TY - JOUR
TI - Ofatumumab in poor-prognosis chronic lymphocytic leukemia: A phase IV, non-interventional, observational study from the European research initiative on chronic lymphocytic leukemia
AU - Moreno, C.
AU - Montillo, M.
AU - Panayiotidis, P.
AU - Dimou, M.
AU - Bloor, A.
AU - Dupuis, J.
AU - Schuh, A.
AU - Norin, S.
AU - Geisler, C.
AU - Hillmen, P.
AU - Doubek, M.
AU - Trněný, M.
AU - Obrtlikova, P.
AU - Laurenti, L.
AU - Stilgenbauer, S.
AU - Smolej, L.
AU - Ghia, P.
AU - Cymbalista, F.
AU - Jaeger, U.
AU - Stamatopoulos, K.
AU - Stavroyianni, N.
AU - Carrington, P.
AU - Zouabi, H.
AU - Leblond, V.
AU - Gomez-Garcia, J.C.
AU - Rubio, M.
AU - Marasca, R.
AU - Musuraca, G.
AU - Rigacci, L.
AU - Farina, L.
AU - Paolini, R.
AU - Pospisilova, S.
AU - Kimby, E.
AU - Bradley, C.
AU - Montserrat, E.
JO - Haematologica-the hematology journal
PY - 2015
VL - 100
TODO - 4
SP - 511-516
PB - Ferrata Storti Foundation
SN - null
TODO - 10.3324/haematol.2014.118158
TODO - alemtuzumab;  antibiotic agent;  antivirus agent;  chlorambucil;  corticosteroid;  erythropoietin;  fludarabine;  granulocyte colony stimulating factor;  ofatumumab;  rituximab;  antineoplastic agent;  monoclonal antibody;  ofatumumab, adult;  aged;  Article;  autoimmune hemolytic anemia;  chronic lymphatic leukemia;  coughing;  dyspnea;  fatigue;  female;  fever;  human;  infection;  infusion related reaction;  major clinical study;  male;  multicenter study (topic);  neoplasm;  neutropenia;  observational study;  overall survival;  phase 4 clinical trial (topic);  progression free survival;  progressive multifocal leukoencephalopathy;  rash;  retrospective study;  thrombocytopenia;  treatment response;  very elderly;  clinical trial;  drug administration;  Leukemia, Lymphocytic, Chronic, B-Cell;  middle aged;  mortality;  phase 4 clinical trial;  remission;  retreatment;  treatment outcome, Adult;  Aged;  Aged, 80 and over;  Antibodies, Monoclonal;  Antineoplastic Agents;  Drug Administration Schedule;  Female;  Humans;  Leukemia, Lymphocytic, Chronic, B-Cell;  Male;  Middle Aged;  Remission Induction;  Retreatment;  Treatment Outcome
TODO - We report the largest retrospective, phase IV non-interventional, observational study of ofatumumab therapy in heavily pre-treated patients with poor-prognosis chronic lymphocytic leukemia. Total number of patients was 103; median age was 65 years (range 39-85). Median number of prior lines of therapy was 4 (range 1-13), including, in most cases, rituximab-, fludarabine-and alemtuzumab-based regimens; 13 patients had been allografted. Of 113 adverse events, 28 (29%) were considered to be directly related to ofatumumab. Grade 3-4 toxicities included neutropenia (10%), thrombocytopenia (5%), anemia (3%), pneumonia (17%), and fever (3%). Two heavily pre-treated patients developed progressive multifocal leukoencephalopathy. On an intention-to-treat analysis, the overall response rate was 22% (3 complete response, 1 incomplete complete response). Median progression-free and overall survival times were 5 and 11 months, respectively. This study confirms in a daily-life setting the feasibility and acceptable toxicity of ofatumumab treatment in advanced chronic lymphocytic leukemia. The complete response rate, however, was low. Therefore, treatment with ofatumumab should be moved to earlier phases of the disease. Ideally, this should be done in combination with other agents, as recently approved for ofatumumab plus chlorambucil as front-line treatment for patients unfit for fludarabine. © 2015 Ferrata Storti Foundation.
ER -