Evidence map›Paper›PMID 39671539›Full record

ArticleJCO clinical cancer informatics2024

Real-World and Clinical Trial Validation of a Deep Learning Radiomic Biomarker for PD-(L)1 Immune Checkpoint Inhibitor Response in Advanced Non-Small Cell Lung Cancer.

Chiharu Sako, Chong Duan, Kevin Maresca, Sean Kent, Taly Gilat Schmidt, Hugo J W L Aerts, Ravi B Parikh, George R Simon, Petr Jordan

Registry-linked trialAbstract read
In one paragraph

Article in JCO clinical cancer informatics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02573259 (A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-06801591 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC MELANOMA, SQUAMOUS CELL HEAD AND NECK CANCER, OVARIAN CANCER, SARCOMA, NON-SMALL CELL LUNG CANCER, UROTHELIAL CARCINOMA OR OTHER SOLID TUMORS.), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT02573259 phase1completednot on this map

A phase 1, open-label, dose escalation and expansion study of pf-06801591 in patients with locally advanced or metastatic melanoma, squamous cell head and neck cancer, ovarian cancer, sarcoma, non-small cell lung cancer, urothelial carcinoma or other solid tumors.

TypeinterventionalSponsorPfizerRan2016 to 2020Enrolled147ConditionsPart 1, MELANOMA, SCCHN, OVCAArmsPF-06801591
3 · Its place in the literature

Who cites it

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

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  8. Tumor Characterization Using [Pharmaceuticals (Basel, Switzerland) · 2026
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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

9 authors.

Chiharu SakoOnc.AI, San Carlos, CA.ORCID 0000-0003-3243-3954
Chong DuanPfizer, Cambridge, MA.ORCID 0000-0001-9817-5340
Kevin MarescaPfizer, Cambridge, MA.
Sean KentPfizer, Cambridge, MA.ORCID 0000-0001-8697-9069
Taly Gilat SchmidtOnc.AI, San Carlos, CA.ORCID 0000-0002-9840-0963
Hugo J W L AertsOnc.AI, San Carlos, CA.
Ravi B ParikhUniversity of Pennsylvania, Philadelphia, PA.ORCID 0000-0003-2692-6306
George R SimonMoffitt Cancer Center, Tampa, FL.ORCID 0000-0002-3894-0773
Petr JordanOnc.AI, San Carlos, CA.ORCID 0000-0002-3278-2866

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study developed and validated a novel deep learning radiomic biomarker to estimate response to immune checkpoint inhibitor (ICI) therapy in advanced non-small cell lung cancer (NSCLC) using real-world data (RWD) and clinical trial data. MATERIALS AND

methodsRetrospective RWD of 1,829 patients with advanced NSCLC treated with PD-(L)1 ICIs were collected from 10 academic and community institutions in the United States and Europe. The RWD included data sets for discovery (Data Set A-Discovery, n = 1,173) and independent test (Data Set B, n = 458). A radiomic pipeline, containing a deep learning feature extractor and a survival model, generated the computed tomography (CT) response score (CTRS) applied to the pretreatment routine CT/positron emission tomography (PET)-CT scan. An enhanced CTRS (eCTRS) also incorporated age, sex, treatment line, and lesion annotations. Performance was evaluated against progression-free survival (PFS) and overall survival (OS). Biomarker generalizability was further evaluated using a secondary analysis of a prospective clinical trial (ClinicalTrials.gov identifier: NCT02573259) evaluating the PD-1 inhibitor sasanlimab in second or later line of treatment (Data Set C, n = 54).

resultsIn RWD Test Data Set B, the CTRS identified patients with a high probability of response to ICI with a PFS hazard ratio (HR) of 0.46 (95% CI, 0.26 to 0.82) and an OS HR of 0.50 (95% CI, 0.28 to 0.92) in the first-line ICI monotherapy cohort, after adjustment for baseline covariates including the PD-L1 tumor proportion score. In Clinical Trial Data Set C, the CTRS demonstrated an adjusted PFS HR of 1.03 (95% CI, 0.43 to 2.47) and an OS HR of 0.33 (95% CI, 0.14 to 0.91). The CTRS and eCTRS outperformed traditional imaging biomarkers of lesion size in PFS and OS for RWD Test Data Set B and in OS for the Clinical Trial Data Set.

conclusionThe study developed and validated a deep learning radiomic biomarker using pretreatment routine CT/PET-CT scans to identify ICI benefit in advanced NSCLC.

Indexed as

B7-H1 AntigenBiomarkers, TumorCarcinoma, Non-Small-Cell LungDeep LearningImmune Checkpoint InhibitorsLung NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedPositron Emission Tomography Computed TomographyRadiomicsRetrospective StudiesB7-H1 AntigenBiomarkers, TumorCD274 protein, humanImmune Checkpoint Inhibitors

Identifiers

PMID39671539
PMCPMC11658027

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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.