Association of ERBB Mutations With Clinical Outcomes of Afatinib- or Erlotinib-Treated Patients With Lung Squamous Cell Carcinoma: Secondary Analysis of the LUX-Lung 8 Randomized Clinical Trial
Open accessAbstract
Importance: Treatment choice for lung squamous cell carcinoma could be aided by identifying predictive biomarkers. Objective: To assess whether patient outcomes in the LUX-Lung 8 trial were associated with ERBB gene family member aberrations in tumor specimens. Design, Setting, and Participants: Ad hoc secondary analysis of the LUX-Lung 8 trial conducted at 183 centers in 23 countries from March 30, 2012, to January 30, 2014. Eligible patients had stage IIIB or IV lung squamous cell carcinoma with progressive disease after 4 or more cycles of platinum-based chemotherapy. Tumor genetic analysis (TGA) was performed using next-generation sequencing in a cohort enriched for patients with progression-free survival (PFS) of more than 2 months. Epidermal growth factor receptor (EGFR) expression levels were assessed by immunohistochemistry in a separate cohort of patients from the LUX-Lung 8 population. Associations of PFS and overall survival (OS) with ERBB gene alterations and EGFR expression levels were assessed. This analysis was conducted from February 26, 2015, to June 12, 2017. Interventions: Patients were randomized 1:1 to treatment with afatinib dimaleate (40 mg/d; n = 398) or erlotinib hydrochloride (150 mg/d; n = 397). Main Outcomes and Measures: Overall survival, PFS, pooled and individual ERBB gene mutations, ERBB copy number alterations, and EGFR expression. Results: Tumor specimens from 245 patients were eligible for next-generation sequencing (TGA subset: 132 patients treated with afatinib; 113 patients treated with erlotinib). In this population, outcomes were improved with afatinib vs erlotinib treatment (PFS: median, 3.5 vs 2.5 months; hazard ratio [HR], 0.69; 95% CI, 0.51-0.92; P = .01; OS: median, 8.4 vs 6.6 months; HR, 0.81; 95% CI, 0.62-1.05; P = .12). Of 245 patients in the TGA subset, 53 (21.6%) had tumors with 1 or more ERBB mutations. Among afatinib-treated patients, PFS (median, 4.9 vs 3.0 months; HR, 0.62; 95% CI, 0.37-1.02; P = .06) and OS (median, 10.6 vs 8.1 months; HR, 0.75; 95% CI, 0.47-1.17; P = .21) were longer among those with ERBB mutation-positive disease than among those without. The presence of HER2 mutations was associated with favorable PFS and OS following afatinib vs erlotinib treatment. There was no apparent association between copy number alteration or EGFR expression level and outcome. Conclusions and Relevance: Next-generation sequencing may help identify patients with lung squamous cell carcinoma who would derive additional benefit from treatment with afatinib. The role of ERBB mutations, particularly HER2 mutations, as predictive biomarkers for afatinib treatment in this setting warrants further evaluation. Trial Registration: ClinicalTrials.gov Identifier: NCT01523587.
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Among patients treated with afatinib in LUX-Lung 8, PFS and OS were numerically longer in patients with ErbB mutation-positive tumors than in those without mutations; this was not observed for erlotinib.
“Biomarker analysis indicated that, among patients treated with afatinib, PFS and OS were numerically longer in patients with ErbB mutation-positive tumors than in those without mutations; this was not observed for erlotinib.”
From Afatinib for the treatment of <i>EGFR</i> mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [85]
The benefit of afatinib over erlotinib among patients with ErbB-positive tumors appeared to be driven by mutations in HER3, HER4, and in particular HER2.
“the benefit of afatinib over erlotinib among patients with ErbB-positive tumors appeared to be driven by mutations in HER3 (ErbB3), HER4 (ErbB4), and in particular, HER2 (ErbB2).”
From Afatinib for the treatment of <i>EGFR</i> mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [85]
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- Authors
- Goss, G. D., Felip, E., Cobo, M., Lu, S., Syrigos, K., Lee, K. H., Göker, E., Georgoulias, V., Li, W., Guclu, S., Isla, D., Min, Y. J., Morabito, A., Ardizzoni, A., Gadgeel, S. M., Fülöp, A., Bühnemann, C., Gibson, N., Krämer, N., Solca, F., Cseh, A., Ehrnrooth, E., & Soria, J.-C.
- Affiliations
- University of Ottawa (CA)
- Vall d'Hebron Hospital Universitari (ES)
- Instituto de Investigación Biomédica de Málaga (ES)
- Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Oncology Unit GPP, Athens School of Medicine, Athens, Greece
- Chungbuk National University (KR)
- Ege University (TR)
- University Hospital of Heraklion (GR)
- Cancer Center, First Hospital Affiliated to Jilin University, Jilin, China
- Chest Diseases Clinic, Izmir Chest Diseases Research Hospital, Izmir, Turkey
- Hospital Clínico Universitario Lozano Blesa (ES)
- Ulsan University Hospital (KR)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Wayne State University (US)
- National Koranyi Institute, Budapest, Hungary
- Boehringer Ingelheim (Germany) (DE)
- Boehringer Ingelheim (Austria) (AT)
- Boehringer Ingelheim (Denmark) (DK)
- Université Paris-Sud (FR)
- Corresponding author
- Goss, Glenwood D.
- ORCID
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2018-09-01
- Volume
- 4
- Issue
- 9
- Pages
- 1189
- ISSN
- 2374-2437 (ISSN-L)
- PMC
- PMC6143014
- OpenAlex
- W2808333976
- Cited by
- 55
- References
- 39
- Citations by year
- 2026: 3 · 2024: 1 · 2023: 3 · 2022: 10 · 2021: 12 · 2020: 11 · 2019: 11 · 2018: 4
- FWCI
- 7.16
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- JAMA Oncology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Keywords
- lung squamous cell carcinoma, EGFR, afatinib, erlotinib, predictive biomarkers, progression-free survival, overall survival, EGFR expression, HER2, HER3, ErbB4, EGFR tyrosine kinase inhibitors, second-line therapy, platinum-refractory disease, copy number alterations
- MeSH terms
- Erlotinib Hydrochloride, Afatinib, Aged, Carcinoma, Squamous Cell, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Treatment Outcome, Disease-Free Survival, Genes, erbB, Protein Kinase Inhibitors
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