A pilot study of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated, diffuse large B-cell lymphoma

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Abstract
BACKGROUND. In this pilot study, the authors assessed the feasibility of combination epratuzumab and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (ER‐CHOP) in patients with newly diagnosed diffuse large B‐cell lymphoma (DLBCL). METHODS. Patients received chemotherapy on the following schedule: epratuzumab 360 mg/m2, rituximab 375 mg/m2, and standard‐dose CHOP every 3 weeks for 6 to 8 cycles. The primary endpoint was the incidence of grade 4 neutropenia and grade 3 or 4 antibody infusional toxicity. Secondary endpoints were the complete response (CR) rate, the overall response rate (ORR), and progression‐free survival (PFS). Weekly blood counts were obtained to monitor hematologic toxicity. Fifteen patients were enrolled and treated. Baseline patient characteristics included a median age of 63 years (range, 42–78 years), 60% of patients had stage III or IV disease, 7 patients had a low‐risk International Prognostic Index (IPI) score (0 or 1), 7 patients had an intermediate‐risk IPI score (2 or 3), and 1 patient was high risk. RESULTS. Grade 3 or 4 neutropenia was observed in 14 patients (93%) or in 28 of 92 treatment cycles (30%). Three patients developed grade ≥3 infection or fever. Eleven patients (73%) required dose reductions. No grade 3 antibody infusion‐related toxicity was reported. Thirteen of 15 patients responded (ORR, 87%,), including 10 CRs (67%), 3 partial responses (20%), 1 patient with stable disease, and 1 patient with disease progression. At a median follow‐up of 30 months, 13 of 15 patients remained alive. The 1‐year PFS and OS rates were 93% and 100%, respectively; and the 2‐year PFS and OS rates were 86% and 86%, respectively. CONCLUSIONS. ER‐CHOP every 21 days was feasible as treatment for newly diagnosed patients with DLBCL. A Phase II multicenter study is underway. Cancer 2006. © 2006 American Cancer Society.

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