title: Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma.
abstract: Approximately 60% of patients with diffuse large B-cell non-Hodgkin lymphoma (DLBCL) are curable with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemoimmunotherapy. Epratuzumab (E) is an unlabeled anti-CD22 monoclonal antibody with efficacy in relapsed DLBCL. This phase 2 trial tested the safety and efficacy of combining E with R-CHOP (ER-CHOP) in untreated DLBCL. A secondary aim was to assess the efficacy of interim positron emission tomography (PET) to predict outcome in DLBCL. Standard R-CHOP with the addition of E 360 mg/m(2) intravenously was administered for 6 cycles. A total of 107 patients were enrolled in the study. Toxicity was similar to standard R-CHOP. Overall response rate in the 81 eligible patients was 96% (74% CR/CRu) by computed tomography scan and 88% by PET. By intention to treat analysis, at a median follow-up of 43 months, the event-free survival (EFS) and overall survival (OS) at 3 years in all 107 patients were 70% and 80%, respectively. Interim PET was not associated with EFS or OS. Comparison with a cohort of 215 patients who were treated with R-CHOP showed an improved EFS in the ER-CHOP patients. ER-CHOP is well tolerated and results appear promising as a combination therapy. This study was registered at www.clinicaltrials.gov as #NCT00301821.
authors.affiliation: Mayo Clinic Rochester, Rochester, MN, USA.
authors.forename: Ivana N M
authors.initials: IN
authors.lastname: Micallef
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Maurer
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Wiseman
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Nikcevich
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Kurtin
authors.forename: Michael W
authors.initials: MW
authors.lastname: Cannon
authors.forename: Domingo G
authors.initials: DG
authors.lastname: Perez
authors.forename: Gamini S
authors.initials: GS
authors.lastname: Soori
authors.forename: Brian K
authors.initials: BK
authors.lastname: Link
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Habermann
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D016403:Lymphoma, Large B-Cell, Diffuse / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D049268:Positron-Emission Tomography; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D011859:Radiography; D000069283:Rituximab; D015996:Survival Rate; D013997:Time Factors; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; C448700:epratuzumab; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011239:Prednisolone