Evidence map›Paper›PMID 30767298›Full record

Trial reportAmerican journal of hematology2019

Outcomes with ibrutinib by line of therapy and post-ibrutinib discontinuation in patients with chronic lymphocytic leukemia: Phase 3 analysis.

Susan M O'Brien, John C Byrd, Peter Hillmen, Steven Coutre, Jennifer R Brown, Paul M Barr, Jacqueline C Barrientos, Stephen Devereux, Tadeusz Robak, Nishitha M Reddy and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.9field-weighted citation impact, top 9% 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

20 citing papers in PubMed, 31 citations in OpenAlex.

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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

18 authors at 16 institutions in 5 countries.

Susan M O'BrienDepartment of Medicine, Division of Hematology/Oncology, University of California Irvine, Irvine, California.ORCID 0000-0002-2481-7504
John C ByrdDepartment of Internal Medicine, Division of Hematology, The Ohio State University Medical Center, Columbus, Ohio.
Peter HillmenDepartment of Haematology, St James's University Hospital, Leeds, United Kingdom.
Steven CoutreDepartment of Medicine, Division of Hematology, Stanford University School of Medicine, Stanford, California.
Jennifer R BrownDepartment of Medicine, Division of Hematological Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Paul M BarrDepartment of Medicine, Wilmot Cancer Institute, University of Rochester, Rochester, New York.
Jacqueline C BarrientosDepartment of Medicine, Division of Hematology and Medical Oncology, Hofstra Northwell School of Medicine, Hempstead, New York.
Stephen DevereuxDepartment of Life Sciences and Medicine, Division of Cancer Studies, Kings College Hospital, London, United Kingdom.
Tadeusz RobakDepartment of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Łódź, Poland.ORCID 0000-0002-3411-6357
Nishitha M ReddyDepartment of Medicine, Division of Hematology/Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
Thomas J KippsDepartment of Medicine, Division of Hematology-Oncology, UC San Diego Health, Moores Cancer Center, San Diego, California.
Alessandra TedeschiDepartment of Hematology, Azienda Ospedaliera Niguarda Cà Granda, Milan, Italy.
Florence CymbalistaService Hematologie Biologique, Hôpital Avicenne, Université Paris 13, Bobigny, France.
Paolo GhiaStrategic Research Program in CLL, Division of Experimental Oncology, Universitè Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.
Stephen ChangBiostatistics, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Joi NinomotoClinical Science, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Danelle F JamesClinical Science, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Jan A BurgerDepartment of Leukemia, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas.
AbbVie (United States) · USAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITCopernicus Memorial Hospital · PLDana-Farber Cancer Institute · USHofstra University · USIRCCS Ospedale San Raffaele · ITKing's College - North Carolina · USStanford Medicine · USSt James's University Hospital · GBThe Ohio State University Wexner Medical Center · USThe University of Texas MD Anderson Cancer Center · USUC San Diego Health System · USUniversité Sorbonne Paris Nord · FRUniversity of California, Irvine · USUniversity of Rochester · USVanderbilt University Medical Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Janssen PharmaceuticalsNCI NIH HHS P30 CA016672Pharmacyclics LLC, an AbbVie Company
6 · The paper itself

Abstract

The efficacy of ibrutinib has been demonstrated in patients with chronic lymphocytic leukemia (CLL), including as first-line therapy. However, outcomes after ibrutinib discontinuation have previously been limited to higher-risk populations with relapsed/refractory (R/R) disease. The objective of this study was to evaluate outcomes of ibrutinib-treated patients based on prior lines of therapy, including after ibrutinib discontinuation. Data were analyzed from two multicenter phase 3 studies of single-agent ibrutinib: RESONATE (PCYC-1112) in patients with R/R CLL and RESONATE-2 (PCYC-1115) in patients with treatment-naive (TN) CLL without del(17p). This integrated analysis included 271 ibrutinib-treated non-del(17p) patients with CLL (136 TN and 135 R/R). Median progression-free survival (PFS) was not reached for subgroups with 0 and 1/2 prior therapies but was 40.6 months for patients with ≥3 therapies (median follow-up: TN, 36 months; R/R, 44 months). Median overall survival (OS) was not reached in any subgroup. Overall response rate (ORR) was 92% in TN and 92% in R/R, with depth of response increasing over time. Adverse events (AEs) and ibrutinib discontinuation due to AEs were similar between patient groups. Most patients (64%) remain on treatment. OS following discontinuation was 9.3 months in R/R patients (median follow-up 18 months, n = 51) and was not reached in TN patients (median follow-up 10 months, n = 30). In this integrated analysis, ibrutinib was associated with favorable PFS and OS, and high ORR regardless of prior therapies in patients with CLL. The best outcomes following ibrutinib discontinuation were for patients receiving ibrutinib in earlier lines of therapy.

Indexed as

AdenineAdultAgedDisease-Free SurvivalFemaleFollow-Up StudiesHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPiperidinesPyrazolesPyrimidinesSurvival RateAdenineibrutinibPiperidinesPyrazolesPyrimidines

Identifiers

PMID30767298
PMCPMC6593416
OpenAlexW2911561350

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Registered trials

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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.