Evidence map›Paper›PMID 33270375›Full record

Trial reportThoracic cancer2021

Phase II open-label multicenter study to assess the antitumor activity of afatinib in lung cancer patients with activating epidermal growth factor receptor mutation from circulating tumor DNA: Liquid-Lung-A.

Cheol-Kyu Park, Sung-Yong Lee, Jae Cheol Lee, Chang-Min Choi, Shin Yup Lee, Tae-Won Jang, In-Jae Oh, Young-Chul Kim

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Thoracic cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.3field-weighted citation impact, top 37% 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

6 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. A Review of Circulating Tumor DNA (ctDNA) and the Liquid Biopsy in Cancer Diagnosis, Screening, and Monitoring Treatment Response.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
  3. Review
  4. Review
  5. Review
  6. 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

8 authors at 4 institutions in 1 country.

Cheol-Kyu ParkDepartment of Internal Medicine, Chonnam National University Medical School and CNU Hwasun Hospital, Hwasun, Jeonnam, Korea.ORCID 0000-0001-8701-0786
Sung-Yong LeeDepartment of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.ORCID 0000-0002-8693-5792
Jae Cheol LeeDepartment of Oncology, Pulmonary and Critical Care Medicine, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Korea.ORCID 0000-0001-5963-0259
Chang-Min ChoiDepartment of Oncology, Pulmonary and Critical Care Medicine, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Korea.ORCID 0000-0002-2881-4669
Shin Yup LeeDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.ORCID 0000-0002-2121-7335
Tae-Won JangDepartment of Internal Medicine, School of Medicine, Kosin University Gospel Hospital, Pusan, Korea.ORCID 0000-0001-8075-8097
In-Jae OhDepartment of Internal Medicine, Chonnam National University Medical School and CNU Hwasun Hospital, Hwasun, Jeonnam, Korea.ORCID 0000-0003-4837-1321
Young-Chul KimDepartment of Internal Medicine, Chonnam National University Medical School and CNU Hwasun Hospital, Hwasun, Jeonnam, Korea.ORCID 0000-0001-7019-7687
Chonnam National University Hwasun Hospital · KRAsan Medical Center · KRKorea University Medical Center · KRKosin University Gospel Hospital · KR

Funding

Boehringer Ingelheim 1200.271
6 · The paper itself

Abstract

backgroundMutation analysis of circulating tumor DNA (ctDNA) is used for diagnosing lung cancer. This trial aimed to assess the efficacy of afatinib in treatment-naïve patients with lung cancer harboring epidermal growth factor receptor mutations (EGFRm, exon 19 deletions or exon 21 point mutations) detected based on ctDNA.

methodsThe primary objective was the objective response rate (ORR) in the response evaluable (RE) population. EGFRm analysis of ctDNA was performed using PANA Mutype. Of the 331 patients screened, ctDNA was positive in 21% (68/331) in the detection of activating EGFRm. Among 81 subjects with tumor EGFRm, 48 showed matched EGFRm in their ctDNA (59% sensitivity).

resultsTherapy with afatinib 40 mg was initiated in 21 (female, 17; adenocarcinoma, 20) patients (intention-to-treat, ITT); dose modifications were made in 15 (71%). The ORR was 74% in the RE population (14/19); 11 patients showed EGFRm only in ctDNA (Group A), whereas 10 exhibited the same EGFRm in their ctDNA and tumor DNA (Group B). There was no significant difference in ORR between Groups A and B (80% and 67% RE, respectively). Median progression-free survival (PFS) was 12.0 months, and no significant difference was observed according to the final afatinib dose, type of EGFRm, and Group A versus B. After progression, T790M mutation was found in 40% (6/15) of patients, and osimertinib was used as a second-line treatment.

conclusionsAfatinib showed similar ORR and PFS in patients with lung cancer harboring EGFRm in their ctDNA regardless of tumor EGFRm results. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: Afatinib showed favorable ORR and PFS regardless of the tumor EGFR mutation status results, similar to the findings of previous trials assessing afatinib as first-line treatment of EGFR-mutated non-small cell lung cancer based on tumor genotyping. WHAT THIS STUDY ADDS: Our findings emphasize that the survival benefit of afatinib treatment can be achieved not only by appropriate dose reduction with frequent and detailed monitoring of toxicities, but also by using noninvasive (ctDNA) assays in a real-world setting.

Indexed as

AfatinibAgedAntineoplastic AgentsCirculating Tumor DNAErbB ReceptorsFemaleHumansLung NeoplasmsMaleMutationProspective StudiesAfatinibAntineoplastic AgentsCirculating Tumor DNAErbB ReceptorsAfatinibcirculating tumor DNAEGFR mutationnon-small cell lung carcinoma

Identifiers

PMID33270375
PMCPMC7882376
OpenAlexW3106970140

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.