DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China
- 31 October 2016
- journal article
- clinical trial
- Published by American Association for Cancer Research (AACR) in Clinical Cancer Research
- Vol. 22 (21), 5223-5228
- https://doi.org/10.1158/1078-0432.ccr-16-0153
Abstract
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 stages III–IV and had performance scores in 0 to 2. Six cycles of DDGP (dexamethasone, cisplatin, gemcitabline, and pegaspargase) or SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide) chemotherapy were randomly assigned to them. The primary end point was progression-free survival (PFS). Secondary end points included response rate and overall survival (OS). 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 PFS and 2-year OS rates were better in the DDGP group than that in the SMILE group (86% vs. 38% for 1-year PFS, P = 0.006; 74% vs. 45% for 2-year OS, P = 0.027). Complete remission (CR) rate and overall response rate (ORR) of the DDGP group were higher than that in the SMILE group (71% vs. 29%, P = 0.005 for CR rate; 95% vs. 67%, P = 0.018 for ORR). The SMILE group showed more serious leucopenia (P = 0.030) and severe allergic reaction (P = 0.015) than the DDGP group. In addition, two cases in the 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. Clin Cancer Res; 22(21); 5223–8. ©2016 AACR.Keywords
Funding Information
- National Natural Science Foundation of China (81172118)
- Henan province, China (201302001)
This publication has 27 references indexed in Scilit:
- Gemcitabine alone and/or containing chemotherapy is efficient in refractory or relapsed NK/T-cell lymphomaInvestigational New Drugs, 2012
- SMILE for natural killer/T-cell lymphoma: analysis of safety and efficacy from the Asia Lymphoma Study GroupBlood, 2012
- L‐asparaginase treatment in acute lymphoblastic leukemiaCancer, 2010
- Intravenous PEG-asparaginase during remission induction in children and adolescents with newly diagnosed acute lymphoblastic leukemiaBlood, 2010
- Extranodal NK/T-cell lymphoma nasal type: Efficacy of pegaspargase. Report of two patients from the United Sates and review of literatureLeukemia Research, 2010
- Phase I study of proteasome inhibitor bortezomib plus CHOP in patients with advanced, aggressive T-cell or NK/T-cell lymphomaAnnals of Oncology, 2008
- Revised Response Criteria for Malignant LymphomaJournal of Clinical Oncology, 2007
- First-line ifosfamide, methotrexate, etoposide and prednisolone chemotherapy ± radiotherapy is active in stage I/II extranodal NK/T-cell lymphomaLeukemia & Lymphoma, 2006
- CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatmentSeminars in Radiation Oncology, 2003
- Chemotherapeutic Agents and Modulation of Natural Killer Cell Activity in VitroJournal of Immunopharmacology, 1985