Evidence map›Paper›PMID 31345012›Full record

Trial reportCancer research and treatment2020

Osimertinib in Patients with T790M-Positive Advanced Non-small Cell Lung Cancer: Korean Subgroup Analysis from Phase II Studies.

Myung-Ju Ahn, Ji-Youn Han, Dong-Wan Kim, Byoung Chul Cho, Jin-Hyoung Kang, Sang-We Kim, James Chih-Hsin Yang, Tetsuya Mitsudomi, Jong Seok Lee

2 registry-linked trialsOpen access · diamondAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.5field-weighted citation impact, top 29% 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.

NCT01802632 phase1 / phase2completednot on this map

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

TypeinterventionalSponsorAstraZenecaRan2013 to 2023Enrolled603ConditionsAdvanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung CancerArmsAZD9291
NCT02094261 phase2completednot on this map

Phase II, Open Label, Single-arm Study to Assess Safety and Efficacy of AZD9291 in Patients With Locally Advanced/Metastatic NSCLC Whose Disease Has Progressed With Previous EGFR TKI and Whose Tumours Are EGFR and T790M Mutation Positive

TypeinterventionalSponsorAstraZenecaRan2014 to 2023Enrolled210ConditionsNon Small Cell Lung CancerArmsAZD9291
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Review
  4. Treatment of Brain Metastases of Non-Small Cell Lung Carcinoma.International journal of molecular sciences · 2021
    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

9 authors at 9 institutions in 3 countries.

Myung-Ju AhnDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Ji-Youn HanCenter for Lung Cancer, National Cancer Center, Goyang, Korea.
Dong-Wan KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Byoung Chul ChoDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Jin-Hyoung KangDivision of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Sang-We KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
James Chih-Hsin YangNational Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.
Tetsuya MitsudomiKindai University Faculty of Medicine, Osaka-Sayama, Japan.
Jong Seok LeeDivision of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Asan Medical Center · KRCatholic University of Korea · KRKindai University · JPNational Cancer Center · KRNational Taiwan University Hospital · TWSamsung Medical Center · KRSeoul National University · KRSeoul National University Bundang Hospital · KRYonsei University · KR

Funding

AstraZeneca
6 · The paper itself

Abstract

purposeOsimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR sensitizing mutation and EGFR T790M and has demonstrated efficacy in non-small cell lung cancer (NSCLC) central nervous system (CNS) metastases. We present results of a subgroup analysis of Korean patients from the pooled data of two global phase II trials: AURA extension (NCT01802632) and AURA2 (NCT02094261). MATERIALS AND

methodsEnrolled patients had EGFR T790M-positive NSCLC and disease progression during or after EGFR-TKI therapy. Patients received osimertinib 80 mg orally once daily until disease progression. The primary endpoint was objective response rate (ORR).

resultsIn total, 66 Korean patients received osimertinib treatment with a median treatment duration of 19 months. In the evaluable-for-response population (n=62), ORR was 74% (95% confidence interval [CI], 61.5 to 84.5) and median duration of response was 9.8 months (95% CI, 7.1 to 16.8). In the full analysis set (n=66), median progression-free survival was 10.9 months (95% CI, 8.3 to 15.0; data cutoff November 1, 2016), and median overall survival was 29.2 months (95% CI, 24.8 to 35.7; data cutoff May 1, 2018). Eight patients with CNS metastases were evaluable for response, none of whom showed CNS progression. The most common adverse events were rash (53%), cough (33%), paronychia, diarrhea, and decreased appetite (each 32%).

conclusionEfficacy and safety profiles of osimertinib in this subgroup are consistent with the global phase II pooled population, which supports osimertinib as a recommended treatment for Korean patients with T790M positive NSCLC.

Indexed as

MutationAcrylamidesAdultAgedAllelesAmino Acid SubstitutionAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleHumansIndolesKaplan-Meier EstimateLung NeoplasmsMaleAcrylamidesAniline CompoundsAntineoplastic AgentsEGFR protein, humanErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesClinical trialEpidermal growth factor receptorNon-small-cell lung carcinomaPhase IISouth KoreaTyrosine kinase inhibitor

Identifiers

PMID31345012
PMCPMC6962491
OpenAlexW2962722173

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.