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Prospective observational study in comorbid patients with chronic lymphocytic leukemia receiving first-line bendamustine with rituximab
M. Špaček, P. Obrtlíková, S. Hrobková, E. Cmunt, J. Karban, J. Molinský, M. Šimkovič, H. Mociková, L. Mohammadová, A. Panovská, J. Novák, M. Trněný, L. Smolej, M. Doubek,
Language English Country Great Britain
Document type Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't
Grant support
NV15-30015A
MZ0
CEP Register
- MeSH
- Bendamustine Hydrochloride administration & dosage adverse effects MeSH
- Leukemia, Lymphocytic, Chronic, B-Cell complications drug therapy epidemiology MeSH
- Comorbidity MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoadjuvant Therapy MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Rituximab administration & dosage adverse effects MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
- Research Support, Non-U.S. Gov't MeSH
Chemoimmunotherapy with bendamustine and rituximab is an alternative treatment for elderly patients with CLL. The aim of this observational multicenter study was to prospectively assess efficacy and safety of bendamustine and rituximab in front-line therapy in patients with CLL and significant comorbidities in real hematological practice. Eighty-three consecutive patients with cumulative illness rating scale (CIRS) >6 who received at least one cycle of BR as first-line treatment were included in the study. The median age was 71 years (range, 53-83), the median CIRS was 8 (range, 7-17), and 60.2% of patients had a creatinine clearance ≤70 mL/min. FISH analysis, available for 78 cases, showed a del(17p) in 11.5% and del(11q) in 20.5% of patients. Overall response rate was 88.0% with a complete response rate of 20.5%. With median follow-up time of 22 months, the estimated median progression free survival was 35.9 months. Progression free survival and overall survival rates at 2 years were 69.9% and 96.2%, respectively. Grade 3 or 4 neutropenia, thrombocytopenia, and anemia were documented in 40 (48.2%), 14 (16.9%), and 8 (9.6%) patients, respectively. Grade 3 or 4 infections occurred in 14.5% of patients. Chemoimmunotherapy with BR is an effective therapeutic option with manageable toxicity for the initial treatment of CLL patients with significant comorbidities. ClinicalTrials.gov Identifier: NCT02381899.
References provided by Crossref.org
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- $a Špaček, Martin $u 1(st) Department of Medicine - Department of Hematology, First Faculty of Medicine, Charles University and General University Hospital in Prague, U Nemocnice 499/2, 128 08 Praha, Czech Republic. Electronic address: m.spacek@centrum.cz.
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- $a Chemoimmunotherapy with bendamustine and rituximab is an alternative treatment for elderly patients with CLL. The aim of this observational multicenter study was to prospectively assess efficacy and safety of bendamustine and rituximab in front-line therapy in patients with CLL and significant comorbidities in real hematological practice. Eighty-three consecutive patients with cumulative illness rating scale (CIRS) >6 who received at least one cycle of BR as first-line treatment were included in the study. The median age was 71 years (range, 53-83), the median CIRS was 8 (range, 7-17), and 60.2% of patients had a creatinine clearance ≤70 mL/min. FISH analysis, available for 78 cases, showed a del(17p) in 11.5% and del(11q) in 20.5% of patients. Overall response rate was 88.0% with a complete response rate of 20.5%. With median follow-up time of 22 months, the estimated median progression free survival was 35.9 months. Progression free survival and overall survival rates at 2 years were 69.9% and 96.2%, respectively. Grade 3 or 4 neutropenia, thrombocytopenia, and anemia were documented in 40 (48.2%), 14 (16.9%), and 8 (9.6%) patients, respectively. Grade 3 or 4 infections occurred in 14.5% of patients. Chemoimmunotherapy with BR is an effective therapeutic option with manageable toxicity for the initial treatment of CLL patients with significant comorbidities. ClinicalTrials.gov Identifier: NCT02381899.
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- $a Hrobková, Stanislava $u Department of Internal Medicine - Hematology and Oncology, University Hospital and Faculty of Medicine, Jihlavská 20, 625 00 Brno, Czech Republic.
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- $a Mociková, Heidi $u Department of Internal Medicine - Hematology, Third Faculty of Medicine, Charles University and Faculty Hospital, Šrobárova 1150/50, 100 34 Praha, Czech Republic.
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- $a Doubek, Michael $u Department of Internal Medicine - Hematology and Oncology, University Hospital and Faculty of Medicine, Jihlavská 20, 625 00 Brno, Czech Republic; CEITEC, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.
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