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

• Published in: Clinical cancer research 2016-11, Vol.22 (21), p.5223-5228
• Main Authors: Li, Xin, Cui, Yingying, Sun, Zhenchang, Zhang, Lei, Li, Ling, Wang, Xinhua, Wu, Jingjing, Fu, Xiaorui, Ma, Wang, Zhang, Xudong, Chang, Yu, Nan, Feifei, Li, Wencai, Su, Liping, Wang, Jinghua, Xue, Hongwei, Zhang, Mingzhi
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Asparaginase - administration & dosage; China; Cisplatin - administration & dosage; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Dexamethasone - administration & dosage; Disease-Free Survival; Etoposide - administration & dosage; Female; Humans; Ifosfamide - administration & dosage; Lymphoma, Extranodal NK-T-Cell - drug therapy; Male; Methotrexate - administration & dosage; Middle Aged; Natural Killer T-Cells - drug effects; Neoplasm Recurrence, Local - drug therapy; Polyethylene Glycols - administration & dosage; Remission Induction - methods; Young Adult
• ISSN: 1078-0432; 1557-3265
• DOI: 10.1158/1078-0432.CCR-16-0153

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. 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). 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. 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.