Journal
BRITISH JOURNAL OF HAEMATOLOGY
Volume 193, Issue 4, Pages 769-778Publisher
WILEY
DOI: 10.1111/bjh.17373
Keywords
chronic lymphocytic leukaemia; fludarabine; rituximab; low‐ dose FCR; comorbidity
Categories
Funding
- Roche
- Bayer Schering
- Sanofi Genzyme
- program PROGRES [Q40/08]
- DRO (UHHK) from Ministry of Health, Czech Republic [00179906]
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The study showed that low-dose FCR is a well-tolerated and effective first-line regimen for selected elderly/comorbid patients with CLL/SLL, particularly those with favorable biology. Neutropenia was a common adverse event, but serious infections were relatively low.
Therapeutic options used to be very limited for treatment-naive 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/m(2) intravenously (iv) or 20 mg/m(2) orally on days 1-3 and cyclophosphamide to 150 mg/m(2) 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).
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