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Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
GAM. Fraser, A. Chanan-Khan, F. Demirkan, R. Santucci Silva, S. Grosicki, A. Janssens, J. Mayer, NL. Bartlett, MS. Dilhuydy, J. Loscertales, A. Avigdor, S. Rule, O. Samoilova, MA. Pavlovsky, A. Goy, A. Mato, M. Hallek, M. Salman, M. Tamegnon, S....
Language English Country United States
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial
- MeSH
- Adenine analogs & derivatives MeSH
- Bendamustine Hydrochloride therapeutic use MeSH
- Leukemia, Lymphocytic, Chronic, B-Cell * drug therapy MeSH
- Humans MeSH
- Piperidines MeSH
- Antineoplastic Combined Chemotherapy Protocols adverse effects MeSH
- Rituximab therapeutic use MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Randomized Controlled Trial MeSH
We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183-0.286]; p < .0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455-0.822]; p = .0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR.
Department of Haematology University of Plymouth Medical School Plymouth UK
Department of Hematology Fundaleu Buenos Aires Argentina
Division of Hematology Dokuz Eylul University Izmir Turkey
Division of Hematology Mayo Clinic Cancer Center Jacksonville FL USA
Hematology Department Hospital Universitario La Princesa IIS IP Madrid Spain
Hopital Haut Leveque 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 Hackensack University Medical Center Hackensack NJ USA
Juravinski Cancer Centre McMaster University Hamilton Canada
Memorial Sloan Kettering Cancer Center NY USA
Nizhny Novogorod Regional Clinical Hospital Nizhny Novogorod Russia
Siteman Cancer Center Washington University School of Medicine St Louis MO USA
References provided by Crossref.org
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- $a We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183-0.286]; p < .0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455-0.822]; p = .0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR.
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