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 and SMILE regimens for advanced NK/T cell lymphoma in a randomized controlled, multicenter and open-label clinical trial. Experimental Design:Patients were newly diagnosed in stage III-IV and had performance scores in 0-2. Six cycles of DDGP (dexamethasone, cisplatin, gemcitabline, pegaspargase) or SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide) chemotherapy were randomly assigned to them. The primary end point was progression free survival. Secondary end points included response rate and overall survival. The trial is ongoing and is registered with ClinicalTrials.gov (No. NCT01501149). Results:Of 42 patients enrolled, 21 were treated with DDGP therapy and 21 patients were treated with SMILE therapy. The 1-year progression-free survival (PFS) and 2-year overall survival (OS) rates were better in DDGP group than that in SMILE group (86% versus 38% for 1-year PFS, P=0.006; 74% versus 45% for 2-year OS, P =0.027). Complete remission (CR) rate and overall response rate (ORR) of DDGP group were higher than that in SMILE group (71% versus 29%, P =0.005 for CR rate; 95% versus 67%, P =0.018 for ORR). SMILE group showed more serious leucopenia (P =0.030) and severe allergic reaction (P =0.015) than DDGP group. In addition, 2 cases in SMILE group underwent grade 4 mucosal reaction. Conclusions:DDGP chemotherapy resulted in significant improvement in PFS, OS and better tolerability compared with SMILE chemotherapy for newly diagnosed advanced NK/T cell lymphoma patients.
- Received January 19, 2016.
- Revision received March 8, 2016.
- Accepted March 30, 2016.
- Copyright ©2016, American Association for Cancer Research.