Kategorie: Maligní lymfomy a leukémie
Téma: Chronic lymphocytic leukemia - Clinical studies
Číslo abstraktu: P109
Autoři: M.D. Carol Moreno; MD Marco Montillo; M.D. Panayiotis Panayiotidis, Ph.D.; Dr. Adrian Bloor, Ph.D., FRCP, FRCPath; Dr. Jehan Dupuis; M.D. Anna Schuh, Ph.D.; M.D. Stefan Norin; MD Christian H. Geisler, PhD; Peter Hillmen, M.B. ChB, Ph.D.; prof. MUDr. Michael Doubek, Ph.D.; Prof. MUDr. Marek Trněný, CSc.; MUDr. Petra Obrtlíková, Ph.D.; MD Luca Laurenti; MD Stephan Stilgenbauer; MUDr. Lukáš Smolej, Ph.D.; M.D. Paolo Ghia, Ph.D.; M.D. Florence Cymbalista, Ph.D.; M.D. Ulrich Jaeger; MD Kostas Stamatopoulos; Niki Stavroyianni; Dr. Patrick Carrington, MB ChB, MRCP, FRCPath; M.D. Hamadi Zouabi; M.D. Veronique Leblond; Dr. Juan Gomez; M.D. Roberto Marasca; Dr. Gerardo Musuraca; Dr. Luigi Rigacci; Dr. Lucia Farina; MD Rossella Paolini; prof. RNDr. Šárka Pospíšilová, Ph.D.; MD Eva Kimby, PhD; Colm Bradley; Prof. Dr. Emili Montserrat
Ofatumumab was given a conditional approval in the EU on April 2010 for the treatment of CLL refractory to fludarabine (F-ref) and alemtuzumab (Aref), encouraging the retrieval of further data in patients treated in a “daily life” setting and to investigate treatment safety.
he main objective of the study was to obtain information on the safety profile of ofatumumab in patients with CLL treated outside clinical trials. The secondary endpoints were efficacy, progression free survival (PFS), and overall survival (OS).
This was an observational, retrospective study. Patients were eligible for the study regardless of prior treatments or disease status and provided they had not been included in phase II or phase III ofatumumab clinical trials. Data on patients’ characteristics at diagnosis, prior treatment, toxicity to therapy, response rate, PFS and OS were recorded.
One hundred and twenty patients were screened, of which 103 from 25 centers in 10 European countries were eligible for the study. There were 71 males; median age at initiation of ofatumumab was 64 years (range, 38-84); 66% patients were in advanced clinical stage;54% were F-ref, 70% A-ref and 41% were both. One hundred and sixty one toxic events were reported in 68 patients, with 28 (17%) of them being considered as ofatumumab-related. Infusion reactions occurred in 19 (30%) patients (grade III-IV: 21%). Neutropenia was reported in 26% patients (grade III-IV: 22%), thrombocytopenia in 15% (grade III-IV: 12%) and anemia in 15% (grade III-IV: 7%). The non-hematological adverse events were infection (29%), dyspnea (10%), fatigue (7%), fever (7%), rash (7%), cough (5%), diarrhea (4%) and nausea (1%). A correlation was observed between the number of prior lines of therapy and 18th Congress of the European Hematology Association hematologic toxicity. Autoimmune hemolytic anemia was recorded in one patient. One patient developed Richter’s syndrome while receiving ofatumumab. Two heavily pre-treated patients presented progressive multifocal leukoencephalopathy.The overall response rate (ORR) was 23% and the median PFS and OS were 5 and 12 months, respectively. The main causes of death were disease progression (61%) and, infection (28%).
Summary / Conclusion:
These results show that with the only exception of the ORR (lower in this study) all endpoints (PFS, OS) and safety profile in CLL patients treated with ofatumumab in daily practice are consistent with those observed in phase II and III clinical trials.
Datum přednesení příspěvku: 14. 6. 2013