Randomized phase III trial of regorafenib in metastatic colorectal cancer: Analysis of the CORRECT Japanese and non-Japanese subpopulations

Investigational New Drugs

Volumn 33, Issue 3, 2015, Pages 740-750

  Yoshino, Takayuki ^a   Komatsu, Yoshito ^b   Yamada, Yasuhide ^c   Yamazaki, Kentaro ^d   Tsuji, Akihito ^e,l   Ura, Takashi ^f   Grothey, Axel ^g   Van Cutsem, Eric ^h   Wagner, Andrea ⁱ   Cihon, Frank ^j   Hamada, Yoko ^k   Ohtsu, Atsushi ^a  

^a NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^b HOKKAIDO UNIVERSITY HOSPITAL   (Japan)

^c NATIONAL CANCER CENTER HOSPITAL   (Japan)

^d SHIZUOKA CANCER CENTER   (Japan)

^e Kochi Health Sciences Center   (Japan)

^f AICHI CANCER CENTER HOSPITAL   (Japan)

^g MAYO CLINIC   (United States)

^h UNIVERSITY HOSPITALS LEUVEN   (Belgium)

ⁱ BAYER PHARMA AG   (Germany)

^j BAYER CORPORATION   (United States)

^k BAYER YAKUHIN LTD   (Japan)

^l KOBE CITY MEDICAL CENTER GENERAL HOSPITAL   (Japan)

more..

Author keywords

Clinical trial; Colorectal cancer; Japanese; Phase III; Protein kinase inhibitors; Regorafenib

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; PLACEBO; REGORAFENIB; TRIACYLGLYCEROL LIPASE; ANTINEOPLASTIC AGENT; CARBANILAMIDE DERIVATIVE; PYRIDINE DERIVATIVE;

ADULT; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BODY MASS; BODY WEIGHT DISORDER; CONSTIPATION; CONTROLLED STUDY; DESQUAMATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; EPISTAXIS; EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER QUALITY OF LIFE QUESTIONNAIRE CORE 30; EUROQOL 5 DIMENSION HEALTH UTILITY INDEX; EUROQOL 5 DIMENSION VISUAL ANALOG SCALE; FEMALE; FEVER; HAND FOOT SYNDROME; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOPHOSPHATEMIA; JAPANESE (PEOPLE); JAUNDICE; LIVER DYSFUNCTION; LIVER METASTASIS; MAJOR CLINICAL STUDY; MALE; METASTATIC COLORECTAL CANCER; MIDDLE AGED; MULTICENTER STUDY (TOPIC); MULTIPLE CYCLE TREATMENT; NAUSEA; ORAL MUCOSITIS; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; PROTEINURIA; QUALITY OF LIFE; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; THROMBOCYTE COUNT; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT; VOICE CHANGE; WEIGHT REDUCTION; ASIAN CONTINENTAL ANCESTRY GROUP; CLINICAL TRIAL; COLORECTAL NEOPLASMS; DEMOGRAPHY; METASTASIS; PATHOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; BODY MASS INDEX; COLORECTAL NEOPLASMS; DEMOGRAPHY; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PHENYLUREA COMPOUNDS; PLACEBOS; PYRIDINES; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84929583273     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-014-0154-x     Document Type: Article

References (21)

1. Globocan (2013) Colorectal cancer. Estimated cancer incidence, mortality and prevalence worldwide in 2012. http://globocan.iarc.fr/Pages/fact-sheets-cancer.aspx. Accessed 18 Aug. 2014
2. Foundation for Promotion of Cancer Research (2013) Cancer statistics in Japan 2013. http://ganjoho.jp/pro/statistics/en/backnumber/2013-en.html. Accessed 4 June 2014
3. Schmoll HJ, Van Cutsem E, Stein A et al (2012) ESMO consensus guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making. Ann Oncol 23:2479-2516
4. National Comprehensive Cancer Network (2014) NCCN clinical practice guidelines in oncology (NCCN guidelines): colon cancer. Version 3. 2014. http://www.nccn.org/professionals/physician-gls/pdf/colon.pdf. Accessed 4 July 2014
5. National Comprehensive Cancer Network (2014) NCCN clinical practice guidelines in oncology (NCCN guidelines): rectal cancer. Version 3. 2014. http://www.nccn.org/professionals/physician-gls/pdf/rectal.pdf. Accessed 4 July 2014
6. Wilhelm SM, Dumas J, Adnane L et al (2011) Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer 129:245-255
7. Grothey A, Van Cutsem E, Sobrero A et al (2013) Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381:303-312
8. US Food and Drug Administration (2012) FDA approves regorafenib (Stivarga) for metastatic colorectal cancer. Oncology (Williston Park) 26:896
9. Bayer HealthCare (2013) Bayer's Stivarga® (regorafenib) tablets approved in Japan for the treatment of advanced or recurrent colorectal cancer. http://press.healthcare.bayer.com/en/press/auth/news-details-page.php/14968/2013-0163. Accessed 4 June 2014
10. Bayer HealthCare (2013) Bayer's Stivarga® (regorafenib) approved in the EU for the treatment of metastatic colorectal cancer. http://press.healthcare.bayer.com/en/press/auth/news-details-page.php/15190/2013-0455. Accessed 4 June 2014
11. Ueda T, Uemura H, Tomita Y et al (2013) Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial. Jpn J Clin Oncol 43:616-628
12. Tsukamoto T, Shinohara N, Tsuchiya N et al (2011) Phase III trial of everolimus in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from RECORD-1. Jpn J Clin Oncol 41:17-24
13. Aaronson NK, Ahmedzai S, Bergman B et al (1993) The European Organisation 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
14. EuroQol Group (1990) EuroQol-a new facility for the measurement of health-related quality of life. Health Pol 16:199-208
15. Shirao K, Hoff PM, Ohtsu A et al (2004) Comparison of the efficacy, toxicity, and pharmacokinetics of a uracil/tegafur (UFT) plus oral leucovorin (LV) regimen between Japanese and American patients with advanced colorectal cancer: joint United States and Japan study of UFT/LV. J Clin Oncol 22:3466-3474
16. Yoshino T, Boku N, Onozawa Y et al (2007) Efficacy and safety of an irinotecan plus bolus 5-fluorouracil and L-leucovorin regimen for metastatic colorectal cancer in Japanese patients: experience in a single institution in Japan. Jpn J Clin Oncol 37:686-691
17. Mross K, Frost A, Steinbild S et al (2012) A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res 18:2658-2667
18. Strumberg D, Scheulen ME, Schultheis B et al (2012) Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study. Br J Cancer 106:1722-1727
19. Sunakawa Y, Furuse J, Okusaka T et al (2013) Regorafenib in Japanese patients with solid tumors: phase I study of safety, efficacy, and pharmacokinetics. Invest New Drugs 32:104-112
20. Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16:139-144
21. Pickard AS, Neary MP, Cella D (2007) Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes 5:70