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
dc.contributor.author | Fraser, GAM | |
dc.contributor.author | Chanan-Khan, A | |
dc.contributor.author | Demirkan, F | |
dc.contributor.author | Santucci Silva, R | |
dc.contributor.author | Grosicki, S | |
dc.contributor.author | Janssens, A | |
dc.contributor.author | Mayer, J | |
dc.contributor.author | Bartlett, NL | |
dc.contributor.author | Dilhuydy, M-S | |
dc.contributor.author | Loscertales, J | |
dc.contributor.author | Avigdor, A | |
dc.contributor.author | Rule, Simon | |
dc.contributor.author | Samoilova, O | |
dc.contributor.author | Pavlovsky, MA | |
dc.contributor.author | Goy, A | |
dc.contributor.author | Mato, A | |
dc.contributor.author | Hallek, M | |
dc.contributor.author | Salman, M | |
dc.contributor.author | Tamegnon, M | |
dc.contributor.author | Sun, S | |
dc.contributor.author | Connor, A | |
dc.contributor.author | Nottage, K | |
dc.contributor.author | Schuier, N | |
dc.contributor.author | Balasubramanian, S | |
dc.contributor.author | Howes, A | |
dc.contributor.author | Cramer, P | |
dc.date.accessioned | 2021-09-21T12:10:03Z | |
dc.date.available | 2021-09-21T12:10:03Z | |
dc.date.issued | 2020-08-06 | |
dc.identifier.issn | 1026-8022 | |
dc.identifier.issn | 1029-2403 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/17905 | |
dc.description.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. | |
dc.format.extent | 3188-3197 | |
dc.format.medium | Print-Electronic | |
dc.language.iso | en | |
dc.publisher | Taylor & Francis | |
dc.subject | Ibrutinib | |
dc.subject | HELIOS phase 3 trial | |
dc.subject | 5-year follow-up | |
dc.subject | overall survival | |
dc.subject | relapsed chronic lymphocytic leukemia | |
dc.title | 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 | |
dc.type | conference | |
dc.type | Clinical Trial, Phase III | |
dc.type | Journal Article | |
dc.type | Randomized Controlled Trial | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000556471600001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 13 | |
plymouth.volume | 61 | |
plymouth.publication-status | Published | |
plymouth.journal | Leukemia and Lymphoma | |
dc.identifier.doi | 10.1080/10428194.2020.1795159 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine/UoA01 Clinical Medicine | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBR | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | United States | |
dcterms.dateAccepted | 2020-07-05 | |
dc.rights.embargodate | 2021-9-22 | |
dc.identifier.eissn | 1029-2403 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1080/10428194.2020.1795159 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2020-08-06 | |
rioxxterms.type | Conference Paper/Proceeding/Abstract |