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Clinical Trial
. 2011 Oct 13;118(15):4053-61.
doi: 10.1182/blood-2011-02-336990. Epub 2011 Jun 14.

Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma

Ivana N M Micallef  1 , 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
Affiliations
Clinical Trial

Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma

Ivana N M Micallef et al. Blood. .

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.

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Figures

Figure 1
Figure 1
Time-to-event curves for EFS, PFS, and OS. (A) Intention-to-treat patients. (B) Eligible patients.
Figure 2
Figure 2
Time-to-event curve by IPI status. (A) EFS. (B) OS.
Figure 3
Figure 3
EFS. (A) Based on interim PET (PET2) results. (B) Based on post-treatment PET (PET6) results.
Figure 4
Figure 4
Comparison of ER-CHOP intention-to-treat results with R-CHOP treated patients from the University of Iowa/Mayo Clinic SPORE Molecular Epidemiology Resource. (A) EFS. (B) OS.
See this image and copyright information in PMC

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