Evidence map›Paper›PMID 38371194›Full record

ArticleJTO clinical and research reports2024

Adjuvant Osimertinib in Patients With Stage IB to IIIA EGFR Mutation-Positive NSCLC After Complete Tumor Resection: ADAURA China Subgroup Analysis.

Jie Wang, Yi-Long Wu, Shun Lu, Qun Wang, Shanqing Li, Wen-Zhao Zhong, Qiming Wang, Wei Li, Buhai Wang, Jun Chen and 9 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JTO clinical and research reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02511106 (A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 17% 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.

NCT02511106 phase3active not recruitingnot on this map

A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).

TypeinterventionalSponsorAstraZenecaRan2015 to 2029Enrolled682ConditionsStage IB-IIIA Non-small Cell Lung CarcinomaArmsAZD9291 80 mg/40 mg, Placebo AZD9291 80 mg/40 mg, Open-label AZD9291 80 mg/40 mg
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Non-small cell lung cancer in China.Cancer communications (London, England) · 2022
    Review
  8. Targeting metastatic cancer.Nature medicine · 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

19 authors at 14 institutions in 3 countries.

Jie WangCancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangzhou, People's Republic of China.
Shun LuShanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Qun WangDepartment of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Shanqing LiDepartment of Thoracic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Wen-Zhao ZhongGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangzhou, People's Republic of China.
Qiming WangDepartment of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, People's Republic of China.
Wei LiThe First Hospital of Jilin University, Changchun, Jilin, People's Republic of China.
Buhai WangDepartment of Oncology of Subei People's Hospital, Yangzhou University, Yangzhou, Jiangsu, People's Republic of China.
Jun ChenDepartment of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, People's Republic of China.
Ying ChengDepartment of Thoracic Oncology, Jilin Cancer Hospital, Changchun, People's Republic of China.
Hongbing DuanZhongshan Hospital, Xiamen University, Xiamen, People's Republic of China.
Gaofeng LiDepartment of Thoracic Surgery II, Yunnan Cancer Hospital, Kunming, People's Republic of China.
Li ShanXinjiang Medical University Affiliated Cancer Hospital, Urumqi, People's Republic of China.
Yangbo LiuResearch & Development China, AstraZeneca, Shanghai, People's Republic of China.
Jing LiuResearch & Development China, AstraZeneca, Shanghai, People's Republic of China.
Xiangning HuangOncology Biometrics, AstraZeneca, Cambridge, United Kingdom.
Ana BolanosOncology Research & Development, AstraZeneca, Mississauga, Ontario, Canada.
Jie HeThoracic Surgery Department, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNGuangdong Academy of Medical Sciences · CNShanghai Innovative Research Center of Traditional Chinese Medicine · CNZhengzhou University · CNAstraZeneca (Canada) · CAAstraZeneca (United Kingdom) · GBJilin Province Tumor Hospital · CNJilin University · CNSecond People's Hospital of Yunnan Province · CNShanghai Jiao Tong University · CNTianjin Medical University General Hospital · CNXinjiang Medical University · CNYangzhou University · CNZhongshan Hospital of Xiamen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: In Chinese patients with NSCLC, prevalence of EGFR-mutated (EGFRm) disease is high. In the global phase 3 ADAURA study (NCT02511106), adjuvant osimertinib was found to have a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus placebo in resected stage IB to IIIA EGFRm NSCLC. We present efficacy and safety data from a subgroup analysis of 159 Chinese patients enrolled in the People's Republic of China from ADAURA. Methods: In ADAURA, patients with completely resected stage IB to IIIA EGFRm (exon 19 deletion/exon 21 L858R) NSCLC were randomized 1:1 to receive osimertinib (80 mg once daily) or placebo for 3 years or until disease recurrence/discontinuation. Adjuvant chemotherapy was permitted before randomization, per physician/patient choice. Primary end point was investigator-assessed DFS in stage II to IIIA disease; secondary end points included DFS in stage IB to IIIA (overall population), overall survival, health-related quality of life (HRQoL), and safety. Results: Of 682 patients enrolled globally, 159 patients in the People's Republic of China were included in this subgroup analysis (osimertinib n = 77; placebo n = 82). Baseline characteristics were balanced across the treatment arms. At data cutoff, stage II to IIIA DFS hazard ratio (HR) was 0.23 (95% confidence interval [CI]: 0.13-0.42; maturity 59%); stage IB to IIIA DFS HR was 0.29 (95% CI: 0.17-0.48; maturity 42%). At 13% maturity (21 deaths), HR for overall survival in the stage IB to IIIA population was 0.51 (95% CI: 0.21-1.20). HRQoL was maintained from baseline, and safety was consistent with the global population. Conclusions: In this population of Chinese patients from ADAURA, adjuvant osimertinib was found to have a clinically meaningful improvement in DFS versus placebo, with maintained HRQoL and a safety profile consistent with the global study population.

Indexed as

AdjuvantChinaEGFRNSCLCOsimertinib

Identifiers

PMID38371194
PMCPMC10874739
OpenAlexW4389850548

What OpenQuestion holds

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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.