A phase III trial comparing R-CHOP 14 and R-CHOP 21 for the treatment of patients with newly diagnosed diffuse large B-cell non-Hodgkin’s lymphoma.
D. Cunningham, P. Smith, P. Mouncey, W. Qian, C. Pocock, K. M. Ardeshna, J. Radford, J. Davies, A. McMillan, D. Linch
Background: The addition of rituximab to standard therapy with cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP21) has resulted in improved survival outcomes in the treatment of diffuse large B-cell non-Hodgkin’s lymphoma (DLBC NHL). In addition, the administration of CHOP as a 14 day cycle (CHOP14) has shown benefit over standard CHOP21 chemotherapy. This randomised study was designed to evaluate the toxicity and survival outcomes achieved with the addition of rituximab to CHOP14 (R-CHOP14), as compared to standard therapy (R-CHOP21) in newly diagnosed DLBC NHL.
Methods: Patients were randomised to receive either eight cycles of standard R-CHOP21 or six cycles of R-CHOP14 (+ G-CSF) with two additional cycles of single agent rituximab. Randomisation was stratified by age (<60 vs >60), WHO performance status (0–1 vs 2) and LDH level (normal vs raised). The primary endpoint is overall survival. The study was powered to detect an improvement in 2-year survival in the R-CHOP14 arm of 8% (70% to 78%) with 5% significance and 90% power (2-sided).
Results: Recruitment is complete with 1080 patients randomised. Patient characteristics in the R-CHOP21 and R-CHOP14 arms are; IPI score of >4 17%:15%, stage III/IV disease 63%:62%, B symptoms 44%:47%, bulk disease 51%:48%. Median age is 61 years in both arms. 82% of patients in the R-CHOP21 arm completed study therapy as compared to 89% in the R-CHOP14 arm. Reported grade III/IV toxicities in the R-CHOP21 and R-CHOP14 arms are; neutropenia 57%:31%, thrombocytopenia 5%:9%, Infection 22%:17%, cardiac 1%:2%, nausea & vomiting 8%:8%, mucositis 2%:3%. The radiological complete response rate (CR/CRu) is 47% in both treatment arms. With a median follow-up 14 months 805 patients remain alive.
Conclusions: Results indicate that R-CHOP14 can be delivered as effectively as R-CHOP21 with comparable levels of acute toxicity. Final analysis will be performed when 330 deaths have occurred.
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