DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China

摘要: Purpose: Optimal treatment strategies for advanced natural killer/T (NK/T)-cell lymphoma have not been fully defined. We compared the safety and efficacy of DDGP SMILE regimens NK/T-cell in a randomized controlled, multicenter, open-label clinical trial. Experimental Design: Patients were newly diagnosed stages III–IV had performance scores 0 to 2. Six cycles (dexamethasone, cisplatin, gemcitabline, pegaspargase) or methotrexate, ifosfamide, L-asparaginase, etoposide) chemotherapy randomly assigned them. The primary end point was progression-free survival (PFS). Secondary points included response rate overall (OS). trial is ongoing registered with ClinicalTrials.gov (No. NCT01501149). Results: Of 42 patients enrolled, 21 treated therapy, therapy. 1-year PFS 2-year OS rates better group than that (86% vs. 38% PFS, P = 0.006; 74% 45% OS, 0.027). Complete remission (CR) (ORR) higher (71% 29%, 0.005 CR rate; 95% 67%, 0.018 ORR). showed more serious leucopenia ( 0.030) severe allergic reaction 0.015) group. In addition, two cases underwent grade 4 mucosal reaction. Conclusions: resulted significant improvement tolerability patients. Clin Cancer Res; 22(21); 5223–8. ©2016 AACR .