Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study.
Czuczman, M Fayad, L Delwail, V Cartron, G Jacobsen, E Kuliczkowski, K Link, B Pinter-Brown, L Radford, John A Hellmann, A
Czuczman, M
Fayad, L
Delwail, V
Cartron, G
Jacobsen, E
Kuliczkowski, K
Link, B
Pinter-Brown, L
Radford, John A
Hellmann, A
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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.
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2012-04-19
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Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study. 2012, 119 (16):3698-704 Blood