Low-dose fludarabine and cyclophosphamide combined with rituximab in the first-line treatment of elderly/comorbid patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL): long-term results of project Q-lite by the Czech CLL Study Group
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie, práce podpořená grantem
PubMed
33618437
DOI
10.1111/bjh.17373
Knihovny.cz E-zdroje
- Klíčová slova
- chronic lymphocytic leukaemia, comorbidity, fludarabine, low-dose FCR, rituximab,
- MeSH
- chronická lymfatická leukemie farmakoterapie mortalita MeSH
- cyklofosfamid aplikace a dávkování škodlivé účinky MeSH
- lidé MeSH
- míra přežití MeSH
- následné studie MeSH
- přežití bez známek nemoci MeSH
- protokoly protinádorové kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- rituximab aplikace a dávkování škodlivé účinky MeSH
- senioři MeSH
- vidarabin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
- Názvy látek
- cyklofosfamid MeSH
- fludarabine MeSH Prohlížeč
- rituximab MeSH
- vidarabin MeSH
Therapeutic options used to be very limited for treatment-naïve elderly/comorbid patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) before the introduction of chemo-immunotherapy. Because dose-reduced fludarabine-based regimens yielded promising results, the Czech CLL Study Group initiated a prospective observational study to assess safety and efficacy of low-dose fludarabine and cyclophosphamide combined with rituximab (FCR) in elderly/comorbid patients. Between March 2009 and July 2012, we enrolled 107 patients considered ineligible for full-dose FCR (median age, 70 years; median Cumulative Illness Rating Scale score, 5; median creatinine clearance, 69 ml/min). Notably, 77% patients had unfavourable biological prognosis [unmutated immunoglobulin heavy-chain variable-region gene (IGHV), 74%; deletion 17p, 9%). Fludarabine was reduced to 12 mg/m2 intravenously (iv) or 20 mg/m2 orally on days 1-3 and cyclophosphamide to 150 mg/m2 iv/orally on days 1-3. Grade 3-4 neutropenia occurred in 56% of the patients, but there were serious infections in only 15%. The median progression-free survival was 29 months, but was markedly longer in patients with mutated IGHV (median 53 months), especially in absence of del 11q or 17p (median 74 months). Low-dose FCR is a well-tolerated and effective first-line regimen for selected elderly/comorbid patients with CLL/SLL with favourable biology. The study was registered at clinicaltrials.gov (NCT02156726).
1st Department of Medicine Haematology General University Hospital Prague Czech Republic
Department of Haematology Oncology University Hospital Olomouc Czech Republic
Department of Haematology University Hospital Královské Vinohrady Prague Czech Republic
Department of Haematology University Hospital Ostrava Czech Republic
Department of Internal Medicine Haematology and Oncology University Hospital Brno Czech Republic
Haematology Tranfusiology Department Silesian Hospital Opava Opava Czech Republic
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ClinicalTrials.gov
NCT02156726
