A phase 2 trial of extended induction epratuzumab and rituximab for previously untreated follicular lymphoma: CALGB 50701

BACKGROUND Rituximab combined with chemotherapy has improved the survival of previously untreated patients with follicular lymphoma (FL). Nevertheless, many patients neither want nor can tolerate chemotherapy, leading to interest in biological approaches. Epratuzumab is a humanized anti‐CD22 monoclo...

Full description

Saved in:
Bibliographic Details
Published in:Cancer 2013-11, Vol.119 (21), p.3797-3804
Main Authors: Grant, Barbara W., Jung, Sin‐Ho, Johnson, Jeffrey L., Kostakoglu, Lale, Hsi, Eric, Byrd, John C., Jones, Jeffrey, Leonard, John P., Martin, S. Eric, Cheson, Bruce D.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized - administration & dosage
Antibodies, Monoclonal, Humanized - adverse effects
Antibodies, Monoclonal, Murine-Derived - administration & dosage
Antibodies, Monoclonal, Murine-Derived - adverse effects
Biological and medical sciences
Drug Administration Schedule
epratuzumab
Female
FLIPI score
follicular lymphoma
Hematologic and hematopoietic diseases
Humans
Immunotherapy - adverse effects
Immunotherapy - methods
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Lymphoma, Follicular - metabolism
Lymphoma, Follicular - mortality
Lymphoma, Follicular - pathology
Lymphoma, Follicular - therapy
Male
Medical sciences
Middle Aged
monoclonal antibody
Neoadjuvant Therapy
Remission Induction
Rituximab
Treatment Outcome
Tumors
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:BACKGROUND Rituximab combined with chemotherapy has improved the survival of previously untreated patients with follicular lymphoma (FL). Nevertheless, many patients neither want nor can tolerate chemotherapy, leading to interest in biological approaches. Epratuzumab is a humanized anti‐CD22 monoclonal antibody with efficacy in relapsed FL. Because both rituximab and epratuzumab have single‐agent activity in FL, the antibody combination was evaluated as initial treatment of patients with FL. METHODS Fifty‐nine untreated patients with FL received epratuzumab 360 mg/m2 with rituximab 375 mg/m2 weekly for 4 induction doses. This combination was continued as extended induction in weeks 12, 20, 28, and 36. Response assessed by computed tomography was correlated with clinical risk factors, [18F]fluorodeoxyglucose positron emission tomography findings at week 3, Fcγ polymorphisms, immunohistochemical markers, and statin use. RESULTS Therapy was well‐tolerated, with toxicities similar to expected with rituximab monotherapy. Fifty‐two (88.2%) evaluable patients responded, including 25 complete responses (42.4%) and 27 partial responses (45.8%). At 3 years follow‐up, 60% of patients remain in remission. Follicular Lymphoma International Prognostic Index (FLIPI) risk strongly predicted progression‐free survival (P = .022). CONCLUSIONS The high response rate and prolonged time to progression observed with this antibody combination are comparable to those observed after standard chemoimmunotherapies and further support the development of biologic, nonchemotherapeutic approaches for these patients. Cancer 2013;119:3797–3804. © 2013 American Cancer Society. The doublet of rituximab and epratuzumab achieved an 88.2% durable response rate in untreated patients with follicular lymphoma, predicted by FLIPI (Follicular Lymphoma International Prognostic Index) score, with a favorable safety profile. These data support noncytotoxic approaches in these patients.
ISSN:0008-543X
1097-0142
DOI:10.1002/cncr.28299