title: Rituximab and escalated chemotherapy in elderly patients with aggressive diffuse large-cell lymphoma: a controlled clinical trial.
abstract: The treatment of elderly patients with aggressive malignant lymphoma has not been defined. The addition of rituximab to conventional chemotherapy has been reported to improve the outcome, but most patients have good prognostic factors (performance status < 2, no severe associated diseases, low or low-intermediate clinical risk). Thus, we developed a combined regimen, including escalated doses of anthracycline and rituximab. The endpoint was to improve event-free survival (EFS) and overall survival. Two hundred and four (204) patients were randomly assigned to receive an escalated chemotherapy regimen (CEOP) with escalated dose of epirubicin, compared to the same regimen and addition of rituximab. All patients had poor prognostic factors: high- or high-intermediate clinical risk, poor performance status, bulky disease, and more than 2 with extranodal involvement. In an intent-to-treat analysis, all patients were evaluable for efficacy and toxicity. The complete response rates were similar in both arms: 74% in chemotherapy and 78% in the rituximab + chemotherapy program. EFS and overall survival were similar: 77% and 84%, respectively, in combined chemotherapy and 75% and 81% in the rituximab-chemotherapy regimen. Toxicity was mild and well tolerated. In elderly patients with diffuse large-cell lymphoma and poor prognostic factors, rituximab did not improve their outcome.
authors.affiliation: Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, México, D.F. Mexico. agustin.aviles@imss.gob.mx
authors.forename: Agustin
authors.initials: A
authors.lastname: Avilés
authors.forename: María Jesus
authors.initials: MJ
authors.lastname: Nambo
authors.forename: Claudia
authors.initials: C
authors.lastname: Castañeda
authors.forename: Sergio
authors.initials: S
authors.lastname: Cleto
authors.forename: Natividad
authors.initials: N
authors.lastname: Neri
authors.forename: Edgar
authors.initials: E
authors.lastname: Murillo
authors.forename: Judith
authors.initials: J
authors.lastname: Huerta-Guzmán
authors.forename: Margarita
authors.initials: M
authors.lastname: Contreras
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007167:Immunotherapy; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology*; D000069283:Rituximab; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D015251:Epirubicin; D000069283:Rituximab