MORENO, Carol, Marco MONTILLO, Panayiotidis 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, Šárka POSPÍŠILOVÁ, Eva KIMBY, Colm BRADLEY and Emili MONTSERRAT. Ofatumumab in poor-prognosis chronic lymphocytic leukemia: a Phase IV, non-interventional, observational study from the European Research Initiative on Chronic Lymphocytic Leukemia. Haematologica. Pavia: Ferrata Storti Foundation, 2015, vol. 100, No 4, p. 514-519. ISSN 0390-6078. doi:10.3324/haematol.2014.118158.
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Basic information
Original name Ofatumumab in poor-prognosis chronic lymphocytic leukemia: a Phase IV, non-interventional, observational study from the European Research Initiative on Chronic Lymphocytic Leukemia
Authors MORENO, Carol (724 Spain), Marco MONTILLO (380 Italy), Panayiotidis PANAYIOTIDIS (300 Greece), Maria DIMOU (300 Greece), Adrian BLOOR (826 United Kingdom of Great Britain and Northern Ireland), Jehan DUPUIS (250 France), Anna SCHUH (826 United Kingdom of Great Britain and Northern Ireland), Stefan NORIN (752 Sweden), Christian GEISLER (208 Denmark), Peter HILLMEN (826 United Kingdom of Great Britain and Northern Ireland), Michael DOUBEK (203 Czech Republic, guarantor, belonging to the institution), Marek TRNĚNÝ (203 Czech Republic), Petra OBRTLIKOVA (203 Czech Republic), Luca LAURENTI (380 Italy), Stephan STILGENBAUER (276 Germany), Lukas SMOLEJ (203 Czech Republic), Paolo GHIA (380 Italy), Florence CYMBALISTA (250 France), Ulrich JAEGER (40 Austria), Kostas STAMATOPOULOS (300 Greece), Niki STAVROYIANNI (300 Greece), Patrick CARRINGTON (826 United Kingdom of Great Britain and Northern Ireland), Hamadi ZOUABI (250 France), Veronique LEBLOND (250 France), Juan C. GOMEZ-GARCIA (724 Spain), Martin RUBIO (724 Spain), Roberto MARASCA (380 Italy), Gerardo MUSURACA (380 Italy), Luigi RIGACCI (380 Italy), Lucia FARINA (380 Italy), Rossella PAOLINI (380 Italy), Šárka POSPÍŠILOVÁ (203 Czech Republic, belonging to the institution), Eva KIMBY (752 Sweden), Colm BRADLEY (826 United Kingdom of Great Britain and Northern Ireland) and Emili MONTSERRAT (724 Spain).
Edition Haematologica, Pavia, Ferrata Storti Foundation, 2015, 0390-6078.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30200 3.2 Clinical medicine
Country of publisher Italy
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 6.671
RIV identification code RIV/00216224:14110/15:00082874
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.3324/haematol.2014.118158
UT WoS 000354786300026
Keywords in English MONOCLONAL-ANTIBODIES; HUMAN CD20; FLUDARABINE; RITUXIMAB; CHEMOIMMUNOTHERAPY; CYCLOPHOSPHAMIDE; ALEMTUZUMAB; THERAPY; CLL
Tags EL OK, podil
Tags International impact, Reviewed
Changed by Changed by: Ing. Mgr. Věra Pospíšilíková, učo 9005. Changed: 12. 2. 2016 10:33.
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.
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