Evidence map›Paper›PMID 31121324›Full record

ArticleJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2019

Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153).

David R Spigel, Michael McCleod, Robert M Jotte, Lawrence Einhorn, Leora Horn, David M Waterhouse, Ben Creelan, Sunil Babu, Natasha B Leighl, Jason C Chandler and 11 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02066636 (A Phase IIIb/IV Safety Trial of Nivolumab), which is not on this map. Cited by 102 papers.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed
–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.

NCT02066636 phase3completednot on this map

A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2021Enrolled1,428ConditionsNon Small Cell Lung Cancer (NSCLC)ArmsNivolumab
3 · Its place in the literature

Who cites it

102 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: CheckMate 153.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Observational
  12. Ageing, immune fitness and cancer.Nature reviews. Cancer · 2025
    Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

David R SpigelSarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, Tennessee. Electronic address: David.Spigel@sarahcannon.com.
Michael McCleodSarah Cannon Research Institute/Florida Cancer Specialists, Fort Myers, Florida.
Robert M JotteRocky Mountain Cancer Centers, Denver, Colorado; US Oncology Research, Houston, Texas.
Lawrence EinhornIndiana University, Indianapolis, Indiana.
Leora HornVanderbilt University Medical Center, Nashville, Tennessee.
David M WaterhouseOncology Hematology Care, Cincinnati, Ohio.
Ben CreelanMoffitt Cancer Center, Tampa, Florida.
Sunil BabuFort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana.
Natasha B LeighlThe Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Jason C ChandlerThe West Cancer Center, Memphis, Tennessee.
Felix CoutureCISSS Chaudiéere-Appalaches, Levis, Quebec, Canada.
George KeoghCharleston Hematology Oncology Associates, Charleston, South Carolina.
Glenwood GossThe Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
Davey B DanielTennessee Oncology, Chattanooga, Tennessee.
Edward B GaronTranslational Research In Oncology-US, Inc. (TRIO-US), Los Angeles, California.
Lee S SchwartzbergThe West Cancer Center, Memphis, Tennessee.
Rohini SenAdelphi Values, Boston, Massachusetts.
Beata KorytowskyBristol-Myers Squibb, Princeton, New Jersey.
Ang LiBristol-Myers Squibb, Princeton, New Jersey.
Nivedita AanurBristol-Myers Squibb, Princeton, New Jersey.
Maen A HusseinSarah Cannon Research Institute/Florida Cancer Specialists, Leesburg, Florida.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCheckMate 153 (NCT02066636) is a phase 3B/4 study assessing nivolumab in previously treated patients with advanced NSCLC. Eligibility criteria allowed enrollment of patients with poor prognostic features of advanced age or diminished Eastern Cooperative Oncology Group performance status (ECOG PS), which are typically underrepresented in or excluded from randomized controlled trials.

methodsPatients with stage IIIB or IV NSCLC and an ECOG PS of 0 to 2 with disease progression after at least one systemic therapy received nivolumab (3 mg/kg every 2 weeks) until progression, unacceptable toxicity, or consent withdrawal. The primary end point was the incidence of grade 3 to 5 select treatment-related adverse events (TRAEs).

resultsAmong 1426 treated patients, 556 (39%) were aged 70 years or older and 128 (9%) had an ECOG PS of 2. The median treatment duration was 3.2 months. Across subgroups and the overall population, the incidences of select grade 3 to 5 TRAEs (6%-9%) and grade 3 or 4 TRAEs (12%-14%) were similar. One grade 5 TRAE was documented. The median overall survival time was comparable in the overall population (9.1 months) and patients aged 70 years or older (10.3 months) but shorter in patients with an ECOG PS of 2 (4.0 months). Patient-reported outcomes generally improved.

conclusionsData from this large predominantly community-based study, which included patients aged 70 years or older and with an ECOG PS of 2, are consistent with registrational studies. As expected, the median overall survival for patients with an ECOG PS of 2 was lower than for the overall population but comparable with historical data.

Indexed as

AdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedNivolumabQuality of LifeYoung AdultNivolumabECOG PSElderlyNivolumabNon–small cell lung cancerSafety

Identifiers

What OpenQuestion holds

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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.