國家衛生研究院 NHRI:Item 3990099045/12265

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Title:	Randomised phase 3 study of regorafenib in refractory advanced gastro-oesophageal cancer (AGOC) - Integrate II
Authors:	Chua, YJ;Pavlakis, N;Sjoquist, KM;Martin, AJ;Tsobanis, E;Yip, S;Bang, YJ;Alcindor, T;O'Callaghan, CJ;Bekaii-Saab, TS;Grothey, A;Chen, LT;Simes, J;Zalcberg, JR;Goldstein, D;Komatsu, Y;Machida, N;Esaki, T;Hara, H;Shitara, K
Contributors:	National Institute of Cancer Research
Abstract:	Background: AGOC has a poor prognosis with limited benefits from treatments following failure of chemotherapy (CT). Regorafenib (BAY 73-4506)(REG) is an oral multi-kinase inhibitor targeting kinases involved in angiogenesis (VEGFR1-3, TIE-2), tumor microenvironment (PDGFR-β, FGFR), and oncogenesis (RAF, RET and KIT). INTEGRATE (phase 2) demonstrated REG effectiveness in prolonging PFS in AGOC pts, with a positive OS trend and less toxicity than other REG trials at the same doses. REG was effective across all regions/subgroups, with regional differences noted in magnitude of effect. INTEGRATE II (phase 3) will explore whether REG is effective in prolonging survival in all patients, and in the Asian sub-population. Methods: International randomised phase III, double-blind, placebo-controlled trial with 2:1 (REG:placebo)(PBO) randomisation and stratification by tumour location, geographic region, and prior VEGF inhibitors. Histologically confirmed AGOC patients, with evaluable metastatic or locally advanced disease refractory to/relapsed following at least 2 lines of CT, will receive best supportive care plus 160mg REG or matched placebo orally on days 1-21 of each 28 day cycle until disease progression or prohibitive adverse events. Primary endpoint is OS. Secondary endpoints: PFS, response rate, quality of life, safety, identification of prognostic/predictive biomarkers for study endpoints, and REG PK across geographical regions. 350 patients (50% from Asia, with at least 50 patients to be recruited from Japan) randomized in a 2:1 ratio will provide 90% power to detect a hazard ratio (HR) for OS of 0.67 with a 2-sided α of 0.05 assuming PBO median survival is 4.5 mos. The sample size accommodates an interim analysis undertaken once 2/3 of required events have occurred. Results: 27 ANZ, 8 Canadian, 15 Korean, 5 Taiwanese, and 2 Japanese sites have been activated with 106 patients enrolled. Remaining Japanese/US sites expected to activate through Q1/Q2 2019.
Date:	2019-10
Relation:	Annals of Oncology. 2019 Oct;30(Suppl. 6):137.
Link to:	http://dx.doi.org/10.1093/annonc/mdz343.087
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:000491239300308
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

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