TY - JOUR
T1 - Ofatumumab monotherapy in rituximab-refractory follicular lymphoma
T2 - Results from a multicenter study
AU - Czuczman, Myron S.
AU - Fayad, Luis
AU - Delwail, Vincent
AU - Cartron, Guillaume
AU - Jacobsen, Eric
AU - Kuliczkowski, Kazimierz
AU - Link, Brian K.
AU - Pinter-Brown, Lauren
AU - Radford, John
AU - Hellmann, Andrzej
AU - Gallop-Evans, Eve
AU - DiRienzo, Christine G.
AU - Goldstein, Nancy
AU - Gupta, Ira
AU - Jewell, Roxanne C.
AU - Lin, Thomas S.
AU - Lisby, Steen
AU - Schultz, Martin
AU - Russell, Charlotte A.
AU - Hagenbeek, Anton
PY - 2012/4/19
Y1 - 2012/4/19
N2 - 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. Threepatien tsexperiencedgrade3infusionrelated reactions, none of which were considered serious events. Grade 3-4 neu-tropenia, leukopenia, anemia, and thrombo-cytopenia occurred in a subset of patients. Ofatumumab was well tolerated and modestly active in this heavily pretreated, ritux-imab-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.
AB - 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. Threepatien tsexperiencedgrade3infusionrelated reactions, none of which were considered serious events. Grade 3-4 neu-tropenia, leukopenia, anemia, and thrombo-cytopenia occurred in a subset of patients. Ofatumumab was well tolerated and modestly active in this heavily pretreated, ritux-imab-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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U2 - 10.1182/blood-2011-09-378323
DO - 10.1182/blood-2011-09-378323
M3 - Article
C2 - 22389254
AN - SCOPUS:84860344201
SN - 0006-4971
VL - 119
SP - 3698
EP - 3704
JO - Blood
JF - Blood
IS - 16
ER -