Evidence map›Paper›PMID 35099678›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2022

Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions.

Andrew Walding, Konstantina Skaltsa, Montserrat Casamayor, Anna Rydén

Erratum issued Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02296125 (A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 26% 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.

NCT02296125 phase3completednot on this map

A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

TypeinterventionalSponsorAstraZenecaRan2014 to 2025Enrolled674ConditionsLocally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung CancerArmsAZD9291 80 mg/40 mg + placebo, Placebo Erlotinib 150/100mg, Placebo Gefitinib 250 mg, Erlotinib 150/100 mg, Gefitinib 250 mg
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 3 countries.

Andrew WaldingAstraZeneca R&D, 132 Hills Road, Cambridge, CB2 1PG, UK. andrew.walding@astrazeneca.com.
Konstantina SkaltsaIQVIA, Provença 392, 3rd floor, 08025, Barcelona, Spain.
Montserrat CasamayorIQVIA, Provença 392, 3rd floor, 08025, Barcelona, Spain.
Anna RydénAstraZeneca Gothenburg, Pepparedsleden 1, 431 83, Mölndal, Sweden.
Instituto Químico Biológico · ESAstraZeneca (Sweden) · SEAstraZeneca (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe clinical relevance of different time-to-deterioration (TTD) definitions for patient-reported outcomes were explored.

methodsTTD definitions differing by reference score and deterioration event were used to analyse data from the phase 3 FLAURA trial of first-line osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small cell lung cancer. Pre-specified key symptoms were fatigue, appetite loss, cough, chest pain and dyspnoea, scored using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-LC13 questionnaires (≥ 10-point difference = clinically relevant).

resultsNo significant treatment differences in TTD (distributions) were observed using definitions based on transient or definitive deterioration alone. TTD definitions based on definitive, sustained deterioration, with death not included as an event, yielded a significant treatment difference for dyspnoea (hazard ratio [HR] 0.71; P = 0.034) when baseline was the reference, and for cough (HR 0.70; P = 0.009) and dyspnoea (HR 0.71; P = 0.004) when best previous score was the reference. With death included as an event, treatment differences were significant for dyspnoea (HR 0.70; P = 0.025) when baseline was the reference, and for cough (HR 0.70; P = 0.011), dyspnoea (HR 0.71; P = 0.003) and chest pain (HR 0.71; P = 0.038) when best previous score was the reference. Irrespective of definition, TTD for appetite loss and fatigue did not differ significantly between arms.

conclusionThis exploratory work showed that different TTD definitions yield different magnitudes of treatment difference, highlighting the importance of pre-specifying TTD definitions upfront in clinical trials. CLINICAL

trial registrationClinicalTrials.gov NCT02296125.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsChest PainCoughDyspneaFatigueHumansPatient Reported Outcome MeasuresQuality of LifeDisease progressionNon-small cell lung cancerPatient-reported outcomes

Identifiers

PMID35099678
PMCPMC9250481
OpenAlexW4210630743

What OpenQuestion holds

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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.