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Association details:
Evidence:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
Excerpt:
On February 16, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A multicenter, open-label, single arm pilot study: Osimertinib as neoadjuvant treatment for resectable stage II-IIIB EGFR mutant lung adenocarcinoma (NEOS)

Excerpt:
...Tested and confirmed to be EGFR mutation-positive (including exon 19 deletion and exon 21 L858R); 6. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib

Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19 deletions, L858R), either alone or in combination with other EGFR mutations....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.

Excerpt:
...Patients with EGFR sensitizing mutations (Ex19del or L858R)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)

Excerpt:
...The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

Excerpt:
...- Treatment-naïve for locally advanced/metastatic EGFR-mutated NSCLC and osimertinib treatment-naïve for NSCLC....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

PET/CT imaging detect EGFR protein mutations of lung cancer with specific molecular probe 11C-AZD9291

Excerpt:
...EGFR mutation status was confirmed by ARMS fluorescence PCR, including 4 cases of 19del mutant, 4 cases of 21L858R mutant, and 2 cases of wild type; 3. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

MEchanisms of resitance in EGFR mutated nonpretreated advanced Lung cancer Receiving OSimErtib Mécanismes de résistance chez des patients avec un cancer du poumon avancé non prétraité, EGFR muté, recevant un traitement par OSIMERTINIB

Excerpt:
...• The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19 deletions, L858R), either alone or in combination with other EGFR mutations. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

Excerpt:
...The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Updated First-line Osimertinib in Asian patients with Advanced EGFR-mutated Lung Cancer

Published date:
08/08/2023
Excerpt:
Median age of patients was 65 years (IQR 57-72), 65.8% were females, 80.7% never-smokers, 91.3% with ECOG 0-1 at start of osimertinib, and 97.5% had adenocarcinoma histology…Majority had sensitizing EGFR exon 19 deletion (exon 19+) (55.9%) and exon 21 mutations (exon 21+) (36.6%)…mOS for exon 19+ patients was 37.0 (95% CI 32.2-52.2) months and 25.1 (95% CI 18.6-38.1) months for exon 21+ (p=0.015)...Osimertinib is an effective first-line treatment in Asian patients with advanced EGFRm+ NSCLC with durable OS, PFS and TTF, comparable with reported data.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Osimertinib as neoadjuvant treatment for resectable stage II-IIIB EGFR mutant lung adenocarcinoma (NEOS).

Published date:
05/19/2021
Excerpt:
Half (9/18) of the patients had EGFR exon 21 L858R mutations and the other half (9/18) had EGFR exon 19del mutations. Amongst all 15 patients who completed efficacy assessment after neoadjuvant osimertinib, the response rate (RR) was 73.3% (11/15) and the disease control rate (DCR) was 100% (15/15)....Interim analysis from this study indicated neoadjuvant osimertinib as an effective and feasible treatment...
DOI:
10.1200/JCO.2021.39.15_suppl.8524
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Pathological complete response in an advance stage IIIB non-small cell lung cancer secondary to neoadjuvant osimertinib targeted therapy: A case report and review of literature

Published date:
06/21/2023
Excerpt:
Following biopsy, a diagnosis of stage IIIB N2 (cT3N2M0) EGFR exon 19 deletion mutation-positive lung adenocarcinoma was established. NTT using osimertinib 80 mg once daily was commenced. Subsequent re-imaging at 3 months (ycT2bN2M0), 6 months (ycT1cN2M0) and 9 months showed tumour downstaging and resolution of the subcarinal LN (ycT1cN0M0)....In conclusion, this case provides some early insights on the efficacy and benefit of osimertinib-NTT in pathologically downstaging and potentially achieving pCR in stage IIIB N2 NSCLC.
DOI:
https://doi.org/10.1002/rcr2.1181
Evidence Level:
Sensitive: C4 – Case Studies
Title:

T790M mutation positive squamous cell carcinoma transformation from EGFR-mutated lung adenocarcinoma after low dose erlotinib: A case report and literature review

Published date:
08/12/2022
Excerpt:
An 80-year-old nonsmoking woman was referred to our hospital because of an abnormal shadow on her chest radiograph. Diagnostic bronchoscopy was performed and pathological examination revealed adenocarcinoma. Mutation analysis of the EGFR gene revealed deletion of E746-A750 in exon 19....Osimertinib 80 mg once a day was started as second line therapy, which resulted in 8 months of PFS and 15 months of survival.
DOI:
10.1097/MD.0000000000029682
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Lung adenocarcinoma with EGFR gene mutation metastatic to the uterine cervix: A case report

Published date:
10/16/2020
Excerpt:
...the diagnosis was lung adenocarcinoma with cervical, brain, adrenal gland and bone metastases. More importantly, EGFR gene mutations (del19) were detected...Osimertinib was chosen as the first-line treatment….Primary injuries and metastatic sites were significantly reduced.
DOI:
10.1097/MD.0000000000022636
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Histological transformation of lung adenocarcinoma to small cell lung cancer with mutant C797S conferring acquired resistance to osimertinib

Published date:
06/30/2020
Excerpt:
CONTRADICTING EVIDENCE:...A man with recurrent lung adenocarcinoma harboring an EGFR exon 19 deletion received erlotinib for 10 months following curative surgery and adjuvant chemotherapy. However, he switched to osimertinib after repeat biopsy showed EGFR exon 19 deletion and T790M mutation leading to erlotinib resistance. His disease progressed after 15 months and repeat biopsy showed SCLC. Next-generation sequencing of peripheral blood detected EGFR exon 19 deletion, T790M mutation, cis-C797S mutation, and RB1 inactivation.
DOI:
10.1177/0300060520927918
Evidence Level:
Sensitive: D – Preclinical
Title:

Novel EGFR-mutant mouse models of lung adenocarcinoma reveal adaptive immunity requirement for durable osimertinib response

Published date:
01/16/2023
Excerpt:
...we developed novel genetically-engineered mouse models of EGFR mutant lung cancer bearing exon 19 deletions (del19) or the L860R missense mutation. Both oncogenic EGFR mouse models developed multifocal LUADs from which transplantable cancer cell lines sensitive to the EGFR-specific TKIs, gefitinib and osimertinib, were derived. When propagated orthotopically in the left lungs of syngeneic C57BL/6 mice, deep and durable shrinkage of the cell line-derived tumors was observed in response to daily treatment with osimertinib.
DOI:
10.1016/j.canlet.2023.216062