Fraser, Graeme A. M., Chanan-Khan, Asher, Demirkan, Fatih, Santucci Silva, Rodrigo, Grosicki, Sebastian, Janssens, Ann, Mayer, Jiri, Bartlett, Nancy L., Dilhuydy, Marie-Sarah, Loscertales, Javier, Avigdor, Abraham, Rule, Simon, Samoilova, Olga, Pavlovsky, Miguel A., Goy, Andre, Mato, Anthony, Hallek, Michael, Salman, Mariya, Tamegnon, Monelle, Sun, Steven, Connor, Anne, Nottage, Kerri, Schuier, Natasha, Balasubramanian, Sriram, Howes, Angela and Cramer, Paula (2020). 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. Leuk. Lymphoma, 61 (13). S. 3188 - 3198. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1029-2403

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Abstract

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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fraser, Graeme A. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chanan-Khan, AsherUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Demirkan, FatihUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Santucci Silva, RodrigoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grosicki, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Janssens, AnnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mayer, JiriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bartlett, Nancy L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dilhuydy, Marie-SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loscertales, JavierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Avigdor, AbrahamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rule, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Samoilova, OlgaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pavlovsky, Miguel A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goy, AndreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mato, AnthonyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salman, MariyaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tamegnon, MonelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sun, StevenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Connor, AnneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nottage, KerriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schuier, NatashaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balasubramanian, SriramUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Howes, AngelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-323959
DOI: 10.1080/10428194.2020.1795159
Journal or Publication Title: Leuk. Lymphoma
Volume: 61
Number: 13
Page Range: S. 3188 - 3198
Date: 2020
Publisher: TAYLOR & FRANCIS LTD
Place of Publication: ABINGDON
ISSN: 1029-2403
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
Oncology; HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/32395

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