Comparison of CHOP‐like with or without Tucidinostat in the first‐line treatment of Peripheral T‐cell lymphoma: a retrospective propensity score‐matched study

Abstract

Introduction: Peripheral T cell lymphoma (PTCL) is a group of highly heterogeneous malignancies with a high rate of disease relapse or progression.Tucidinostat (formerly known as chidamide(C)),a novel histone deacetylase inhibitor, has shown promising results in T-cell lymphomas by multiple mechanisms and is currently approved by the Chinese FDA for relapsed/refractory PTCL.In this retrospective study,we compared the efficacy of Tucidinostat with CHOP-like (C+CHT) and CHOP-like (CHT) alone in newly diagnosed PTCL. Methods: We reviewed 132 patients with PTCL diagnosed at the Shanxi Provincial Cancer Hospital Hematology Oncology Center from January 2015 to July 2021,of whom 109 patients were diagnosed with newly diagnosed PTCL,with last follow-up as of November 2022.Those in the C+CHT group who achieved complete remission received Tucidinostat maintenance therapy.The two groups of patients were subjected to 1:1 propensity score matching, according to whether the Prognostic index for PTCL-NOS(PIT) ≥2, pathological subtype, age＞60 years, and gender (matching tolerance = 0.024),36 pairs (n = 72) were matched. The primary study endpoint of this study was progression-free survival (PFS), and the secondary study endpoints were overall survival (OS), objective remission rate (ORR) at the end of the first-line chemotherapy regimen, CR rate and adverse events (AEs). Results: After matching,no statistical difference was found in baseline characteristics between C+CHT (n = 36) and control (n = 36) groups (all P > 0.05).The ORR for C+CHT group and control group were 72.2% and 52.8% (p = 0.088), with the CR rate of 44.4% and 33.3% (p = 0.334). After median follow-up of 18.7 (range 1.0–82.8) months, the median PFS in C+CHT group and control group were 17.2 and 5.0 months, respectively; the 2-year PFS was 67.9% and 25.3%, respectively; the median OS was 43.7 and 18.5 months, respectively; and the 2-year survival rate was 65.6% and 35.7%, respectively. Compared with control group, C+CHT group displayed significantly longer PFS(HR = 0.553, 95% CI: 0.319–0.959,p = 0.035, Figure 1A) and OS(HR = 0.483, 95% CI: 0.251–0.930, p = 0.029, Figure 1B). Cox analyses further verify that the effect values were basically consistent with the matching results (PFS HR = 0.552, OS HR = 0.469). Common grade 3–4 hematological AEs in the C+CHT group were leukopenia (55.9%), neutropenia (52.9%), thrombocytopenia (26.5%), and anemia (20.6%), the incidence of AEs was comparable to that of the control group. Common non-hematological AEs, the incidences of elevated AST and ALT were higher in the C+CHT group than in the control group(p = 0.028 and p = 0.021, respectively), but they were mainly grade 1 AEs, which could be resolved with supportive treatment. Keyword: aggressive T-cell non-Hodgkin lymphoma No conflicts of interests pertinent to the abstract.