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

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 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. (C) 2009 Elsevier Ireland Ltd. All rights reserved Radiotherapy and Oncology 93 (2009) 492-497