title: Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study.
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.
authors.affiliation: Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. myron.czuczman@roswellpark.org
authors.forename: Myron S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: Luis
authors.initials: L
authors.lastname: Fayad
authors.forename: Vincent
authors.initials: V
authors.lastname: Delwail
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cartron
authors.forename: Eric
authors.initials: E
authors.lastname: Jacobsen
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Kuliczkowski
authors.forename: Brian K
authors.initials: BK
authors.lastname: Link
authors.forename: Lauren
authors.initials: L
authors.lastname: Pinter-Brown
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.forename: Andrzej
authors.initials: A
authors.lastname: Hellmann
authors.forename: Eve
authors.initials: E
authors.lastname: Gallop-Evans
authors.forename: Christine G
authors.initials: CG
authors.lastname: DiRienzo
authors.forename: Nancy
authors.initials: N
authors.lastname: Goldstein
authors.forename: Ira
authors.initials: I
authors.lastname: Gupta
authors.forename: Roxanne C
authors.initials: RC
authors.lastname: Jewell
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Lin
authors.forename: Steen
authors.initials: S
authors.lastname: Lisby
authors.forename: Martin
authors.initials: M
authors.lastname: Schultz
authors.forename: Charlotte A
authors.initials: CA
authors.lastname: Russell
authors.forename: Anton
authors.initials: A
authors.lastname: Hagenbeek
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived / Q000276:immunology* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000276:immunology / Q000627:therapeutic use; D001402:B-Lymphocytes / Q000187:drug effects / Q000276:immunology; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm / Q000276:immunology*; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000276:immunology*; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D000069283:Rituximab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; C527517:ofatumumab