CHOEP versus Alternating hCHOP/IVEP for High Grade Non-Hodgkin’s Lymphomas: A Randomized Multicentre Trial

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185 patients with high grade non-Hodgkin’s lymphoma stages II-IV entered this multicentre trial and were randomized to receive either four cycles of CHOEP (cyclophosphamide 750mg/m2 i.v. d 1, dox-orubicin 50 mg/m2 i.v. d 1, vincristine 2 mg i.v. d 1, etoposide 100 mg/ m2 i.v. d 3–5, prednisolone 100 mg p.o. d 1–5) (treatment arm A), or four cycles of chemotherapy with hCHOP (cyclophosphamide 1,200 mg/m2 i.v. d 1, doxorubicin 40 mg/m2 i.v. d 1 + 2, vincristine 2mg i.v. d 1, prednisolone 100 mg p.o. d 1–5) alternating with IVEP (ifosfamide 1,500 mg/m2 i.v. d 1–5, vindesine 3 mg/m2 i.v. d 1, etoposide 120mg/m2 i.v. d 3–5, prednisolone 100mg p.o. d 1–5) in treatment arm B. After four cycles of chemotherapy an involved field irradiation with a total dose of 35 Gy was given to all patients demonstrated to be in complete or partial remission without persisting extranodal disease. So far, 146 patients have completed treatment and are evaluable for response and survival. A complete response (CR) was seen in 124/146 patients (86%) with 89% CR in arm A vs. 83% CR in arm B. During a median follow-up of 17 months (range 2–40) 30 patients relapsed (16 pts. arm A, 14 pts. arm B). The overall survival at 40 months is projected to be 70% vs. 71 % for arm A and B, respectively. Disease-free survival is projected to be 68% in arm A and 59% in arm B at 40 months. So far, the differences in CR, survival and disease-free survival are not statistically significant. Toxicity of all regimens was acceptable, however, with a significant morbidity and one treatment-related death in patients > 70 years after hCHOP. Main side effects were mild nausea/vomiting, leukopenia and fever/infection associated with leukopenia. In conclusion, both treatment modalities produced high complete remission rates. A longer follow-up will be needed to exclude differences in overall and disease-free survival.

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