As reported in the Journal of Clinical Oncology by Camus et al, the final analysis of the phase III Ro-CHOP trial showed no significant progression-free or overall survival benefit with the addition of romidepsin (Ro) to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated patients with peripheral T-cell lymphoma (PTCL).
Study Details
In the international open-label study, 421 patients were randomly assigned between January 2013 and December 2017 to receive Ro-CHOP (n = 211) or CHOP (n = 210). Primary analysis of the trial showed no increased efficacy with Ro-CHOP. The current analysis was performed at 5 years after enrollment of the last patient.
Key Findings
With a median follow-up of 6 years, median progression-free survival was 12.0 months in the Ro-CHOP group vs 10.2 months in the CHOP group (hazard ratio [HR] = 0.79, 95% confidence interval [CI] = 0.62–1.005, P = .054). Median overall survival was 62.2 months (95% CI = 35.7–86.6 months) in the Ro-CHOP group vs 43.8 months (95% CI = 30.1–70.2 months) in the CHOP group (HR = 0.88, 95% CI = 0.68–1.14, P = .324). In an exploratory analysis among the subgroup of 201 patients with centrally reviewed follicular helper T-cell lymphoma, median progression-free survival was significantly longer in the Ro-CHOP arm (19.5 months vs 10.6 months, HR = 0.703, 95% CI = 0.502–0.985, P = .039).
Among a total of 251 patients who received second-line treatments, median progression-free survival–2 and overall survival–2 after relapse or disease progression were 3.3 months and 11.5 months, respectively. Among the group of “highly heterogeneous” second-line treatments, no specific treatment appeared to provide better disease control. A potential progression-free survival–2 benefit was observed for second-line brentuximab vedotin plus chemotherapy (n = 31) vs the same chemotherapy without brentuximab vedotin (n = 82), even after excluding six patients with anaplastic large cell lymphoma (ALCL; median progression-free survival–2 = 8.6 months vs 2.8 months, P = .002). The benefit remained significant in multivariate analysis adjusting for histology and international prognostic index (HR = 0.431, 95% CI = 0.238–0.779, P = .005).
The investigators concluded, “With an additional 3 years of follow-up in the Ro-CHOP study, there were no significant changes in efficacy or safety endpoints compared with the primary analysis. This large international randomized trial across various PTCL entities (excluding ALK-positive ALCL) confirmed the overall poor outcome for these patients. Toxicity associated with romidepsin use led to decreased dose intensity in the CHOP backbone, potentially explaining the failure of the regimen to improve progression-free survival.”
Emmanuel Bachy, MD, PhD, of the Claude Bernard Lyon 1 University, Lyon, France, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Celgene, a Bristol Myers Squibb Company, and the Lymphoma Academic Research Organisation (LYSARC). For full disclosures of the study authors, visit ascopubs.org.
