Impact of TP53 Mutations on Outcome in EGFR -Mutated Patients Treated with First-Line Tyrosine Kinase Inhibitors

Canale, Matteo; Petracci, Elisabetta; Delmonte, Angelo; Chiadini, Elisa; Dazzi, Claudio; Papi, Maximilian; Capelli, Laura; Casanova, Claudia; De Luigi, Nicoletta; Mariotti, Marita; Gamboni, Alessandro; Chiari, Rita; Bennati, Chiara; Calistri, Daniele; Ludovini, Vienna; Crinò, Lucio; Amadori, Dino; Ulivi, Paola

doi:10.1158/1078-0432.ccr-16-0966

Cited by 291Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchLung Cancer Diagnosis and Treatment

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Impact of TP53 Mutations on Outcome in EGFR -Mutated Patients Treated with First-Line Tyrosine Kinase Inhibitors

Canale, Matteo, Petracci, Elisabetta, Delmonte, Angelo, Chiadini, Elisa, Dazzi, Claudio, Papi, Maximilian, Capelli, Laura, Casanova, Claudia, De Luigi, Nicoletta, Mariotti, Marita, Gamboni, Alessandro, Chiari, Rita, Bennati, Chiara, Calistri, Daniele, Ludovini, Vienna, Crinò, Lucio, Amadori, Dino, Ulivi, Paola·2017·Clinical Cancer Research

DOI 10.1158/1078-0432.ccr-16-0966

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Abstract

Purpose: To analyze the impact of TP53 mutations on response to first-line tyrosine kinase inhibitors (TKI) in patients with EGFR-mutated non–small cell lung cancer (NSCLC). Experimental Design: 136 EGFR-mutated NSCLC patients receiving first-line TKIs were analyzed. TP53 mutations were evaluated in 123 patients in relation to disease control rate (DCR), objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: TP53 mutations were observed in 37 (30.1%), 10 (27.0%), 6 (16.2%), 9 (24.3%), and 12 (32.4%) patients in exons 5, 6, 7, and 8, respectively. DCR was 70% in TP53-mutated patients compared with 88% in TP53-wild type (wt) patients [relative risk, RR, of disease progression: 3.17 (95% CI, 1.21–8.48), P = 0.019]. In particular, a 42% DCR was observed in patients with TP53 exon 8 mutation versus 87% in exon 8 wt patients [RR of disease progression 9.6 (2.71–36.63), P < 0.001]. Shorter median PFS and OS were observed in patients with TP53 exon 8 mutations compared with others (4.2 vs. 12.5, P = 0.058, and 16.2 vs. 32.3, P = 0.114, respectively); these differences became significant in the subgroup with EGFR exon 19 deletion (4.2 vs. 16.8, P < 0.001, and 7.6 vs. not reached, P = 0.006, respectively), HR 6.99 (95% CI, 2.34–20.87, P < 0.001) and HR 4.75 (95% CI, 1.38–16.29, P = 0.013), respectively. Conclusions: TP53 mutations, especially exon 8 mutations, reduce responsiveness to TKIs and worsen prognosis in EGFR-mutated NSCLC patients, mainly those carrying exon 19 deletions. Clin Cancer Res; 23(9); 2195–202. ©2016 AACR.

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Multiple clinical studies have identified TP53 co-alterations as a negative prognostic marker in EGFR-mutant LUAD and a consistent predictor of worse clinical outcomes following EGFR TKI therapy.
“In keeping with a more complex genomic landscape and a larger burden of clonal or sub-clonal co-drivers, multiple clinical studies have identified TP53 co-alterations as a negative prognostic marker in EGFR-mutant LUAD and a consistent predictor of worse clinical outcomes following EGFR TKI therapy72, 73, 111–116.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [112]

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The Polemic Diagnostic Role of TP53 Mutations in Liquid Biopsies from Breast, Colon and Lung Cancers
Garrido-Navas, M. C., García-Díaz, A., Molina-Vallejo, M., González‐Martínez, C., Lucena, M. A., García, I. C., Bayarri, C., Delgado, J. R., González‐Flores, E., Lorente, J. A., et al. (2020) · Cancers · doi:10.3390/cancers12113343 · Cited by 22

Role of TP53 mutations in predicting response to TKI treatment in EGFR-mutated NSCLC patients.
Ulivi, P., Canale, M., Petracci, E., Chiadini, E., Dazzi, C., Capelli, L., Gamboni, A., Casanova, C., Papi, M., Mariotti, M., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2016.34.15_suppl.9052 · Cited by 4
Self-citation
Concomitant TP53 Mutation Confers Worse Prognosis in EGFR-Mutated Non-Small Cell Lung Cancer Patients Treated with TKIs
Canale, M., Petracci, E., Delmonte, A., Bronte, G., Chiadini, E., Ludovini, V., Dubini, A., Papi, M., Baglivo, S., Luigi, N. D., et al. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9041047 · Cited by 76
Self-citation
P3.02b-006 Role of TP53 Mutations in Determining Primary Resistance to First-Line Tyrosine Kinase Inhibitors in EGFR-Mutated NSCLC Patients
Ulivi, P., Canale, M., Delmonte, A., Petracci, E., Chiadini, E., Dazzi, C., Papi, M., Capelli, L., Casanova, C., Luigi, N. D., et al. (2017) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2016.11.1673
Self-citation
TP53 mutations predicts worse prognosis in EGFR-mutated NSCLC patients receiving TKIs in first- or further line of treatment
Canale, M., Luigi, N. D., Petracci, E., Delmonte, A., Ludovini, V., Dubini, A., Baglivo, S., Minenza, E., Chiadini, E., Landi, L. M., et al. (2019) · Annals of Oncology · doi:10.1093/annonc/mdz260.056
Self-citation
Concurrent TP53 mutations predict poor outcomes of EGFR-TKI treatments in Chinese patients with advanced NSCLC
Hou, H., Qin, K., Yu, L., Zhang, C., Liu, D., Jiang, H., Liu, K., Zhu, J., Lv, H., Li, T., et al. (2019) · Cancer Management and Research · doi:10.2147/cmar.s201513 · Cited by 78

Authors: Canale, M., Petracci, E., Delmonte, A., Chiadini, E., Dazzi, C., Papi, M., Capelli, L., Casanova, C., De Luigi, N., Mariotti, M., Gamboni, A., Chiari, R., Bennati, C., Calistri, D., Ludovini, V., Crinò, L., Amadori, D., & Ulivi, P.
Affiliations: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
Ospedale "Santa Maria delle Croci" di Ravenna (IT)
Ospedale Infermi di Rimini (IT)
4Medical Oncology Unit, S.Maria delle Croci Hospital, Ravenna, Italy.
3Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Ospedale per gli Infermi (IT)
Azienda Ospedaliera di Perugia (IT)
Corresponding author: Ulivi, Paola
ORCID: Canale, Matteo
Petracci, Elisabetta
Delmonte, Angelo
Chiadini, Elisa
Dazzi, Claudio
Papi, Maximilian
Capelli, Laura
Mariotti, Marita
Chiari, Rita
Bennati, Chiara
Calistri, Daniele
Ludovini, Vienna
Crinò, Lucio
Ulivi, Paola
Venue: Clinical Cancer Research
Publisher: American Association for Cancer Research (AACR)
Published: 2017-04-30
Volume: 23
Issue: 9
Pages: 2195-2202
ISSN: 1078-0432 (ISSN-L)
1557-3265
DOI: 10.1158/1078-0432.ccr-16-0966
OpenAlex: W2534288116
Semantic Scholar: 1d67fc833ce2ba30f358dc72de4e727fc1633ea0
Cited by: 288
References: 37
Citations by year: 2026: 21 · 2025: 26 · 2024: 26 · 2023: 31 · 2022: 38 · 2021: 45 · 2020: 52 · 2019: 25 · 2018: 20 · 2017: 4
FWCI: 14.64
Type: journal article
Language: en
Open access: closed
Locations: Clinical Cancer Research (publishedVersion)
PubMed (publishedVersion)
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: TP53 mutation, EGFR-mutant non-small cell lung cancer, tyrosine kinase inhibitors, first-line therapy, EGFR exon 19 deletion, disease control rate, progression-free survival, overall survival, treatment response, prognostic factors, predictive biomarkers, EGFR tyrosine kinase inhibitors
MeSH terms: Aged, Carcinoma, Non-Small-Cell Lung, Exons, Female, Humans, Male, Middle Aged, Mutation, Prognosis, Tumor Suppressor Protein p53, Sequence Deletion, Disease-Free Survival, Protein Kinase Inhibitors, ErbB Receptors

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Impact of TP53 Mutations on Outcome in EGFR -Mutated Patients Treated with First-Line Tyrosine Kinase Inhibitors

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