CURRENT TREATMENT FOR NK/T CELL LYMPHOMA:SUN YAT‐SEN UNIVERSITY CANCER CENTER EXPERIENCE, CHINA

Abstract

Optimal therapeutic strategies have not been fully defined for NK/TCL yet. SMILE, AspaMetDex and P-Gemox were recommended as major effective chemotherapy regimen by 2016 NCCN guideline. We initiated a prospective, multicenter, randomized, clinical trial in March 2014. And the purpose of this study is to evaluate the efficacy and toxicity between P-Gemox and AspaMetDex for newly diagnosed stage I/ II patients as well as stage III/IV or relapsed/refractory NK/TCL. All patients were randomly assigned to receive either P-Gemox + thalidomide regimen (Group A: Pegaspargase 2000 U/m2; im d1, Gemcitabine 1000 mg/m2; ivdrip, d1, d8. Oxaliplatin 130 mg/m2; ivdrip, d1, thalidomide 100 mg/d po, for one year) or AspaMetDex regimen (Group B: Pegaspargase 2000 U/m2; im, d1, Methotrexate 3000 mg/ m2; civ 6-hour,d1, calcium folinate 30 mg iv, q6h, until reached safe serum MTX induction chemotherapy of both regimens were administered and followed by EIFRT. ASCT as consolidation was given to good responders (CR and PR) to two Groups for advanced cases. The results of interim analysis for 110 cases were shown as Table 1. For the patients with early stage (I/II) and advanced stage (III/IV) or relapsed disease, PFS and OS were similar in Group A and Group B. Agranulocytosis, thrombocytopenia, and infections relative were more common in Group B, whereas anemia, hyperbilirubinemia, edema, and increased BUN/Cr were more common in Group B. All 3 patients died of treatment related toxicity in Group B. Therefore, our preliminary results showed both P-Gemox and AspaMetDex yielded promising efficacy for early stage as well as advanced or relapsed NK/TCL, though survival still is unsatisfied for this patients population. Meanwhile, (Figure Presented) P-Gemox may be less toxic, and can be used in outpatients clinics. This clinical trial is still ongoing (ClinicalTrials.gov, NCT 2085655). Furthermore, promising response of single agent, chidamide, a new oral HDAC inhibitor, for the treatment of relapsed or refractory NK/ TCL without significant EBV-reactivation was recently observed in SYSUCC. PD/PK of chidamide for different dosage and schedule will be presented. Table 1: Comparison of effectiveness between two Groups. EIFRT: Extensive involved field radiotherapy.