Ofatumumab in poor-prognosis chronic lymphocytic leukemia: a phase IV, non-interventional, observational study from the European Research Initiative on Chronic Lymphocytic Leukemia
Carol Moreno, Marco Montillo, Panayiotis Panayiotidis, Maria Dimou, Adrian Bloor, Jehan Dupuis, Anna Schuh, Stefan Norin, Christian Geisler, Peter Hillmen, Michael Doubek, Marek Trněný, Petra Obrtlikova, Luca Laurenti, Stephan Stilgenbauer, Lukas Smolej, Paolo Ghia, Florence Cymbalista, Ulrich Jaeger, Kostas Stamatopoulos, Niki Stavroyianni, Patrick Carrington, Hamadi Zouabi, Veronique Leblond, Juan C Gomez-Garcia, Martin Rubio, Roberto Marasca, Gerardo Musuraca, Luigi Rigacci, Lucia Farina, Rossella Paolini, Sarka Pospisilova, Eva Kimby, Colm Bradley, Emili Montserrat, Carol Moreno, Marco Montillo, Panayiotis Panayiotidis, Maria Dimou, Adrian Bloor, Jehan Dupuis, Anna Schuh, Stefan Norin, Christian Geisler, Peter Hillmen, Michael Doubek, Marek Trněný, Petra Obrtlikova, Luca Laurenti, Stephan Stilgenbauer, Lukas Smolej, Paolo Ghia, Florence Cymbalista, Ulrich Jaeger, Kostas Stamatopoulos, Niki Stavroyianni, Patrick Carrington, Hamadi Zouabi, Veronique Leblond, Juan C Gomez-Garcia, Martin Rubio, Roberto Marasca, Gerardo Musuraca, Luigi Rigacci, Lucia Farina, Rossella Paolini, Sarka Pospisilova, Eva Kimby, Colm Bradley, Emili Montserrat
Abstract
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. This study is registered at clinicaltrials.gov identifier:01453062.
Trial registration: ClinicalTrials.gov NCT01453062.
Copyright© Ferrata Storti Foundation.
Source: PubMed