Evidence map›Paper›PMID 36108559›Full record

ArticleESMO open2022

The value of disease-free survival (DFS) and osimertinib in adjuvant non-small-cell lung cancer (NSCLC): an international Delphi consensus report.

M C Hardenberg, B Patel, C Matthews, R Califano, R Garcia Campelo, C Grohe, M H Hong, G Liu, S Lu, F de Marinis and 5 more

Open access · goldAbstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

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

15 authors at 13 institutions in 11 countries.

M C HardenbergCharles River Associates, Cambridge, UK. Electronic address: mhardenberg@crai.com.
B PatelCharles River Associates, Cambridge, UK.
C MatthewsCharles River Associates, Cambridge, UK.
R CalifanoDepartment of Medical Oncology, The Christie NHS Foundation Trust and Division of Cancer Sciences, The University of Manchester, Manchester, UK.
R Garcia CampeloCoruña University Hospital, Medical Oncology Unit, Coruña, Spain.
C GroheDepartment of Respiratory Diseases, ELK Thorax Center, Berlin, Germany.
M H HongDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
G LiuUniversity of Toronto, Princess Margaret Cancer Centre, Toronto, Canada.
S LuDepartment of Shanghai Lung Cancer Center, Shanghai Jiao Tong University, Shanghai Chest Hospital, Shanghai, China.
F de MarinisEuropean Institute of Oncology, IRCCS, Milan, Italy.
M PérolMedical Oncology Department, Léon Bérard Cancer Center, Lyon, France.
R A SooDepartment of Haematology-Oncology, National University Cancer Institute, Singapore, Singapore.
B M StilesAlbert Einstein College of Medicine, Montefiore Health System, Cardiothoracic and Vascular Surgery, New York, USA.
M TiseoUniversity of Parma, Department of Medicine and Surgery and Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
M TsuboiDepartment of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Charles River Laboratories (United Kingdom) · GBAlbert Einstein College of Medicine · USCentre de Recherche en Cancérologie de Lyon · FREuropean Institute of Oncology · ITGerman Society for Thoracic and Cardiovascular Surgery · DENational Cancer Center Hospital East · JPNational University Cancer Institute, Singapore · SGPrincess Margaret Cancer Centre · CAShanghai Chest Hospital · CNUniversidade da Coruña · ESUniversity of Manchester · GBUniversity of Parma · ITYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRates of disease recurrence and death following surgery remain high in early-stage non-small-cell lung cancer (NSCLC), despite adjuvant treatment and curative intent. Recently, osimertinib showed overwhelming evidence for disease-free survival (DFS), as demonstrated by an overall reduction in the risk of disease recurrence or death in the adjuvant setting of 80% versus control in the ADAURA study (stage IB-IIIA; hazard ratio 0.20; 99.12% confidence interval 0.14-0.30; P < 0.001). However, due to the early unblinding of ADAURA and lack of mature overall survival data, there is a need to qualitatively confirm consensus on the clinical and patient relevance of DFS. MATERIALS AND

methodsWe conducted a modified Delphi panel study consisting of two rounds of surveys, followed by a consensus meeting. An international panel of experts in the field of NSCLC and epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) (n = 13) was asked to rate agreement and comment on a list of pre-defined statements covering key consensus gaps. Statements were eliminated or updated between surveys, depending on the level of agreement. A final list of agreed-upon statements was drafted in the consensus meeting.

resultsConsensus was reached on 32 qualitative statements, with topics including unmet needs in early-stage NSCLC, the value of DFS, and the value of osimertinib. Crucially, DFS was agreed to be a clinically and patient-relevant endpoint in adjuvant NSCLC. The relevance of DFS was found to relate to the ability of an adjuvant therapy, such as osimertinib, to keep patients in the clinically valuable curative intent setting, while preventing the burden associated with distant and locoregional recurrence, and progressive disease.

conclusionsAddressing the need for measures that reflect clinical benefit is essential to continue improving outcomes for NSCLC patients. To that end, this work provides a qualitative framework for clinicians to consider the clinical and patient relevance of DFS in adjuvant NSCLC and the benefit demonstrated in ADAURA thus far.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAcrylamidesAniline CompoundsChemotherapy, AdjuvantDelphi TechniqueDisease-Free SurvivalErbB ReceptorsHumansIndolesMutationNeoplasm Recurrence, LocalProtein Kinase InhibitorsPyrimidinesAcrylamidesAniline CompoundsErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesADAURAadjuvant treatmentDFSearly stageEGFRmNSCLC

Identifiers

PMID36108559
PMCPMC9588882
OpenAlexW4295592704

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.