Journal article
Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study
Blood, Vol.119(16), pp.3698-3704
04/19/2012
DOI: 10.1182/blood-2011-09-378323
PMID: 22389254
Abstract
Abstract New treatments are required for rituximab-refractory follicular lymphoma (FL). In the present study, patients with rituximab-refractory FL received 8 weekly infusions of ofatumumab (CD20 mAb; dose 1, 300 mg and doses 2-8, 500 or 1000 mg; N = 116). The median age of these patients was 61 years, 47% had high-risk Follicular Lymphoma International Prognostic Index scores, 65% were chemotherapy-refractory, and the median number of prior therapies was 4. The overall response rate was 13% and 10% for the 500-mg and 1000-mg arms, respectively. Among 27 patients refractory to rituximab monotherapy, the overall response rate was 22%. The median progression-free survival was 5.8 months. Forty-six percent of patients demonstrated tumor reduction 3 months after therapy initiation, and the median progression-free survival for these patients was 9.1 months. The most common adverse events included infections, rash, urticaria, fatigue, and pruritus. Three patients experienced grade 3 infusion-related reactions, none of which were considered serious events. Grade 3-4 neutropenia, leukopenia, anemia, and thrombocytopenia occurred in a subset of patients. Ofatumumab was well tolerated and modestly active in this heavily pretreated, rituximab-refractory population and is therefore now being studied in less refractory FL and in combination with other agents in various B-cell neoplasms. The present study was registered at www.clinicaltrials.gov as NCT00394836.
Details
- Title: Subtitle
- Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study
- Creators
- Myron S Czuczman - Departments of Medicine and Immunology, Roswell Park Cancer Institute, Buffalo, NYLuis Fayad - The University of Texas MD Anderson Cancer Center, Houston, TXVincent Delwail - Les Centres d'Investigation Clinique 0802 Inserm, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceGuillaume Cartron - Service d'Hématologie Centre Hospitalier Universitaire Montpellier Unité Mixte de Recherche 5235, Montpellier, FranceEric Jacobsen - Dana-Farber Cancer Institute, Boston, MAKazimierz Kuliczkowski - Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku, Wroclaw, PolandBrian K Link - University of Iowa, Iowa City, IALauren Pinter-Brown - University of California, Los Angeles, Los Angeles, CAJohn Radford - Christie National Health Service Foundation Trust and The University of Manchester, Manchester, United KingdomAndrzej Hellmann - Department of Hematology and Transplantology, Medical University of Gdańsk, Gdańsk, PolandEve Gallop-Evans - Velindre Hospital, Cardiff, United KingdomChristine G DiRienzo - GlaxoSmithKline, Collegeville, PANancy Goldstein - GlaxoSmithKline, Research Triangle Park, NCIra Gupta - GlaxoSmithKline, Collegeville, PARoxanne C Jewell - GlaxoSmithKline, Research Triangle Park, NCThomas S Lin - GlaxoSmithKline, Collegeville, PASteen Lisby - Genmab, Copenhagen, Denmark; andMartin Schultz - Genmab, Copenhagen, Denmark; andCharlotte A Russell - Genmab, Copenhagen, Denmark; andAnton Hagenbeek - Department of Hematology, Academic Medical Center, Amsterdam, The Netherlands405 Study Investigators
- Resource Type
- Journal article
- Publication Details
- Blood, Vol.119(16), pp.3698-3704
- DOI
- 10.1182/blood-2011-09-378323
- PMID
- 22389254
- ISSN
- 0006-4971
- eISSN
- 1528-0020
- Language
- English
- Date published
- 04/19/2012
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984094515302771
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