Raadpleeg ook literatuurlijst niet-toxische middelen en behandelingen specifiek bij longkanker van arts-bioloog drs. Engelbert Valstar

22 februari 2023: Bron: Journal of Clinical Oncology Published online January 31, 2023.

Uit een nieuwe definitieve analyse van de fase III studie ADAURA blijkt dat Tyrosine Kinase Remmer Osimertinib aanvullend op chemo bij patiënten met niet-kleincellige longkanker met EGFR-gemuteerde stadium IB tot IIIA na volledige operatie een heel goed resultaat geeft op overall overleving en progressievrije ziekte. 

Het ziektevrije overlevingspercentage na 4 jaar was 73% voor osimertinib en 38% voor placebo.
Onder behandeling met osimertinib aanvullend op chemo had op 4-jaars meting 13% van de patiënten metastasen op afstand en 12% had alleen lokaal/regionaal recidief. In vergelijking met percentages van respectievelijk 31% en 23% onder behandeling met chemo plus placebo. Met geen extra bijwerkingen t.o.v. alleen chemo. Een behoorlijk groot verschil dus met een verdubbeling van de ziektevrije overleving en statistisch significant.

figure

Hier de originele tekst over het belang van deze studie:

CONTEXT

  • Key Objective

  • ADAURA is an ongoing phase III trial assessing efficacy and safety of osimertinib versus placebo in patients with completely resected stage IB-IIIA non–small-cell lung cancer, with/without adjuvant chemotherapy. After 2 years of additional follow-up, we report updated analyses of final disease-free survival (DFS) data, recurrence patterns, and long-term safety.

  • Knowledge Generated

  • These updated data, in which all patients had the opportunity to receive 3 years of planned treatment, were consistent with the primary analysis and demonstrated prolonged DFS benefit with adjuvant osimertinib versus placebo: stage II-IIIA DFS hazard ratio, 0.23; 95% CI, 0.18 to 0.30; stage IB-IIIA DFS hazard ratio, 0.27; 95% CI, 0.21 to 0.34. Adjuvant osimertinib reduced the risk of local and distant recurrence, and improved CNS DFS. The long-term safety profile of osimertinib was consistent with the primary analysis.

  • Relevance (T.E. Stinchcombe)

  • The final DFS analysis demonstrated that adjuvant osimertinib improved DFS in resected EGFR-mutant non–small-cell lung cancer, and in the patient subgroups analyzed.*

  • *Relevance section written by JCO Associate Editor Thomas E. Stinchcombe, MD.


Het volledige studierapport is gratis in te zien. Klik op de titel van het abstract. 

Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial

Roy S. Herbst , MD, PhD1; Yi-Long Wu , MD2; Thomas John, PhD3; Christian Grohe, MD4; Margarita Majem, MD, PhD5; Jie Wang , MD, PhD6; ...Show More

*R.S.H. and Y.-L.W. contributed equally to this work.

Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

PURPOSE

The phase III ADAURA (ClinicalTrials.gov identifier: NCT02511106) primary analysis demonstrated a clinically significant disease-free survival (DFS) benefit with adjuvant osimertinib versus placebo in EGFR-mutated stage IB-IIIA non–small-cell lung cancer (NSCLC) after complete tumor resection (DFS hazard ratio , 0.20 [99.12% CI, 0.14 to 0.30]; P < .001). We report an updated exploratory analysis of final DFS data.

METHODS

Overall, 682 patients with stage IB-IIIA (American Joint Committee on Cancer/Union for International Cancer Control, seventh edition) EGFR-mutated (exon 19 deletion/L858R) NSCLC were randomly assigned 1:1 (stratified by stage, mutational status, and race) to receive osimertinib 80 mg once-daily or placebo for 3 years. The primary end point was DFS by investigator assessment in stage II-IIIA disease analyzed by stratified log-rank test; following early reporting of statistical significance in DFS, no further formal statistical testing was planned. Secondary end points included DFS in stage IB-IIIA, overall survival, and safety. Patterns of recurrence and CNS DFS were prespecified exploratory end points.

RESULTS

At data cutoff (April 11, 2022), in stage II-IIIA disease, median follow-up was 44.2 months (osimertinib) and 19.6 months (placebo); the DFS HR was 0.23 (95% CI, 0.18 to 0.30); 4-year DFS rate was 70% (osimertinib) and 29% (placebo). In the overall population, DFS HR was 0.27 (95% CI, 0.21 to 0.34); 4-year DFS rate was 73% (osimertinib) and 38% (placebo). Fewer patients treated with osimertinib had local/regional and distant recurrence versus placebo. CNS DFS HR in stage II-IIIA was 0.24 (95% CI, 0.14 to 0.42). The long-term safety profile of osimertinib was consistent with the primary analysis.

CONCLUSION

These updated data demonstrate prolonged DFS benefit over placebo, reduced risk of local and distant recurrence, improved CNS DFS, and a consistent safety profile, supporting the efficacy of adjuvant osimertinib in resected EGFR-mutated NSCLC.

© 2023 by American Society of Clinical Oncology
PRIOR PRESENTATION

Presented at the European Society for Medical Oncology (ESMO) annual meeting, Paris, France, September 9-13, 2022.

SUPPORT

The study (ClinicalTrials.gov identifier: NCT02511106) was supported by AstraZeneca, the manufacturer of osimertinib.

CLINICAL TRIAL INFORMATION

NCT02511106

DATA SHARING STATEMENT

Provision of standard data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca's data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

AUTHOR CONTRIBUTIONS

Conception and design: Roy S. Herbst, Yi-Long Wu, Thomas John, Christian Grohe, Sang-We Kim, Manuel Domine, Frances A. Shepherd, Masahiro Tsuboi

Provision of study materials or patients: Roy S. Herbst, Yi-Long Wu, Thomas John, Margarita Majem, Jie Wang, Jonathan W. Goldman, Sang-We Kim, Chong-Jen Yu, Shun Lu, Guzel Mukhametshina, Charuwan Akewanlop, Laura Bonanno, Manuel Domine, Frances A. Shepherd, Damien Urban, Masahiro Tsuboi

Collection and assembly of data: Roy S. Herbst, Yi-Long Wu, Thomas John, Christian Grohe, Margarita Majem, Jie Wang, Terufumi Kato, Jonathan W. Goldman, Konstantin Laktionov, Sang-We Kim, Chong-Jen Yu, Huu Vinh Vu, Shun Lu, Kye Young Lee, Guzel Mukhametshina, Charuwan Akewanlop, Filippo de Marinis, Laura Bonanno, Frances A. Shepherd, Damien Urban, Masahiro Tsuboi

Data analysis and interpretation: Roy S. Herbst, Yi-Long Wu, Thomas John, Christian Grohe, Margarita Majem, Terufumi Kato, Jonathan W. Goldman, Konstantin Laktionov, Sang-We Kim, Chong-Jen Yu, Filippo de Marinis, Damien Urban, Xiangning Huang, Ana Bolanos, Marta Stachowiak, Masahiro Tsuboi

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Roy S. Herbst

Leadership: Junshi Pharmaceuticals, Immunocore

Consulting or Advisory Role: AstraZeneca, Genentech/Roche, Merck, Pfizer, AbbVie, Biodesix, Bristol-Myers Squibb, Lilly, EMD Serono, Heat Biologics, Junshi Pharmaceuticals, Loxo, Nektar, NextCure, Novartis, Sanofi, Seattle Genetics, Shire, Spectrum Pharmaceuticals, Symphogen, Tesaro, Neon Therapeutics, Infinity Pharmaceuticals, ARMO Biosciences, Genmab, Halozyme, Tocagen, Bolt Biotherapeutics, I-Mab, Mirati Therapeutics, Takeda, Cybrexa Therapeutics, eFFECTOR Therapeutics, Candel Therapeutics, Oncternal Therapeutics, STCube Pharmaceuticals Inc, WindMIL, Xencor, Bayer, Checkpoint Therapeutics, DynamiCure Biotechnology, Foundation Medicine, Gilead/Forty Seven, HiberCell, Immune-Onc Therapeutics, Johnson & Johnson, Ocean Biomedical, OncoCyte, Refactor Health, Ribon Therapeutics, Ventana Medical Systems

Research Funding: AstraZeneca, Merck, Lilly, Genentech/Roche

Yi-Long Wu

Honoraria: AstraZeneca, Lilly, Roche, Pfizer, Boehringer Ingelheim, MSD Oncology, Bristol Myers Squibb/China, Hengrui Pharmaceutical, BeiGene Beijing

Consulting or Advisory Role: AstraZeneca, Roche, Boehringer Ingelheim, Takeda

Research Funding: Boehringer Ingelheim (Inst), Roche (Inst), Pfizer (Inst), Bristol‐Myers Squibb (Inst)

Thomas John

Honoraria: AstraZeneca/MedImmune, Roche/Genentech, Bristol Myers Squibb, MSD Oncology

Consulting or Advisory Role: AstraZeneca, Pfizer, AstraZeneca/MedImmune, Roche/Genentech, Ignyta, Boehringer Ingelheim, Novartis, MSD Oncology, Merck KGaA, Bristol Myers Squibb, Amgen (Inst), PharmaMar (Inst), Specialised Therapeutics, Gilead Sciences

Travel, Accommodations, Expenses: Boehringer Ingelheim, Roche, AstraZeneca, Bristol Myers Squibb, Roche, Merck Sharp & Dohme

Christian Grohe

Honoraria: Boehringer Ingelheim, AstraZeneca, Lilly, Roche, Novartis, MSD Oncology, Takeda

Consulting or Advisory Role: MSD Oncology, AstraZeneca, Boehringer Ingelheim

Research Funding: AstraZeneca (Inst)

Travel, Accommodations, Expenses: Roche, Boehringer Ingelheim, Bristol Myers Squibb

Margarita Majem

Consulting or Advisory Role: AstraZeneca, Roche, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer, Boehringer Ingelheim, Novartis, Tesaro, Helsinn Therapeutics, Takeda, Sanofi, Janssen Oncology, Pierre Fabre

Research Funding: Bristol‐Myers Squibb (Inst), AstraZeneca (Inst), Roche (Inst)

Travel, Accommodations, Expenses: AstraZeneca, Roche, Lilly

Terufumi Kato

Employment: Lilly (I)

Honoraria: Chugai Pharma, Ono Pharmaceutical, Lilly, AstraZeneca, Taiho Pharmaceutical, Pfizer, Merck Sharp & Dohme, Novartis, Takeda, Daiichi Sankyo, GlaxoSmithKline, Amgen, Merck KGaA

Consulting or Advisory Role: AstraZeneca, MSD, Lilly, Pfizer, Merck Serono

Research Funding: Chugai Pharma (Inst), Merck Sharp & Dohme (Inst), Pfizer (Inst), AstraZeneca (Inst), Lilly (Inst), AbbVie (Inst), Regeneron (Inst), Novartis (Inst), Amgen (Inst), Merck KGaA (Inst), Takeda (Inst), Haihe Biopharma (Inst), Blueprint Medicines (Inst), Turning Point Therapeutics (Inst)

Jonathan W. Goldman

Consulting or Advisory Role: AstraZeneca, Bristol Myers Squibb, Lilly, Pfizer, AbbVie, Genentech

Research Funding: Lilly (Inst), Genentech/Roche (Inst), Bristol Myers Squibb (Inst), AstraZeneca/MedImmune (Inst), AbbVie (Inst), Corvus Pharmaceuticals (Inst), Spectrum Pharmaceuticals (Inst), Advaxis (Inst), Pfizer (Inst)

Travel, Accommodations, Expenses: AstraZeneca

Open Payments Link: https://openpaymentsdata.cms.gov/physician/124819

Shun Lu

Consulting or Advisory Role: AstraZeneca, Pfizer, Boehringer Ingelheim, Hutchison MediPharma, Simcere Diagnostics, Zai Lab, GenomiCare, Yuhan, Prime Oncology, Roche

Speakers' Bureau: AstraZeneca, Roche, Hansoh Pharma, Hengrui Therapeutics

Research Funding: AstraZeneca (Inst), Hutchison MediPharma (Inst), Bristol‐Myers Squibb (Inst), Hengrui Therapeutics (Inst), BeiGene (Inst), Roche (Inst), Hansoh (Inst), Lilly Suzhou Pharmaceutical Co Ltd (Inst)

Kye Young Lee

Employment: Exosignal Inc

Stock and Other Ownership Interests: Exosignal Inc

Research Funding: MSD Oncology

Charuwan Akewanlop

Speakers' Bureau: Merck Sharp & Dohme, Novartis, Amgen, AstraZeneca/MedImmune, Roche

Filippo de Marinis

Consulting or Advisory Role: AstraZeneca, MSD Oncology, Bristol Myers Squibb, Roche/Genentech, Pfizer, Novartis, Takeda

Laura Bonanno

Consulting or Advisory Role: AstraZeneca, Roche/Genentech, Novartis, Bristol Myers Squibb/Medarex, MSD Oncology

Speakers' Bureau: Novartis/Ipsen, Bristol Myers Squibb/Medarex, AstraZeneca/MedImmune

Manuel Domine

Consulting or Advisory Role: AstraZeneca, MSD Oncology, Pfizer, Roche, Takeda

Frances A. Shepherd

Stock and Other Ownership Interests: Lilly, AstraZeneca

Honoraria: AstraZeneca, Merck Serono, Takeda, Daiichi Sankyo

Consulting or Advisory Role: AstraZeneca, Merck Serono

Research Funding: Lilly (Inst), Pfizer (Inst), Bristol Myers Squibb (Inst), AstraZeneca/MedImmune (Inst), Roche Canada (Inst)

Damien Urban

Honoraria: Merck Sharp & Dohme, Roche, Bristol Myers Squibb, Takeda, AstraZeneca, Merck Serono

Consulting or Advisory Role: Merck Sharp & Dohme, Takeda, Roche Israel, Nucleai, Rhenium/Oncotest

Xiangning Huang

Employment: AstraZeneca/MedImmune

Stock and Other Ownership Interests: AstraZeneca/MedImmune

Ana Bolanos

Employment: AstraZeneca Canada, Bayer (I)

Stock and Other Ownership Interests: Bayer (I)

Marta Stachowiak

Employment: AstraZeneca/MedImmune

Masahiro Tsuboi

Honoraria: AstraZeneca Japan, Chugai Pharma, Taiho Pharmaceutical, Johnson & Johnson, Novartis, MSD K.K, Ono Pharmaceutical, Bristol Myers Squibb Japan, Medtronic, Lilly Japan, Daiichi-Sankyo

Consulting or Advisory Role: AstraZeneca Japan, Chugai Pharma, MSD, Novartis, AstraZeneca

Research Funding: Boehringer Ingelheim (Inst), Merck (Inst), AstraZeneca Japan (Inst), Ono Pharmaceutical (Inst), Bristol Myers Squibb KK (Inst), Novartis (Inst), MiRXES Japan (Inst), BMG KK (Inst)

No other potential conflicts of interest were reported.

ACKNOWLEDGMENT

The authors thank all the patients and their families, as well as the staff and investigators at all study sites. The authors would like to acknowledge Ajlan Atasoy for her valuable contributions to the study. The authors would like to acknowledge Sally Cotterill, PhD, CMPP, of Ashfield MedComms, Macclesfield, United Kingdom, an Inizio Company, for medical writing support that was funded by AstraZeneca in accordance with Good Publications Practice (GPP) guidelines (https://www.ismpp.org/gpp-2022).

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niet-kleincellige longkanker, chemotherapie, osimertinib, overall overleving, EGFR-gemuteerde stadium IB tot IIIA, fase III studie ADAURA


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