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: Ivana N M Micallef, Matthew J Maurer, Gregory A Wiseman, Daniel A Nikcevich, Paul J Kurtin, Michael W Cannon, Domingo G Perez, Gamini S Soori, Brian K Link, Thomas M Habermann, Thomas E Witzig
• Journal: Blood (Blood) Vol. 118 Issue 15 Pg. 4053-61 (Oct 13 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21673350 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antibodies, Monoclonal, Murine-Derived
• epratuzumab
• Rituximab
• Vincristine
• Doxorubicin
• Cyclophosphamide
• Prednisolone

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Murine-Derived (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Cyclophosphamide (administration & dosage, adverse effects)
• Disease-Free Survival
• Doxorubicin (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Humans
• Infusions, Intravenous
• Lymphoma, Large B-Cell, Diffuse (diagnostic imaging, drug therapy, mortality)
• Male
• Middle Aged
• Positron-Emission Tomography
• Prednisolone (administration & dosage, adverse effects)
• Prospective Studies
• Radiography
• Rituximab
• Survival Rate
• Time Factors
• Vincristine (administration & dosage, adverse effects)