Chidamide combined with cyclophosphamide, epirubicin, vindesine, prednisone, and etoposide (C-CHOEP) regimen is superior to the GDP-ML and CHOEP regimen for patients with newly diagnosed peripheral T-cell lymphoma

Background Outcomes with CHOP (cyclophosphamide, epirubicin, vindesine, and prednisone) or CHOP-like regimens are poor in most types of peripheral T-cell lymphomas (PTCLs). In this study, we investigated whether the combination of chidamide with CHOEP (cyclophosphamide, epirubicin, vindesine, etoposide, and prednisone) regimen (C-CHOEP) was superior to CHOEP and GDP-ML (gemcitabine, cisplatin, dexamethasone, methotrexate, and pegaspargase) regimen for previously untreated PTCL patients. Methods Between January 2012 and August 2019, a total of 94 newly diagnosed PTCL patients were included in this study, including 34 patients from the C-CHOEP phase 2 trial, 34 patients treated with CHOEP regimen matched to those in the C-CHOEP group, and 26 patients from a previous phase 2 trial of GDP-ML therapy. Results The complete remission rate of patients in the C-CHOEP group was significantly higher than that of GDP-ML and CHOEP group (55.9% vs. 32.0% and 29.4%, p = 0.047), with an overall response rate of 82.4 vs. 64.7%, and 72.0%, respectively (p = 0.244). The overall survival of patients in the C-CHOEP group was significantly superior than that of the GDP-ML and CHOEP group, with 1- and 3- year OS rates of 80.9% and 73.5% in the C-CHOEP group vs. 67.4% and 36.9% in the GDP-ML group, and 64.6% and 48.9% in the CHOEP group (p = 0.048). Progression-free survival (PFS) was also improved with median PFS of 19.8 months in the C-CHOEP group vs. 6.6 and 8.1 months in the GDP-ML and CHOEP group. The most common adverse events were hematologic toxicities. Grade 3–4 neutropenia and febrile neutropenia occurred in 58.8% and 20.6% of patients in the C-CHOEP group with no significant difference compared with the CHOEP group. Conclusion Our study suggested that C-CHOEP therapy was superior to CHOEP and GDP-ML therapy for newly diagnosed PTCL patients as shown by a significant improvement of CR rate and OS with a favorable safety profile. Trial registration: The study of C-CHOEP regimen is registered at ClinicalTrials.gov on December 2nd 2016 (NCT02987244). The study of GDP-ML regimen is registered at Chinese Clinical Trial Registry on March 30th 2012 (ChiCTR-ONC-12002055).