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

Ivana Micallef, Brad S. Kahl, Matthew J. Maurer, Ahmet Dogan, Stephen Maxted Ansell, Joseph P. Colgan, Susan Geyer, David J. Inwards, William L. White, Thomas Matthew Habermann

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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/m 2, 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.

Original languageEnglish (US)
Pages (from-to)2826-2832
Number of pages7
JournalCancer
Volume107
Issue number12
DOIs
StatePublished - Dec 15 2006

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Lymphoma, Large B-Cell, Diffuse
Vincristine
Prednisone
Doxorubicin
Cyclophosphamide
Drug Therapy
Disease-Free Survival
epratuzumab
Rituximab
Neutropenia
Survival Rate
Antibodies

Keywords

  • DLBCL
  • Epratuzumab
  • ER-CHOP
  • International Prognostic Index
  • non-Hodgkin Lymphoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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. / Micallef, Ivana; Kahl, Brad S.; Maurer, Matthew J.; Dogan, Ahmet; Ansell, Stephen Maxted; Colgan, Joseph P.; Geyer, Susan; Inwards, David J.; White, William L.; Habermann, Thomas Matthew.

In: Cancer, Vol. 107, No. 12, 15.12.2006, p. 2826-2832.

Research output: Contribution to journalArticle

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title = "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",
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/m 2, 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.",
keywords = "DLBCL, Epratuzumab, ER-CHOP, International Prognostic Index, non-Hodgkin Lymphoma",
author = "Ivana Micallef and Kahl, {Brad S.} and Maurer, {Matthew J.} and Ahmet Dogan and Ansell, {Stephen Maxted} and Colgan, {Joseph P.} and Susan Geyer and Inwards, {David J.} and White, {William L.} and Habermann, {Thomas Matthew}",
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T1 - 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

AU - Micallef, Ivana

AU - Kahl, Brad S.

AU - Maurer, Matthew J.

AU - Dogan, Ahmet

AU - Ansell, Stephen Maxted

AU - Colgan, Joseph P.

AU - Geyer, Susan

AU - Inwards, David J.

AU - White, William L.

AU - Habermann, Thomas Matthew

PY - 2006/12/15

Y1 - 2006/12/15

N2 - 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/m 2, 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.

AB - 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/m 2, 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.

KW - DLBCL

KW - Epratuzumab

KW - ER-CHOP

KW - International Prognostic Index

KW - non-Hodgkin Lymphoma

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DO - 10.1002/cncr.22342

M3 - Article

C2 - 17099879

AN - SCOPUS:33845597766

VL - 107

SP - 2826

EP - 2832

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 12

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