Evidence map›Paper›PMID 34310172›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial.

John C Byrd, Peter Hillmen, Paolo Ghia, Arnon P Kater, Asher Chanan-Khan, Richard R Furman, Susan O'Brien, Mustafa Nuri Yenerel, Arpad Illés, Neil Kay and 14 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05643235 (Implanted Loop Recorders), which is not on this map. Cited by 341 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
341citing papers in PubMed, 9 pooled it
56.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05643235 narecruitingnot on this mapstarted 2023, after this paper: background citation

Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors

TypeinterventionalSponsorNorthwell HealthRan2023 to 2030Enrolled50ConditionsAtrial Fibrillation, Supraventricular Arrhythmia, Ventricular Arrhythmias and Cardiac Arrest, Chronic Lymphocytic LeukemiaArmsMedtronic LINQ-2 Insertable Cardiac Monitor (ILR)
3 · Its place in the literature

Who cites it

341 citing papers in PubMed, 9 syntheses or guidelines pooled it, 610 citations in OpenAlex.

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281 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 19 institutions in 11 countries.

John C ByrdThe Ohio State University Comprehensive Cancer Center, Columbus, OH.ORCID 0000-0001-9830-0711
Peter HillmenSt James's University Hospital, Leeds, UK.ORCID 0000-0001-5617-4403
Paolo GhiaUniversità Vita-Salute San Raffaele, Milano, Italy.ORCID 0000-0003-3750-7342
Arnon P KaterAmsterdam University Medical Centers, University of Amsterdam, on behalf of Hovon, Amsterdam, the Netherlands.ORCID 0000-0003-3190-1891
Asher Chanan-KhanMayo Clinic Jacksonville, Jacksonville, FL.
Richard R FurmanWeill Cornell Medicine, New York Presbyterian Hospital, New York, NY.ORCID 0000-0003-1677-7626
Susan O'BrienChao Family Comprehensive Cancer Center, University of California-Irvine, Irvine, CA.
Mustafa Nuri YenerelIstanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.ORCID 0000-0002-6473-1342
Arpad IllésUniversity of Debrecen, Debrecen, Hungary.
Neil KayMayo Clinic Rochester, Rochester, MN.ORCID 0000-0002-5951-5055
Jose A Garcia-MarcoHospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
Anthony MatoUniversity of Pennsylvania, Philadelphia, PA.ORCID 0000-0001-8724-1875
Javier Pinilla-IbarzMoffitt Cancer Center, Tampa, FL.
John F SeymourPeter MacCallum Cancer Centre, Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0003-2188-6835
Stephane LepretreCentre Henri Becquerel, Rouen, France.
Stephan StilgenbauerInternal Medicine III, University of Ulm, Ulm, Germany.
Tadeusz RobakMedical University of Lodz, Lodz, Poland.
Wayne RothbaumAcerta, South San Francisco, CA.
Raquel IzumiAcerta, South San Francisco, CA.
Ahmed HamdyAcerta, South San Francisco, CA.
Priti PatelAstraZeneca, South San Francisco, CA.
Kara HigginsAstraZeneca, South San Francisco, CA.
Sophia SohoniAstraZeneca, South San Francisco, CA.
Wojciech JurczakMaria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland.
AstraZeneca (United States) · USHospital Universitario Puerta de Hierro Majadahonda · ESHovon · NLIstanbul University · TRJacksonville College · USMayo Clinic · USMedical University of Lodz · PLMoffitt Cancer Center · USNewYork–Presbyterian Hospital · USNormandie Université · FRSt James's University Hospital · GBThe Maria Sklodowska-Curie National Research Institute of Oncology · PLThe Ohio State University · USThe Royal Melbourne Hospital · AUUniversität Ulm · DEUniversity of California, Irvine · USUniversity of Debrecen · HUUniversity of Pennsylvania · USVita-Salute San Raffaele University · IT

Funding

Targeted Therapy for LeukemiaR35CA197734 · NCI · UNIVERSITY OF CINCINNATI · PI BYRD, JOHN C. · 2015 to 2021
$6.6M
NCI NIH HHS R35 CA197734
6 · The paper itself

Abstract

purposeAmong Bruton's tyrosine kinase inhibitors, acalabrutinib has greater selectivity than ibrutinib, which we hypothesized would improve continuous therapy tolerability. We conducted an open-label, randomized, noninferiority, phase III trial comparing acalabrutinib and ibrutinib in patients with chronic lymphocytic leukemia (CLL).

methodsPatients with previously treated CLL with centrally confirmed del(17)(p13.1) or del(11)(q22.3) were randomly assigned to oral acalabrutinib 100 mg twice daily or ibrutinib 420 mg once daily until progression or unacceptable toxicity. The primary end point was independent review committee-assessed noninferiority of progression-free survival (PFS).

resultsOverall, 533 patients (acalabrutinib, n = 268; ibrutinib, n = 265) were randomly assigned. At the data cutoff, 124 (46.3%) acalabrutinib patients and 109 (41.1%) ibrutinib patients remained on treatment. After a median follow-up of 40.9 months, acalabrutinib was determined to be noninferior to ibrutinib with a median PFS of 38.4 months in both arms (95% CI acalabrutinib, 33.0 to 38.6 and ibrutinib, 33.0 to 41.6; hazard ratio: 1.00; 95% CI, 0.79 to 1.27). All-grade atrial fibrillation/atrial flutter incidence was significantly lower with acalabrutinib versus ibrutinib (9.4%

conclusionIn this first direct comparison of less versus more selective Bruton's tyrosine kinase inhibitors in CLL, acalabrutinib demonstrated noninferior PFS with fewer cardiovascular adverse events.

Indexed as

AdenineAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzamidesFemaleFollow-Up StudiesHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPiperidinesPrognosisProspective StudiesPyrazinesacalabrutinibAdenineBenzamidesibrutinibPiperidinesPyrazines

Identifiers

PMID34310172
PMCPMC8547923
OpenAlexW3185756680

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.