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Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma
G. Fraser, P. Cramer, F. Demirkan, RS. Silva, S. Grosicki, A. Pristupa, A. Janssens, J. Mayer, NL. Bartlett, MS. Dilhuydy, H. Pylypenko, J. Loscertales, A. Avigdor, S. Rule, D. Villa, O. Samoilova, P. Panagiotidis, A. Goy, MA. Pavlovsky, C....
Language English Country England, Great Britain
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 2000-01-01 to 1 year ago
Open Access Digital Library
from 1997-01-01
Nursing & Allied Health Database (ProQuest)
from 2000-01-01 to 1 year ago
Health & Medicine (ProQuest)
from 2000-01-01 to 1 year ago
Public Health Database (ProQuest)
from 2000-01-01 to 1 year ago
- MeSH
- Bendamustine Hydrochloride administration & dosage MeSH
- Leukemia, Lymphocytic, Chronic, B-Cell drug therapy pathology MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate MeSH
- Adolescent MeSH
- Young Adult MeSH
- Follow-Up Studies MeSH
- Prognosis MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Pyrazoles administration & dosage MeSH
- Pyrimidines administration & dosage MeSH
- Rituximab administration & dosage MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. Overall, 578 patients were randomized 1:1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. Median follow-up was 34.8 months (range: 0.1-45.8). Investigator-assessed median progression-free survival (PFS) was not reached for ibrutinib+BR, versus 14.3 months for placebo+BR (hazard ratio [HR] [95% CI], 0.206 [0.159-0.265]; P < 0.0001); 36-month PFS rates were 68.0% versus 13.9%, respectively. The results are consistent with the primary analysis findings (HR = 0.203, as assessed by independent review committee, with 17-month median follow-up). Median overall survival was not reached in either arm; HR (95% CI) for ibrutinib+BR versus placebo: 0.652 (0.454-0.935; P = 0.019). Minimal residual disease (MRD)-negative response rates were 26.3% for ibrutinib+BR and 6.2% for placebo+BR (P < 0.0001). Incidence of treatment-emergent adverse events (including grades 3-4) were generally consistent with the initial HELIOS report. These long-term data support improved survival outcomes and deepening responses with ibrutinib+BR compared with BR in relapsed CLL/SLL.
1st Department of Propedeutic Medicine National and Kapodistrian University of Athens Athens Greece
Department 1 of Internal Medicine University of Cologne Cologne Germany
Department of Cancer Prevention Faculty of Public Health Silesian Medical University Katowice Poland
Department of Haematology Plymouth University Medical School Plymouth UK
Department of Hematology Cherkassy Regional Oncological Center Cherkassy Ukraine
Department of Hematology Fundaleu Buenos Aires Argentina
Division of Hematology Dokuz Eylul University Izmir Turkey
Division of Medical Oncology British Columbia Cancer Agency Vancouver BC Canada
Hematology Department Hospital Universitario La Princesa IIS IP Madrid Spain
Hôpital Haut Lévêque Pessac Bordeaux France
IEP São Lucas Hemomed Oncologia e Hematologia São Paulo Brazil
Janssen Research and Development High Wycombe UK
Janssen Research and Development Raritan NJ USA
Janssen Research and Development Spring House PA USA
John Theurer Cancer Center at Hackensack University Medical Center Hackensack NJ USA
Juravinski Cancer Centre McMaster University Hamilton ON Canada
Mayo Clinic Cancer Center Jacksonville FL USA
Nizhny Novogorod Regional Clinical Hospital Nizhny Novogorod Russia
Regional Clinical Hospital Ryazan Russia
Siteman Cancer Center Washington University School of Medicine St Louis MO USA
References provided by Crossref.org
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