Dose dense (CEOP-14) vs dose dense and rituximab (CEOP-14 +R) in high-risk diffuse large cell lymphoma

• Published in: Medical oncology (Northwood, London, England) London, England), 2007-01, Vol.24 (1), p.85-89
• Main Authors: Avilés, Agustin, Nambo, María J, Neri, Natividad, Cleto, Sergio, Castañeda, Claudia, Huerta-Guzmàn, Judith, Murillo, Edgar, Contreras, Margarita, Talavera, Alejandra, González, Martha
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cyclophosphamide - therapeutic use; Dose-Response Relationship, Drug; Epirubicin - therapeutic use; Female; Humans; Lymphoma, Large B-Cell, Diffuse - drug therapy; Male; Middle Aged; Oncology; Prednisone - therapeutic use; Rituximab; Survival Rate; Treatment Outcome; Vincristine - therapeutic use
• ISSN: 1357-0560; 1559-131X
• DOI: 10.1007/BF02685907

To assess efficacy and toxicity of rituximab and dose chemotherapy in high-risk diffuse large cell lymphoma, we conducted a controlled clinical trial to assess efficacy and toxicity of a dose-dense regimen CEOP- 14 (cyclophosphamide, epirubicin, vincristine, and prednisone every 14 d) compared to CEOP-14 plus rituximab. One hundred and ninety-six patients were randomized to received CEOP-rituximab (cyclophosphamide 1500 mg/m2, epirubicin 120 mg/m2, vincristine, and prednisone at standard dose and rituximab at 375 mg/m2) compared with the same chemotherapy administered every 14 d (CEOP-14). In an intent-to-treat analysis all patients were available for efficacy and toxicity. Complete response in CEOP-14 was observed in 73 cases (74%) and in 75 patients (76%) in the CEOP-R regimen (76%) (p = 0.8). With a median follow-up of 53.4 mo, median has not been reached in time to tumor-progression (TTP) and overall survival (OS). Actuarial curves at 5 yr showed that TTP and OS in patients treated with CEOP-R were 74% and 67%, respectively, that were not statistical different when compared to CEOP-14, 72% and 65%, respectively (p = 0.8). Acute toxicity was mild and well tolerated. The use of a dense-dose regimen is useful and well tolerated in patients with very high risk diffuse large cell lymphoma. The addition of rituximab did not improve outcome in these setting of patients.