A randomized phase II study of CEOP with or without semustine as induction chemotherapy in patients with stage I(E)/II(E) extranodal NK/T-cell lymphoma, nasal type in the upper aerodigestive tract

作者：Ma Xuejun; Guo Ye; Pang Ziqiang; Wang Biyun; Lu Hongfen; Gu Ya Jia; Guo Xiaomao^*

来源：Radiotherapy and Oncology, 2009, 93(3): 492-497.

DOI：10.1016/j.radonc.2009.08.045

• NK/T-cell lymphoma
• Chemotherapy
• Semustine

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)/II(E) extianodal NK/T-cell lymphoma, nasal type in the tipper aerodigestive tract
Patients and methods: Seventy-five eligible patients were randomized to receive either CEOP or CLOP Plus semustine followed by involved-field radiotherapy
Results: 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.

• 出版日期2009-12
• 单位复旦大学