[Treatment outcome analysis of CTOP or CHOP regimen in newly diagnosed aggressive non-Hodgkin's lymphoma patients-results of a prospective, open, randomized, multicenter clinical trial].

OBJECTIVE: To compare the efficacy and toxicity of CTOP and CHOP regimen for newly diagnosed aggressive non-Hodgkin's lymphoma (NHL) patients. METHOD: From Oct 2006 to Jun 2009, 196 patients enrolled into this clinical trial from 72 centers in China were randomized into CTOP or CHOP group. RESULTS: Of 154 patients evaluated, 105 assigned in CTOP group and 49 in CHOP. Complete remission (CR) rate was 73.3%, and response rate (RR) was 87.6% in CTOP group and CR rate 71.4%, RR 86.2% in CHOP group, respectively (both P > 0.05). For B cell lymphomas, there was no difference in outcome between the two groups, but for T cell lymphomas, CR was 71.1% in CHOP, being significantly higher than that of 58.8% in CHOP group. There was no difference in hematological toxicity, GI reaction, liver and kidney function abnormality, but the occurrence of grade 3-4 alopecia in CTOP group (12.4%) was significantly lower than that in CHOP group (40.8%). The progress-free survival and overall survival (PFS and OS) at 1-, 2-, 3-year in CTOP group were 79%, 64.8%, 51.4% and 82.9%, 70.5%, 58.1%respectively; while in CTOP group were 77.6%, 61.2%, 49% and 81.6%, 67.3%, 55.1% respectively. CONCLUSION: CTOP regimen has similar effectiveness to CHOP regimen in newly diagnosed aggressive NHL, but with less side effects, and better efficacy for T cell lymphomas.