THE EFFICACY AND TOLERANCE OF CHIDAMIDE, PREDNISONE, CYCLOPHOSPHAMIDE AND THALIDOMIDE (C‐PCT) IN RELAPSED OR REFRACTORY PERIPHERAL T‐CELL LYMPHOMA: A PILOT STUDY

Abstract

Introduction: The aim of this study was to evaluate the clinical efficacy and safety of chidamide, prednisone, cyclophosphamide and thalidomide (C-PCT) in relapsed or refractory (R/R) Peripheral T-cell lymphoma (PTCL). The primary endpoint was overall response rate (ORR). Methods: Between June 2015 and September 2016, 12 Chinese patients with R/R PTCL were enrolled in this study. The median age was 52 years (range 28−69). Four patients were males, and 8 were females. Four (33.3%) patients were diagnosed as subtypes of PTCL not otherwise specified (PTCL, NOS), 4 (33.3%) were angioimmunoblastic T-cell lymphoma (AITL), 2 (16.7%) were type II enteropathy-associated T-cell lymphoma (EATL-II), 1 (8.3%) was ALK negative anaplastic large-cell lymphoma (ALK- ALCL) and 1 (8.3%) was cutaneous T-cell lymphoma (CTCL). Majority (11/12, 91.7%) of patients had an Ann Arbor stage III or IV, the only patient with CTCL had a TNMB stage IIB; 75% (9/12) patients had poor performance status, with ECOG 2 or more. The median IPI score was 2 (range 1−5) and 50% of patients had IPI between 3 and 5. The median number of prior systemic chemotherapies was 2 (range 1−4), 10 (83.3%) patients presented with PD to last line of prior systemic chemotherapy at enrollment, 1 was in SD, only 1 achieved PR but failed to autologous stem cell mobilization. C-PCT regimen was administered orally until disease progression or unacceptable toxicity. Results: The median time on treatment was 12 months (range 3–18 months). The ORR was 83.3% (10/12), 5 (41.7%) and 4 (33.3%) patients achieved CR and PR, respectively, 1(8.3%) patients obtained SD and 2 (16.7%) patients presented with PD. The median time to response was 3 months (range 3−6 months). All (100%, 4/4) the AITL patients responded to C-PCT regimen, including 2 CR and 2 PR; Notably, the patient relapsed after autologous stem transplantation (ASCT) achieved PR at 3 months and experienced further CR at 9 months. Approximately 75% (3/4) of PTCL-NOS patients achieved CR and 2 patients of EATL-II achieved PR and SD, respectively. The patient with CTCL progressed to the previous systemic chemotherapies and achieved PR at 3 months. With a median follow-up of 13 (3–18) months, 2 patients relapsed and 3 patients died of PD. The median overall survival (OS) and progression-free survival (PFS) have not been reached. The most common grade 3/4 adverse events were neutropenia (22%), thrombocytopenia (16%) and anemia (20%). Moreover, one patient experienced epstein-barr virus reactivation. Conclusions: C-PCT as salvage therapy was effective with manageable toxicity for patients with R/R PTCL. Further prospective trials are warranted to validate the efficacy of C-PCT in a large cohort of patients. Keywords: Chemotherapy; peripheral T-cell lymphomas (PTCL).