Experience with afatinib in patients with non-small cell lung cancer progressing after clinical benefit from gefitinib and erlotinib

Oncologist

Volumn 19, Issue 10, 2014, Pages 1100-1109

  Schuler, Martin ^a,b,c   Fischer, Jürgen R ^d   Grohé, Christian ^e   Gütz, Sylvia ^e   Thomas, Michael ^f   Kimmich, Martin ^g   Schneider, Claus Peter ^e   Laack, Eckart ^h   Märten, Angela ⁱ  

^a UNIVERSITY HOSPITAL ESSEN   (Germany)

^b UNIVERSITY OF DUISBURG ESSEN   (Germany)

^c GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^d Klinik Lowenstein   (Germany)

^e Department of Respiratory Medicine Evangelische· Lungenklinik ^*  (Germany)

^f Translational Lung Research Center   (Germany)

^g Klinik Schillerhoehe Thoraxchirurgie   (Germany)

^h Haemato Oncology Hamburg   (Germany)

ⁱ BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Afatinib; Epidermal growth factor receptor; Erlotinib; Gefitinib; Non small cell lung cancer

Indexed keywords

AFATINIB; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; GEFITINIB; ANTINEOPLASTIC AGENT; EGFR PROTEIN, HUMAN; PROTEIN KINASE INHIBITOR; QUINAZOLINE DERIVATIVE;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CLINICAL TRIAL (TOPIC); DIARRHEA; DISEASE CONTROL; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; GENE MUTATION; HUMAN; KIDNEY FAILURE; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PRIORITY JOURNAL; SKIN TOXICITY; TREATMENT DURATION; TREATMENT FAILURE; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR GROWTH; CARCINOMA, NON-SMALL-CELL LUNG; COMPASSIONATE USE; GENETICS; LUNG NEOPLASMS; MIDDLE AGED; MUTATION; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; COMPASSIONATE USE TRIALS; ERLOTINIB HYDROCHLORIDE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; TREATMENT FAILURE;

EID: 84926418869     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2014-0103     Document Type: Article

References (38)

1. World cancer factsheet. Available at http://publications. cancerresearchuk. org/downloads/product/CS_FS_WORLD_A4. pdf. Accessed February 28, 2014.
2. Weir BA, Woo MS, Getz G et al. Characterizing the cancer genome in lung adenocarcinoma. Nature 2007; 450: 893-898.
3. Ding L, Getz G, Wheeler DA et al. Somatic mutations affect key pathways in lung adenocarcinoma. Nature 2008; 455: 1069-1075.
4. Cancer Genome Atlas Research Network. Comprehensive genomic characterization of squamous cell lung cancers. Nature 2012; 489: 519-525.
5. 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 2004; 350: 2129-2139.
6. Paez JG, Jänne PA, Lee JC et al. EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497-1500.
7. Mok TS, Wu YL, Thongprasert S et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947-957.
8. 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 2012; 13: 239-246.
9. Mitsudomi T, Morita S, Yatabe Y et al. Gefitinib versus cisplatin plus docetaxel in patients with nonsmall-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): An open label, randomised phase 3 trial. Lancet Oncol 2010; 11: 121-128.
10. Maemondo M, Inoue A, Kobayashi K et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl JMed 2010; 362: 2380-2388.
11. Yu HA, Arcila ME, Rekhtman N et al. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFRmutant lung cancers. Clin Cancer Res 2013; 19: 2240-2247.
12. 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.
13. 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 2008; 7: 1880-1889.
14. Targeting resistance in lung cancer. Cancer Discov 2013; 3: OF9.
15. Sequist LV, Yang JC, YamamotoNet al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013; 31: 3327-3334.
16. Yang JC, Hirsh V, Schuler M et al. Symptom control and quality of life in LUX-Lung 3: A phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013; 31: 3342-3350.
17. Miller VA, Hirsh V, Cadranel J et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): A phase 2b/3 randomised trial. Lancet Oncol 2012; 13: 528-538.
18. MurakamiH, Tamura T, Takahashi T et al. Phase I study of continuous afatinib (BIBW 2992) in patients with advanced non-small cell lung cancer after prior chemotherapy/erlotinib/gefitinib (LUXLung 4). Cancer Chemother Pharmacol 2012; 69: 891-899.
19. Miller V, Hirsh V, Cadranel J et al. Phase IIb/III double-blind randomized trial of afatinib (BIBW2992), an irreversible inhibitor of EGFR/Her1 and Her2 plus best supportive care (BSC) versus placebo 1 BSC in patients with NSCLC failing 1-2 lines of chemotherapy and erlotinib or gefitinib (LUX-Lung 1). Ann Oncol 2010; 21(suppl 8): LBA1a.
20. Jackman D, Pao W, Riely GJ et al. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol 2010; 28: 357-360.
21. Chmielecki J, Foo J, Oxnard GR et al. Optimization of dosing for EGFR-mutant non-small cell lung cancer with evolutionary cancermodeling. Sci Transl Med 2011; 3: 90ra59.
22. Hata A, Katakami N, Yoshioka H et al. Erlotinib after gefitinib failure in relapsed non-small cell lung cancer: Clinical benefit with optimal patient selection. Lung Cancer 2011; 74: 268-273.
23. Wong MK, Lo AI, Lam B et al. Erlotinib as salvage treatment after failure to first-line gefitinib in non-small cell lung cancer. Cancer Chemother Pharmacol 2010; 65: 1023-1028.
24. Guo R, Chen X, Wang T et al. Subsequent chemotherapy reverses acquired tyrosine kinase inhibitor resistance and restores response to tyrosine kinase inhibitor in advanced non-smallcell lung cancer. BMC Cancer 2011; 11: 90.
25. Weickhardt AJ, Scheier B, Burke JM et al. Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. J Thorac Oncol 2012; 7: 1807-1814.
26. Oxnard GR, Arcila ME, Chmielecki J et al. New strategies in overcoming acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in lung cancer. Clin Cancer Res 2011; 17: 5530-5537.
27. Goldberg SB, Oxnard GR, Digumarthy S et al. Chemotherapy with erlotinib or chemotherapy alone in advanced non-small cell lung cancer with acquired resistance to EGFR tyrosine kinase inhibitors. TheOncologist 2013; 18: 1214-1220.
28. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Non-small cell lung cancer, version 3. Available at http://www. nccn. org/professionals/physician_gls/pdf/nscl. pdf. Accessed March 4, 2014.
29. 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; 343: 342-350.
30. Hanna N, Shepherd FA, Fossella FV et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22: 1589-1597.
31. Shepherd FA, Dancey J, Ramlau R et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18: 2095-2103.
32. Shepherd FA, Rodrigues Pereira J, Ciuleanu T et al. Erlotinib in previously treated non-smallcell lung cancer. N Engl J Med 2005; 353: 123-132.
33. 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, placebocontrolled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366: 1527-1537.
34. RamalingamSS, Blackhall F, KrzakowskiMet al. Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer. J Clin Oncol 2012; 30: 3337-3344.
35. HerbstRS, SunY, EberhardtWEetal. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-smallcell lung cancer (ZODIAC): A double-blind, randomised, phase 3 trial. Lancet Oncol 2010; 11: 619-626.
36. de Boer RH, Arrieta Ó, Yang CH et al. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small-cell lung cancer: A randomized, double-blind phase III trial. J Clin Oncol 2011; 29: 1067-1074.
37. Natale RB, Bodkin D, Govindan R et al. Vandetanib versus gefitinib in patients with advanced non-small-cell lung cancer: Results froma two-part, double-blind, randomized phase II study. J Clin Oncol 2009; 27: 2523-2529.
38. Myung-Ju Ahn, Sang-We Kim, Byoung-Chul Cho et al. Phase II Study of Afatinib as Third-Line Treatment for Patients in Korea With Stage IIIB/IV Non-Small Cell Lung Cancer Harboring Wild-Type EGFR. The Oncologist 2014; 19: 702-703.