Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine and rituximab in 1 relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma
dc.contributor.author | Rule, Simon | |
dc.date.accessioned | 2018-10-03T08:15:34Z | |
dc.date.accessioned | 2018-10-22T10:30:14Z | |
dc.date.issued | 2019-04 | |
dc.identifier.issn | 0887-6924 | |
dc.identifier.issn | 1476-5551 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/12590 | |
dc.description.abstract |
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. | |
dc.format.extent | 969-980 | |
dc.format.medium | Print-Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | Nature Publishing Group | |
dc.relation.replaces | http://hdl.handle.net/10026.1/12444 | |
dc.relation.replaces | 10026.1/12444 | |
dc.relation.replaces | 10026.1/12445 | |
dc.relation.replaces | http://hdl.handle.net/10026.1/12445 | |
dc.subject | Adenine | |
dc.subject | Adolescent | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Bendamustine Hydrochloride | |
dc.subject | Double-Blind Method | |
dc.subject | Female | |
dc.subject | Follow-Up Studies | |
dc.subject | Humans | |
dc.subject | Leukemia, Lymphocytic, Chronic, B-Cell | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Piperidines | |
dc.subject | Prognosis | |
dc.subject | Pyrazoles | |
dc.subject | Pyrimidines | |
dc.subject | Rituximab | |
dc.subject | Survival Rate | |
dc.subject | Young Adult | |
dc.title | Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine and rituximab in 1 relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma | |
dc.type | journal-article | |
dc.type | Clinical Trial, Phase III | |
dc.type | Journal Article | |
dc.type | Multicenter Study | |
dc.type | Randomized Controlled Trial | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000463162400012&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 4 | |
plymouth.volume | 33 | |
plymouth.publication-status | Published | |
plymouth.journal | Leukemia | |
dc.identifier.doi | 10.1038/s41375-018-0276-9 | |
pubs.merge-from | 10026.1/12445 | |
pubs.merge-from | http://hdl.handle.net/10026.1/12445 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/00 Groups by role | |
plymouth.organisational-group | /Plymouth/00 Groups by role/Academics | |
plymouth.organisational-group | /Plymouth/Faculty of Medicine and Dentistry | |
plymouth.organisational-group | /Plymouth/Faculty of Medicine and Dentistry/Centre for Clinical Trials & Health Research | |
plymouth.organisational-group | /Plymouth/Faculty of Medicine and Dentistry/Centre for Clinical Trials & Health Research/RC reporting group CTPS | |
plymouth.organisational-group | /Plymouth/Faculty of Medicine and Dentistry/Collaboration for the Advancement of Medical Education Research Assessment | |
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/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 | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2018-06-22 | |
dc.rights.embargodate | 2019-1-11 | |
dc.identifier.eissn | 1476-5551 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1038/s41375-018-0276-9 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.type | Journal Article/Review |