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Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma
Author(s) -
Czuczman Myron S.,
Hess Georg,
Gadeberg Ole V.,
Pedersen Lars M.,
Goldstein Nancy,
Gupta Ira,
Jewell Roxanne C.,
Lin Thomas S.,
Lisby Steen,
Strange Claus,
Windfeld Kristian,
Viardot Andreas
Publication year - 2012
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2012.09086.x
Subject(s) - medicine , follicular lymphoma , ofatumumab , chop , gastroenterology , vincristine , rituximab , common terminology criteria for adverse events , international prognostic index , surgery , prednisone , neutropenia , cyclophosphamide , adverse effect , chemoimmunotherapy , lymphoma , chemotherapy
Summary An international, Phase II trial was conducted to assess two doses of ofatumumab, a human CD 20 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 ( CR u). 76% of patients with FLIPI score 3–5 attained CR / CR u. 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 ( NCT 00494780).