Icotinib in patients with pretreated advanced esophageal squamous cell Carcinoma with EGFR overexpression or EGFR gene amplification: A single-arm, multicenter phase 2 study

Journal of Thoracic Oncology

Volumn 11, Issue 6, 2016, Pages 910-917

  Huang, Jing ^a   Fan, Qingxia ^b   Lu, Ping ^c   Ying, Jianming ^a   Ma, Changwu ^d   Liu, Wei ^e   Liu, Ying ^f   Tan, Fenlai ^g   Sun, Yan ^a  

^a CANCER HOSPITAL   (China)

^b THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY   (China)

^c XINXIANG MEDICAL UNIVERSITY   (China)

^d Chifeng Municipal Hospital   (China)

^e HEBEI MEDICAL UNIVERSITY   (China)

^f HENAN CANCER HOSPITAL   (China)

^g Betta Pharmaceuticals Co Ltd   (China)

Author keywords

EGFR amplification; EGFR overexpression; Esophageal carcinoma; Icotinib; Squamous cell carcinoma

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; FLUOROURACIL; ICOTINIB; IRINOTECAN; PACLITAXEL; CROWN ETHER; EGFR PROTEIN, HUMAN; QUINAZOLINE DERIVATIVE; TUMOR MARKER;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER CONTROL; CANCER PATIENT; CHINESE; COUGHING; DIARRHEA; DISEASE SEVERITY; DRUG TOLERABILITY; EGFR GENE; ESOPHAGEAL SQUAMOUS CELL CARCINOMA; FATIGUE; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE AMPLIFICATION; GENE OVEREXPRESSION; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; ONCOGENE; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; SURVIVAL TIME; TREATMENT RESPONSE; VOMITING; ADOLESCENT; CANCER STAGING; CARCINOMA, SQUAMOUS CELL; CLINICAL TRIAL; ESOPHAGEAL NEOPLASMS; FOLLOW UP; GENETICS; METABOLISM; MIDDLE AGED; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BIOMARKERS, TUMOR; CARCINOMA, SQUAMOUS CELL; CROWN ETHERS; ESOPHAGEAL NEOPLASMS; FEMALE; FOLLOW-UP STUDIES; GENE AMPLIFICATION; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL RATE; YOUNG ADULT;

EID: 84979779235     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1016/j.jtho.2016.02.020     Document Type: Article

References (29)

1. Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136:E359-E386.
2. Chen W, He Y, Zheng R, et al. Esophageal cancer incidence and mortality in China, 2009. J Thorac Dis. 2013;5:19-26.
3. Dawsey SM, Lewin KJ, Wang GQ, et al. Squamous esophageal histology and subsequent risk of squamous cell carcinoma of the esophagus. A prospective follow-up study from Linxian, China. Cancer. 1994;74:1686-1692.
4. Huang Q, Fang DC, Yu CG, et al. Barrett's esophagus-related diseases remain uncommon in China. J Dig Dis. 2011;12:420-427.
5. Pera M, Manterola C, Vidal O, et al. Epidemiology of esophageal adenocarcinoma. J Surg Oncol. 2005;92: 151-159.
6. Hayashi K, Ando N, Watanabe H, et al. Phase II evaluation of protracted infusion of cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG) trial (JCOG9407). Jpn J Clin Oncol. 2001;31:419-423.
7. Bleiberg H, Conroy T, Paillot B, et al. Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer. Eur J Cancer. 1997;33:1216-1220.
8. Huang J, Zhou Y, Zhang H, et al. A phase II study of biweekly paclitaxel and cisplatin chemotherapy for recurrent or metastatic esophageal squamous cell carcinoma: ERCC1 expression predicts response to chemotherapy. Med Oncol. 2013;30:343.
9. Gibault L, Metges JP, Conan-Charlet V, et al. Diffuse EGFR staining is associated with reduced overall survival in locally advanced oesophageal squamous cell cancer. Br J Cancer. 2005;93:107-115.
10. Abedi-Ardekani B, Dar NA, Mir MM, et al. Epidermal growth factor receptor (EGFR) mutations and expression in squamous cell carcinoma of the esophagus in central Asia. BMC Cancer. 2012;12:602.
11. Hanawa M, Suzuki S, Dobashi Y, et al. EGFR protein overexpression and gene amplification in squamous cell carcinomas of the esophagus. Int J Cancer. 2006;118: 1173-1180.
12. Kato H, Arao T, Matsumoto K, et al. Gene amplification of EGFR, HER2, FGFR2 and MET in esophageal squamous cell carcinoma. Int J Oncol. 2013;42:1151-1158.
13. Janmaat ML, Gallegos-Ruiz MI, Rodriguez JA, et al. Predictive factors for outcome in a phase II study of gefitinib in second-line treatment of advanced esophageal cancer patients. J Clin Oncol. 2006;24:1612-1619.
14. Ferry DR, Anderson M, Beddard K, et al. A phase II study of gefitinib monotherapy in advanced esophageal adenocarcinoma: evidence of gene expression, cellular, and clinical response. Clin Cancer Res. 2007;13:5869-5875.
15. Ilson DH, Kelsen D, Shah M, et al. A phase 2 trial of erlotinib in patients with previously treated squamous cell and adenocarcinoma of the esophagus. Cancer. 2011;117:1409-1414.
16. Adelstein DJ, Rodriguez CP, Rybicki LA, et al. A phase II trial of gefitinib for recurrent or metastatic cancer of the esophagus or gastroesophageal junction. Invest New Drugs. 2012;30:1684-1689.
17. Dutton SJ, Ferry DR, Blazeby JM, et al. Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial. Lancet Oncol. 2014;15: 894-904.
18. Petty RD, Dahle-Smith A, Miedzybrodzka Z, et al. Epidermal growth factor receptor copy number gain (EGFR CNG) and response to gefitinib in esophageal cancer (EC): results of biomarker analysis of a phase III trial of gefitinib versus placebo (TRANS-COG) [abstract]. J Clin Oncol. 2014;32(suppl 5):4016.
19. Shi Y, Zhang L, Liu X, et al. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013;14:953-961.
20. Fichter CD, Gudernatsch V, Przypadlo CM, et al. ErbB targeting inhibitors repress cell migration of esophageal squamous cell carcinoma and adenocarcinoma cells by distinct signaling pathways. J Mol Med. 2014;92:1209-1223.
21. Tan F, Shen X, Wang D, et al. Icotinib (BPI-2009H), a novel EGFR tyrosine kinase inhibitor, displays potent efficacy in preclinical studies. Lung Cancer. 2012;76: 177-182.
22. Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A, eds. American Joint Committee on Cancer Tumor, Node, and Metastasis Staging System Manual. 7th ed. New York, NY: Springer; 2010.
23. Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzu-mab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376:687-697.
24. Lorenzen S, Schuster T, Porschen R, et al. Cetuximab plus cisplatin-5-FU versus cisplatin-5-FU alone in first-line metastatic squamous cell carcinoma of the esophagus: a randomized phase II study of the Arbeitsgemeins-chaft Internistische Onkologie. Ann Oncol. 2009;10: 1667-1673.
25. Waddell T, Chau I, Cunningham D, et al. Epirubicin, oxa-liplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oeso-phagogastric cancer (REAL3): a randomised, open-label phase 3 trial. Lancet Oncol. 2013;14:481-489.
26. Rizvi NA, Mazières J, Planchard D, et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squa-mous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015;3:257-265.
27. Lyu Xiao, Huang J, Liu J, et al. Detection and significance of epidermal growth factor receptor mutation in esophageal, esophagogastric junction and gastric cancers [Article in Chinese]. Zhonghua Zhong Liu Za Zhi. 2014;36:346-350.
28. Wang CY, Deng JY, Cai XW, et al. High EGFR and low p-Akt expression is associated with better outcome after nimotuzumab-containing treatment in esophageal cancer patients: preliminary clinical result and testable hypothesis. Oncotarget. 2015;6:18674-18682.
29. Chong CR, Jänne PA. The quest to overcome resistance to EGFR-targeted therapies in cancer. Nat Med. 2013;19: 1389-1400.