472
Views
14
CrossRef citations to date
0
Altmetric
Drug Evaluation

Afatinib in squamous cell carcinoma of the head and neck

&
Pages 1295-1301 | Received 03 Mar 2016, Accepted 25 Apr 2016, Published online: 19 May 2016

References

  • Normanno N, De LA, Bianco C, et al. Epidermal growth factor receptor (EGFR) signaling in cancer. Gene. 2006 Jan 17;366(1):2–16.
  • Agulnik M. New approaches to EGFR inhibition for locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN). Med Oncol. 2012 Dec;29(4):2481–2491.
  • Pectasides E, Rampias T, Kountourakis P, et al. Comparative prognostic value of epidermal growth factor quantitative protein expression compared with FISH for head and neck squamous cell carcinoma. Clin Cancer Res. 2011 May 1;17(9):2947–2954.
  • Specenier P, Vermorken JB. Cetuximab: its unique place in head and neck cancer treatment. Biologics. 2013;7:77–90.
  • Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567–578.
  • Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21–28.
  • Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116–1127.
  • Genova C, Rijavec E, Barletta G, et al. Afatinib for the treatment of advanced non-small-cell lung cancer. Expert Opin Pharmacother. 2014 Apr;15(6):889–903.
  • Li D, Ambrogio L, Shimamura T, et al. BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models. Oncogene. 2008 Aug 7;27(34):4702–4711.
  • Riely GJ, Pao W, Pham D, et al. Clinical course of patients with non-small cell lung cancer and epidermal growth factor receptor exon 19 and exon 21 mutations treated with gefitinib or erlotinib. Clin Cancer Res. 2006 Feb 1;12(3 Pt 1):839–844.
  • Giaccone G, Wang Y. Strategies for overcoming resistance to EGFR family tyrosine kinase inhibitors. Cancer Treat Rev. 2011 Oct;37(6):456–464.
  • Sharma SV, Bell DW, Settleman J, et al. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007 Mar;7(3):169–181.
  • Suda K, Onozato R, Yatabe Y, et al. EGFR T790M mutation: a double role in lung cancer cell survival? J Thorac Oncol. 2009 Jan;4(1):1–4.
  • Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther. 2012 Nov;343(2):342–350.
  • 2016 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002280/WC500152392.pdf. Ref Type: Online Source.
  • Young NR, Soneru C, Liu J, et al. Afatinib efficacy against squamous cell carcinoma of the head and neck cell lines in vitro and in vivo. Target Oncol. 2015 Dec;10(4):501–508.
  • Schutze C, Dorfler A, Eicheler W, et al. Combination of EGFR/HER2 tyrosine kinase inhibition by BIBW 2992 and BIBW 2669 with irradiation in FaDu human squamous cell carcinoma. Strahlenther Onkol. 2007 May;183(5):256–264.
  • Stopfer P, Marzin K, Narjes H, et al. Afatinib pharmacokinetics and metabolism after oral administration to healthy male volunteers. Cancer Chemother Pharmacol. 2012 Apr;69(4):1051–1061.
  • Yap TA, Vidal L, Adam J, et al. Phase I trial of the irreversible EGFR and HER2 kinase inhibitor BIBW 2992 in patients with advanced solid tumors. J Clin Oncol. 2010 Sep 1;28(25):3965–3972.
  • Freiwald M, Schmid U, Fleury A, et al. Population pharmacokinetics of afatinib, an irreversible ErbB family blocker, in patients with various solid tumors. Cancer Chemother Pharmacol. 2014 Apr;73(4):759–770.
  • Cohen EE, Fayette J, Cupissol D, et al. A randomized, open-label, phase II study of afatinib (BIBW 2992) versus cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck: final data. Eur Arch Otorhinolaryngol. 2012;269(4):1374.
  • Marshall J, Hwang J, Eskens FA, et al. A Phase I, open-label, dose escalation study of afatinib, in a 3-week-on/1-week-off schedule in patients with advanced solid tumors. Invest New Drugs. 2013 Apr;31(2):399–408.
  • Gordon MS, Mendelson DS, Gross M, et al. A Phase I, open-label, dose-escalation study of continuous once-daily oral treatment with afatinib in patients with advanced solid tumors. Invest New Drugs. 2013 Apr;31(2):409–416.
  • Eskens FA, Mom CH, Planting AS, et al. A phase I dose escalation study of BIBW 2992, an irreversible dual inhibitor of epidermal growth factor receptor 1 (EGFR) and 2 (HER2) tyrosine kinase in a 2-week on, 2-week off schedule in patients with advanced solid tumours. Br J Cancer. 2008 Jan 15;98(1):80–85.
  • Molife LR, Rudman SM, Alam S, et al. Phase II, open-label trial to assess QTcF effects, pharmacokinetics and antitumor activity of afatinib in patients with relapsed or refractory solid tumors. Cancer Chemother Pharmacol. 2013 Dec;72(6):1213–1222.
  • Shibata Y, Chiba M. The role of extrahepatic metabolism in the pharmacokinetics of the targeted covalent inhibitors afatinib, ibrutinib, and neratinib. Drug Metab Dispos. 2015 Mar;43(3):375–384.
  • Schnell D, Buschke S, Fuchs H, et al. Pharmacokinetics of afatinib in subjects with mild or moderate hepatic impairment. Cancer Chemother Pharmacol. 2014 Aug;74(2):267–275.
  • Vermorken JB, Rottey S, Ehrnrooth E, et al. A phase Ib, open-label study to assess the safety of continuous oral treatment with afatinib in combination with two chemotherapy regimens: cisplatin plus paclitaxel and cisplatin plus 5-fluorouracil, in patients with advanced solid tumors. Ann Oncol. 2013 May;24(5):1392–1400.
  • Chung CH, Rudek MA, Kang H, et al. A phase I study afatinib/carboplatin/paclitaxel induction chemotherapy followed by standard chemoradiation in HPV-negative or high-risk HPV-positive locally advanced stage III/IVa/IVb head and neck squamous cell carcinoma. Oral Oncol. 2016;53:54–59.
  • Awada AH, Dumez H, Hendlisz A, et al. Phase I study of pulsatile 3-day administration of afatinib (BIBW 2992) in combination with docetaxel in advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):734–741.
  • Marshall J, Shapiro GI, Uttenreuther-Fischer M, et al. Phase I dose-escalation study of afatinib, an ErbB family blocker, plus docetaxel in patients with advanced cancer. Future Oncol. 2013 Feb;9(2):271–281.
  • Yang JC-H, Ahn MJ, Dickgreber NJ, et al. Influence of dose adjustment on afatinib safety and efficacy in patients (pts) with advanced EGFR mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC). J Clin Oncol. 2015;33(suppl): abstr 8053.
  • Seiwert TY, Fayette J, Cupissol D, et al. A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Sep;25(9):1813–1820.
  • Machiels JP, Licitra LF, Haddad RI, et al. Rationale and design of LUX-Head & Neck 1: a randomised, Phase III trial of afatinib versus methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who progressed after platinum-based therapy. BMC Cancer. 2014;14:473.
  • Machiels JP, Haddad RI, Fayette J, et al. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):583–594.
  • Cohen EE, Licitra LF, Fayette J, et al. Biomarker analysis in recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients (pts) treated with second-line afatinib versus methotrexate (MTX): LUX-Head & Neck 1 (LUX-H&N1). J Clin Oncol. 2015;33(suppl): abstract 6023.
  • Quesnelle KM, Grandis JR. Dual kinase inhibition of EGFR and HER2 overcomes resistance to cetuximab in a novel in vivo model of acquired cetuximab resistance. Clin Cancer Res. 2011 Sep 15;17(18):5935–5944.
  • Janjigian YY, Smit EF, Groen HJ, et al. Dual inhibition of EGFR with afatinib and cetuximab in kinase inhibitor-resistant EGFR-mutant lung cancer with and without T790M mutations. Cancer Discov. 2014 Sep;4(9):1036–1045.
  • Gazzah A, Boni V, Soria JC, et al. Phase Ib study of afatinib plus standard-dose cetuximab in patients (pts) with advanced solid tumors. J Clin Oncol. 2015;33(suppl):abstr 2536.
  • Burtness B, Bourhis JP, Vermorken JB, et al. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014;15:469.
  • 2016 Available from: https://clinicaltrials.gov/ct2/results?term=afatinib+head+and+neck+cancer&Search=Search. Ref Type: Online Source
  • FDA approves afatinib for advanced lung cancer. Oncology (Williston Park). 2013 August;27(8):813–814.
  • 2016 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/192013/201292s000lbl.pdf. Ref Type: Online Source.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.