Afatinib in Non-Small Cell Lung Cancer Harboring Uncommon EGFR Mutations Pretreated With Reversible EGFR Inhibitors

Heigener, David F.; Schumann, Christian; Sebastian, Martin; Sadjadian, Parvis; Stehle, Ingo; Märten, Angela; Lüers, Anne; Griesinger, Frank; Scheffler, Matthias; for the Afatinib Compassionate Use Consortium (ACUC)

doi:10.1634/theoncologist.2015-0073

Cited by 78Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchLung Cancer Diagnosis and Treatment

Afatinib in Non-Small Cell Lung Cancer Harboring Uncommon EGFR Mutations Pretreated With Reversible EGFR Inhibitors

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Heigener, David F., Schumann, Christian, Sebastian, Martin, Sadjadian, Parvis, Stehle, Ingo, Märten, Angela, Lüers, Anne, Griesinger, Frank +2 more·2015·The Oncologist

DOI 10.1634/theoncologist.2015-0073PMC PMC4591955

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Abstract

Background.: Afatinib, an irreversible ErbB family blocker, is approved for treatment of patients with previously untreated non-small cell lung cancer (NSCLC) harboring activating epidermal growth factor receptor (EGFR) mutations. Efficacy of afatinib in EGFR tyrosine kinase inhibitor-naïve (TKI-naïve) patients with uncommon EGFR mutations (other than exon 19 deletions or exon 21 point mutations) has been reported; however, efficacy in TKI-pretreated patients with uncommon EGFR mutations is unknown. Materials and Methods.: In the afatinib compassionate use program (CUP), patients with advanced or metastatic, histologically confirmed NSCLC progressing after at least one line of chemotherapy and one line of EGFR-TKI treatment were enrolled. Demographic data, mutation type, response rates, time to treatment failure (TTF), and safety in patients harboring uncommon EGFR mutations were reported. Results.: In 60 patients (63% female, median age 63 years [range: 30–84 years]), a total of 66 uncommon EGFR mutations including 30 T790M mutations were reported (18.4% and 11%, respectively, of known EGFR mutations within the CUP). Most patients (67%) received afatinib as third- or fourth-line treatment. Median TTF was 3.8 months (range: 0.2 to >24.6 months; p = .244) in patients with uncommon mutations compared with 5.1 months (range: 0.1 to >21.1 months) in patients with common mutations (n = 165). Pronounced activity was observed with E709X mutations (TTF >12 months). No new safety signals were detected. Conclusion.: Afatinib is clinically active and well tolerated in many TKI-pretreated NSCLC patients harboring uncommon EGFR mutations. Compared with results reported in TKI-naïve patients, activity was also indicated in patients with T790M and exon 20 insertion mutations. Implications for Practice: This analysis consists of a large database of non-small cell lung cancer patients with uncommon EGFR mutations who were previously treated with reversible EGFR tyrosine kinase inhibitors. Although indirectly assessed, the results indicate that patients with uncommon EGFR mutations can derive benefit from treatment with the irreversible ErbB family blocker afatinib, even in some cases of tumors harboring resistance-mediating exon 20 mutations. In this study, adverse events were modest and consistent with previous reports on afatinib.

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Uncommon mutations within exons 18-21 are present in up to 23% of EGFRm+ NSCLC tumors.
“Uncommon mutations within exons 18–21 are present in up to 23% of EGFRm+ NSCLC tumors.69–75”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [70]
The Demographics section reports uncommon mutations in 18.4% of known EGFR-mutated cases in this pretreated cohort, and the Uncommon EGFR Mutations section places them in exons 18–21. The paper does not report the claimed figure of up to 23% for EGFR-mutated NSCLC tumors generally. (LLM, conf=0.85)
Experimental — accuracy not yet measured
In TKI-pretreated patients harboring complex E709X mutations, afatinib produced an ORR of 50%, a DCR of 100%, and a time-to-treatment failure exceeding 12 months.
“reported, in TKI-pretreated patients harboring complex E709X mutations, an intriguing time-to-treatment failure exceeding 12 months, with an ORR of 50% and a disease control rate (DCR) of 100% [53].”
From Heterogeneous Responses to Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors (TKIs) in Patients with Uncommon EGFR Mutations: New Insights and Future Perspectives in this Complex Clinical Scenario (2019) · cites this paper as [53]
Two out of four patients with tumors harboring E709X+G719X or L858R, as well as the authors' patient with Del18 tumor, achieved partial responses to afatinib after treatment with first-generation TKIs.
“In addition, two out of four patients with tumors harboring E709X+G719X or L858R, as well as our patient with Del18‐tumor, achieved partial responses to afatinib after the treatment with 1G‐TKI.29, 74”
From Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy (2016) · cites this paper as [74]

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Authors: Heigener, D. F., Schumann, C., Sebastian, M., Sadjadian, P., Stehle, I., Märten, A., Lüers, A., Griesinger, F., Scheffler, M., & for the Afatinib Compassionate Use Consortium (ACUC)
Affiliations: German Center for Lung Research (DE)
Clinic for Pulmonary, Thoracic Oncology, Sleep and Respiratory Critical Care, Kempten-Oberallgaeu Hospitals GmbH, Immenstadt, Germany
University Hospital Frankfurt (DE)
Johannes Wesling Klinikum Minden (DE)
Universitätsklinikum des Saarlandes (DE)
Boehringer Ingelheim (Germany) (DE)
Carl von Ossietzky Universität Oldenburg (DE)
University Hospital Cologne (DE)
Corresponding author: Heigener, David F.
ORCID: Heigener, David F.
Schumann, Christian
Sebastian, Martin
Sadjadian, Parvis
Griesinger, Frank
Scheffler, Matthias
Venue: The Oncologist
Publisher: Oxford University Press (OUP)
Published: 2015-09-09
Volume: 20
Issue: 10
Pages: 1167-1174
ISSN: 1083-7159 (ISSN-L)
1549-490X
DOI: 10.1634/theoncologist.2015-0073
PMC: PMC4591955
OpenAlex: W2096439166
Cited by: 78
References: 30
Citations by year: 2025: 3 · 2024: 4 · 2023: 5 · 2022: 22 · 2021: 6 · 2020: 8 · 2019: 9 · 2018: 9 · 2017: 7 · 2016: 5
FWCI: 5.54
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations: The Oncologist (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
Funders: Boehringer Ingelheim
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: afatinib, non-small cell lung cancer, EGFR mutation, uncommon EGFR mutations, EGFR tyrosine kinase inhibitors, T790M mutation, exon 20 insertion mutations, compassionate use program, time to treatment failure, drug safety and tolerability, anti-EGFR therapy
MeSH terms: Afatinib, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Quinazolines, Treatment Failure, Protein Kinase Inhibitors, Compassionate Use Trials, ErbB Receptors

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Afatinib in Non-Small Cell Lung Cancer Harboring Uncommon EGFR Mutations Pretreated With Reversible EGFR Inhibitors

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