A randomized phase II study of CEOP with or without semustine as induction chemotherapy in patients with stage IE/IIE extranodal NK/T-cell lymphoma, nasal type in the upper aerodigestive tract
A randomized phase II study of CEOP with or without semustine as induction chemotherapy in patients with stage IE/IIE extranodal NK/T-cell lymphoma, nasal type in the upper aerodigestive tract
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DOI：
10.1016/j.radonc.2009.08.045
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发表时间：
2009-12-01
影响因子：
5.7
通讯作者：
Guo, Xiaomao
中科院分区：
文献类型：
--
作者：
Ma, Xuejun;Guo, Ye;Guo, Xiaomao
目的：在这项随机II期研究中，我们评估了半胱氨酸加入CEOP方案作为诱导化疗对I-E/IIE期外淋巴结NK/ t细胞淋巴瘤患者的疗效，鼻部气消化道鼻部型患者。患者和方法：75名符合条件的患者随机接受CEOP或CLOP加半胱氨酸，随后接受涉及野放疗。CFOP组诱导化疗总有效率为57.9%，CEOP + semusstine组为62.2% (P= 0.71)，中位随访时间为30.1个月。2年总生存率分别为73.3%和62.2% （P = 0.37）。两组的毒性相当且可控。通过单因素和多因素分析，确定2期PS、IIE期和LDH水平升高是不良预后因素。一种新的预后指标将患者分为三组（低危，无不良因素；中危，1个因素；高危，2个或3个因素），预后差异高度显著。两年总生存率为87.5%,60.6；5%和30% （P=0.0002）。结论：在CEOP方案中加入半胱氨酸并不会提高疗效。需要对中高危患者探索更有效的治疗方法。2009爱思唯尔爱尔兰有限公司放射与肿瘤93(2009)492-497版权所有
Purpose: In this randomized phase II study, we evaluated the efficacy of semustmine added to CEOP regimen as induction chemotherapy in patients with stage I-E/IIE extianodal NK/T-cell lymphoma, nasal type in the tipper aerodigestive tractPatients and methods: Seventy-five eligible patients were randomized to receive either CEOP or CLOP Plus semustine followed by involved-field radiotherapyResults: The overall response rate of induction chemotherapy was 57.9% in CFOP arm compared with 62 2 to CEOP plus semustine arm (P=0 71) With a median follow-up of 30.1 months. 2-year overall survival was 73.3% and 62.2%, respectively (P = 0.37). Toxicities in both arms were comparable and manageable. Through univariate to and multivariate analysts, PS of 2, Stage IIE and elevated LDH level were identified to be adverse prognostic factors. A new prognostic index categorized three groups of patients (low risk, no adverse factors; intermediate risk, one factor, and high risk, 2 or 3 factors) with highly significant difference of prognosis. Two-year overall survival was 87.5%, 60.6;5 and 30% respectively (P=0.0002).Conclusions: The addition of semustine to CEOP regimen was not associated with improved efficacy. More effective treatment needs to be explored in patients with intermediate or high risk. (C) 2009 Elsevier Ireland Ltd. All rights reserved Radiotherapy and Oncology 93 (2009) 492-497