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Article: Afatinib in EGFR TKI-Naïve Patients with Locally Advanced or Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Pooled Analysis of Three Phase IIIb Studies

TitleAfatinib in EGFR TKI-Naïve Patients with Locally Advanced or Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Pooled Analysis of Three Phase IIIb Studies
Authors
Keywordsafatinib
real world
safety
EGFR mutation
EGFR TKI-naïve
Issue Date2021
PublisherFrontiers Research Foundation. The Journal's web site is located at http://www.frontiersin.org/oncology
Citation
Frontiers in Oncology, 2021, v. 11, p. article no. 709877 How to Cite?
AbstractBackground: Afatinib is approved for first-line treatment of patients with epidermal growth factor receptor mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC). Here, we report findings from a combined analysis of three phase IIIb studies of afatinib in EGFR tyrosine kinase inhibitor (TKI)-naïve patients. Methods: EGFR-TKI-naïve patients with EGFRm+ NSCLC received afatinib 40 mg/day. Dose reductions were permitted for adverse events (AEs). Efficacy endpoints included progression-free survival (PFS), time to symptomatic progression (TTSP), and tumor response. Subgroup analyses were performed by Eastern Cooperative Oncology Group performance status (ECOG PS), presence of brain metastasis, age and common/uncommon EGFR mutations (plus other factors). Results: 1108 patients were treated. Median age was 61 years (range, 25–89); 19.2% had baseline brain metastases, 4.4% had ECOG PS ≥2, and 17.9% had tumors harboring uncommon mutations. Treatment-related AEs (TRAEs) were reported in 97.2%, most commonly diarrhea and rash. 41.6% had AEs leading to dose reduction. Median PFS was 13.0 months [95% confidence interval (CI): 12.0–13.8]; median TTSP was 14.8 months (95% CI: 13.9–16.1). Objective response rate (ORR) was 55.0%. Age, presence of baseline brain metastases, major (G719X, L861Q, S768I) or compound uncommon mutations had little/no effect on PFS, TTSP, or ORR, while outcomes were poorer in patients with ECOG PS 2 or exon 20 insertion/T790M mutations. Conclusions: Afatinib was tolerable with no new safety signals. Afatinib demonstrated encouraging efficacy in a broad patient population, including those with brain metastases or uncommon EGFR mutations.
Persistent Identifierhttp://hdl.handle.net/10722/305306
ISSN
2023 Impact Factor: 3.5
2023 SCImago Journal Rankings: 1.066
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorPassaro, A-
dc.contributor.authorde Marinis, F-
dc.contributor.authorTu, HY-
dc.contributor.authorLaktionov, KK-
dc.contributor.authorFeng, J-
dc.contributor.authorPoltoratskiy, A-
dc.contributor.authorZhao, J-
dc.contributor.authorTan, EH-
dc.contributor.authorGottfried, M-
dc.contributor.authorLee, V-
dc.contributor.authorKowalski, D-
dc.contributor.authorYang, CT-
dc.contributor.authorSrinivasa, BJ-
dc.contributor.authorClementi, L-
dc.contributor.authorJalikop, T-
dc.contributor.authorHuang, DCL-
dc.contributor.authorCseh, A-
dc.contributor.authorPark, K-
dc.contributor.authorWu, YL-
dc.date.accessioned2021-10-20T10:07:33Z-
dc.date.available2021-10-20T10:07:33Z-
dc.date.issued2021-
dc.identifier.citationFrontiers in Oncology, 2021, v. 11, p. article no. 709877-
dc.identifier.issn2234-943X-
dc.identifier.urihttp://hdl.handle.net/10722/305306-
dc.description.abstractBackground: Afatinib is approved for first-line treatment of patients with epidermal growth factor receptor mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC). Here, we report findings from a combined analysis of three phase IIIb studies of afatinib in EGFR tyrosine kinase inhibitor (TKI)-naïve patients. Methods: EGFR-TKI-naïve patients with EGFRm+ NSCLC received afatinib 40 mg/day. Dose reductions were permitted for adverse events (AEs). Efficacy endpoints included progression-free survival (PFS), time to symptomatic progression (TTSP), and tumor response. Subgroup analyses were performed by Eastern Cooperative Oncology Group performance status (ECOG PS), presence of brain metastasis, age and common/uncommon EGFR mutations (plus other factors). Results: 1108 patients were treated. Median age was 61 years (range, 25–89); 19.2% had baseline brain metastases, 4.4% had ECOG PS ≥2, and 17.9% had tumors harboring uncommon mutations. Treatment-related AEs (TRAEs) were reported in 97.2%, most commonly diarrhea and rash. 41.6% had AEs leading to dose reduction. Median PFS was 13.0 months [95% confidence interval (CI): 12.0–13.8]; median TTSP was 14.8 months (95% CI: 13.9–16.1). Objective response rate (ORR) was 55.0%. Age, presence of baseline brain metastases, major (G719X, L861Q, S768I) or compound uncommon mutations had little/no effect on PFS, TTSP, or ORR, while outcomes were poorer in patients with ECOG PS 2 or exon 20 insertion/T790M mutations. Conclusions: Afatinib was tolerable with no new safety signals. Afatinib demonstrated encouraging efficacy in a broad patient population, including those with brain metastases or uncommon EGFR mutations.-
dc.languageeng-
dc.publisherFrontiers Research Foundation. The Journal's web site is located at http://www.frontiersin.org/oncology-
dc.relation.ispartofFrontiers in Oncology-
dc.rightsThis Document is Protected by copyright and was first published by Frontiers. All rights reserved. It is reproduced with permission.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectafatinib-
dc.subjectreal world-
dc.subjectsafety-
dc.subjectEGFR mutation-
dc.subjectEGFR TKI-naïve-
dc.titleAfatinib in EGFR TKI-Naïve Patients with Locally Advanced or Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Pooled Analysis of Three Phase IIIb Studies-
dc.typeArticle-
dc.identifier.emailLee, V: vhflee@hku.hk-
dc.identifier.authorityLee, V=rp00264-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.3389/fonc.2021.709877-
dc.identifier.pmid34307179-
dc.identifier.pmcidPMC8298067-
dc.identifier.scopuseid_2-s2.0-85111068931-
dc.identifier.hkuros327861-
dc.identifier.volume11-
dc.identifier.spagearticle no. 709877-
dc.identifier.epagearticle no. 709877-
dc.identifier.isiWOS:000675596300001-
dc.publisher.placeSwitzerland-

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