Department of Oncology, The First Affiliated Hospital of Zhengzhou University; Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Clin Cancer Res. 2016 Nov 1;22(21):5223-5228. doi: 10.1158/1078-0432.CCR-16-0153. Epub 2016 Apr 8.
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.
尚未完全明确晚期自然杀伤（NK）/T 细胞淋巴瘤的最佳治疗策略。我们在一项随机对照、多中心、开放性临床试验中比较了 DDGP 和 SMILE 方案治疗晚期 NK/T 细胞淋巴瘤的安全性和疗效。
新诊断为 III-IV 期且表现评分为 0-2 的患者被随机分配接受 6 个周期的 DDGP（地塞米松、顺铂、吉西他滨和培门冬酶）或 SMILE（地塞米松、甲氨蝶呤、异环磷酰胺、左旋门冬酰胺酶和依托泊苷）化疗。主要终点为无进展生存期（PFS）。次要终点包括缓解率和总生存期（OS）。该试验正在进行中，并在 ClinicalTrials.gov 注册（登记号：NCT01501149）。
42 例患者入组，其中 21 例接受 DDGP 治疗，21 例接受 SMILE 治疗。DDGP 组 1 年 PFS 和 2 年 OS 率均优于 SMILE 组（1 年 PFS 为 86%比 38%，P=0.006；2 年 OS 为 74%比 45%，P=0.027）。DDGP 组完全缓解（CR）率和总缓解率（ORR）高于 SMILE 组（CR 率为 71%比 29%，P=0.005；ORR 为 95%比 67%，P=0.018）。SMILE 组白细胞减少症（P=0.030）和严重过敏反应（P=0.015）发生率高于 DDGP 组。此外，SMILE 组有 2 例发生 4 级黏膜反应。
与 SMILE 化疗相比，DDGP 化疗可显著改善新诊断的晚期 NK/T 细胞淋巴瘤患者的 PFS、OS，且耐受性更好。Clin Cancer Res; 22(21); 5223-8. ©2016 AACR.
