2012
DOI: 10.1200/jco.2012.30.4_suppl.lba3
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Phase III trial of everolimus (EVE) in previously treated patients with advanced gastric cancer (AGC): GRANITE-1.

Abstract: LBA3 Background: The prognosis for patients with AGC after failure of first-line chemotherapy is poor. Currently, there is no level 1 evidence established for second-line treatment. EVE inhibits the PI3K/Akt/mTOR pathway, a key regulator of cell proliferation, metabolism, and angiogenesis, and has shown efficacy against AGC in preclinical and phase I/II studies. Methods: In a randomized, double-blind, multicenter, phase III study, patients age ≥18 years with confirmed AGC and disease progression after 1 or 2… Show more

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Cited by 40 publications
(23 citation statements)
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“…Everolimus, an oral mTOR inhibitor, failed to improve OS in patients treated with 1 or 2 lines of systemic chemotherapy when given as monotherapy, but did improve PFS [64]. A phase III trial of the German Arbeitsgemeinschaft Internistische Onkologie (AIO-STO 0111) is currently evaluating paclitaxel with and without everolimus in patients with GC after initial treatment with a fluoropyrimidine-containing regimen (http://clinicalTrials.…”
Section: Biologically Targeted Therapymentioning
confidence: 99%
“…Everolimus, an oral mTOR inhibitor, failed to improve OS in patients treated with 1 or 2 lines of systemic chemotherapy when given as monotherapy, but did improve PFS [64]. A phase III trial of the German Arbeitsgemeinschaft Internistische Onkologie (AIO-STO 0111) is currently evaluating paclitaxel with and without everolimus in patients with GC after initial treatment with a fluoropyrimidine-containing regimen (http://clinicalTrials.…”
Section: Biologically Targeted Therapymentioning
confidence: 99%
“…5 Although phase II studies of antiEGFR therapy in advanced stage gastric cancer were promising, negative results from two large firstline phase III randomized trials that compared the use of standard firstline chemotherapy plus or minus an antiEGFR antibody were presented in 2012. [6][7][8] The REAL3 study (n = 553) compared the addition of panitu mumab (P) to EOC (epirubicin, oxali platin and capecitabine) chemotherapy (Table 1). 6 Median overall survival was significantly worse in the EOCP combina tion arm (8.8 months versus 11.3 months), and enrolment was terminated early.…”
mentioning
confidence: 99%
“…At a median followup duration of 9.6 months, the median OS was 10.1 months and good tolerability was observed [53]. Based on this provocative result, a phase III randomized trial, GRANITE-1 study was conducted to compare everolimus with placebo plus best supportive care in patients with progressive disease after one or two prior lines of chemotherapy [54]. A total of 656 patients from 23 countries were enrolled; 439 were randomized to everolimus, 217 to placebo.…”
Section: Other Targets In Advanced Gastric Cancermentioning
confidence: 99%