title: DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Yingying
authors.initials: Y
authors.lastname: Cui
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Zhenchang
authors.initials: Z
authors.lastname: Sun
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Li
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xinhua
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Jingjing
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xiaorui
authors.initials: X
authors.lastname: Fu
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Wang
authors.initials: W
authors.lastname: Ma
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xudong
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Chang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Feifei
authors.initials: F
authors.lastname: Nan
authors.affiliation: Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
authors.forename: Wencai
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Hematology, Shanxi Cancer Hospital, Taiyuan, Shanxi, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Su
authors.affiliation: Department of Oncology, Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China.
authors.forename: Jinghua
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
authors.forename: Hongwei
authors.initials: H
authors.lastname: Xue
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China. mingzhi_zhang1@163.com.
authors.forename: Mingzhi
authors.initials: M
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001215:Asparaginase / Q000008:administration & dosage; D002681:China; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D054391:Lymphoma, Extranodal NK-T-Cell / Q000188:drug therapy*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D055611:Natural Killer T-Cells / Q000187:drug effects*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012074:Remission Induction / Q000379:methods; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D011092:Polyethylene Glycols; D005047:Etoposide; C042705:pegaspargase; D003907:Dexamethasone; D001215:Asparaginase; D002945:Cisplatin; D007069:Ifosfamide; D008727:Methotrexate; D000093542:Gemcitabine