Evidence map›Paper›PMID 29382669›Full record

Trial reportCancer immunology research2018

Treatment-Related Adverse Events Predict Improved Clinical Outcome in NSCLC Patients on KEYNOTE-001 at a Single Center.

Aaron Lisberg, D Andrew Tucker, Jonathan W Goldman, Brian Wolf, James Carroll, Ariana Hardy, Karolyn Morris, Paulina Linares, Carlos Adame, Marshall L Spiegel and 16 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer immunology research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 12 pooled it
–field-weighted citation impact
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

66 citing papers in PubMed, 12 syntheses or guidelines pooled it.

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  9. Anti-PD-1/L1-associated immune-related adverse events as harbinger of favorable clinical outcome: systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Pooled it
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  13. Entinostat plus Pembrolizumab in Patients with Metastatic NSCLC Previously Treated with Anti-PD-(L)1 Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
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  15. Observational
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Aaron LisbergDavid Geffen School of Medicine at UCLA, Los Angeles, California.
D Andrew TuckerDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Jonathan W GoldmanDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Brian WolfDavid Geffen School of Medicine at UCLA, Los Angeles, California.
James CarrollDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Ariana HardyDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Karolyn MorrisDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Paulina LinaresDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Carlos AdameDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Marshall L SpiegelDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Courtney WellsDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Jordan McKenzieDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Blanca LedezmaDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Melody MendenhallDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Phillip AbarcaDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Krikor BornazyanDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Jaime HuntDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Nima MoghadamDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Natalie ChongDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Danielle NamethDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Caitlin MarxDavid Geffen School of Medicine at UCLA, Los Angeles, California.
John MadrigalDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Sitaram VangalaDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Narek ShaverdianDavid Geffen School of Medicine at UCLA, Los Angeles, California.
David ElashoffDavid Geffen School of Medicine at UCLA, Los Angeles, California.
Edward B GaronDavid Geffen School of Medicine at UCLA, Los Angeles, California. egaron@mednet.ucla.edu.

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Samuel Wheeler French · 1985 to 2026
$134.5M
UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
A model for predicting response to PD-1 inhibitors in NSCLCR01CA208403 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI GARON, EDWARD B · 2017 to 2021
$3.2M
NCATS NIH HHS UL1 TR001881NCI NIH HHS P30 CA016042NCI NIH HHS R01 CA208403
6 · The paper itself

Abstract

We retrospectively analyzed non-small cell lung cancer (NSCLC) patients from a single center treated with pembrolizumab on the KEYNOTE-001 trial and evaluated the association between treatment-related adverse events (trAEs) and clinical outcomes. Investigators reported AEs on trial and graded them according to Common Terminology Criteria for Adverse Events v4.0, labeling them as unlikely, possibly, or probably treatment-related. AEs labeled as possibly/probably related were considered trAEs for this analysis. The relationship between the incidence of a trAE and clinical outcomes was evaluated. Ninety-seven NSCLC patients treated on KEYNOTE-001 at the University of California, Los Angeles were evaluated. Ten percent (85/826) of AEs were trAEs, occurring in 40% (39/97) of patients. The most frequent trAEs were rash (21% patients), fatigue (6% patients), and hypothyroidism (6% patients). The 39 patients that experienced a trAE had increased objective response rate (ORR, 38.5%), progression-free survival (PFS: median, 248 days), and overall survival (OS: median, 493 days), compared with the 58 patients that did not (ORR: 8.9%, PFS: median 60 days, OS: median 144.5 days). The observed association between trAEs and improved clinical outcome persisted when using Cox proportional hazards regression models to assess the confounding effect of covariates and mitigate guarantee-time bias. The association also remained when data were substratified by grade, degree of association, and treatment-related select AE designation. This single-center analysis revealed that trAEs predicted for improved clinical outcome with pembrolizumab, and when controlling for guarantee-time bias and plausible confounders, this association remained. This observed relationship adds to our understanding of anti-PD-1 therapy and could aid clinicians in identifying patients most likely to benefit from therapy.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungExanthemaFatigueFemaleHumansHypothyroidismLung NeoplasmsMaleMiddle AgedProgrammed Cell Death 1 ReceptorTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalPDCD1 protein, humanpembrolizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID29382669
PMCPMC6066474

What OpenQuestion holds

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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.