Dacomitinib in non-small-cell lung cancer: a comprehensive review for clinical application

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

• 1. Lynch TJ , Bell DW , Sordella R et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N. Engl. J. Med. 350(21), 2129–2139 (2004).
  Medline CASGoogle Scholar
• 2. Paez JG , Jänne PA , Lee JC et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304(5676), 1497–1500 (2004).
  Medline CASGoogle Scholar
• 3. Rosell R , Carcereny E , Gervais R et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised Phase 3 trial. Lancet Oncol. 13(3), 239–246 (2012).
  Medline CASGoogle Scholar
• 4. Zhou C , Wu Y-L , Chen G et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, Phase 3 study. Lancet Oncol. 12(8), 735–742 (2011).
  Medline CASGoogle Scholar
• 5. Maemondo M , Inoue A , Kobayashi K et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 362(25), 2380–2388 (2010).
  Medline CASGoogle Scholar
• 6. Mok TS , Wu Y-L , Thongprasert S et al. Gefitinib or carboplatin–paclitaxel in pulmonary adenocarcinoma. N. Engl. J. Med. 361(10), 947–957 (2009).
  Medline CASGoogle Scholar
• 7. Gonzales AJ , Hook KE , Althaus IW et al. Antitumor activity and pharmacokinetic properties of PF-00299804, a second-generation irreversible pan-erbB receptor tyrosine kinase inhibitor. Mol. Cancer Ther. 7(7), 1880–1889 (2008).
  Medline CASGoogle Scholar
• 8. Engelman JA , Zejnullahu K , Gale C-M et al. PF00299804, an irreversible pan-ERBB inhibitor, is effective in lung cancer models with EGFR and ERBB2 mutations that are resistant to gefitinib. Cancer Res. 67(24), 11924–11932 (2007).
  Medline CASGoogle Scholar
• 9. Wu YL , Cheng Y , Zhou X et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, Phase 3 trial. Lancet Oncol. 18(11), 1454–1466 (2017). •• An important study demonstrates that dacomitinib is superior to gefitinib respect to progression-free survival and response rate in the first-line therapy of EGFR mutation non-small-cell lung cancer (NSCLC).
  Medline CASGoogle Scholar
• 10. Mok TS , Cheng Y , Zhou X et al. Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations. J. Clin. Oncol. 36(22), 2244–2250 (2018). •• The Following analysis of ARCHER 1050 which demonstrate dacomitinib can bring a longer overal survival than gefitinib as first-line therapy for EGFR mutation NSCLC.
  Medline CASGoogle Scholar
• 11. Wang SE , Narasanna A , Perez-Torres M et al. HER2 kinase domain mutation results in constitutive phosphorylation and activation of HER2 and EGFR and resistance to EGFR tyrosine kinase inhibitors. Cancer Cell. 10(1), 25–38 (2006).
  MedlineGoogle Scholar
• 12. Cappuzzo F , Ligorio C , Jänne PA et al. Prospective study of gefitinib in epidermal growth factor receptor fluorescence in situ hybridization-positive/phospho-Akt-positive or never smoker patients with advanced non-small-cell lung cancer: the ONCOBELL trial. J. Clin. Oncol. 25(16), 2248–2255 (2007).
  Medline CASGoogle Scholar
• 13. Zahonero C , Aguilera P , Ramírez-Castillejo C et al. Preclinical test of dacomitinib, an irreversible EGFR inhibitor, confirms its effectiveness for glioblastoma. Mol. Cancer Ther. 14(7), 1548–1558 (2015).
  Medline CASGoogle Scholar
• 14. Zugazagoitia J , Díaz A , Jimenez E et al. Second-line treatment of non-small cell lung cancer: focus on the clinical development of dacomitinib. Front. Med. 4(8), 947–945 (2017).
  Google Scholar
• 15. Ramalingam SS , Janne PA , Mok T et al. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, Phase 3 trial. Lancet Oncol. 15(12), 1369–1378 (2014).
  Medline CASGoogle Scholar
• 16. Ellis PM , Shepherd FA , Millward M et al. Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, Phase 3 trial. Lancet Oncol. 15(12), 1379–1388 (2014).
  Medline CASGoogle Scholar
• 17. Arcila ME , Chaft JE , Nafa K et al. Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas. Clin. Cancer Res. 18(18), 4910–4918 (2012).
  Medline CASGoogle Scholar
• 18. Takezawa K , Pirazzoli V , Arcila ME et al. HER2 amplification: a potential mechanism of acquired resistance to EGFR inhibition in EGFR-mutant lung cancers that lack the second-site EGFRT790M mutation. Cancer Discov. 2(10), 922–933 (2012).
  Medline CASGoogle Scholar
• 19. Kris MG , Camidge DR , Giaccone G et al. Targeting HER2 aberrations as actionable drivers in lung cancers: Phase II trial of the pan-HER tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors. Ann. Oncol. 26(7), 1421–1427 (2015).
  Medline CASGoogle Scholar
• 20. Jänne PA , Boss DS , Camidge DR et al. Phase I dose-escalation study of the pan-HER inhibitor, PF299804, in patients with advanced malignant solid tumors. Clin. Cancer Res. 17(5), 1131–1139 (2011).
  Medline CASGoogle Scholar
• 21. Janne PA , Ou SH , Kim DW et al. Dacomitinib as first-line treatment in patients with clinically or molecularly selected advanced non-small-cell lung cancer: a multicentre, open-label, Phase 2 trial. Lancet Oncol. 15(13), 1433–1441 (2014). • This single-arm ARCHER 1017 trial first supported that dacomitinib can bring a promising progression-free survival (18.2 months) for untreated NSCLC harboring EGFR-mutant non-small-lung cancer.
  Medline CASGoogle Scholar
• 22. Chen Y , Wang M , Zhong W , Zhao J . Pharmacokinetic and pharmacodynamic study of Gefitinib in a mouse model of non-small-cell lung carcinoma with brain metastasis. Lung Cancer. 82(2), 313–318 (2013).
  MedlineGoogle Scholar
• 23. McGranahan T , Nagpal S . A neuro-oncologist's perspective on management of brain metastases in patients with EGFR mutant non-small cell lung cancer. Curr. Treat. Options in Oncol. 18(4), 22 (2017).
  MedlineGoogle Scholar
• 24. Kelly WJ , Shah NJ , Subramaniam DS . Management of brain metastases in epidermal growth factor receptor mutant non-small-cell lung cancer. Front. Oncol. 8, 59950 (2018).
  Google Scholar
• 25. Piotrowska Z , Gainor JF . ARCHER 1050: hitting an important mark in EGFR-mutant lung cancer? J. Clin. Oncol. 36(22), 2241–2243 (2018).
  Medline CASGoogle Scholar
• 26. Sequist LV , Yang JC , Yamamoto N et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J. Clin. Oncol. 31(27), 3327–3334 (2013).
  Medline CASGoogle Scholar
• 27. Reckamp KL , Giaccone G , Camidge DR et al. A Phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib. Cancer 120(8), 1145–1154 (2014).
  Medline CASGoogle Scholar
• 28. Lacouture ME , Keefe DM , Sonis S et al. A Phase II study (ARCHER 1042) to evaluate prophylactic treatment of dacomitinib-induced dermatologic and gastrointestinal adverse events in advanced non-small-cell lung cancer. Ann. Oncol. 27(9), 1712–1718 (2016).
  Medline CASGoogle Scholar
• 29. Mok T , Nakagawa K , Rosell R et al. Effects of dose modifications on the safety and efficacy of dacomitinib for EGFR mutation-positive NSCLC. J. Thorac. Oncol. 13(10), S454 (2018).
  MedlineGoogle Scholar
• 30. Wong HH , Halford S . Dose-limiting toxicity and maximum tolerated dose: still fit for purpose? Lancet Oncol. 16(13), 1287–1288 (2015).
  MedlineGoogle Scholar
• 31. Jain RK , Lee JJ , Hong D et al. Phase I oncology studies: evidence that in the era of targeted therapies patients on lower doses do not fare worse. Clinical Cancer Research. 16(4), 1289–1297 (2010).
  Medline CASGoogle Scholar
• 32. Goulart BHL , Clark JW , Pien HH , Roberts TG , Finkelstein SN , Chabner BA . Trends in the use and role of biomarkers in Phase I oncology trials. Clinical Cancer Research. 13(22 Pt 1), 6719–6726 (2007).
  Medline CASGoogle Scholar
• 33. Van Cutsem E , Tejpar S , Vanbeckevoort D et al. Intrapatient cetuximab dose escalation in metastatic colorectal cancer according to the grade of early skin reactions: the randomized EVEREST study. J. Clin. Oncol. 30(23), 2861–2868 (2012).
  Medline CASGoogle Scholar
• 34. Soria JC , Ohe Y , Vansteenkiste J et al. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N. Engl. J. Med. 378(2), 113–125 (2018). •• An important clinical trial which indicated that osimertinib is superior to first-generation TKI (gefitinib) regarding to PFS.
  Medline CASGoogle Scholar
• 35. Park K , Tan E-H , O'Byrne K et al. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a Phase 2B, open-label, randomised controlled trial. Lancet Oncol. 17(5), 577–589 (2016). • A study compared the efficacy of afatinib and gefitinib as first-line treatment for advanced NSCLC
  Medline CASGoogle Scholar