Gefitinib for oesophageal cancer progressing after chemotherapy (COG): A phase 3, multicentre, double-blind, placebo-controlled randomised trial

The Lancet Oncology

Volumn 15, Issue 8, 2014, Pages 894-904

  Dutton, Susan J ^a   Ferry, David R ^b,c   Blazeby, Jane M ^d,e   Abbas, Haider ^b   Dahle Smith, Asa ^f   Mansoor, Wasat ^g   Thompson, Joyce ^h   Harrison, Mark ⁱ   Chatterjee, Anirban ^j   Falk, Stephen ^d   Garcia Alonso, Angel ^k   Fyfe, David W ^l   Hubner, Richard A ^g   Gamble, Tina ^h   Peachey, Lynnda ^m   Davoudianfar, Mina ^m   Pearson, Sarah R ^m   Julier, Patrick ^m   Jankowski, Janusz ⁿ   Kerr, Rachel ^m   Petty, Russell D ^f   more..

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST   (United Kingdom)

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

^e UNIVERSITY OF BRISTOL   (United Kingdom)

^f UNIVERSITY OF ABERDEEN   (United Kingdom)

^g CHRISTIE HOSPITAL   (United Kingdom)

^h BIRMINGHAM HEARTLANDS HOSPITAL   (United Kingdom)

ⁱ MOUNT VERNON CANCER CENTRE   (United Kingdom)

^j ROYAL SHREWSBURY HOSPITAL   (United Kingdom)

^k GLAN CLWYD HOSPITAL   (United Kingdom)

^l FURNESS GENERAL HOSPITAL   (United Kingdom)

^m UNIVERSITY OF OXFORD   (United Kingdom)

ⁿ Institute for Clean Growth and Future Mobility   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GEFITINIB; PLACEBO;

ADULT; ADVANCED CANCER; AGED; ANXIETY DISORDER; ARTICLE; BODY WEIGHT DISORDER; CANCER GROWTH; CANCER SURVIVAL; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPHAGIA; DYSPNEA; ESOPHAGUS CANCER; FATIGUE; FEMALE; HAIR LOSS; HEART DISEASE; HEPATOBILIARY DISEASE; HUMAN; INSOMNIA; KIDNEY DISEASE; LIFE EXPECTANCY; LOSS OF APPETITE; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; NEUROLOGIC DISEASE; NUTRITIONAL DISORDER; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SKIN TOXICITY; STOMACH DISCOMFORT; STOMACH PAIN; VOMITING; XEROSTOMIA;

ADENOCARCINOMA; AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, SQUAMOUS CELL; DEGLUTITION DISORDERS; DIARRHEA; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; DRUG ERUPTIONS; EATING; ESOPHAGEAL NEOPLASMS; FATIGUE; FEMALE; HUMANS; MALE; MIDDLE AGED; PAIN; PROPORTIONAL HAZARDS MODELS; QUALITY OF LIFE; QUINAZOLINES; RETREATMENT;

EID: 84903547873     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70024-5     Document Type: Article

References (29)

1. Jemal A, Center MM, DeSantis C, Ward EM Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev 2010, 19:1893-1907.
2. Cancer survival in England: patients diagnosed 2006-2010 and followed up to 2011 2012, Office for National Statistics, Office for National Statistics, Newport.
3. Ajani JA Gastroesophageal cancers: progress and problems. J Natl Compr Canc Netw 2008, 6:813-814.
4. Higuchi K, Koizumi W, Tanabe S, et al. Current management of esophageal squamous-cell carcinoma in Japan and other countries. Gastrointest Cancer Res 2009, 3:153.
5. Blazeby JM, Blencowe N Palliative treatments of carcinoma of oesophagus and stomach. Oesophagogastric surgery: a companion to specialist surgical practice 2013, Saunders Elsevier. 5th edn. S.M. Griffin, S.A. Raimes, J. Shenfine (Eds.).
6. Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008, 358:36-46.
7. Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab 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.
8. Darnton S, Archer V, Stocken D, Mulholland P, Casson A, Ferry DR Preoperative mitomycin, ifosfamide, and cisplatin followed by esophagectomy in squamous cell carcinoma of the esophagus: pathologic complete response induced by chemotherapy leads to long-term survival. J Clin Oncol 2003, 21:4009-4015.
9. Thallinger CMR, Raderer M, Hejna M Esophageal cancer: a critical evaluation of systemic second-line therapy. J Clin Oncol 2011, 29:4709-4714.
10. Lordick F, Allum W, Carneiro F, et al. Unmet needs and challenges in gastric cancer: the way forward. Cancer Treat Rev 2014, 40:692-700.
11. Wang KL, Wu TT, Choi IS, et al. Expression of epidermal growth factor receptor in esophageal and esophagogastric junction adenocarcinomas. Cancer 2007, 109:658-667.
12. Dulak AM, Schumacher SE, van Lieshout J, et al. Gastrointestinal adenocarcinomas of the esophagus, stomach, and colon exhibit distinct patterns of genome instability and oncogenesis. Cancer Res 2012, 72:4383-4393.
13. Kwak EL, Jankowski J, Thayer SP, et al. Epidermal growth factor receptor kinase domain mutations in esophageal and pancreatic adenocarcinomas. Clin Cancer Res 2006, 12:4283-4287.
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. Dragovich T, McCoy S, Fenoglio-Preiser CM, et al. Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127. J Clin Oncol 2006, 24:4922-4927.
16. Rojo F, Tabernero J, Albanell J, et al. Pharmacodynamic studies of gefitinib in tumor biopsy specimens from patients with advanced gastric carcinoma. J Clin Oncol 2006, 24:4309-4316.
17. 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 1993, 85:365-376.
18. Lagergren P, Fayers P, Conroy T, et al. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago' gastric junction and the stomach. Eur J Cancer 2007, 43:2066-2073.
19. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A The EORTC QLQ-C30 scoring manual 2001, on behalf of the EORTC Quality of Life Group, European Organisation for Research and Treatment of Cancer, Brussels. 3rd edn.
20. Stewart JSW, Cohen EEW, Licitra L, et al. Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck. J Clin Oncol 2009, 27:1864-1871.
21. Bandla S, Pennathur A, Luketich JD, et al. Comparative genomics of esophageal adenocarcinoma and squamous cell carcinoma. Ann Thorac Surg 2012, 93:1101-1106.
22. Chan J, Blaszkowsky L, Enzinger P, et al. A multicenter phase II trial of single-agent cetuximab in advanced esophageal and gastric adenocarcinoma. Ann Oncol 2011, 22:1367-1373.
23. Waddell T, Chau I, Cunningham D, et al. Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): a randomised, open-label phase 3 trial. Lancet Oncol 2013, 14:481-489.
24. Lordick F, Kang Y-K, Chung HC, et al. Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): a randomised, open-label phase 3 trial. Lancet Oncol 2013, 14:490-499.
25. Lynch TJ, Patel T, Dreisbach L, et al. Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non-small-cell lung cancer: results of the randomized multicenter phase III trial BMS099. J Clin Oncol 2010, 28:911-917.
26. Maughan TS, Adams RA, Smith CG, et al. Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. Lancet 2011, 377:2103-2114.
27. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008, 359:1757-1765.
28. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005, 353:123-132.
29. Heinemann V, Fischer von Weikersthal L, Decker T, et al. Randomized comparison of FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment of KRAS-wildtype metastatic colorectal cancer: German AIO study KRK-0306 (FIRE-3). Proc Am Soc Clin Oncol 2013, 31(15 suppl). LBA3506.