Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): A multinational placebo-controlled phase II Trial

Journal of Clinical Oncology

Volumn 34, Issue 23, 2016, Pages 2728-2735

  Pavlakis, Nick ^a,b   Sjoquist, Katrin M ^b,c   Martin, Andrew J ^b   Tsobanis, Eric ^b   Yip, Sonia ^b,d   Kang, Yoon Koo ^k   Bang, Yung Jue ^l   Alcindor, Thierry ^p   O'Callaghan, Christopher J ^q   Burnell, Margot J ^r   Tebbutt, Niall C ^a,g   Rha, Sun Young ^m   Lee, Jeeyun ⁿ   Cho, Jae Yong ^m   Lipton, Lara R ^a,h   Wong, Mark ^e   Strickland, Andrew ⁱ   Kim, Jin Won ^o   Zalcberg, John R ^a,j   Simes, John ^a,b   Goldstein, David ^a,f   more..

^a Australasian Gastro Intestinal Trials Group   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c ST GEORGE HOSPITAL   (Australia)

^d Sydney West Translational Cancer Research Centre   (Australia)

^e WESTMEAD HOSPITAL   (Australia)

^f PRINCE OF WALES HOSPITAL   (Australia)

^g AUSTIN HEALTH   (Australia)

^h WESTERN HEALTH   (Australia)

ⁱ MONASH MEDICAL CENTRE   (Australia)

^j PETER MACCALLUM CANCER CENTRE   (Australia)

^k University of Ulsan College of Medicine   (South Korea)

^l Seoul National University Hospital   (South Korea)

^m Yonsei University College of Medicine   (South Korea)

ⁿ Sungkyunkwan University School of Medicine   (South Korea)

^o Seoul National University Bundang Hospital   (South Korea)

^p MCGILL UNIVERSITY HEALTH CENTRE   (Canada)

^q Queen's Cancer Research Institute   (Canada)

^r SAINT JOHN REGIONAL HOSPITAL   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GAMMA GLUTAMYLTRANSFERASE; PLACEBO; REGORAFENIB; TRASTUZUMAB; VASCULOTROPIN A; ANTINEOPLASTIC AGENT; CARBANILAMIDE DERIVATIVE; PYRIDINE DERIVATIVE;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; AUSTRALIA; CANADA; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL DISEASE; HUMAN; HYPERTENSION; HYPOPHOSPHATEMIA; INFECTION; LIVER FAILURE; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MULTICENTER STUDY; NEUTROPHIL LYMPHOCYTE RATIO; NEW ZEALAND; NUTRITIONAL DISORDER; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN DISEASE; SOFT TISSUE DISEASE; SOUTH KOREA; STOMACH ADENOCARCINOMA; SUBCUTANEOUS TISSUE DISORDER; ADENOCARCINOMA; CLINICAL TRIAL; DISEASE FREE SURVIVAL; MIDDLE AGED; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; STOMACH NEOPLASMS; VERY ELDERLY;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; AUSTRALIA; CANADA; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; NEW ZEALAND; PHENYLUREA COMPOUNDS; PLACEBOS; PYRIDINES; REPUBLIC OF KOREA; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; STOMACH NEOPLASMS;

EID: 84981717709     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.65.1901     Document Type: Article

References (28)

1. Brenner H, Rothenbacher D, Arndt V: Epidemiology of stomach cancer. Methods Mol Biol 472: 467-477, 2009
2. Wagner AD, Unverzagt S, Grothe W, et al: Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev 3:CD004064, 2010
3. Kang JH, Lee SI, Lim H, et al: Salvage chemotherapy for pretreated gastric cancer: A randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol 30:1513-1518, 2012
4. Ford HER, Marshall A, Bridgewater JA, et al: Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): An open-label, phase 3 randomised controlled trial. Lancet Oncol 15:78-86, 2014
5. Thuss-Patience PC, Kretzschmar A, Bichev D, et al: Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer: A randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer 47:2306-2314, 2011
6. Ku GY, Ilson DH: Esophagogastric cancer: Targeted agents. Cancer Treat Rev 36:235-248, 2010
7. Ferrara N: Vascular endothelial growth factor: Basic science and clinical progress. Endocr Rev 25: 581-611, 2004
8. Fondevila C, Metges JP, Fuster J, et al: p53 and VEGF expression are independent predictors of tumour recurrence and survival following curative resection of gastric cancer. Br J Cancer 90:206-215, 2004
9. Yao JC, Wang L, Wei D, et al: Association between expression of transcription factor Sp1 and increased vascular endothelial growth factor expression, advanced stage, and poor survival in patients with resected gastric cancer. Clin Cancer Res 10:4109-4117, 2004
10. Ohtsu A, Shah MA, Van Cutsem E, et al: Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: A randomized, double-blind, placebo-controlled phase III study. J Clin Oncol 29:3968-3976, 2011
11. Bang YJ, Kang YK, Kang WK, et al: Phase II study of sunitinib as second-line treatment for advanced gastric cancer. Invest New Drugs 29:1449-1458, 2011
12. Doi T, Muro K, Boku N, et al: Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancer. J Clin Oncol 28:1904-1910, 2010
13. Wehland M, Bauer J, Magnusson NE, et al: Biomarkers for anti-Angiogenic therapy in cancer. Int J Mol Sci 14:9338-9364, 2013
14. Van Cutsem E, de Haas S, Kang Y-K, et al: Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: A biomarker evaluation from the AVAGAST randomized phase III trial. J Clin Oncol 30:2119-2127, 2012
15. Demetri GD, Reichardt P, Kang Y-K, et al: Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): An international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381:295-302, 2013
16. Grothey A, Van Cutsem E, Sobrero A, et al: Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): An international, multicentre, randomised, placebocontrolled, phase 3 trial. Lancet 381:303-312, 2013
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 85:365-376, 1993
18. Blazeby JM, Conroy T, Bottomley A, et al: Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer. Eur J Cancer 40:2260-2268, 2004
19. EuroQol Group: EuroQol: A new facility for the measurement of health-related quality of life. Health Policy 16:199-208, 1990
20. Stockler MR, O'Connell R, Nowak AK, et al: Effect of sertraline on symptoms and survival in patients with advanced cancer, but without major depression: A placebo-controlled double-blind randomised trial. Lancet Oncol 8: 603-612, 2007
21. Davis ID, Long A, Yip S, et al: EVERSUN: A phase 2 trial of alternating sunitinib and everolimus as first-line therapy for advanced renal cell carcinoma. Ann Oncol 26:1118-1123, 2015
22. Fuchs CS, Tomasek J, Yong CJ, et al: Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): An international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 383:31-39, 2014
23. Wilke H, Muro K, Van Cutsem E, et al: Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): A double-blind, randomised phase 3 trial. Lancet Oncol 15:1224-1235, 2014
24. Qin S: Phase III study of apatinib in advanced gastric cancer: A randomized, double-blind, placebo-controlled trial. J Clin Oncol 32:5s, 2014 suppl; abstr 4003
25. Kim KH, Kim YM, Kim MC, et al: Analysis of prognostic factors and outcomes of gastric cancer in younger patients: A case control study using propensity score methods. World J Gastroenterol 20: 3369-3375, 2014
26. Zhang X, Zhang W, Feng LJ: Prognostic significance of neutrophil lymphocyte ratio in patients with gastric cancer: A meta-Analysis. PLoS One 9:e111906, 2014
27. Cancer Genome Atlas Research Network: Comprehensive molecular characterization of gastric adenocarcinoma. Nature 513:202-209.28, 2014
28. Miyamoto N, Yamanoto H, Taniguchi H, et al: Differential expression of angiogenesis-related genes in human gastric cancers with and those without highfrequency microsatellite instability. Cancer Lett 254: 42-53, 2007