Evidence map›Paper›PMID 35012927›Full record

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

Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial.

Margarita Majem, Jonathan W Goldman, Thomas John, Christian Grohe, Konstantin Laktionov, Sang-We Kim, Terufumi Kato, Huu Vinh Vu, Shun Lu, Shanqing Li and 14 more

Open access · bronzeAbstract read
In one paragraph

Article 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 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Oral targeted therapy for the treatment of non-small cell lung carcinoma.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2024
    Review
  9. Review
  10. ADAURA update: only the end of the beginning.Translational lung cancer research · 2023
    Article
  11. Review
  12. Article
  13. A Delphi consensus panel about clinical management of early-stage EGFR-mutated non-small cell lung cancer (NSCLC) in Spain: a Delphi consensus panel study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Article
  14. Article
  15. Cancers · 2022
    Review
  16. The role of patient-reported outcome and experience measures in cardio-thoracic surgery.Interdisciplinary cardiovascular and thoracic surgery · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 20 institutions in 15 countries.

Margarita MajemDepartment of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.ORCID 0000-0002-9919-7485
Jonathan W GoldmanDavid Geffen School of Medicine at University of California Los Angeles, Los Angeles, California.ORCID 0000-0002-4925-8243
Thomas JohnDepartment of Medical Oncology, Austin Health, Melbourne, Victoria, Australia.ORCID 0000-0003-3399-5342
Christian GroheKlinik für Pneumologie-Evangelische Lungenklinik Berlin Buch, Berlin, Germany.
Konstantin LaktionovFederal State Budgetary Institution "N.N.Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russia.
Sang-We KimDepartment of Oncology, Asan Medical Center, Seoul, South Korea.ORCID 0000-0003-1065-8095
Terufumi KatoDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.ORCID 0000-0002-5853-1424
Huu Vinh VuDepartment of Thoracic Surgery, Choray Hospital, Ho Chi Minh City, Vietnam.ORCID 0000-0001-6872-2403
Shun LuLung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Shanqing LiDepartment of Thoracic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Kye Young LeePrecision Medicine Lung Cancer Center, Konkuk University Medical Center, Seoul, Republic of Korea.ORCID 0000-0003-4687-5593
Charuwan AkewanlopDivision of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand.ORCID 0000-0003-1022-3745
Chong-Jen YuDepartment of Internal Medicine, National Taiwan University Hospital Hsinchu Branch and National Taiwan University College of Medicine, Taipei, Taiwan.
Filippo de MarinisThoracic Oncology Division, European Institute of Oncology (IEO), IRCCS, Milan, Italy.
Laura BonannoMedical Oncology 2, Istituto Oncologico Veneto (IOV), IRCCS, Padua, Italy.ORCID 0000-0001-5218-4970
Manuel DomineDepartment of Oncology, Hospital Universitario Fundación Jiménez Díaz (IIS-FJD), Madrid, Spain.ORCID 0000-0002-1128-434X
Frances A ShepherdDepartment of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Center and the University of Toronto, Toronto, Ontario, Canada.
Shinji AtagiDepartment of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.ORCID 0000-0003-1876-7069
Lingmin ZengLate Oncology Statistics, AstraZeneca, Gaithersburg, Maryland.
Dakshayini KulkarniLate Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Nenad MedicAstraZeneca Oncology Business Unit, Academy House, Cambridge, United Kingdom.
Masahiro TsuboiDepartment of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Roy S HerbstMedical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut.
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.ORCID 0000-0002-3611-0258
Academy of Arts · EGAsan Medical Center · KRAstraZeneca (Netherlands) · NLAstraZeneca (Singapore) · SGAustin Health · AUChinese Academy of Medical Sciences & Peking Union Medical College · CNCho Ray Hospital · VNEuropean Institute of Oncology · ITEvangelische Lungenklinik Berlin · DEGuangdong Academy of Medical Sciences · CNHospital de Sant Pau · ESHospital Universitario Fundación Jiménez Díaz · ESIstituto Oncologico Veneto · ITKanagawa Prefectural Hospital Organization · JPKonkuk University Medical Center · KRMinistry of Health · ESNational Cancer Center Hospital East · JPNational Taiwan University Hospital · TWNHO Kinki Chuo Chest Medical Center · JPPrincess Margaret Cancer Centre · CA

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

purposeIn the phase III ADAURA trial, adjuvant treatment with osimertinib versus placebo, with/without prior adjuvant chemotherapy, resulted in a statistically significant and clinically meaningful disease-free survival benefit in completely resected stage IB-IIIA EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQoL) outcomes from ADAURA. PATIENTS AND

methodsPatients randomized 1:1 received oral osimertinib 80 mg or placebo for 3 years or until recurrence/discontinuation. HRQoL (secondary endpoint) was measured using the Short Form-36 (SF-36) health survey at baseline, 12, and 24 weeks, then every 24 weeks until recurrence or treatment completion/discontinuation. Exploratory analyses of SF-36 score changes from baseline until week 96 and time to deterioration (TTD) were performed in the overall population (stage IB-IIIA; N = 682). Clinically meaningful changes were defined using the SF-36 manual.

resultsBaseline physical/mental component summary (PCS/MCS) scores were comparable between osimertinib and placebo (range, 46-47) and maintained to Week 96, with no clinically meaningful differences between arms; difference in adjusted least squares (LS) mean [95% confidence intervals (CI), -1.18 (-2.02 to -0.34) and -1.34 (-2.40 to -0.28), for PCS and MCS, respectively. There were no differences between arms for TTD of PCS and MCS; HR, 1.17 (95% CI, 0.82-1.67) and HR, 0.98 (95% CI, 0.70-1.39), respectively.

conclusionsHRQoL was maintained with adjuvant osimertinib in patients with stage IB-IIIA EGFRm NSCLC, who were disease-free after complete resection, with no clinically meaningful differences versus placebo, further supporting adjuvant osimertinib as a new treatment in this setting. See related commentary by Patil and Bunn, p. 2204.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsSmall Cell Lung CarcinomaAcrylamidesAdjuvants, ImmunologicAniline CompoundsErbB ReceptorsHumansIndolesMutationPyrimidinesQuality of LifeAcrylamidesAdjuvants, ImmunologicAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesosimertinibPyrimidines

Identifiers

PMID35012927
PMCPMC9359973
OpenAlexW4205646635

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.