title: Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma.
abstract: An international, Phase II trial was conducted to assess two doses of ofatumumab, a human CD20 monoclonal antibody, combined with cyclophosphamide (750 mg/m(2) ), doxorubicin (50 mg/m(2) ), prednisone (100 mg days 3-7) and vincristine (1·4 mg/m(2) ) (O-CHOP), as frontline treatment for follicular lymphoma (FL). 59 patients with previously untreated FL were randomized to ofatumumab 500 mg (n = 29) or 1000 mg (n = 30) day 1, with CHOP on day 3 every 3 weeks for six cycles. Median duration of FL was 0·1 years for both dose groups; 34% and 38% of patients had high-risk Follicular Lymphoma International Prognostic Index (FLIPI) scores in the 500- and 1000-mg dose groups, respectively. Overall response rate was 90% for the 500-mg group and 100% for the 1000-mg group. 62% of patients achieved complete response (CR)/unconfirmed CR (CRu). 76% of patients with FLIPI score 3-5 attained CR/CRu. Longer follow-up time is needed for analysis of survival end points. The most common Common Terminology Criteria grade 3-4 investigator-reported adverse events were leucopenia (29%) and neutropenia (22%). No deaths have been reported. O-CHOP was safe and efficacious in patients with previously untreated FL, including high-risk FLIPI groups. This trial was registered at www.clinicaltrials.gov (NCT00494780).
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY, USA. myron.czuczman@roswellpark.org
authors.forename: Myron S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: Georg
authors.initials: G
authors.lastname: Hess
authors.forename: Ole V
authors.initials: OV
authors.lastname: Gadeberg
authors.forename: Lars M
authors.initials: LM
authors.lastname: Pedersen
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: Claus
authors.initials: C
authors.lastname: Strange
authors.forename: Kristian
authors.initials: K
authors.lastname: Windfeld
authors.forename: Andreas
authors.initials: A
authors.lastname: Viardot
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D049268:Positron-Emission Tomography; D011241:Prednisone / Q000008:administration & dosage; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; C527517:ofatumumab; D011241:Prednisone