Please use this identifier to cite or link to this item:
https://ahro.austin.org.au/austinjspui/handle/1/17389
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DC Field | Value | Language |
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dc.contributor.author | Abou-Alfa, Ghassan K | - |
dc.contributor.author | Blanc, Jean-Frederic | - |
dc.contributor.author | Miles, Steven | - |
dc.contributor.author | Ganten, Tom | - |
dc.contributor.author | Trojan, Jörg | - |
dc.contributor.author | Cebon, Jonathan S | - |
dc.contributor.author | Liem, Andre K | - |
dc.contributor.author | Lipton, Lara | - |
dc.contributor.author | Gupta, Charu | - |
dc.contributor.author | Wu, Benjamin | - |
dc.contributor.author | Bass, Michael | - |
dc.contributor.author | Hollywood, Ellen | - |
dc.contributor.author | Ma, Jennifer | - |
dc.contributor.author | Bradley, Margaret | - |
dc.contributor.author | Litten, Jason | - |
dc.contributor.author | Saltz, Leonard B | - |
dc.date | 2017-06-07 | - |
dc.date.accessioned | 2018-04-05T02:26:47Z | - |
dc.date.available | 2018-04-05T02:26:47Z | - |
dc.date.issued | 2017-07 | - |
dc.identifier.citation | The oncologist 2017; 22(7): 780-e65 | - |
dc.identifier.uri | https://ahro.austin.org.au/austinjspui/handle/1/17389 | - |
dc.description.abstract | Trebananib leveraging anti-angiogenic mechanism that is distinct from the classic sorafenib anti-vascular endothelial growth factor inhibition did not demonstrate improved progression-free survival at 4 months in patients with advanced hepatocellular carcinoma (HCC).In support of previously reported high Ang-2 levels' association with poor outcome in HCC for patients, trebananib treatment with lower baseline Ang-2 at study entry was associated with improved overall survival to 22 months and may suggest future studies to be performed within the context of low baseline Ang-2. Ang-1 and Ang-2 are angiopoietins thought to promote neovascularization via activation of the Tie-2 angiopoietin receptor. Trebananib sequesters Ang-1 and Ang-2, preventing interaction with the Tie-2 receptor. Trebananib plus sorafenib combination has acceptable toxicity. Elevated Ang-2 levels are associated with poor prognosis in hepatocellular carcinoma (HCC). Patients with HCC, Eastern Cooperative Oncology Group ≤2, and Childs-Pugh A received IV trebananib at 10 mg/kg or 15 mg/kg weekly plus sorafenib 400 mg orally twice daily. The study was planned for ≥78% progression-free survival (PFS) rate at 4 months relative to 62% for sorafenib historical control (power = 80% α = 0.20). Secondary endpoints included safety, tolerability, overall survival (OS), and multiple biomarkers, including serum Ang-2. Thirty patients were enrolled sequentially in each of the two nonrandomized cohorts. Demographics were comparable between the two arms and the historical controls. PFS rates at 4 months were 57% and 54% on the 10 mg/kg and 15 mg/kg trebananib cohorts, respectively. Median OS was 17 and 11 months, respectively. Grade 3 and above events noted in ≥10% of patients included fatigue, hypertension, diarrhea, liver failure, palmar-plantar erythrodysesthesia syndrome, dyspnea, and hypophosphatemia. One death was due to hepatic failure. Serum Ang-2 dichotomized at the median was associated with improved OS in both cohorts. There was no improvement in PFS rate at 4 months in either cohort, when compared with sorafenib historical control. | - |
dc.language.iso | eng | - |
dc.title | Phase II Study of First-Line Trebananib Plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma. | - |
dc.type | Journal Article | - |
dc.identifier.journaltitle | The oncologist | - |
dc.identifier.affiliation | Memorial Sloan Kettering Cancer Center, New York, New York, USA | - |
dc.identifier.affiliation | Weill Cornell Medical College, New York, New York, USA | - |
dc.identifier.affiliation | Hôpital Saint-André, Bordeaux, France | - |
dc.identifier.affiliation | Cedars Sinai Hospital, Los Angeles, California, USA | - |
dc.identifier.affiliation | University of Heidelberg, Heidelberg, Germany | - |
dc.identifier.affiliation | Johann Wolfgang Goethe University, Frankfurt, Germany | - |
dc.identifier.affiliation | Olivia Newton-John Cancer Research Institute, Austin Health, Heidelberg, Victoria, Australia | - |
dc.identifier.affiliation | Translational Oncology Research International, Long Beach, California, USA | - |
dc.identifier.affiliation | Western Hospital, Footscray, Victoria, Australia | - |
dc.identifier.affiliation | Amgen Inc., ThoUSAnd Oaks, California, USA | - |
dc.identifier.doi | 10.1634/theoncologist.2017-0058 | - |
dc.identifier.pubmedid | 28592620 | - |
dc.type.austin | Clinical Trial, Phase II | - |
dc.type.austin | Journal Article | - |
dc.type.austin | Randomized Controlled Trial | - |
local.name.researcher | Cebon, Jonathan S | |
item.openairetype | Journal Article | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.languageiso639-1 | en | - |
item.grantfulltext | none | - |
item.cerifentitytype | Publications | - |
item.fulltext | No Fulltext | - |
crisitem.author.dept | Olivia Newton-John Cancer Research Institute | - |
Appears in Collections: | Journal articles |
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