The dawn of a new era, adjuvant EGFR inhibition in resected non-small cell lung cancer

1. Sung, H, Ferlay, J, Siegel, RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2021; 71: 209–249.
Google Scholar | Crossref | Medline2. Herbst, RS, Heymach, JV, Lippman, SM. Lung cancer. N Engl J Med 2008; 359: 1367–1380.
Google Scholar | Crossref | Medline | ISI3. Datta, D, Lahiri, B. Preoperative evaluation of patients undergoing lung resection surgery. Chest 2003; 123: 2096–2103.
Google Scholar | Crossref | Medline4. Cagle, PT, Allen, TC, Olsen, RJ. Lung cancer biomarkers: present status and future developments. Arch Pathol Lab Med 2013; 137: 1191–1198.
Google Scholar | Crossref | Medline5. Le Chevalier, T . Adjuvant chemotherapy for resectable non-small-cell lung cancer: where is it going? Ann Oncol 2010; 21: vii196–vii198.
Google Scholar | Crossref6. Pignon, J-P, Tribodet, H, Scagliotti, GV, et al. Lung adjuvant Cisplatin evaluation: a pooled analysis by the LACE collaborative group. J Clin Oncol 2008; 26: 3552–3559.
Google Scholar | Crossref | Medline | ISI7. Kris, MG, Gaspar, LE, Chaft, JE, et al. Adjuvant systemic therapy and adjuvant radiation therapy for stage I to IIIA completely resected non-small-cell lung cancers: American Society of Clinical Oncology/Cancer Care Ontario clinical practice guideline update. J Clin Oncol 2017; 35: 2960–2974.
Google Scholar | Crossref | Medline8. Nicholson, AG, Tsao, MS, Travis, WD, et al. Staging of thoracic malignancies: implications for the reporting pathologist. Arch Pathol Lab Med 2018; 142: 645–661.
Google Scholar | Crossref | Medline9. National Comprehensive Cancer Network . NCCN clinical practice guidelines in oncology: non-small cell lung cancer (version 3.2020). National Comprehensive Cancer Network, 2020, https://www2.tri-kobe.org/nccn/guideline/lung/english/non_small.Pdf (accessed 21 October 2021).
Google Scholar10. Amin, MB, Edge, SB. AJCC cancer staging manual. Cham: Springer, 2017.
Google Scholar | Crossref11. Butts, CA, Ding, K, Seymour, L, et al. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non–small-cell lung cancer: updated survival analysis of JBR-10. J Clin Oncol 2010; 28: 29–34.
Google Scholar | Crossref | Medline12. Goldstraw, P, Chansky, K, Crowley, J, et al. The IASLC lung cancer staging project: proposals for revision of the TNM stage groupings in the forthcoming (eighth) edition of the TNM classification for lung cancer. J Thorac Oncol 2016; 11: 39–51.
Google Scholar | Crossref | Medline | ISI13. Chan, BA, Hughes, BG. Targeted therapy for non-small cell lung cancer: current standards and the promise of the future. Transl Lung Cancer Res 2015; 4: 36–54.
Google Scholar | Medline | ISI14. Gazdar, A . Activating and resistance mutations of EGFR in non-small-cell lung cancer: role in clinical response to EGFR tyrosine kinase inhibitors. Oncogene 2009; 28: S24–S31.
Google Scholar | Crossref | Medline | ISI15. Sharma, SV, Bell, DW, Settleman, J, et al. Epidermal growth factor receptor mutations in lung cancer. Nature Rev Cancer 2007; 7: 169–181.
Google Scholar | Crossref | Medline | ISI16. Chintala, L, Kurzrock, R. Epidermal growth factor receptor mutation and diverse tumors: case report and concise literature review. Mol Oncol 2010; 4: 306–308.
Google Scholar | Crossref | Medline17. Cohen, MH, Williams, GA, Sridhara, R, et al. FDA drug approval summary: gefitinib (ZD1839) (Iressa) tablets. Oncologist 2003; 8: 303–306.
Google Scholar | Crossref | Medline | ISI18. Hanna, NH, Robinson, AG, Temin, S, et al. Therapy for stage IV non-small-cell lung cancer with driver alterations: ASCO and OH (CCO) joint guideline update. J Clin Oncol 2021; 39: 1040–1091.
Google Scholar | Crossref | Medline19. Gelatti, AC, Drilon, A, Santini, FC. Optimizing the sequencing of tyrosine kinase inhibitors (TKIs) in epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Lung Cancer 2019; 137: 113–122.
Google Scholar | Crossref | Medline20. Zhang, H . Three generations of epidermal growth factor receptor tyrosine kinase inhibitors developed to revolutionize the therapy of lung cancer. Drug Des Devel Ther 2016; 10: 3867–3872.
Google Scholar | Crossref | Medline21. Malapelle, U, Ricciuti, B, Baglivo, S, et al. Osimertinib. Recent Results Cancer Res 2018; 211: 257–276.
Google Scholar | Crossref | Medline22. Mok, TS, Wu, Y-L, Ahn, M-J, et al. Osimertinib or platinum–pemetrexed in EGFR T790M–positive lung cancer. N Engl J Med 2017; 376: 629–640.
Google Scholar | Crossref | Medline | ISI23. Papadimitrakopoulou, V, Mok, T, Han, J-Y, et al. Osimertinib versus platinum–pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis. Ann Oncol 2020; 31: 1536–1544.
Google Scholar | Crossref | Medline24. OncLive.com. FDA approves osimertinib for EGFR T790M-positive NSCLC, https://www.onclive.com/view/fda-approves-osimertinib-for-egfr-t790m-positive-nsclc (accessed 16 March 2021).
Google Scholar25. AstraZeneca.com. US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer, https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-approves-tagrisso-as-1st-line-treatment-for-EGFR-mutated-non-small-cell-lung-cancer.html#! (accessed 16 March 2021).
Google Scholar26. FDA.gov . TAGRISSO® (osimertinib), https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf (accessed 11 March 2021).
Google Scholar27. Goss, GD, O’Callaghan, C, Lorimer, I, et al. Gefitinib versus placebo in completely resected non–small-cell lung cancer: results of the NCIC CTG BR19 study. J Clin Oncol 2013; 31: 3320–3326.
Google Scholar | Crossref | Medline | ISI28. Kelly, K, Altorki, NK, Eberhardt, WE, et al. Adjuvant erlotinib versus placebo in patients with stage IB-IIIA non-small-cell lung cancer (RADIANT): a randomized, double-blind, phase III trial. J Clin Oncol 2015; 33: 4007–4014.
Google Scholar | Crossref | Medline | ISI29. Zhong, W-Z, Wang, Q, Mao, W-M, et al. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC: final overall survival analysis of CTONG1104 phase III trial. J Clin Oncol 2021; 39: 713–722.
Google Scholar | Crossref | Medline30. Wu, Y-L, Tsuboi, M, He, J, et al. Osimertinib in resected EGFR-mutated non–small-cell lung cancer. N Engl J Med 2020; 383: 1711–1723.
Google Scholar | Crossref | Medline31. Tada, H, Mitsudomi, T, Yamanaka, T, et al. Adjuvant gefitinib versus cisplatin/vinorelbine in Japanese patients with completely resected, EGFR-mutated, stage II-III non-small cell lung cancer (IMPACT, WJOG6410L): a randomized phase 3 trial. Philadelphia, PA: Wolters Kluwer Health, 2021.
Google Scholar | Crossref32. Tsuboi, M, Kato, H, Nagai, K, et al. Gefitinib in the adjuvant setting: safety results from a phase III study in patients with completely resected non-small cell lung cancer. Anticancer Drugs 2005; 16: 1123–1128.
Google Scholar | Crossref | Medline33. Zhong, W-Z, Wang, Q, Mao, W-M, et al. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol 2018; 19: 139–148.
Google Scholar | Crossref | Medline34. Thatcher, N, Chang, A, Parikh, P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366: 1527–1537.
Google Scholar | Crossref | Medline | ISI35. Kelly, K, Chansky, K, Gaspar, LE, et al. Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non–small-cell lung cancer: SWOG S0023. J Clin Oncol 2008; 26: 2450–2456.
Google Scholar | Crossref | Medline | ISI36. Majem, M, Goldman, J, John, T, et al. OA06.03 patient-reported outcomes from ADAURA: osimertinib as adjuvant therapy in patients with resected EGFR mutated (EGFRm) NSCLC. J Thorac Oncol 2021; 16: S112–S113.
Google Scholar | Crossref37. Postmus, P, Kerr, K, Oudkerk, M, et al. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2017; 28: iv1–iv21.
Google Scholar | Crossref | Medline38. Ballard, P, Yates, JW, Yang, Z, et al. Preclinical comparison of osimertinib with other EGFR-TKIs in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. Clin Cancer Res 2016; 22: 5130–5140.
Google Scholar | Crossref | Medline | ISI39. Colclough, N, Ballard, P, Barton, P, et al. Preclinical comparison of the blood brain barrier (BBB) permeability of osimertinib (AZD9291) with other irreversible next generation EGFR TKIs. Eur J Cancer 2016; 69: S28.
Google Scholar | Crossref | Medline40. Vishwanathan, K, Varrone, A, Varnas, K, et al. Abstract CT013: osimertinib displays high brain exposure in healthy subjects with intact blood-brain barrier: a microdose positron emission tomography (PET) study with 11C-labelled osimertinib. Philadelphia, PA: AACR, 2018.
Google Scholar | Crossref41. Lyu, C, Wang, R, Li, S, et al. Different exposure duration of adjuvant icotinib in stage II-IIIA non-small cell lung cancer patients with positive EGFR mutation (ICOMPARE study): a randomized, open-label phase 2 study. Philadelphia, PA: Wolters Kluwer Health, 2021.
Google Scholar42. Wu, Y-L, Zhong, W, Wang, Q, et al. CTONG1104: adjuvant gefitinib versus chemotherapy for resected N1-N2 NSCLC with EGFR mutation—final overall survival analysis of the randomized phase III trial 1 analysis of the randomized phase III trial. Alexandria, VA: American Society of Clinical Oncology, 2020.
Google Scholar43. Wakelee, HA, Altorki, NK, Zhou, C, et al. IMpower010: primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC). Philadelphia, PA: Wolters Kluwer Health, 2021.
Google Scholar44. Zeng, J, Mao, W-M, Chen, Q-X, et al. Quality of life with adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant non-small-cell lung cancer: results from the ADJUVANT (CTONG1104) study. Lung Cancer 2020; 150: 164–171.
Google Scholar | Crossref | Medline45. Yue, D, Xu, S-D, Wang, Q, et al. Updated overall survival (OS) and exploratory analysis from the randomized, phase II EVAN study of erlotinib (E) versus vinorelbine plus cisplatin (NP) as adjuvant therapy in Chinese patients with stage IIIA EGFR+ NSCLC. Philadelphia, PA: Wolters Kluwer Health, 2021.
Google Scholar | Crossref46. Wu, Y-L, Herbst, RS, Mann, H, et al. ADAURA: phase III, double-blind, randomized study of osimertinib versus placebo in EGFR mutation-positive early-stage NSCLC after complete surgical resection. Clin Lung Cancer 2018; 19: e533–e536.
Google Scholar | Crossref | Medline47. Pennell, NA, Neal, JW, Chaft, JE, et al. SELECT: a phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor–mutant non–small-cell lung cancer. J Clin Oncol 2019; 37: 97–104.
Google Scholar | Crossref | Medline48. Chang, W-Y, Wu, Y-L, Su, P-L, et al. The impact of EGFR mutations on the incidence and survival of stages I to III NSCLC patients with subsequent brain metastasis. PLoS ONE 2018; 13: e0192161.
Google Scholar | Crossref | Medline49. Ahluwalia, MS, Becker, K, Levy, BP. Epidermal growth factor receptor tyrosine kinase inhibitors for central nervous system metastases from non-small cell lung cancer. Oncologist 2018; 23: 1199–1209.

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