Evidence map›Paper›PMID 31825714›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Osimertinib for Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09).

Jang Ho Cho, Sung Hee Lim, Ho Jung An, Ki Hwan Kim, Keon Uk Park, Eun Joo Kang, Yoon Hee Choi, Mi Sun Ahn, Myung Hee Lee, Jong-Mu Sun and 4 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 212 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
212citing papers in PubMed, 4 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.

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

212 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. UncommonCurrent oncology (Toronto, Ont.) · 2022
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Observational
  14. Article
  15. Article
  16. Lung cancer withTranslational lung cancer research · 2026
    Review
  17. Article
  18. Article
  19. Article
  20. Review

152 more citing papers are in PubMed but not listed here.

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

14 authors.

Jang Ho ChoSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Sung Hee LimSoonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
Ho Jung AnSt Vincent's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Ki Hwan KimBoramae Medical Center, Seoul National University Hospital, Seoul, Republic of Korea.
Keon Uk ParkDongsan Hospital, Keimyung University, Daegu, Republic of Korea.
Eun Joo KangGuro Hospital, Korea University Medical Center, Seoul, Republic of Korea.
Yoon Hee ChoiDongnam Institute of Radiological and Medical Sciences, Busan, Republic of Korea.
Mi Sun AhnAjou University Medical Center, Suwon, Republic of Korea.
Myung Hee LeeSamsung Medical Center, Seoul, Republic of Korea.
Jong-Mu SunSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Se-Hoon LeeSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Jin Seok AhnSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Keunchil ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Myung-Ju AhnSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeApproximately 10% of patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) harbor uncommon mutations. Here, we report the efficacy and safety of osimertinib in patients with NSCLC harboring uncommon EGFR mutations. PATIENT AND

methodsThis was a multicenter, single-arm, open-label, phase II study in Korea. Patients with histologically confirmed metastatic or recurrent NSCLC harboring EGFR mutations other than the exon 19 deletion, L858R and T790M mutations, and exon 20 insertion were eligible for the study. The primary end point of objective response rate was assessed every 6 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary end points were progression-free survival, overall survival, duration of response, and safety.

resultsBetween March 2016 and October 2017, 37 patients were enrolled. All were evaluable except one patient who withdrew consent after starting treatment. Median age was 60 years, and 22 (61%) were male. Among patients, 61% received osimertinib as first-line therapy. The mutations identified were G719X (n = 19; 53%), followed by L861Q (n = 9; 25%), S768I (n = 8; 22%), and others (n = 4; 11%). Objective response rate was 50% (18 of 36 patients; 95% CI, 33% to 67%). Median progression-free survival was 8.2 months (95% CI, 5.9 to 10.5 months), and median overall survival was not reached. Median duration of response was 11.2 months (95% CI, 7.7 to 14.7 months). Adverse events of any grade were rash (n = 11; 31%), pruritus (n = 9; 25%), decreased appetite (n = 9; 25%), diarrhea (n = 8; 22%), and dyspnea (n = 8; 22%), but all adverse events were manageable.

conclusionOsimertinib demonstrated favorable activity with manageable toxicity in patients with NSCLC harboring uncommon EGFR mutations.

Indexed as

AcrylamidesAdministration, OralAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleHumansIndolesLung NeoplasmsMaleMiddle AgedMutationAcrylamidesAniline CompoundsAntineoplastic AgentsEGFR protein, humanErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidines

Identifiers

PMID31825714
PMCPMC7098834

What OpenQuestion holds

Textmetadata
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.