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Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study
- Publication Year :
- 2018
-
Abstract
- We performed an observational study on the efficacy of bendamustine and rituximab (BR) as first salvage regimen in chronic lymphocytic leukemia (CLL). In an intention-to-treat analysis including 237 patients, the median progression-free survival (PFS) was 25 months. The presence of del (17p), unmutated IGHV and advanced stage were associated with a shorter PFS at multivariate analysis. The median time-to-next treatment was 31.3 months. Front-line treatment with a chemoimmunotherapy regimen was the only predictive factor for a shorter time to next treatment at multivariate analysis. The median overall survival (OS) was 74.5 months. Advanced disease stage (i.e. Rai stage III-IV or Binet stage C) and resistant disease were the only parameters significantly associated with a shorter OS. Grade 3-5 infections were recorded in 6.3% of patients. A matched-adjusted indirect comparison with ibrutinib given second-line within Named Patient Programs in the United Kingdom and in Italy was carried out with OS as objective end point. When restricting the analysis to patients with intact 17p who had received chemoimmunotherapy in first line, there was no difference in OS between patients treated with ibrutinib (63% alive at 36 months) and patients treated with BR (74.4% alive at 36 months). BR is an efficacious first salvage regimen in CLL in a real-life population, including the elderly and unfit patients. BR and ibrutinib may be equally effective in terms of OS when used as first salvage treatment in patients without 17p deletion. (Registered at clinicaltrials.gov identifier: 02491398).
- Subjects :
- Oncology
Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study
Salvage therapy
chemistry.chemical_compound
rituximab
0302 clinical medicine
Piperidines
Antineoplastic Combined Chemotherapy Protocols
Bendamustine Hydrochloride
Aged, 80 and over
education.field_of_study
clinical trial
Hematology
Middle Aged
Prognosis
Fludarabine
Treatment Outcome
Italy
030220 oncology & carcinogenesis
Ibrutinib
Bendamustine
Retreatment
Rituxima
Rituximab
medicine.drug
Chronic Lymphocytic Leukemia
bendamustine
ibrutinib
Adult
medicine.medical_specialty
Population
NO
03 medical and health sciences
Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA
Chemoimmunotherapy
CLL, Bendamustine, Rituxima, prognosis, Hematology
Internal medicine
medicine
Biomarkers, Tumor
Humans
Progression-free survival
education
Aged
Salvage Therapy
business.industry
Adenine
ERIC and UK CLL FORUM study
Leukemia, Lymphocytic, Chronic, B-Cell
Survival Analysis
United Kingdom
Regimen
Pyrimidines
chemistry
chronic lymphocytic leukemia
Pyrazoles
prognosis
business
CLL
030215 immunology
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....d24b88f44e2262e2f6fabc65579c98fe