from a Final Analysis of the Phase 3 Ro-CHOP Trial

The final 5-year analysis of the phase 3 Ro-CHOP trial published in the Journal of Clinical Oncology demonstrated that cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with romidepsin (Ro) did not yield better disease control among patients with previously untreated peripheral T-cell lymphoma compared to CHOP alone. 

The initial analysis of the Ro-CHOP trial showed that romidepsin plus CHOP (Ro-CHOP) failed to demonstrate increased efficacy compared to a CHOP regimen alone as a first-line treatment for this patient population. Here, Vincent Camus, MD, PhD, Centre Henri Becquerel, Rouen, France, and coauthors aimed to assess a final analysis of this study, 5 years after the last patient was enrolled. 

Findings indicated that at a 6-year follow-up, the median progression-free survival was 12 months in the Ro-CHOP arm versus 10.2 months in the CHOP arm. The median overall survival (OS) was 62.2 months in the Ro-CHOP arm versus 43.8 months in the CHOP arm. 

The study authors also performed an exploratory analysis, which showed that the median progression-free survival (PFS) in the centrally reviewed follicular helper T-cell lymphoma subgroup was significantly longer among patients who received Ro-CHOP (19.5 months) than CHOP alone (10.6 months). A total of 251 patients received second-line treatments, with a median PFS2 of 3.3 months and OS2 of 11.5 months. 

“Within the limits of highly heterogeneous second-line treatments, no specific regimen seemed to provide superior disease control,” the study authors concluded. 

However, they added that, “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.” 

Source: 

Camus V, Thieblemont C, Gaulard P, 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. J Clin Oncol. Published online: February 16, 2024. doi: 10.1200/JCO.23.01687