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.
2012-04-20
Eng.
Blood
Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. myron.czuczman [at] roswellpark.org
Blood. 2012 Apr;119(16):3698-704
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