Evidence map›Paper›PMID 32187452›Full record

ArticleCancer medicine2020

The impact of dose modification and temporary interruption of ibrutinib on outcomes of chronic lymphocytic leukemia patients in routine clinical practice.

Sameer A Parikh, Sara J Achenbach, Timothy G Call, Kari G Rabe, Wei Ding, Jose F Leis, Saad S Kenderian, Asher A Chanan-Khan, Amber B Koehler, Susan M Schwager and 9 more

Open access · goldAbstract read
In one paragraph

Article in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
4.8field-weighted citation impact, top 4% 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

36 citing papers in PubMed, 53 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

19 authors at 4 institutions in 1 country.

Sameer A ParikhDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-3221-7314
Sara J AchenbachDivision of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN, USA.
Timothy G CallDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Kari G RabeDivision of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN, USA.
Wei DingDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0001-9811-4601
Jose F LeisDepartment of Hematology and Oncology, Mayo Clinic, Phoenix, AZ, USA.
Saad S KenderianDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0003-2767-3830
Asher A Chanan-KhanDivision of Hematology and Oncology, Mayo Clinic, Jacksonville, FL, USA.
Amber B KoehlerDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-2539-040X
Susan M SchwagerDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Eli MuchtarDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Amie L FonderDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Kristen B McCulloughDepartment of Pharmacy, Mayo Clinic, Rochester, MN, USA.
Adrienne N NedvedDepartment of Pharmacy, Mayo Clinic, Rochester, MN, USA.
Matthew D SmithDepartment of Pharmacy, Mayo Clinic, Rochester, MN, USA.
Susan L SlagerDivision of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN, USA.
Neil E KayDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Heidi D FinnesDepartment of Pharmacy, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-1117-0983
Tait D ShanafeltDivision of Hematology, Stanford University School of Medicine, Palo Alto, CA, USA.
Mayo Clinic in Arizona · USMayo Clinic · USWinnMed · USPalo Alto University · US

Funding

Paul Calabresi Program in Clinical/Translational Research at Mayo ClinicK12CA090628 · NCI · MAYO CLINIC ROCHESTER · PI WEROHA, SARAVUT · 2001 to 2025
$19.7M
Predicting clinical outcome in individuals with small CLL B cell clonesR01CA197120 · NCI · MAYO CLINIC ROCHESTER · PI KAY, NEIL E, SHANAFELT, TAIT D · 2015 to 2019
$3.0M
NCI NIH HHS K12 CA090628NCI NIH HHS R01 CA197120
6 · The paper itself

Abstract

To study the impact of dose modification and temporary interruption of ibrutinib in routine clinical practice, we conducted a retrospective study of consecutive CLL patients treated with ibrutinib outside the context of a clinical trial at Mayo Clinic, (Rochester, MN) from 11/2013 to 12/2017. Of 209 patients, 131 (74%) had unmutated IGHV, 38 (20%) had TP53 disruption, and 47 (22%) were previously untreated. A total of 87/209 (42%) patients started reduced dose ibrutinib (<420 mg daily; n = 43, physician preference; n = 33, concomitant medications; and n = 11, other). During 281 person-years of treatment, 91/209 patients had temporary dose interruption (54%, nonhematologic toxicity; 29%, surgical procedures; 10%, hematologic toxicity; and 7%, other). After a median follow-up of 24 months, the estimated median event-free survival (EFS) was 36 months, and median overall survival (OS) was not reached. On multivariable analyses, temporary ibrutinib interruption (hazard ratio [HR]: 2.37, P = .006) and TP53 disruption at ibrutinib initiation (HR: 1.81, P = .048) were associated with shorter EFS, whereas only TP53 disruption (HR: 2.38, P = .015) was associated with shorter OS. Initial ibrutinib dose and dose modification during therapy did not appear to impact EFS or OS. These findings illustrate the challenges associated with continuous oral therapy with ibrutinib in patients with CLL.

Indexed as

DeprescriptionsAdenineAdultAgedAged, 80 and overDose-Response Relationship, DrugFemaleHumansImmunoglobulin Heavy ChainsLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedMultivariate AnalysisPiperidinesProgression-Free SurvivalProportional Hazards ModelsAdenineibrutinibImmunoglobulin Heavy ChainsPiperidinesProtein Kinase InhibitorsTP53 protein, humanTumor Suppressor Protein p53

Identifiers

PMID32187452
PMCPMC7221301
OpenAlexW3012494088

What OpenQuestion holds

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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.