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

The Lancet Oncology

Volumn 18, Issue 11, 2017, Pages 1454-1466

  Wu, Yi Long ^a   Cheng, Ying ^b   Zhou, Xiangdong ^c   Lee, Ki Hyeong ^d   Nakagawa, Kazuhiko ^e   Niho, Seiji ^f   Tsuji, Fumito ^g   Linke, Rolf ^h   Rosell, Rafael ⁱ   Corral, Jesus ^j   Migliorino, Maria Rita ^k   Pluzanski, Adam ^l   Sbar, Eric I ^m   Wang, Tao ^m   White, Jane Liang ^m   Nadanaciva, Sashi ^m   Sandin, Rickard ^m   Mok, Tony S ⁿ  

^a GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL   (China)

^b JILIN PROVINCIAL CANCER HOSPITAL   (China)

^c THIRD MILITARY MEDICAL UNIVERSITY   (China)

^d Chungbuk National University Hospital   (South Korea)

^e KINDAI UNIVERSITY HOSPITAL   (Japan)

^f NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^g SFJ Pharma Japan   (Japan)

^h SFJ Pharma Group   (United States)

ⁱ CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^j HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^k SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^l INSTITUTE OF ONCOLOGY   (Poland)

^m PFIZER INC   (United States)

ⁿ CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; DACOMITINIB; EPIDERMAL GROWTH FACTOR RECEPTOR; GEFITINIB; QUINAZOLINE DERIVATIVE; QUINAZOLINONE DERIVATIVE;

ACNE; ACUTE KIDNEY FAILURE; AGED; ALOPECIA; AMINO ACID SUBSTITUTION; ANEMIA; ARTICLE; ASIAN; ASTHENIA; BACKACHE; BODY WEIGHT DISORDER; CANCER SURVIVAL; CHEMOTHERAPY; CHOLELITHIASIS; CHRONIC MYELOID LEUKEMIA; COLON DIVERTICULOSIS; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DERMATITIS; DIARRHEA; DISEASE COURSE; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; DYSESTHESIA; DYSPNEA; EGFR GENE; ETHNIC DIFFERENCE; ETHNICITY; EXON; FEMALE; FIRST LINE TREATMENT; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GENE MUTATION; HEPATOBILIARY DISEASE; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOKALEMIA; INFECTION; INSOMNIA; INTENTION TO TREAT ANALYSIS; INTERSTITIAL LUNG DISEASE; KERATITIS; LIVER DISEASE; LYMPHOCYTE COUNT; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MOUTH ULCER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; MUTATIONAL ANALYSIS; NAUSEA; NON ASIAN; NON SMALL CELL LUNG CANCER; NUTRITIONAL DISORDER; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PALMAR PLANTAR ERYTHRODYSESTHESIA SYNDROME; PARONYCHIA; PHASE 3 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; PUSTULAR RASH; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN DISEASE; STOMATITIS; SUBCUTANEOUS DISORDER; SURVIVAL RATE; SURVIVAL TIME; THORAX PAIN; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; ADULT; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; GENETICS; KAPLAN MEIER METHOD; LUNG TUMOR; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; MUTATION; PROGNOSIS; PROTO ONCOGENE; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

ADULT; AGED; CARCINOMA, NON-SMALL-CELL LUNG; CONFIDENCE INTERVALS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENES, ERBB-1; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MUTATION; PROGNOSIS; QUINAZOLINES; QUINAZOLINONES; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 85029907586     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(17)30608-3     Document Type: Article

References (32)

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 (2004), 2129–2139.
2. Paez, JG, Janne, PA, Lee, JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304 (2004), 1497–1500.
3. Wu, YL, Zhong, WZ, Li, LY, et al. Epidermal growth factor receptor mutations and their correlation with gefitinib therapy in patients with non-small cell lung cancer: a meta-analysis based on updated individual patient data from six medical centers in mainland China. J Thorac Oncol 2 (2007), 430–439.
4. Mok, TS, Wu, YL, Thongprasert, S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361 (2009), 947–957.
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 (2010), 2380–2388.
6. Zhou, C, Wu, YL, 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 (2011), 735–742.
7. 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 (2012), 239–246.
8. 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 (2013), 3327–3334.
9. Wu, YL, Zhou, C, Hu, CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol 15 (2014), 213–222.
10. Thongprasert, S, Duffield, E, Saijo, N, et al. Health-related quality-of-life in a randomized phase III first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients from Asia with advanced NSCLC (IPASS). J Thorac Oncol 6 (2011), 1872–1880.
11. 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 31 (2013), 3342–3350.
12. 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 (2008), 1880–1889.
13. Engelman, JA, Zejnullahu, K, Gale, CM, 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 (2007), 11924–11932.
14. Li, D, Ambrogio, L, Shimamura, T, et al. BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models. Oncogene 27 (2008), 4702–4711.
15. 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 343 (2012), 342–350.
16. Park, K, Tan, EH, 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 (2016), 577–589.
17. Paz-Ares, L, Tan, EH, O'Byrne, K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol 28 (2017), 270–277.
18. Jänne, 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 (2014), 1433–1441.
19. Aaronson, NK, Ahmedzai, S, Bergman, B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85 (1993), 365–376.
20. Fayers, P, Bottomley, A EORTC Quality of Life Group, Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer 38:suppl 4 (2002), S125–S133.
21. Bergman, B, Aaronson, NK, Ahmedzai, S, Kaasa, S, Sullivan, M, The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer 30A (1994), 635–642.
22. EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16 (1990), 199–208.
23. Fukuoka, M, Wu, Y-L, Thongprasert, S, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol 29 (2011), 2866–3828.
24. Schoenfeld, D, Partial residuals for the proportional hazards regression-model. Biometrika 69 (1982), 239–241.
25. Osoba, D, Rodrigues, G, Myles, J, Zee, B, Pater, J, Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16 (1998), 139–144.
26. Wu, YL, Zhou, C, Liam, CK, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol 26 (2015), 1883–1889.
27. Yang, JJ, Zhou, Q, Yan, HH, et al. A phase III randomised controlled trial of erlotinib vs gefitinib in advanced non-small cell lung cancer with EGFR mutations. Br J Cancer 116 (2017), 568–574.
28. Lee, CK, Wu, YL, Ding, PN, et al. Impact of specific epidermal growth factor receptor (EGFR) mutations and clinical characteristics on outcomes after treatment with EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR-mutant lung cancer: a meta-analysis. J Clin Oncol 33 (2015), 1958–1965.
29. Yu, JY, Yu, SF, Wang, SH, et al. Clinical outcomes of EGFR-TKI treatment and genetic heterogeneity in lung adenocarcinoma patients with EGFR mutations on exons 19 and 21. Chin J Cancer, 35, 2016, 30.
30. 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 (2014), 1369–1378.
31. 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 (2014), 1379–1388.
32. 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 (2016), 1712–1718.