Efficacy and Adverse Effects of Rituximab Combined with a TCOP Regimen in Patients with Untreated Diffuse Large B-cell Lymphoma and Follicular Lymphoma

Pirarubicin (tetrahydropyranyl adriamycin: THP) is a doxorubicin (DOX) derivative with lower cardiotoxicity than DOX. However, there is little information on clinical outcome and toxicity in patients treated with an R-TCOP regimen including this drug (rituximab, THP, cyclophosphamide, vincristine, and prednisolone). We retrospectively analyzed the efficacy and safety of R-TCOP compared to TCOP in patients with diffuse large B-cell lymphoma (DLBCL) (n = 91) or follicular lymphoma (FL) (n = 25). In cases of DLBCL, the median follow-up times for surviving patients were 864 days in the TCOP group (n = 41) and 430 days in the R-TCOP group (n = 50). Patients treated with R-TCOP showed a significantly better response to treatment than those treated with TCOP (P < 0.01) and a significantly longer three-year overall survival (OS) (70% for R-TCOP vs. 50% for TCOP,P = 0.02). Factors influencing the improved OS with R-TCOP treatment were age < 60 years, clinical stage IV disease, International Prognostic Index HI-risk and H-risk, serum lactate dehydrogenase > normal, performance status ≥ 2, B symptoms, extranodal sites ≥ 2, and bone marrow involvement. In a Cox proportional hazard model, the addition of rituximab was associated with good OS. In cases of FL, the response to treatment, OS, and progression-free survival did not differ significantly between the two regimens. Adverse events including cardiac toxicities did not differ significantly between R-TCOP and TCOP treatment, and there were no deaths associated with adverse events. OS was significantly improved among IPI HI-risk or H-risk cases and in advanced-stage patients with DLBCL who received R-TCOP compared to those receiving TCOP. The incidence of adverse events did not differ between the two regimens.