Ofatumumab retreatment and maintenance in fludarabine-refractory chronic lymphocytic leukaemia patients
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, práce podpořená grantem
PubMed
25825041
DOI
10.1111/bjh.13380
Knihovny.cz E-zdroje
- Klíčová slova
- anti-CD20 monoclonal antibody, chronic lymphocytic leukaemia, maintenance, ofatumumab, retreatment,
- MeSH
- chemorezistence MeSH
- chronická lymfatická leukemie farmakoterapie MeSH
- humanizované monoklonální protilátky MeSH
- lidé středního věku MeSH
- lidé MeSH
- monoklonální protilátky aplikace a dávkování škodlivé účinky MeSH
- opakovaná terapie MeSH
- progrese nemoci MeSH
- protinádorové látky terapeutické užití MeSH
- senioři MeSH
- udržovací chemoterapie MeSH
- vidarabin analogy a deriváty farmakologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- práce podpořená grantem MeSH
- Názvy látek
- fludarabine MeSH Prohlížeč
- humanizované monoklonální protilátky MeSH
- monoklonální protilátky MeSH
- ofatumumab MeSH Prohlížeč
- protinádorové látky MeSH
- vidarabin MeSH
There are limited data on retreatment with monoclonal antibodies (mAb) in patients with chronic lymphocytic leukaemia (CLL). In a pivotal study, ofatumumab (human anti-CD20 mAb) monotherapy demonstrated a 47% objective response rate (ORR) in fludarabine refractory CLL patients. From this study, a subset of 29 patients who had at least stable disease and then progressed were retreated with eight weekly ofatumumab infusions (induction treatment period), followed by monthly infusions for up to 2 years (maintenance treatment period). The ORR after 8 weeks of induction retreatment was 45% and 24% had continued disease control after maintenance at 52 weeks. Efficacy and safety of the retreated patients were compared with their initial results in the pivotal study. Response duration was 24.1 months vs. 6.8 months; time to next therapy was 14.8 months vs. 12.3 months; and progression-free survival was 7.4 months vs. 7.9 months (medians). Upon retreatment, 72% had infusion reactions, mostly Grade 1-2. Three patients had fatal infections. In summary, ofatumumab retreatment and maintenance therapy was feasible in patients with heavily pretreated CLL and appeared to result in more durable disease control than initial ofatumumab treatment in this subset of patients who may have a more favourable disease profile.
Akademia Medyczna w Gdansku Gdansk Poland
Azienda Ospendaliero Universitaria Policlinico Consorziale Bari Italy
Cancer Therapy Research Center San Antonio TX USA
Department of Haematology Karolinska University Hospital Stockholm Sweden
Department of Internal Medicine Haemato Oncology Faculty Hospital Brno Brno Czech Republic
Ernest and Helen Scott Haematological Research Institute University of Leicester Leicester UK
Fakultni nemocnice Praha10 Czech Republic
GlaxoSmithKline Collegeville PA USA
GlaxoSmithKline Research Triangle Park NC USA
Haematologisch Onkologisches Institut Moenchengladbach Rheydt Germany
Hopital Jean Bernanrd Poitiers France
Johannes Gutenberg Universtitaer Mainz Mainz Germany
Leeds Teaching Hospital Leeds UK
The University of Texas M D Anderson Cancer Center Houston TX USA
Universitaesklinikum des Saarlandes Homburg Germany
Citace poskytuje Crossref.org