Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma
Lynn G Feun,¹ Medhi Wangpaichitr,² Ying-Ying Li,¹ Deukwoo Kwon,³ Stephen P Richman,¹ Peter J Hosein,¹ Niramol Savaraj¹,² ¹Department of Medicine, Medical Oncology, Sylvester Comprehensive Cancer Center, University of Mi...
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doaj-71b6bf3aa8c841d39c0b1fa517ad39ff2020-11-25T00:39:36ZengDove Medical PressJournal of Hepatocellular Carcinoma2253-59692018-01-01Volume 591536364Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinomaFeun LGWangpaichitr MLi YYKwon DRichman SPHosein PJSavaraj NLynn G Feun,¹ Medhi Wangpaichitr,² Ying-Ying Li,¹ Deukwoo Kwon,³ Stephen P Richman,¹ Peter J Hosein,¹ Niramol Savaraj¹,² ¹Department of Medicine, Medical Oncology, Sylvester Comprehensive Cancer Center, University of Miami, ²Department of Surgery, Miami VA Healthcare System, Research Service, ³Biostatistics and Bioinformatics Core, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA Background: A phase II trial of pasireotide was performed to assess its efficacy and safety in advanced or metastatic hepatocellular carcinoma (HCC).Patients and methods: Patients with advanced HCC and Child–Pugh score ≤7 received pasireotide LAR 60 mg intramuscularly every 28 days. Primary endpoint was disease control rate. Secondary endpoints were time to tumor progression, response rate, treatment-related adverse events, and overall survival. Serum insulin growth factor-1 was measured before and after pasireotide.Results: Twenty patients were treated and evaluable. Eighteen patients (90%) had prior therapy; 16 patients (80%) had multiple therapies. Median age was 65, 75% had Barcelona Clinic Liver Cancer stage C, and 55% had metastatic disease. The main toxicity was hyperglycemia. Rare adverse effects included reversible grade 4 elevation in alanina transaminase/aspartate transaminase in one patient. The best response was stable disease in 9 patients (45%). Median time to tumor progression for the 20 patients was 3 months, and median survival was 9 months.Conclusion: Pasireotide had limited clinical benefit as second-line or third-line treatment in patients with advanced or metastatic HCC. Low baseline insulin growth factor-1 level may be indicative when SOM230 treatment may be ineffective, and decreasing levels after treatment may be indicative of disease control. Keywords: pasireotide, hepatocellular carcinoma, insulin growth factor-1 https://www.dovepress.com/phase-ii-trial-of-som230-pasireotide-lar-in-patients-with-unresectable-peer-reviewed-article-JHCpasireotidehepatocellular carcinoma |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Feun LG Wangpaichitr M Li YY Kwon D Richman SP Hosein PJ Savaraj N |
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Feun LG Wangpaichitr M Li YY Kwon D Richman SP Hosein PJ Savaraj N Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma Journal of Hepatocellular Carcinoma pasireotide hepatocellular carcinoma |
author_facet |
Feun LG Wangpaichitr M Li YY Kwon D Richman SP Hosein PJ Savaraj N |
author_sort |
Feun LG |
title |
Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma |
title_short |
Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma |
title_full |
Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma |
title_fullStr |
Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma |
title_full_unstemmed |
Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma |
title_sort |
phase ii trial of som230 (pasireotide lar) in patients with unresectable hepatocellular carcinoma |
publisher |
Dove Medical Press |
series |
Journal of Hepatocellular Carcinoma |
issn |
2253-5969 |
publishDate |
2018-01-01 |
description |
Lynn G Feun,¹ Medhi Wangpaichitr,² Ying-Ying Li,¹ Deukwoo Kwon,³ Stephen P Richman,¹ Peter J Hosein,¹ Niramol Savaraj¹,² ¹Department of Medicine, Medical Oncology, Sylvester Comprehensive Cancer Center, University of Miami, ²Department of Surgery, Miami VA Healthcare System, Research Service, ³Biostatistics and Bioinformatics Core, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA Background: A phase II trial of pasireotide was performed to assess its efficacy and safety in advanced or metastatic hepatocellular carcinoma (HCC).Patients and methods: Patients with advanced HCC and Child–Pugh score ≤7 received pasireotide LAR 60 mg intramuscularly every 28 days. Primary endpoint was disease control rate. Secondary endpoints were time to tumor progression, response rate, treatment-related adverse events, and overall survival. Serum insulin growth factor-1 was measured before and after pasireotide.Results: Twenty patients were treated and evaluable. Eighteen patients (90%) had prior therapy; 16 patients (80%) had multiple therapies. Median age was 65, 75% had Barcelona Clinic Liver Cancer stage C, and 55% had metastatic disease. The main toxicity was hyperglycemia. Rare adverse effects included reversible grade 4 elevation in alanina transaminase/aspartate transaminase in one patient. The best response was stable disease in 9 patients (45%). Median time to tumor progression for the 20 patients was 3 months, and median survival was 9 months.Conclusion: Pasireotide had limited clinical benefit as second-line or third-line treatment in patients with advanced or metastatic HCC. Low baseline insulin growth factor-1 level may be indicative when SOM230 treatment may be ineffective, and decreasing levels after treatment may be indicative of disease control. Keywords: pasireotide, hepatocellular carcinoma, insulin growth factor-1 |
topic |
pasireotide hepatocellular carcinoma |
url |
https://www.dovepress.com/phase-ii-trial-of-som230-pasireotide-lar-in-patients-with-unresectable-peer-reviewed-article-JHC |
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