Evidence map›Paper›PMID 35429903›Full record

ReviewTranslational oncology2022

Analysis of patient reported outcomes included in the registrational clinical trials of nivolumab for advanced non-small cell lung cancer.

Remziye Zaim, Ken Redekop, Carin A Uyl-de Groot

4 registry-linked trialsAbstract readReview
In one paragraph

Review in Translational oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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.

NCT01642004 phase3completednot on this map

An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorBristol-Myers SquibbRan2012 to 2021Enrolled272ConditionsSquamous Cell Non-small Cell Lung CancerArmsNivolumab, Docetaxel
NCT01673867 phase3completednot on this map

An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorBristol-Myers SquibbRan2012 to 2021Enrolled582ConditionsNon-Squamous Cell Non-small Cell Lung CancerArmsNivolumab, Docetaxel
NCT02477826 phase3completednot on this map

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorBristol-Myers SquibbRan2015 to 2024Enrolled2,747ConditionsNon-Small Cell Lung CancerArmsNivolumab, Ipilimumab, Carboplatin, Cisplatin, Gemcitabine
NCT03215706 phase3completednot on this map

A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

TypeinterventionalSponsorBristol-Myers SquibbRan2017 to 2024Enrolled719ConditionsNon-Small Cell Lung CancerArmsIpilimumab, Nivolumab, Carboplatin, Paclitaxel, Pemetrexed
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Review
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

3 authors.

Remziye ZaimErasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, the Netherlands. Electronic address: zaim@eshpm.eur.nl.
Ken RedekopErasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, the Netherlands.
Carin A Uyl-de GrootErasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the era of value-based oncology care, stakeholders are increasingly using patient reported outcomes (PROs) to guide clinical and regulatory decisions. PROs are also included in health technology assessments to guide patient access, drug reimbursement and pricing. We reviewed PROs collected in the United States Food and Drug Administration approved indications of nivolumab in advanced NSCLC. We analyzed the PRO data reported in the CheckMate 9LA (NCT03215706), CheckMate 227 (NCT02477826), CheckMate 057 (NCT01673867), and CheckMate 017 (NCT01642004) registrational clinical trials, and concluded that nivolumab alleviated symptom burden and improved health status of patients in this setting. However, inability of the included PRO instruments to measure immune-related adverse events, differences in the timing of PRO evaluation between treatment groups, incomplete patient participation at all time points, limited patient participation in the later time points, and interpretation of the longitudinal data are key challenges that impede accurate analysis and validation of PROs.

Indexed as

Health-related quality of lifeImmune-related adverse eventIpilimumabNivolumabNon-small cell lung cancerPatient reported outcomes

Identifiers

PMID35429903
PMCPMC9034386

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.