Key result
The CPOP regimen (pixantrone, cyclophosphamide, vincristine, prednisone) yielded an objective response rate of 73% and a complete response rate of 47% in phase II patients with relapsed aNHL.
Why the study?
Does the CPOP regimen (pixantrone, cyclophosphamide, vincristine, prednisone) provide effective response rates and acceptable cardiotoxicity in patients with relapsed aggressive non-Hodgkin lymphoma?
Does the CPOP regimen (pixantrone, cyclophosphamide, vincristine, prednisone) provide effective response rates and acceptable cardiotoxicity in patients with relapsed aggressive non-Hodgkin lymphoma?
The CPOP regimen utilizing pixantrone instead of doxorubicin demonstrated a 73% objective response rate in relapsed aggressive NHL, though myelosuppression and some cardiotoxicity were still observed.
Supports further study of CPOP in relapsed aNHL; leaves open its role versus standard regimens pending randomized data.
Pixantrone is a potentially more effective, less cardiotoxic alternative to doxorubicin for patients with aggressive non-Hodgkin lymphoma (aNHL). This phase I/II non-comparative study evaluated pixantrone in place of doxorubicin in the standard CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone), i.e. CPOP (cyclophosphamide, pixantrone, vincristine, and prednisone), in patients with relapsed aNHL who had previously received CHOP ± rituximab. Patients were administered pixantrone on day 1 of each 21-day cycle. Phase I (n = 35) dose escalation from 80 mg/m(2) to 180 mg/m(2) established the phase II (n = 30) dose as 150 mg/m(2). In phase II, 20 patients (67%) received all six planned cycles. The objective response rate was 73%, complete response/complete response unconfirmed (CR/CRu) rate was 47%, and median overall survival was 17.9 months. Myelosuppression was nearly universal. Six patients (20%) developed febrile neutropenia. Overall, left ventricular ejection fraction (LVEF) declines ≥10% occurred in 14 patients; declines seemed transient and unrelated to dose. Symptomatic cardiac failure occurred in four patients; however, pre-existing conditions confounded causality.
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Borchmann et al. (2011) studied relapsed aggressive non-Hodgkin lymphoma (n=65). Pixantrone in combination with cyclophosphamide, vincristine, and prednisone (CPOP) was evaluated on Objective response rate. The CPOP regimen (pixantrone, cyclophosphamide, vincristine, prednisone) yielded an objective response rate of 73% and a complete response rate of 47% in phase II patients with relapsed aNHL.
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