Evidence map›Paper›PMID 31628428›Full record

Trial reportLeukemia2020

Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.

Jan A Burger, Paul M Barr, Tadeusz Robak, Carolyn Owen, Paolo Ghia, Alessandra Tedeschi, Osnat Bairey, Peter Hillmen, Steven E Coutre, Stephen Devereux and 9 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 273 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
273citing papers in PubMed, 5 pooled it
37.1field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

273 citing papers in PubMed, 5 syntheses or guidelines pooled it, 453 citations in OpenAlex.

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  14. Adding Umbralisib and Ublituximab (U2) to Ibrutinib in Patients with CLL: A Phase II Study of an MRD-Driven Approach.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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213 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 17 institutions in 9 countries.

Jan A BurgerDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.
Paul M BarrWilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.
Tadeusz RobakMedical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
Carolyn OwenTom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.
Paolo GhiaUniversità Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.ORCID http://orcid.org/0000-0003-3750-7342
Alessandra TedeschiASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Osnat BaireyRabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Peter HillmenThe Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.
Steven E CoutreStanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.
Stephen DevereuxKings College Hospital, NHS Foundation Trust, London, UK.
Sebastian GrosickiDepartment of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.
Helen McCarthyRoyal Bournemouth General Hospital, Bournemouth, UK.
David SimpsonNorth Shore Hospital, Auckland, New Zealand.
Fritz OffnerUniversitair Ziekenhuis Gent, Gent, Belgium.
Carol MorenoHospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.
Sandra DaiPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Indu LalPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
James P DeanPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Thomas J KippsUCSD Moores Cancer Center, San Diego, CA, USA.
AbbVie (United States) · USAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITCopernicus Memorial Hospital · PLGhent University Hospital · BEKing's College Hospital NHS Foundation Trust · GBMedical University of Silesia · PLMoores Cancer CenterNorth Shore Hospital · NZRoyal Bournemouth Hospital · GBStanford University · USTel Aviv University · ILThe University of Texas MD Anderson Cancer Center · USUniversitat Autònoma de Barcelona · ESUniversity of Calgary · CAUniversity of Leeds · GBUniversity of Rochester Medical Center · USVita-Salute San Raffaele University · IT

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.

Indexed as

AdenineAgedAged, 80 and overChlorambucilDisease-Free SurvivalDrug Administration ScheduleFemaleFollow-Up StudiesHumansLeukemia, Lymphocytic, Chronic, B-CellMalePatient SafetyPiperidinesPrognosisProgression-Free SurvivalPyrazolesAdenineChlorambucilibrutinibPiperidinesPyrazolesPyrimidines

Identifiers

PMID31628428
PMCPMC7214263
OpenAlexW2980937306

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.