Non Small Cell Lung Cancer - afatinib - EGFR mutation

Title:

The Effect of Afatinib on the Anti-Tumour Immune Response in Patients with Advanced Non-Small Cell Lung Cancer

Excerpt:

...* Documented EGFR mutation and any line of therapy (including first-line), or...

Trial ID:

ACTRN12613001221741

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

The role of Afatinib to come to radical surgery in patients with non-squamous lung cancer with EGFR gene mutation. Il ruolo di Afatinib per giungere alla chirurgia radicale in pazienti con tumore polmonare non squamoso con mutazione del gene EGFR

Excerpt:

...Patients with histologically or cytologically confirmed IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 IIIa NSCLCEpidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution’s testing methodology. ...

Trial ID:

2014-005364-14

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Excerpt:

...- Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology....

Trial ID:

NCT01853826

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

The effects of the proton pump inhibitor esomeprazole on the bioavailability of afatinib (Giotrif®) in patients with lung cancer 'the BIO-GIO study' Het effect van protonpompremmer esomeprazol op de biologische beschikbaarheid van afatinib (Giotrif®) bij patiënten met longkanker 'de BIO-GIO studie'

Excerpt:

...Histological or cytological confirmed diagnosis of EGFR-mutated NSCLC3. ...

Trial ID:

2017-001284-20

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

The START Study Observes Afatinib as First-line Treatment and Sequential Therapy in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Nonsmall Cell Lung Cancer

Excerpt:

...- Patients who are diagnosed with locally advanced or metastatic NSCLC with EGFR sensitive mutation positive...

Trial ID:

START

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Excerpt:

...- EGFR mutation or six months or longer benefit from EGFR TKIs...

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC

Excerpt:

...To detect EGFR T790M and activating mutation status`To assess the physical, physiological and social functions. ...

Trial ID:

NCT03711422

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings

Excerpt:

...- Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) NSCLC of any histological type with activating EGFR mutation(s) according to local laboratory EGFR testing;...

Trial ID:

NCT02440854

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation

Excerpt:

...- Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation...

Trial ID:

NCT01746251

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

Excerpt:

...- presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy...

Trial ID:

NCT01953913

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC)

Excerpt:

...Epidermal Growth Factor Receptor mutation positive result per the institution's testing methodology....

Trial ID:

NCT01931306

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Long-term Observation PMS for Afatinib

Excerpt:

...- Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included....

Trial ID:

NCT02131259

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Understanding Mechanisms of Acquired Resistance to BIBW2992

Excerpt:

...- A somatic mutation in epidermal growth factor receptor (EGFR) must be present as documented by a CLIA-certified laboratory...

Trial ID:

NCT01074177

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations

Excerpt:

...Epidermal Growth Factor Receptor (EGFR) mutation-positive results per the institution's testing methodology 3....

Trial ID:

NCT02044380

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations

Excerpt:

...Presence of activating mutation(s) in exon 18 to exon 21 of the EGFR-receptor confirmed by direct DNA sequencing of NSCLC tumor tissue....

Trial ID:

LUX Lung 2

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

Excerpt:

...- Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine kinase inhibitor and at least one line of systemic chemotherapy...

Trial ID:

NCT02625168

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation

Excerpt:

...- Documentation of a sensitizing EGFR mutation...

Trial ID:

NCT01836341

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

ADAM-Afatinib Diarrhea Assessment and Management

Excerpt:

...Pathologically confirmed diagnosis of Stage IIIB or Stage IV adenocarcinoma of the lung, with EGFR mutations-positive status, who are...

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

LUX-Lung 4: BIBW 2992 (Afatinib) Phase I Trial in Advanced Non Small Cell Lung Cancer Patients & Phase II Trial in Non Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

Excerpt:

...Phase I Step: AUC0-24, AUCtau,ss of BIBW 2992 After Multiple Oral Administration`Phase II Step: Clinical Benefit`Phase II Step: Time to Objective Response`Phase II Step: Duration of Objective Response`Phase I Step: Summary of Epidermal Growth Factor Receptor (EGFR) Mutation Findings`Phase II Step: Duration of Clinical Benefit`Phase II Step: Progression-free Survival (PFS)`Phase II Step: Overall Survival (OS)`Phase II Step: Safety of BIBW 2992 as Indicated by Intensity and Incidence of Adverse Events, Graded According to CTCAE`Phase II Step: Maximum CTC Grade During the Trial for Laboratory Parameters, Among Patients Who Experienced an Increase in CTC Grade From Baseline`Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course1 Day 15`Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 1`Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 15`Phase II Step: Summary of EGFR Mutation Findings`Phase I Step: Cmax,Cmax,ss of BIBW 2992 After Multiple Oral Administration...

Trial ID:

LUX-Lung 4

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

A non-interventional, single-arm, prospective clinical study for the efficacy and safety of low-dose alfaatinib combined with pemetrexed and carboplatin in first-line treatment of advanced EGFR mutant non-squamous non-small cell lung cancer

Excerpt:

...7) Gene test from tumor tissues confirmed EGFR sensitive mutation positive (including classical mutation and non-classical mutation :19del, L858R, L861Q, G719X, S768I); 8) No brain metastasis, or accompanied by asymptomatic brain metastasis, or symptomatic brain metastasis after treatment which change to stable; 9) Adequate hematological function: neutrophil absolute count >=1.5x10^9/L, platelet count >= 100x10^9/L exclusion, hemoglobin >= 90 g/L; 10) Adequate liver function: all patients whose total bilirubin level is the normal upper limit; 11) Adequate renal function: creatinine clearance rate >= 50ml/min (Cockcroft-Gault formula); 12) Adequate coagulation function: international standardized ratio (INR) or prothrombin time (PT) ...

Trial ID:

ChiCTR1900024983

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

Excerpt:

...- Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC)...

Trial ID:

NCT04795245

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung

Excerpt:

...Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status`Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status`Chart abstractors (i.e. the patients treating physician) were asked to abstract information regarding severe (grade 3 or higher) irAEs of specific interest (including pneumonitis, colitis, hepatitis, interstitial lung disease, higher indeterminate pulmonary events, death, or discontinuation of therapy due to toxicity) during first line (1L) treatment and second line (2L) for both patients treated with afatinib in 2L and those treated with chemotherapy in 2L. ...

Trial ID:

NCT04552535

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib

Excerpt:

...- EGFR mutated...

Trial ID:

NCT04640870

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

Excerpt:

...- EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations...

Trial ID:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

Excerpt:

...EGFR(Epidermal Growth Factor Receptor) mutation detected by central laboratory analysis of tumor biopsy material 3....

Trial ID:

LUX-Lung 6

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer

Excerpt:

...1) A tumor which harbors an Epidermal Growth Factor Receptor (EGFR) -mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) from previous tumor biopsy or surgery....

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Excerpt:

...Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6....

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity

Excerpt:

...- Patients must have tumours harbouring a sensitising EGFR mutation or HER2 mutation in at least one biopsy at recurrence, or region of the primary sample....

Trial ID:

DARWIN1

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib

Excerpt:

...Diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naive advanced EGFR mutated non-small cell lung cancer (NSCLC), 3....

Trial ID:

UpSwinG

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma

Excerpt:

...- Non-small cell lung cancer with positive mutation of EGFR verified...

Trial ID:

DPTA

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Observational Study of Afatinib 30 mg Daily

Excerpt:

...Documented EGFR mutation(s)-positive NSCLC (common mutations: Del19 and L858R) from tumour biopsy material....

Trial ID:

NCT04909073

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma

Excerpt:

...- Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy;...

Trial ID:

LungMate-004

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

BIBW 2992 Plus Simvastatin vs. BIBW 2992 in Previously Treated Patients With Advanced Non-adenocarcinomatous NSCLC

Excerpt:

...For this study, predictive efficacy analyses will be performed with such biomarkers as EGFR mutation status. ...

Trial ID:

NCT01156545

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib Osimertinib Sequencing NIS

Excerpt:

...- Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)...

Trial ID:

GioTag

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)

Excerpt:

...Progression or recurrence of disease after receiving prior continuous gefitinib, afatinib, or erlotinib; A tumor known to harbor a de novo T790M mutation, which is known to confer EGFR TKI resistance....

Trial ID:

NCT01999985

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib With CT and RT for EGFR-Mutant NSCLC

Excerpt:

...- Have lung cancer harboring an EGFR mutation...

Trial ID:

The ASCENT Trial

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

Excerpt:

...Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues....

Trial ID:

LUX-Lung 7

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

Excerpt:

...- Evidence of common EGFR mutation (Del 19 and/or L858R)...

Trial ID:

NCT02514174

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non Small Cell Lung Cancer

Excerpt:

...Evaluation of the HER-2 gene copy number and amplification`DNA Extraction and Mutational Analysis of EGFR and HER-2`Toxicity evaluation`Determination of plasma HGF pre and post-treatment concentration...

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

Excerpt:

...Confirmed activating EGFR mutation (exons 18-21; e.g....

Trial ID:

NCT01415011

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Excerpt:

...Documented EGFR mutation (L858R and/or Deletion 19) with...

Trial ID:

NCT02208843

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

Excerpt:

...- Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material....

Trial ID:

LUX-Lung 3

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib Genomic Landscape

Excerpt:

...Types of mutations in signaling kinases associated with therapeutic response`Allelic ratio of wild type to mutant EGFR (roughly corrected for intrinsic differences in tumor cellularity) with duration of response...

Trial ID:

NCT02491775

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Maintaining ERBB Blockade in EGFR-mutated Lung Cancer

Excerpt:

...Documented somatic EGFR mutation as determined by medically accepted assay technology 3....

Trial ID:

MARBLE

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

Excerpt:

...- Evidence of common EGFR activating mutations (Del 19 and/or L858R)...

Trial ID:

NCT02695290

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations

Excerpt:

...Documented Epidermal Growth Factor Receptor (EGFR) T790M mutation 4....

Trial ID:

NCT01647711

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Afatinib Expanded Access Program

Excerpt:

...Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology....

Trial ID:

NCT01649284

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

Excerpt:

...- are EGFR mutation-positive or...

Trial ID:

NCT00993499

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients

Excerpt:

...presence of activating mutation(s) in exon 18 to exon 21 of the EGFR or HER2-neu-receptor confirmed by direct DNA sequencing of NSCLC tumor tissue or increased copy number of the EGFR gene as determined by FISH analysis 4....

Trial ID:

NCT00730925

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

Multicentre, prospective, real-world clinical study of afatinib or gefitinib in combination with first-line chemotherapy for advanced EGFR mutant non-squamous NSCLC

Excerpt:

...1.Non-squamous NSCLC patients confirmed by imaging and histopathology as III B to IV stage; 2.Positive EGFR gene mutation (including 19DEL, 21L858R, G719A, G719C, G719S, L861Q, V689M, N700D, E709K/Q, S720P, L858R, N826S, A839T, K846R, G863D, G719X, S768I complex mutation, G719X complex mutation, etc.); 3.Has not received any previous systemic anti-tumor therapy; 4.No brain metastases, or asymptomatic brain metastases, or symptomatic brain metastases are treated and stable....

Trial ID:

ChiCTR2100047133

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

Title:

BI 1361849 (CV9202) + afatinib compared with placebo + afatinib in first-line NSCLC harbouring common EGFR mutations BI 1361849 (CV9202) + afatinib comparado con placebo + afatinib como tratamiento de primera línea en pacientes con NSCLC portadores de mutaciones comunes del EGFR.

Excerpt:

...Documented activating EGFR mutation (Del 19 and/or L858R) determined in tumour tissues ? ...

Trial ID:

2015-001477-41

Less C2 evidence

Evidence Level:

Sensitive: C3 – Early Trials

Source:

ESMO Asia 2023

Title:

578P - Tyrosine kinase inhibitor treatment of elderly patients with epidermal growth factor receptor mutated advanced non-small cell lung cancer: A multi-institute retrospective study

Published date:

11/27/2023

Excerpt:

In elderly patients, afatinib showed significantly better efficacy, with a median progression-free survival (PFS) of 14.7 months and overall survival (OS) of 22.2 months, than gefitinib (9.9 months and 17.7 months, respectively) and erlotinib (10.8 months and 18.5 months, respectively; PFS: p=0.003; OS: p=0.026)...For elderly patients with EGFR-mutated advanced NSCLC, afatinib was associated with better efficacy than gefitinib or erlotinib in elderly patients with EGFR-mutated advanced NSCLC as a first-line treatment with acceptable AEs.

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Acta Oncol

Title:

Treatment outcomes of non-small cell lung cancers treated with EGFR tyrosine kinase inhibitors: a real-world cohort study

Published date:

11/07/2023

Excerpt:

EGFR mutants treated with afatinib have improved outcomes compared to gefitinib…

DOI:

10.1080/0284186X.2023.2274481

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Thorac Cancer

Title:

Survival outcomes of east Asian patients with advanced non-small cell lung cancer treated with first-line EGFR tyrosine kinase inhibitors: A network meta-analysis of real-world evidence

Published date:

09/14/2023

Excerpt:

The NMA included observational real-world evidence studies on adult patients with EGFR-mutated advanced NSCLC who received first (gefitinib and erlotinib), second (afatinib), or third (osimertinib) generation EGFR-TKIs as frontline therapy....This real-world evidence shows that afatinib confers better survival than other first-line EGFR-TKIs in East Asian patients with advanced NSCLC.

DOI:

10.1111/1759-7714.15112

Evidence Level:

Sensitive: C3 – Early Trials

Source:

IASLC-WCLC 2023

Title:

Intracranial Efficacy of Afatinib as First-line Treatment in Common/Uncommon EGFR-Mutant Advanced Non-small Cell Lung Cancer Patients

Published date:

08/08/2023

Excerpt:

First-line afatinib demonstrated encouraging efficacy on BMs in NSCLC patients harboring either common or major uncommon EGFR mutations, with manageable toxicities.

Evidence Level:

Sensitive: C3 – Early Trials

Source:

IASLC-WCLC 2023

Title:

Single-Center Real-World Study of First Line Afatinib Treatment in Advanced EGFR-mutated Non-small Cell Lung Cancer in Vietnam

Published date:

08/08/2023

Excerpt:

Among 79 patients with measurable lesions, ORR and DCR in overall were 60% and 100%, respectively….1-year and 2-year OS were 87% and 72%, respectively….This real-world experience suggested that first-line afatinib is efficacious in Vietnamese patients with EGFR-mutated NSCLC, demonstrating an encouraging survival outcome, high response rate, low incidence of intracranial progression, and manageable tolerability profile.

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Nat Commun

Title:

Neoadjuvant Afatinib for stage III EGFR-mutant non-small cell lung cancer: a phase II study

Published date:

08/03/2023

Excerpt:

Forty-seven patients received neoadjuvant Afatinib treatment (40 mg daily)….The ORR was 70.2% (95% CI: 56.5% to 84.0%), meeting the pre-specified endpoint. The major pathological response (MPR), pCR, pathological downstaging, and R0 rates were 9.1%, 3.0%, 57.6%, and 87.9%, respectively....Neoadjuvant Afatinib is feasible for stage III NSCLC+ patients and leads to dynamic changes in the tumor microenvironment.

DOI:

https://doi.org/10.1038/s41467-023-40349-z

Trial ID:

LungMate-004

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Thorac Cancer

Title:

Epidermal growth factor receptor tyrosine kinase inhibitors for non-small cell lung cancer harboring uncommon EGFR mutations: Real-world data from Taiwan

Published date:

11/24/2022

Excerpt:

Afatinib demonstrated better survival outcomes than gefitinib/erlotinib for NSCLC patients harboring major EGFR uncommon mutations and compound mutations.

DOI:

https://doi.org/10.1111/1759-7714.14537

Evidence Level:

Sensitive: C3 – Early Trials

Source:

ESMO Asia 2022

Title:

381P - Real-world experience of treatment with afatinib in advanced non-small cell lung cancer (NSCLC) in Vietnam

Published date:

11/23/2022

Excerpt:

In the single center study, afatinib demonstrated an encouraging clinical activity in the first-line settings of advanced NSCLC harboring EGFR mutation...

Evidence Level:

Sensitive: C3 – Early Trials

Source:

J Geriatr Oncol

Title:

Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study

Published date:

10/30/2022

Excerpt:

Patients with EGFRm + NSCLC aged ≥70 years showed clinical benefit from first-line afatinib with no unexpected safety signals, supporting the use of afatinib in this setting.

DOI:

https://doi.org/10.1016/j.jgo.2022.10.009

Trial ID:

Evidence Level:

Sensitive: C3 – Early Trials

Source:

IASLC-WCLC 2022

Title:

EP08.02-142 - Effects of Afatinib on the Treatment and Prognosis of Brain Metastasis in Advanced EGFR Mutation (+) NSCLC

Published date:

07/12/2022

Excerpt:

We conducted a study on the effect on brain metastasis in EGFR M(+) patients who received afatinib as the 1st line from the KATRD EGFR cohort data.…The OS of the cohort was promising, especially in patients without brain metastasis.

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Anticancer Res

Title:

First-line Afatinib in Patients With Non-small-cell Lung Cancer With Uncommon EGFR Mutations in South Korea

Published date:

02/26/2022

Excerpt:

Mutations were categorized according to their incidence: 1) major uncommon mutations (G719X and L861Q), 2) compound mutations, and 3) minor uncommon mutations (exon 20 insertion, S768I, and de novo T790M)....Afatinib demonstrated activity against tumors harboring major uncommon mutations [median time of treatment (TOT): 20.3 months, 95% confidence interval (CI)=15.1-25.5; overall survival (OS): 30.6 months, 95% CI=26.3-34.8] and compound mutations (median TOT: 12.3 months, 95% CI=7.7-17.0; OS: 29.1 months, 95% CI=20.4-37.7)....Afatinib is effective in patients with NSCLC harboring major uncommon and compound EGFR mutations.

DOI:

https://doi.org/10.21873/anticanres.15636

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Future Oncol

Title:

Biomarker subset analysis of a phase IIIb, open-label study of afatinib in EGFR tyrosine kinase inhibitor-naive patients with EGFR m+ non-small-cell lung cancer

Published date:

02/04/2022

Excerpt:

In total, 64 patients from one Chinese site with locally advanced/metastatic EGFRm+ non-small-cell lung cancer, who received afatinib 40 mg once daily, were included….Afatinib provided clinical benefit for patients with EGFRm+ non-small-cell lung cancer across all subgroups.

DOI:

10.2217/fon-2021-0394

Trial ID:

NCT01953913

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Eur J Cancer

Title:

Pharmacokinetic and pharmacogenomic analysis of low-dose afatinib treatment in elderly patients with EGFR mutation-positive non-small cell lung cancer

Published date:

01/29/2022

Excerpt:

The median age of the patients was 79 years. The ORR was 80.0% and the disease control rate was 91.4%. The median PFS and OS were 15.6 and 29.5 months, respectivelyAn afatinib starting dose of 30 mg/day could be an effective and safe treatment option for elderly patients.

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Lung Cancer

Title:

The EPICAL trial, a phase Ib study combining first line afatinib with anti-EGF vaccination in EGFR-mutant metastatic NSCLC

Published date:

12/23/2021

Excerpt:

The EPICAL was a single arm, phase 1b study to evaluate safety, tolerability and anti-tumor activity of first line afatinib combined with anti-EGF vaccination in advanced EGFR-mut patients….Objective response and disease control rates were 78.3% (95%CI = 53.6-92.5) and 95.7% (95%CI = 78.1-99.9), respectively. After a median follow-up of 24.2 months, median progression-free survival (PFS) was 14.8 months (95% CI = 9.5-20.1) and median overall survival (OS) 26.9 months (95% CI = 23.0-30.8).

DOI:

10.1016/j.lungcan.2021.12.014

Trial ID:

EPICAL

Evidence Level:

Sensitive: C3 – Early Trials

Source:

J Oncol

Title:

Efficacy and Safety of Afatinib in the Treatment of Advanced Non-Small-Cell Lung Cancer with EGFR Mutations: A Meta-Analysis of Real-World Evidence

Published date:

12/18/2021

Excerpt:

The summarized disease control rate (DCR) was 87.6% (81.5%, 92.7%), and the overall response rate (ORR) was 58.9% (48.8%, 68.7%). The pooled median progression-free survival (PFS) was 12.4 (10.3, 14.5) months, mean time to failure (TTF) was 15.4 (13.6, 17.2) months, and median overall survival (OS) was 31.6 (26.7, 36.5) months....The efficacy and safety of afatinib has been confirmed by real-world evidence in advanced NSCLC with EGFR mutation, consistent with randomized controlled trial results.

DOI:

10.1155/2021/8736288

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Eur J Cancer

Title:

Pharmacokinetic and pharmacogenomic analysis of low-dose afatinib treatment in elderly patients with EGFR mutation-positive non-small cell lung cancer

Published date:

11/30/2021

Excerpt:

We conducted a prospective multicentre, single-arm, and open-label phase II trial for low-dose afatinib (30 mg/day) use in elderly patients with NSCLC with EGFR mutation...The ORR was 80.0% and the disease control rate was 91.4%. The median PFS and OS were 15.6 and 29.5 months, respectively.

DOI:

10.1016/j.ejca.2021.10.024

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Dovepress

Title:

Efficacy and Prognosis of First-Line EGFR-Tyrosine Kinase Inhibitor Treatment in Older Adults Including Poor Performance Status Patients with EGFR-Mutated Non-Small-Cell Lung Cancer

Published date:

09/15/2021

Excerpt:

The PFS and OS were 17.1 and 26.7 months respectively in patients with good PS and 12.7 and 18.2 months in those with poor PS (both p < 0.001). In the multivariate analysis, good PS, < 3 metastatic sites, and first-line treatment with afatinib compared with erlotinib and gefitinib were associated with longer PFS....In older patients with EGFR-mutated NSCLC and receive EGFR-TKI treatment, a good PS and < 3 metastatic sites at diagnosis were associated with a longer PFS and OS. In addition, afatinib as first-line treatment was associated with a longer PFS whereas a relatively younger age and no brain metastasis at diagnosis were associated with better OS.

DOI:

https://doi.org/10.2147/CMAR.S322967

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Cancer Manag Res

Title:

Efficacy and Prognosis of First-Line EGFR-Tyrosine Kinase Inhibitor Treatment in Older Adults Including Poor Performance Status Patients with EGFR-Mutated Non-Small-Cell Lung Cancer

Published date:

09/15/2021

Excerpt:

We enrolled patients 65 years or older with EGFR-mutated Stage IIIB-IV NSCLC and evaluated the efficacy and prognosis of first-line EGFR-TKI treatment…. In the multivariate analysis, good PS, <3 metastatic sites, and first-line treatment with afatinib compared with erlotinib and gefitinib were associated with longer PFS. A relatively younger age, good PS, < 3 metastatic sites, and no brain metastasis at diagnosis were associated with better OS.

DOI:

10.2147/CMAR.S322967

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Dovepress

Title:

An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece

Published date:

08/30/2021

Excerpt:

A total of 59 patients were treated with afatinib for their EGFR mutation-positive advanced NSCLC...At a median follow-up of 41.8 months (95% CI 35.9– 51.4), the median PFS was 14.3 months (95% CI 12.2– 16.4), and the median OS was 29 months (95% CI 25.6– 33.4).

DOI:

https://doi.org/10.2147/LCTT.S318007

Trial ID:

NCT04640870

Evidence Level:

Sensitive: C3 – Early Trials

Source:

IASLC-WCLC 2021

Title:

P50.03 - A Real-World Cohort Study of EGFR TKIs in Patients with NSCLC with Uncommon EGFR mutations (UpSwinG)

Published date:

08/18/2021

Excerpt:

In this non-interventional, global, multicenter, retrospective study (NCT04179890), existing medical or electronic health records were searched for consecutive patients with uncommon EGFR mutations (T790M, ex20ins, major uncommon [G719X, L861Q or S768I], ‘other’, or compound mutations) who were EGFR TKI-naïve at diagnosis, treated with erlotinib, gefitinib, afatinib, osimertinib, or other systemic therapy....Patients treated with afatinib had longer median TTF and DoR, vs those treated with first-generation EGFR TKIs.

Trial ID:

UpSwinG

Evidence Level:

Sensitive: C3 – Early Trials

Source:

IASLC-WCLC 2021

Title:

Radiomic Signature to Predict Outcomes in EGFR-Mutant Non-Small Cell Lung Cancer

Published date:

08/18/2021

Excerpt:

A total of 44 patients with EGFR variant–positive NSCLC receiving EGFR-TKI therapy were included...25 (66%) presented PFS of more than 12 months (age at treatment start: 74 (9) years; 76% females; 16 on erlotinib, 4 on afatinib, 4 on osimertinib, 1 on gefitinib).

Evidence Level:

Sensitive: C3 – Early Trials

Source:

BMC Cancer

Title:

Feasibility and effectiveness of afatinib for poor performance status patients with EGFR-mutation-positive non-small-cell lung cancer: a retrospective cohort study

Published date:

07/27/2021

Excerpt:

This study aimed to retrospectively review the clinical outcomes and safety of afatinib treatment in EGFR-mutation-positive (EGFRm+) NSCLC patients with PS ≥ 2….the objective response rate, disease control rate, median progression-free survival (PFS), and overall survival (OS) were 58.1% (36/62), 69.4% (43/62), 8.8 months, and 12.9 months, respectively....Afatinib demonstrated acceptable efficacy and safety in the current cohort.

DOI:

10.1186/s12885-021-08587-w

Evidence Level:

Sensitive: C3 – Early Trials

Source:

BMC Cancer

Title:

An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naïve patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations

Published date:

07/12/2021

Excerpt:

Eighty-eight patients received afatinib, including 27 (31%) with brain metastases and 16 (18%) with uncommon EGFR mutations. Median PFS was 17.0 months (95% confidence interval [CI] 12.9–23.3 months)....Afatinib showed encouraging efficacy in a broad patient population including those with brain metastases or tumors harboring uncommon EGFR mutations.

DOI:

https://doi.org/10.1186/s12885-021-08445-9

Trial ID:

NCT01931306

Evidence Level:

Sensitive: C3 – Early Trials

Source:

PLoS One

Title:

Real-world outcomes of first- and second-generation tyrosine kinase inhibitors first-line in patients with epidermal growth factor receptor mutation-positive non-small cell lung cancer: A retrospective observational cohort study

Published date:

06/24/2021

Excerpt:

This cohort study analyzed the overall survival (OS) and progression-free survival (PFS) of afatinib compared with erlotinib and gefitinib first-line. EGFRm+, advanced NSCLC patients treated with either afatinib, erlotinib or gefitinib were retrospectively analyzed....Median OS were 19.1, 22.9, and 35.6 months for gefitinib, erlotinib, and afatinib groups, respectively, with statistical significance between the gefitinib and afatinib groups (p = 0.009). Patients on afatinib also had longer median OS than erlotinib and gefitinib pooled together (35.5 versus 21.4 months; hazard ratio = 0.54, p = 0.016), despite similar median PFS.

DOI:

10.1371/journal.pone.0253335

Evidence Level:

Sensitive: C3 – Early Trials

Source:

ASCO 2021

Title:

Efficacy and safety of afatinib in advanced non-small cell lung cancer with EGFR mutations: A real-world study based meta-analysis.

Published date:

05/19/2021

Excerpt:

The efficacy of DCR and ORR were 87.6 % (81.5, 92.7) and 58.9 % (48.8, 68.7)....The efficacy of afatinib in first-line only group was superior than those in second-line....Afatinib was a safe and effective TKI for real-world EGFR-mutated NSCLC patients, which was consistent with the results of RCT.

DOI:

10.1200/JCO.2021.39.15_suppl.e21134

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Ther Adv Med Oncol

Title:

Afatinib as first-line treatment in patients with EGFR-mutated non-small cell lung cancer in routine clinical practice

Published date:

05/06/2021

Excerpt:

In NCT02047903, a prospective non-interventional study in Germany, patients with EGFRm+ NSCLC received first-line afatinib until disease progression or intolerable adverse events….Overall, the 12-month PFS rate was 50.2% while the median PFS was 12.2 months. The ORR was 74.6% and the median OS was 30.4 months.

DOI:

10.1177/17588359211012361

Trial ID:

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Asian Pac J Cancer Prev

Title:

Effectiveness and Tolerability of First-Line Afatinib for Advanced EGFR-Mutant Non-Small Cell Lung Cancer in Vietnam

Published date:

05/01/2021

Excerpt:

First-line afatinib is beneficial for Vietnamese patients with advanced EGFR-mutant NSCLC with a good response rate and prolonged TTF with manageable adverse event profile.

DOI:

10.31557/APJCP.2021.22.5.1581

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Int J Clin Oncol

Title:

Experience from Asian centers in a named-patient-use program for afatinib in patients with advanced non-small-cell lung cancer who had progressed following prior therapies, including patients with uncommon EGFR mutations

Published date:

03/30/2021

Excerpt:

Patients had progressed after initial benefit with erlotinib or gefitinib, and/or had an EGFR or HER2 mutation, had no other treatment options, and were ineligible for afatinib trials. The recommended starting dose of afatinib was 50 mg/day….Objective response rate (ORR) was 24% overall (n = 431 with data available), 27% for patients with common EGFR mutations (n = 230) and 28% for those with uncommon mutations (n = 32); median time to treatment failure (TTF) in these groups was 7.6 months (n = 1550), 6.4 months (n = 692) and 8.4 months (n = 83), respectively.

DOI:

10.1007/s10147-021-01869-0

Evidence Level:

Sensitive: C3 – Early Trials

Source:

IASLC-WCLC 2020

Title:

Real-world Experience of the Utility in Afatinib Therapy for Patients with EGFR-Mutant Advanced NSCLC

Published date:

01/12/2021

Excerpt:

Afatinib is effective for patients with NSCLC harboring common EGFR mutations irrespective of their clinicopathological backgrounds unlike gefitinib and erlotinib.

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Thorac Cancer

Title:

First-line treatment with irreversible tyrosine kinase inhibitors associated with longer OS in EGFR mutation-positive non-small cell lung cancer

Published date:

12/18/2020

Excerpt:

Those given afatinib had better OS (39.3 vs. 26.0 months; HR 0.65, P = 0.033) and PFS (14.1 vs.11.2 months; HR 0.58, P < 0.001)….The results indicated that afatnib resulted in significantly better OS and PFS than gefitnib and erlotinib for EGFR mutation-positive advanced NSCLC patients without brain metastases.

DOI:

10.1111/1759-7714.13462

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Future Oncol

Title:

Making the case for EGFR TKI sequencing in EGFR mutation-positive NSCLC: a GioTag study US patient analysis

Published date:

08/06/2020

Excerpt:

To assess time-to-treatment failure (TTF) in US patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC)...In 129 patients at US centers, median TTF was 28.4 months (90% CI: 27.0-34.1). Median overall survival was 47.6 months (90% CI: 35.5-51.5)...Sequential afatinib-osimertinib in this US-treated population was associated with long median TTF and represents an effective, evidence-based treatment option for US patients with EGFR mutation-positive NSCLC not presenting with active brain metastases or de novo T790M.

DOI:

10.2217/fon-2020-0188

Trial ID:

GioTag

Evidence Level:

Sensitive: C3 – Early Trials

Source:

ASCO 2020

Title:

Efficacy of afatinib in the clinical practice: Final results of the GIDEON study in EGFR mutated non-small cell lung cancer (NSCLC) in Germany.

Published date:

05/28/2020

Excerpt:

Afatinib is a standard therapy for patients with activating EGFR mut…Among pat. with uncommon EGFR-mut., the 12-months PFS rate was 40.2% with a mPFS of 10.7 months. ORR and DCR were 83.3% and 91.7%...

DOI:

10.1200/JCO.2020.38.15_suppl.e21636

Trial ID:

Evidence Level:

Sensitive: C3 – Early Trials

Source:

ESMO 2018

Title:

3698 - Efficacy of Afatinib in the clinical practice - First results of the GIDEON trial: a prospective non-interventional study (NIS) in EGFR mutated NSCLC in Germany

Published date:

10/09/2018

Excerpt:

ORR for the total treated population was 73% with a DCR of 90 %....Afatinib is a standard therapy for patients with activating EGFR mutations in Germany. The first results of this prospective NIS confirm the robust clinical data for Afatinib in the clinical routine setting...

Trial ID: