Afatinib and Erlotinib in the treatment of squamous-cell lung cancer

References

• Stewart BW , Wild CP. World cancer report 2014. Lyon: International Agency for Research on Cancer/World Health Organization; 2014.
   Google Scholar
• Cancer Statistics Review, 1975–2014 - SEER statistics [Internet]. 2018 [cited 2018 Apr 1 ]. Available from: https://seer.cancer.gov/csr/1975_2014/.
   Google Scholar
• Hirsh V. New developments in the treatment of advanced squamous cell lung cancer: focus on afatinib. OncoTargets Ther. 2017;10:2513–2526.
   PubMed Web of Science ®Google Scholar
• Hammerman PS , Lawrence MS , Voet D , et al. Comprehensive genomic characterization of squamous cell lung cancers. Nature. 2012;489:519–525.
   PubMed Web of Science ®Google Scholar
• Rekhtman N , Paik PK , Arcila ME , et al. Clarifying the spectrum of driver oncogene mutations in biomarker-verified squamous carcinoma of lung: lack of EGFR/KRAS and presence of PIK3CA/AKT1 mutations. Clin Cancer Res. 2012;18:1167–1176.
   PubMed Web of Science ®Google Scholar
• Joshi A , Zanwar S , Noronha V , et al. EGFR mutation in squamous cell carcinoma of the lung: does it carry the same connotation as in adenocarcinomas? OncoTargets Ther. 2017;10:1859–1863.
   PubMed Web of Science ®Google Scholar
• Hata A , Katakami N , Yoshioka H , et al. How sensitive are epidermal growth factor receptor–tyrosine kinase inhibitors for squamous cell carcinoma of the lung harboring EGFR gene–sensitive mutations? J Thorac Oncol. 2013;8:89–95.
   PubMed Web of Science ®Google Scholar
• Hirsch FR , Varella-Garcia M , Bunn PA , et al. Epidermal growth factor receptor in non–small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clin Oncol. 2003;21:3798–3807.
   PubMed Web of Science ®Google Scholar
• The Clinical Lung Cancer Genome Project (CLCGP) and Network Genomic Medicine (NGM) . A genomics-based classification of human lung tumors. Sci Transl Med. 2013;5:209ra153–209ra153.
   PubMed Web of Science ®Google Scholar
• Meert A-P , Martin B , Delmotte P , et al. The role of EGF-R expression on patient survival in lung cancer: a systematic review with meta-analysis. Eur Respir J. 2002;20:975–981.
   PubMed Web of Science ®Google Scholar
• Pirker R , Pereira JR , Szczesna A , et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. The Lancet. 2009;373:1525–1531.
   PubMed Web of Science ®Google Scholar
• Lynch TJ , Patel T , Dreisbach L , et al. Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non-small-cell lung cancer: results of the randomized multicenter phase III trial BMS099. J Clin Oncol Off J Am Soc Clin Oncol. 2010;28:911–917.
   PubMed Web of Science ®Google Scholar
• Pirker R , Filipits M. Cetuximab in non-small-cell lung cancer. Transl Lung Cancer Res. 2012;1:54–60.
   PubMedGoogle Scholar
• Pujol J-L , Pirker R , Lynch TJ , et al. Meta-analysis of individual patient data from randomized trials of chemotherapy plus cetuximab as first-line treatment for advanced non-small cell lung cancer. Lung Cancer Amst Neth. 2014;83:211–218.
   PubMed Web of Science ®Google Scholar
• Thatcher N , Hirsch FR , Luft AV , et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015;16:763–774.
   PubMed Web of Science ®Google Scholar
• Zugazagoitia J , Ponce S , Paz-Ares L . Necitumumab for first-line treatment of advanced, squamous, non-small-cell lung cancer: a relevant step forward?. Transl Lung Cancer Res. 2016;5:95–97.
   PubMed Web of Science ®Google Scholar
• Reck M , Socinski MA , Luft A , et al. The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life: results from the phase 3 SQUIRE Trial. J Thorac Oncol. 2016;11:808–818.
   PubMed Web of Science ®Google Scholar
• Ettinger DS , Wood DE , Aisner DL , et al. Non–small cell lung cancer, version 5.2017, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2017;15:504–535.
   PubMed Web of Science ®Google Scholar
• Genova C , Socinski MA , Hozak RR , et al. EGFR Gene copy number by FISH may predict outcome of necitumumab in squamous lung carcinomas: analysis from the SQUIRE study. J Thorac Oncol. 2018;13:228–236.
   PubMed Web of Science ®Google Scholar
• Lee NY , Hazlett TL , Koland JG . Structure and dynamics of the epidermal growth factor receptor C-terminal phosphorylation domain. Protein Sci Publ Protein Soc. 2006;15:1142–1152.
   PubMed Web of Science ®Google Scholar
• Ferguson KM . A structure-based view of epidermal growth factor receptor regulation. Annu Rev Biophys. 2008;37:353–373.
   PubMed Web of Science ®Google Scholar
• Sanborn RE , Davies AM . Erlotinib: applications in therapy and current status of research. Expert Rev Clin Pharmacol. 2009;2:15–36.
   PubMedGoogle Scholar
• Pinkas-Kramarski R , Soussan L , Waterman H , et al. Diversification of Neu differentiation factor and epidermal growth factor signaling by combinatorial receptor interactions. Embo J. 1996;15:2452–2467.
   PubMed Web of Science ®Google Scholar
• Hidalgo M , Bloedow D . Pharmacokinetics and pharmacodynamics: maximizing the clinical potential of Erlotinib (Tarceva). Semin Oncol. 2003;30:25–33.
   PubMed Web of Science ®Google Scholar
• Genova C , Rijavec E , Barletta G , et al. Afatinib for the treatment of advanced non-small-cell lung cancer. Expert Opin Pharmacother. 2014;15:889–903.
   PubMed Web of Science ®Google Scholar
• Vavalà T . Role of afatinib in the treatment of advanced lung squamous cell carcinoma. Clin Pharmacol Adv Appl. 2017;9:147–157.
   PubMed Web of Science ®Google Scholar
• Wind S , Schnell D , Ebner T , et al. Clinical pharmacokinetics and pharmacodynamics of afatinib. Clin Pharmacokinet. 2017;56:235–250.
   PubMed Web of Science ®Google Scholar
• Li D , Ambrogio L , Shimamura T , et al. BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models. Oncogene. 2008;27:4702–4711.
   PubMed Web of Science ®Google Scholar
• Tseng J-S , Yang T-Y , Chen K-C , et al. Retrospective study of erlotinib in patients with advanced squamous lung cancer. Lung Cancer. 2012;77:128–133.
   PubMed Web of Science ®Google Scholar
• Monnet I , Audigier-Valette C , Girard N , et al. Real-life effectiveness of erlotinib as second-line treatment of stage IIIB/IV squamous non-small cell lung cancer: results of the PEPiTA observational study. Lung Cancer. 2016;98:84–90.
   PubMed Web of Science ®Google Scholar
• Pérez-Soler R , Chachoua A , Hammond LA , et al. Determinants of tumor response and survival with erlotinib in patients with non—small-cell lung cancer. J Clin Oncol. 2004;22:3238–3247.
   PubMed Web of Science ®Google Scholar
• Shepherd FA , Rodrigues Pereira J , Ciuleanu T , et al. Erlotinib in previously treated non–small-cell lung cancer. N Engl J Med. 2005;353:123–132.
   PubMed Web of Science ®Google Scholar
• Clark GM , Zborowski DM , Culbertson JL , et al. Clinical utility of epidermal growth factor receptor expression for selecting patients with advanced non-small cell lung cancer for treatment with erlotinib. J Thorac Oncol. 2006;1:837–846.
   PubMed Web of Science ®Google Scholar
• Clark GM , Zborowski DM , Santabárbara P , et al. Smoking history and epidermal growth factor receptor expression as predictors of survival benefit from erlotinib for patients with non–small-cell lung cancer in the National Cancer Institute of Canada Clinical Trials Group study BR. 21. Clin Lung Cancer. 2006;7:389–394.
   PubMed Web of Science ®Google Scholar
• Cappuzzo F , Ciuleanu T , Stelmakh L , et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010;11:521–529.
   PubMed Web of Science ®Google Scholar
• Leon L , Lee G Comparative efficacy and safety of erlotinib in non-small cell lung cancer of squamous cell and adenocarcinoma histology in the phase 3 NCIC CTG BR21 and SATURN (Bo18192) trials. 37th ESMO Conference, Vienna. 2012.
   Google Scholar
• Reck M , van Zandwijk N , Gridelli C , et al. Erlotinib in advanced non-small cell lung cancer: efficacy and safety findings of the global phase IV tarceva lung cancer survival treatment study. J Thorac Oncol Off Publ Int Assoc Study Lung Cancer. 2010;5:1616–1622.
   Google Scholar
• Ciuleanu T , Stelmakh L , Cicenas S , et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012;13:300–308.
   PubMed Web of Science ®Google Scholar
• Garassino MC , Martelli O , Broggini M , et al. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial. Lancet Oncol. 2013;14:981–988.
   PubMed Web of Science ®Google Scholar
• Kawaguchi T , Ando M , Asami K , et al. Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non–small-cell lung cancer: docetaxel and erlotinib lung cancer trial (DELTA). J Clin Oncol. 2014;32:1902–1908.
   PubMed Web of Science ®Google Scholar
• Schuler M , Yang JC-H , Park K , et al. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial. Ann Oncol. 2016;27:417–423.
   PubMed Web of Science ®Google Scholar
• Park K , Kim J , Schuler M , et al. 1263pafatinib (a) followed by a + paclitaxel (p) or investigator’s choice of single-agent chemotherapy (ic) in patients (pts) with advanced squamous cell carcinoma (scc) of the lung: subgroup analysis of Lux-lung 5 (ll5). Ann Oncol. 2014;25:iv443–iv444.
   Google Scholar
• He B , Xu Y , Ding V , et al. Spotlight on afatinib and its potential in the treatment of squamous cell lung cancer: the evidence so far. Ther Clin Risk Manag. 2016;807.
   PubMed Web of Science ®Google Scholar
• Soria J-C , Felip E , Cobo M , et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16:897–907.
   PubMed Web of Science ®Google Scholar
• Felip E , Hirsh V , Popat S , et al. Symptom and quality of life improvement in LUX-Lung 8, an open-label phase III study of second-line afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung after first-line platinum-based chemotherapy. Clin Lung Cancer. 2018;19:74–83.e11.
   PubMed Web of Science ®Google Scholar
• Yang J-H , Goss G , Felip E , et al. 102PLUX-Lung 8 phase III trial: analysis of long-term response to second-line afatinib in patients with advanced squamous cell carcinoma (SCC) of the lung. Ann Oncol. 2017;28:mdx091.022-mdx091.022.
   Google Scholar
• Gadgeel S , Goss G , Soria J-C , et al. Evaluation of the VeriStrat ® serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study. Lung Cancer. 2017;109:101–108.
   PubMed Web of Science ®Google Scholar
• Cappuzzo F , Finocchiaro G , Grossi F , et al. Phase II study of afatinib, an irreversible ErbB family blocker, in EGFR FISH-positive non–small-cell lung cancer. J Thorac Oncol. 2015;10:665–672.
   PubMed Web of Science ®Google Scholar
• Grève JD , Moran T , Graas M-P , et al. Phase II study of afatinib, an irreversible ErbB family blocker, in demographically and genotypically defined lung adenocarcinoma. Lung Cancer. 2015;88:63–69.
   PubMed Web of Science ®Google Scholar
• Baselga J , Albanell J , Ruiz A , et al. Phase II and tumor pharmacodynamic study of gefitinib in patients with advanced breast cancer. J Clin Oncol. 2005;23:5323–5333.
   PubMed Web of Science ®Google Scholar
• Polychronis A , Sinnett HD , Hadjiminas D , et al. Preoperative gefitinib versus gefitinib and anastrozole in postmenopausal patients with oestrogen-receptor positive and epidermal-growth-factor-receptor-positive primary breast cancer: a double-blind placebo-controlled phase II randomised trial. Lancet Oncol. 2005;6:383–391.
   PubMed Web of Science ®Google Scholar
• Hirsch FR , Herbst RS , Gandara DR . EGFR tyrosine kinase inhibitors in squamous cell lung cancer. Lancet Oncol. 2015;16:872–873.
   PubMed Web of Science ®Google Scholar
• Reck M , Rodríguez-Abreu D , Robinson AG , et al. Pembrolizumab versus Chemotherapy for PD-L1–positive non–small-cell lung cancer. N Engl J Med. 2016;375:1823–1833.
   PubMed Web of Science ®Google Scholar
• Herbst RS , Baas P , Kim D-W , et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet. 2016;387:1540–1550.
   PubMed Web of Science ®Google Scholar
• Brahmer J , Reckamp KL , Baas P , et al. Nivolumab versus docetaxel in advanced squamous-cell non–small-cell lung cancer. N Engl J Med. 2015;373:123–135.
   PubMed Web of Science ®Google Scholar
• Rittmeyer A , Barlesi F , Waterkamp D , et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. The Lancet. 2017;389:255–265.
   PubMed Web of Science ®Google Scholar
• Soo RA , Lim SM , Syn NL , et al. Immune checkpoint inhibitors in epidermal growth factor receptor mutant non-small cell lung cancer: current controversies and future directions. Lung Cancer. 2018;115:12–20.
   PubMed Web of Science ®Google Scholar
• Tan H-Y , Wang N , Lam W , et al. Targeting tumour microenvironment by tyrosine kinase inhibitor. Mol Cancer. Internet]. 2018 [cited 2018 Oct 6 ];17. Available from. ;. https://molecular-cancer.biomedcentral.com/articles/10.1186/s12943-018-0800-6.
   Web of Science ®Google Scholar
• Goss GD , Spaans JN . Epidermal growth factor receptor inhibition in the management of squamous cell carcinoma of the lung. Oncologist. 2016;21:205–213.
   PubMed Web of Science ®Google Scholar
• Lee J-K , Hahn S , Kim D-W , et al. Epidermal growth factor receptor tyrosine kinase inhibitors vs conventional chemotherapy in non–small cell lung cancer harboring wild-type epidermal growth factor receptor: a meta-analysis. JAMA. 2014;311:1430–1437.
   PubMed Web of Science ®Google Scholar
• Ellis LM , Bernstein DS , Voest EE , et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol Off J Am Soc Clin Oncol. 2014;32:1277–1280.
   PubMed Web of Science ®Google Scholar
• Sacher AG , Le LW , Leighl NB . Shifting patterns in the interpretation of phase III clinical trial outcomes in advanced non-small-cell lung cancer: the bar is dropping. J Clin Oncol Off J Am Soc Clin Oncol. 2014;32:1407–1411.
   PubMed Web of Science ®Google Scholar
• Herbst RS , Gandara DR , Hirsch FR , et al. Lung master protocol (lung-map)-a biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400. Clin Cancer Res Off J Am Assoc Cancer Res. 2015;21:1514–1524.
   PubMed Web of Science ®Google Scholar
• Gandara DR , Hammerman PS , Sos ML , et al. Squamous cell lung cancer: from tumor genomics to cancer therapeutics. Clin Cancer Res Off J Am Assoc Cancer Res. 2015;21:2236–2243.
   PubMed Web of Science ®Google Scholar