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Clin Cancer Res. 2016 Nov 1;22(21):5223-5228. Epub 2016 Apr 8.

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

Author information

1
Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
2
Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
3
Department of Hematology, Shanxi Cancer Hospital, Taiyuan, Shanxi, China.
4
Department of Oncology, Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China.
5
Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
6
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.

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.

Comment in

PMID:
27060152
DOI:
10.1158/1078-0432.CCR-16-0153
[Indexed for MEDLINE]
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