Evidence map›Paper›PMID 40788169›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025

Tumor-Informed ctDNA Assay to Predict Outcome in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Treated with PD-1 Inhibitor.

Natasha Honoré, George Laliotis, Vasily N Aushev, Sharlene Velichko, Charuta C Palsuledesai, Hajar Dahou, Cédric van Marcke, Rachel Galot, Minetta C Liu, Jean-Pascal Machiels

Abstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

10 authors.

Natasha HonoréPôle oncologie, Institut de Recherche Clinique et Expérimentale, Université catholique de Louvain (UC Louvain), Brussels, Belgium.ORCID 0009-0007-0684-9143
George LaliotisNatera, Inc., Austin, Texas.ORCID 0000-0001-9205-8258
Vasily N AushevNatera, Inc., Austin, Texas.ORCID 0000-0001-8003-358X
Sharlene VelichkoNatera, Inc., Austin, Texas.ORCID 0000-0002-0133-100X
Charuta C PalsuledesaiNatera, Inc., Austin, Texas.ORCID 0000-0002-3850-260X
Hajar DahouPôle oncologie, Institut de Recherche Clinique et Expérimentale, Université catholique de Louvain (UC Louvain), Brussels, Belgium.ORCID 0009-0001-4479-5760
Cédric van MarckePôle oncologie, Institut de Recherche Clinique et Expérimentale, Université catholique de Louvain (UC Louvain), Brussels, Belgium.ORCID 0000-0003-3454-0630
Rachel GalotPôle oncologie, Institut de Recherche Clinique et Expérimentale, Université catholique de Louvain (UC Louvain), Brussels, Belgium.ORCID 0000-0002-0596-4752
Minetta C LiuNatera, Inc., Austin, Texas.ORCID 0000-0002-8206-5232
Jean-Pascal MachielsPôle oncologie, Institut de Recherche Clinique et Expérimentale, Université catholique de Louvain (UC Louvain), Brussels, Belgium.ORCID 0000-0001-6369-9742

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAlthough immunotherapy improves the overall survival (OS) of patients with recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN), only 15% to 20% of patients derive a long-term benefit. We hypothesized that ctDNA kinetics during immunotherapy, with or without chemotherapy, could predict treatment efficacy in patients with R/M SCCHN. EXPERIMENTAL

designUsing a personalized, tumor-informed ctDNA assay, we evaluated ctDNA kinetics from pre- to on-treatment (6-10 weeks after treatment initiation) time points. The primary endpoint was the concordance between ctDNA kinetics and best overall response (BOR). Secondary endpoints were the association of ctDNA clearance and kinetics with OS and progression-free survival (PFS).

resultsOf the 41 patients, ctDNA assays were successfully designed for 29, and ctDNA was detected before treatment in 25 patients. ctDNA kinetics was significantly correlated with BOR (P = 0.00032). Patients with unfavorable ctDNA kinetics had significantly worse PFS compared with those with favorable ctDNA kinetics (HR = 16.98; 95% confidence interval, 3.35-86.1; P = 0.0006). Six patients had ctDNA clearance, all of whom presented a complete or partial response as BOR. PFS and OS were significantly improved in patients with ctDNA clearance compared with those without clearance (PFS: P = 0.0006, OS: P = 0.027).

conclusionsctDNA kinetics, assessed with a tumor-informed assay, can predict anti-PD-1 therapy efficacy in R/M SCCHN. Early ctDNA clearance during the initial weeks of immunotherapy seems to be a strong predictive marker for a favorable response, as well as improved PFS and OS.

Indexed as

Biomarkers, TumorCirculating Tumor DNAHead and Neck NeoplasmsImmune Checkpoint InhibitorsNeoplasm Recurrence, LocalProgrammed Cell Death 1 ReceptorSquamous Cell Carcinoma of Head and NeckAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm MetastasisPrognosisBiomarkers, TumorCirculating Tumor DNAImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

PMID40788169
PMCPMC12616250

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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.