Cyclophosphamide, pegylated liposomal doxorubicin (Caelyx), vincristine and prednisone (CCOP) in elderly patients with diffuse large B-cell lymphoma: results from a prospective phase II study

Servei d'Hematologia Clinica, Hospital de la Santa Creu i Sant Pau, Av. Sant Antoni M(a) Claret 167, 08025 Barcelona, Spain. rmartino@hsp.santpau.es BACKGROUND AND OBJECTIVES. Anthracycline-based combination chemotherapy regimens are the standard therapy for patients with diffuse large B-cell lymphoma (DLBCL), but such regimens may be poorly tolerated in elderly patients. DESIGN AND METHODS. In a prospective phase II study we analyzed the feasibility of a regimen (CCOP) that includes pegylated liposomal doxorubicin (Caelyx ) plus vincristine, cyclophosphamide and prednisone in patients with DLBCL above the age of 60 years. RESULTS. Thirty-three patients, with a median age of 74 years, were enrolled in the study. The overall response rate was 64% (49% complete remissions and 15% partial remissions). The estimated one-year overall and event-free survivals were 55% (95% CI, 38-72) and 45% (95%CI, 28-62), respectively. The only relevant toxicity was neutropenia, which reached grades 3-4 in 21 cases (64%). INTERPRETATION AND CONCLUSIONS. These results suggest that CCOP appears to be an acceptable alternative for elderly patients with DLBCL, and randomized trials against a conventional doxorubicin-containing regimen are justified.