Evidence Level:Sensitive: C1 - Off-label
(Approved for Non Small Cell Lung Cancer)
New
Title:
Tagrisso approved in Japan for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Excerpt:AstraZeneca’s Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery.
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:
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....
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)....
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....
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....
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:
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:
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Excerpt:...Histologically or cytologically confirmed adenocarcinoma of the lung (patients with mixed histology are eligible if adenocarcinoma is the predominant histology) harboring EGFR mutation(s) known to be associated with EGFR TKI sensitivity at diagnosis....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib
Excerpt:...- Patients with histologically confirmed, by the National Cancer Institute (NCI) Laboratory of Pathology or by Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified Next Generation Sequencing or Cobas estimated Epidermal Growth Factor Receptor (EGFR) Mutation Test v1/2 at an outside institution, advanced lung adenocarcinoma with EGFR-sensitizing somatic mutations or a germline T790M mutation (detected histologically or via circulating tumor deoxyribonucleic acid (ctDNA) analysis using a CLIA assay) with:...
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....
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
Treatment pattern and outcomes in patients with uncommon or compound EGFR mutations in India: CRSF 2020-03 study.
Excerpt:CONTRADICTING EVIDENCE: Total 99 patients with uncommon or compound mutations were included in the study….Thirty-two patients (32%) received first-generation TKI, 30 patients (30%) received palliative chemotherapy and 11 patients (11 %) received Osimertinib. Gefitinib with chemotherapy was used in 2 patients and combination of Gefitinib with Afatinib was used in one patient. Overall response rate and clinical benefit rate with first line treatment was 23% and 35% respectively....Outcomes of patients with these rare mutations are dismal in the real world setting with the available treatment options.
DOI:10.1200/JCO.2022.40.16_suppl.e21034
Evidence Level:Sensitive: C3 – Early Trials
Title:
Osimertinib as neoadjuvant therapy in patients with EGFR mutated resectable stage II-IIIB lung adenocarcinoma (NEOS): Updated results
Excerpt:Eligible patients aged 18-75 with resectable, stage II-IIIB (T3-4N2), EGFR-mutant lung adenocarcinoma were enrolled and treated with osimertinib....Of the 38 patients who completed 6-week osimertinib neoadjuvant treatment, the objective response rate was 71.1% (27/38)….10.7% of the 28 pathological evaluable patients achieved major pathological response, including one (3.6%) patient achieved pathological complete response. 13(46.4%) patients had a 50% pathological response.
DOI:https://doi.org/10.1016/j.annonc.2022.02.091
Evidence Level:Sensitive: C3 – Early Trials
Title:
Phase I study of the aurora kinase A inhibitor alisertib in combination with osimertinib in EGFR-mutant lung cancer.
Excerpt:We performed a single institution phase Ia clinical trial of alisertib in combination with the 3rd generation EGFR inhibitor osimertinib in patients with metastatic EGFR-mutant LUAD who had experienced disease progression on osimertinib monotherapy (NCT04085315)....The ORR was 10% (1/10) and DCR 70% (7/10), with the majority of patients, 60% (6/10), achieving stable disease (SD)....
DOI:10.1200/JCO.2021.39.15_suppl.9074
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Standard-Dose Osimertinib in EGFR-Mutated Non-Small-Cell Lung Adenocarcinoma With Leptomeningeal Disease
Excerpt:This study reports on outcomes of patients with EGFR-mutated non-small-cell lung cancer who developed LMD and were subsequently treated with osimertinib....The extracranial DCR and ORR were 60% and 54%, and the intracranial DCR and ORR were 68% and 53%, respectively. Median overall survival was 10.5 months (95% CI, 8.17 to 15.05 months).
Evidence Level:Sensitive: C4 – Case Studies
Title:
Concurrent EGFR wild-type tongue squamous cell carcinoma and EGFR-mutant lung adenocarcinoma and response to osimertinib.
Excerpt:We found an advanced lung adenocarcinoma patient who harbored an EGFR-mutation….PET-CT scans demonstrated a partial response (PR) of the lung tumor...after two months of treatment of osimertinib. The lung tumor maintian partial response until now (nearly 30 months)....The result indicates a clear response of lung cancer to osimertinib...
DOI:10.1200/JCO.2023.41.16_suppl.e18074
Evidence Level:Sensitive: C4 – Case Studies
Title:
Response of Lung Adenocarcinoma Harbouring Sensitizing EGFR Mutation to the Fourth-line Combination Treatment of Pembrolizumab and Anlotinib
Excerpt:CONTRADICTING EVIDENCE: Herein we reported a case that till January 12, 2021, an 82-year-old female with EGFR-mutant advanced lung adenocarcinoma received a surprising progression-free survival (PFS) benefit of over 21 months from the combination therapy of pembrolizumab and anlotinib after her failure of treatments of osimertinib, chemotherapy and anlotinib-monotherapy.
DOI:10.3779/j.issn.1009-3419.2021.102.25
Evidence Level:Sensitive: D – Preclinical
Title:
De Novo and Histologically Transformed Small-Cell Lung Cancer Is Sensitive to Lurbinectedin Treatment Through the Modulation of EMT and NOTCH Signaling Pathways
Excerpt:We further demonstrate that lurbinectedin, either as a single agent or in combination with osimertinib, causes an appreciable antitumor response in multiple models of EGFR-mutant lung adenocarcinoma...
DOI:https://doi.org/10.1158/1078-0432.CCR-23-0471