Abstract
7513 Background: The addition of etoposide to CHOP (CHOEP) resulted in improved outcome of young patients with good-prognosis aggressive lymphoma (NHL-B1 trial; Blood 2004, 104:626). In order to improve results further, the maximal dose-escalated version of CHOEP-21 tolerable without stem cell support in a preceding dose-escalation study (Hi-CHOEP: C: 1400 mg/m2, H: 65 mg/m2, O: 2 mg, E: 175 mg/m2 × 3, P: 100 mg × 5) was compared to baseline CHOEP-21 in a randomized trial. Methods: Intention-to-treat-analysis comparing CHOEP-21 (n = 194) with Hi-CHOEP (n = 195) in 389 young (18–60 years) patients with good-prognosis (aaIPI = 0,1) aggressive lymphoma. Results: Despite excellent adherence to the protocol (median relative dose of myelosuppressive drugs CHOEP-21: 98%; Hi-CHOEP: 93%), CR/CRu (78.4% vs. 79.5%; p = 0.783), and progressions (12.4% vs. 9.7%; p = 0.409) were not significantly different. After 37 months median observation, there was no difference in the primary endpoint time to treatment failure (64% vs. 68%; p = 0.639) nor overall survival (83% vs. 86%; p = 0.849). Neither low-risk nor low-intermediate risk patients profited from Hi-CHOEP. In a multivariate analysis, elevated LDH and advanced stage (III&IV) were confirmed as independent risk factors for TTF and survival. Hi-CHOEP was considerably more toxic than CHOEP-21 (grade 3 & 4 leukocytopenia 100% vs. 87.2%, p < 0.001, thrombocytopenia 80.8% vs. 9.6%, p < 0.001; infections 19.7% vs. 5.4%, p ≤ 0.001; therapy associated deaths 2.6% vs. 0%). Conclusions: Due to its equal efficacy and lower toxicity, CHOEP-21 is to be preferred over dose-escalated Hi-CHOEP. Our results indicate that dose escalation (in contrast to dose-densification and/or addition of rituximab) does not hold promise for young good-prognosis patients with aggressive lymphoma. Supported by Deutsche Krebshilfe. [Table: see text]
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