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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

Excerpt:
...Confirmed activating EGFR mutation (exons 18-21; e.g....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
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:
In the 152 patients enrolled in GIDEON (69.7% female, 64.5%/22.4%/13.2% with Del19/L858R/other exon 18-21 mutations...twelve-month PFS rate was 58.9% and 43.9%, median PFS was 17.2 months and 10.6 months, ORR was 72.0% and 76.5%, twelve-month OS rate was 79.1% and 79.2%, 24-month OS rate was 52.0% and 61.7%, and median OS was 30.4 months and 27.4 months, respectively....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:
10.1016/j.jgo.2022.10.009
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-life comparison of afatinib and erlotinib in non-small cell lung cancer with rare EGFR exon 18 and exon 20 mutations: a Turkish Oncology Group (TOG) study

Published date:
04/05/2022
Excerpt:
We retrospectively evaluated survival characteristics of 125 patients with EGFR exon 18 and exon 20 mutated NSCLC who received erlotinib or afatinib as first line treatment between 2012 and 2021 from 34 oncology centres….PFS of exon 18 mutated arm was 7.0 months, exon 20 mutated arm was 4.3 months, and complex mutation positive group was 17.3 months, and this was statistically significant (p = 0.036).
DOI:
https://doi.org/10.1007/s00432-022-03984-5
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real Life Comparison of Afatinib and Erlotinib in Non-small Cell Lung Cancer With Rare EGFR Exon 18 and Exon 20 Mutations: a Turkish Oncology Group (TOG) Study.

Published date:
12/10/2021
Excerpt:
We retrospectively evaluated survival characteristics of 125 patients with EGFR exon 18 and exon 20 mutated NSCLC who received erlotinib or afatinib….OS of all patients was 21.4 months (95%CI: 16.1-26.6), while PFS was 7.2 months (95%CI: 5.1-9.3). When PFS and OS were compared according to the type of TKI used, PFS was 8.0 months (95%CI: 4.7-11.3) in the erlotinib arm and 7.0 months (95%CI: 4.4-9.6) in the afatinib arm.
DOI:
10.21203/rs.3.rs-1125056/v1
Evidence Level:
Sensitive: C3 – Early Trials
Title:

EGFR Exon 18 Mutations in Advanced Non-Small Cell Lung Cancer: A Real-World Study on Diverse Treatment Patterns and Clinical Outcomes

Published date:
09/02/2021
Excerpt:
There was a significant difference in median progression-free survival (mPFS) by therapeutic strategy (P = 0.017). The mPFS of 1G TKI, 2G TKI afatinib, chemotherapy, and 1G TKI in combination with chemotherapy were 7.7 (95% CI, 4.2-11.2), 11.3 (95% CI, 5.6-17.0), 5.0 (95% CI, 2.3-17.7), and 11.1 (95% CI, 5.9-16.4) months, respectively....Like afatinib, 1G TKI in combination with chemotherapy might be an effective treatment option for patients harboring EGFR exon 18 mutations.
Secondary therapy:
Chemotherapy
DOI:
10.3389/fonc.2021.713483