Evidence map›Paper›PMID 35275991›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial.

Rafal Dziadziuszko, Solange Peters, Tony Mok, D Ross Camidge, Shirish M Gadgeel, Sai-Hong Ignatius Ou, Krzysztof Konopa, Johannes Noé, Malgorzata Nowicka, Walter Bordogna and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 2% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
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  6. Review
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  8. Longitudinal Tracking ofJTO clinical and research reports · 2025
    Article
  9. EML4-ALK: Update on ALK Inhibitors.International journal of molecular sciences · 2025
    Review
  10. Review
  11. Article
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  15. Overcoming Central β-Sheet #6 (Cβ6)Lung Cancer (Auckland, N.Z.) · 2024
    Article
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  18. Review
  19. Review
  20. Efficacy and safety of alectinib inTranslational lung cancer research · 2022
    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

13 authors at 8 institutions in 4 countries.

Rafal DziadziuszkoMedical University of Gdańsk, Gdańsk, Poland.ORCID 0000-0001-8080-9843
Solange PetersLausanne University Hospital, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.ORCID 0000-0002-0412-7143
Tony MokState Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China.
D Ross CamidgeUniversity of Colorado, Denver, Colorado.
Shirish M GadgeelDepartment of Internal Medicine, Henry Ford Cancer Institute/Henry Ford Health System, Detroit, Michigan.
Sai-Hong Ignatius OuChao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, California.ORCID 0000-0002-1764-4975
Krzysztof KonopaMedical University of Gdańsk, Gdańsk, Poland.
Johannes NoéF. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0002-6563-2186
Malgorzata NowickaF. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0002-5918-5981
Walter BordognaF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Peter N MorcosF. Hoffmann-La Roche Ltd., New York, New York.
Vlatka SmoljanovicF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Alice T ShawMassachusetts General Hospital, Boston, Massachsuetts.
Roche (Switzerland) · CHUniversity of Gdańsk · PLChinese University of Hong Kong · HKHenry Ford Health System · USMassachusetts General Hospital · USUniversity Hospital of Lausanne · CHUniversity of California, Irvine Medical Center · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe retrospectively assessed prognostic value of circulating cell-free DNA (cfDNA) using data from the phase III ALEX study in treatment-naïve, advanced ALK+ non-small cell lung cancer (NSCLC). PATIENTS AND

methodsPatients were randomized to receive twice-daily alectinib 600 mg (n = 152) or crizotinib 250 mg (n = 151). cfDNA was quantified from baseline plasma samples, with patients stratified into ≤median and >median cfDNA biomarker-evaluable populations (BEP). Effect of cfDNA concentration on outcomes was analyzed using a Cox regression model with treatment group as covariate, and in multivariate analyses.

resultsMedian cfDNA concentration in the BEP was 11.53 ng/mL (n = 276). A positive correlation was found between cfDNA concentration and number of lesions, organ lesion sites, and tumor size (sum of longest diameter; all P < 0.0001). In both treatment arms, patients in the >median BEP were more likely to experience disease progression than the ≤median BEP [alectinib adjusted HR = 2.04; 95% confidence interval (CI), 1.07-3.89; P = 0.0305 and crizotinib adjusted HR = 1.83; 95% CI, 1.11-3.00, P = 0.0169]. Median progression-free survival was longer with alectinib than crizotinib in both ≤median and >median BEPs (P < 0.0001). Overall survival data remain immature; survival probability was lower in the >median versus ≤median BEP in both treatment arms (alectinib HR = 2.52; 95% CI, 1.08-5.88; P = 0.0333 and crizotinib HR = 2.63; 95% CI, 1.27-5.47; P = 0.0096).

conclusionsThese data suggest that plasma cfDNA concentration may have prognostic value in advanced ALK+ NSCLC. Prospectively designed studies are warranted to investigate this finding.

Indexed as

Carcinoma, Non-Small-Cell LungCell-Free Nucleic AcidsLung NeoplasmsAnaplastic Lymphoma KinaseCarbazolesCrizotinibHumansPrognosisProtein Kinase InhibitorsRetrospective StudiesAnaplastic Lymphoma KinaseCarbazolesCell-Free Nucleic AcidsCrizotinibProtein Kinase Inhibitors

Identifiers

PMID35275991
PMCPMC9365376
OpenAlexW4220787540

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.