Evidence map›Paper›PMID 37922432›Full record

ArticleJCO clinical cancer informatics2023

Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials.

Hugo Loureiro, Theresa M Kolben, Astrid Kiermaier, Dominik Rüttinger, Narges Ahmidi, Tim Becker, Anna Bauer-Mehren

Abstract read
In one paragraph

Article in JCO clinical cancer informatics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

7 authors.

Hugo LoureiroData & Analytics, Pharmaceutical Research and Early Development, Roche Innovation Center Munich (RICM), Penzberg, Germany.ORCID 0000-0002-5335-7025
Theresa M KolbenEarly Clinical Development Oncology, Pharmaceutical Research and Early Development, Roche Innovation Center Munich (RICM), Penzberg, Germany.
Astrid KiermaierResearch and Early Development, Roche Innovation Center Basel (RICB), Basel, Switzerland.
Dominik RüttingerResearch and Early Development Oncology, Pharmaceuticals, Bayer AG, Berlin, Germany.
Narges AhmidiComputational Health Center, Helmholtz Munich, Munich, Germany.ORCID 0000-0003-0983-9964
Tim BeckerData & Analytics, Pharmaceutical Research and Early Development, Roche Innovation Center Munich (RICM), Penzberg, Germany.
Anna Bauer-MehrenData & Analytics, Pharmaceutical Research and Early Development, Roche Innovation Center Munich (RICM), Penzberg, Germany.ORCID 0000-0001-8905-9161

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOverall survival (OS) is the primary end point in phase III oncology trials. Given low success rates, surrogate end points, such as progression-free survival or objective response rate, are used in early go/no-go decision making. Here, we investigate whether early trends of OS prognostic biomarkers, such as the ROPRO and DeepROPRO, can also be used for this purpose.

methodsUsing real-world data, we emulated a series of 12 advanced non-small-cell lung cancer (aNSCLC) clinical trials, originally conducted by six different sponsors and evaluated four different mechanisms, in a total of 19,920 individuals. We evaluated early trends (until 6 months) of the OS biomarker alongside early OS within the joint model (JM) framework. Study-level estimates of early OS and ROPRO trends were correlated against the actual final OS hazard ratios (HRs).

resultsWe observed a strong correlation between the JM estimates and final OS HR at 3 months (adjusted

conclusionWe describe a pipeline to predict trial OS HRs using emulated aNSCLC studies and their early OS and OS biomarker trends. The method has the potential to accelerate and improve decision making in drug development.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsBiomarkersDisease-Free SurvivalHumansPrognosisBiomarkers

Identifiers

PMID37922432
PMCPMC10730042

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.