Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study)
Hamdy A Azim,1 Ashraf Omar,2 Hesham Atef,1,† Heba Zawahry,3 Mohamed K Shaker,4 AH Kamel Abdelmaksoud,5 Mohamed EzzElarab,6 Omar Abdel-Rahman,7 Mohamed Ismail,8 Loay Kassem,1 Imam Waked9 1Department of Clinical Oncology, Faculty of Medicine, Cairo University, Cairo, Egypt; 2Department of G...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2018-11-01
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| Series: | Journal of Hepatocellular Carcinoma |
| Subjects: | |
| Online Access: | https://www.dovepress.com/sorafenib-plus-tegafur-uracil-uft-versus-sorafenib-as-first-line-syste-peer-reviewed-article-JHC |
| _version_ | 1828293739659919360 |
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| author | Azim HA Omar A Atef H Zawahry H Shaker MK Abdelmaksoud AHK EzzElarab M Abdel-Rahman O Ismail M Kassem L Waked I |
| author_facet | Azim HA Omar A Atef H Zawahry H Shaker MK Abdelmaksoud AHK EzzElarab M Abdel-Rahman O Ismail M Kassem L Waked I |
| author_sort | Azim HA |
| collection | DOAJ |
| description | Hamdy A Azim,1 Ashraf Omar,2 Hesham Atef,1,† Heba Zawahry,3 Mohamed K Shaker,4 AH Kamel Abdelmaksoud,5 Mohamed EzzElarab,6 Omar Abdel-Rahman,7 Mohamed Ismail,8 Loay Kassem,1 Imam Waked9 1Department of Clinical Oncology, Faculty of Medicine, Cairo University, Cairo, Egypt; 2Department of Gastroenterology, Faculty of Medicine, Cairo University, Cairo, Egypt; 3Department of Medical Oncology, National Cancer Institute, Cairo, Egypt; 4Tropical Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 5Department of Diagnostic and Intervention Radiology, Cairo University, Cairo, Egypt; 6National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt; 7Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 8Clinical Oncology Department, Cairo Oncology Center, Cairo, Egypt; 9Institute of Liver Disease, Menoufiya University, Menoufiya, Egypt †Dr Hesham Atef passed away on November 16, 2017, during the preparation of the manuscript Background: Phase II trials found that tegafur–uracil (UFT) is an effective drug in hepatocellular carcinoma (HCC), while preclinical data suggested that its combination with sorafenib may have a promising activity. Our Phase II randomized trial aimed to evaluate efficacy and tolerability of sorafenib plus UFT vs sorafenib in advanced HCC.Methods: Patients with advanced HCC, with no prior systemic therapy, were randomized to receive either UFT at 125 mg/m2 twice daily for 4 out of 5 weeks plus sorafenib at 400 mg twice daily (arm 1) or single agent sorafenib at 400 mg twice daily (arm 2). Primary end point was time to progression (TTP).Results: Between March 2012 and March 2014, 76 eligible patients – out of 143 preplanned – were randomized. The study was terminated early because of futility. This is the final analysis of the study, after a median follow-up of 10.2 months and death of 86% of randomized patients (n=64). Median TTP was 7.5 months and 8.2 months in arms 1 and 2 respectively (HR: 1.07; 95% CI, 0.52–2.22; P=0.855), while the median overall survival was 8.2 months and 10.5 months respectively (HR: 1.58; 95% CI: 0.90–2.76, P=0.112). Nine patients (25%) in the combination arm discontinued treatment because of toxicity vs eight patients (21.1%) in the sorafenib monotherapy arm (P=0.899).Conclusion: In patients with advanced HCC, adding UFT to sorafenib is feasible, but it did not improve efficacy outcome over sorafenib monotherapy. Keywords: advanced hepatocellular carcinoma, sorafenib, tegafur/uracil, Egypt |
| first_indexed | 2024-04-13T11:25:02Z |
| format | Article |
| id | doaj.art-3dca050900bd4e6d9d22622836f1c67b |
| institution | Directory Open Access Journal |
| issn | 2253-5969 |
| language | English |
| last_indexed | 2024-04-13T11:25:02Z |
| publishDate | 2018-11-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Journal of Hepatocellular Carcinoma |
| spelling | doaj.art-3dca050900bd4e6d9d22622836f1c67b2022-12-22T02:48:42ZengDove Medical PressJournal of Hepatocellular Carcinoma2253-59692018-11-01Volume 510911942398Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study)Azim HAOmar AAtef HZawahry HShaker MKAbdelmaksoud AHKEzzElarab MAbdel-Rahman OIsmail MKassem LWaked IHamdy A Azim,1 Ashraf Omar,2 Hesham Atef,1,† Heba Zawahry,3 Mohamed K Shaker,4 AH Kamel Abdelmaksoud,5 Mohamed EzzElarab,6 Omar Abdel-Rahman,7 Mohamed Ismail,8 Loay Kassem,1 Imam Waked9 1Department of Clinical Oncology, Faculty of Medicine, Cairo University, Cairo, Egypt; 2Department of Gastroenterology, Faculty of Medicine, Cairo University, Cairo, Egypt; 3Department of Medical Oncology, National Cancer Institute, Cairo, Egypt; 4Tropical Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 5Department of Diagnostic and Intervention Radiology, Cairo University, Cairo, Egypt; 6National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt; 7Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 8Clinical Oncology Department, Cairo Oncology Center, Cairo, Egypt; 9Institute of Liver Disease, Menoufiya University, Menoufiya, Egypt †Dr Hesham Atef passed away on November 16, 2017, during the preparation of the manuscript Background: Phase II trials found that tegafur–uracil (UFT) is an effective drug in hepatocellular carcinoma (HCC), while preclinical data suggested that its combination with sorafenib may have a promising activity. Our Phase II randomized trial aimed to evaluate efficacy and tolerability of sorafenib plus UFT vs sorafenib in advanced HCC.Methods: Patients with advanced HCC, with no prior systemic therapy, were randomized to receive either UFT at 125 mg/m2 twice daily for 4 out of 5 weeks plus sorafenib at 400 mg twice daily (arm 1) or single agent sorafenib at 400 mg twice daily (arm 2). Primary end point was time to progression (TTP).Results: Between March 2012 and March 2014, 76 eligible patients – out of 143 preplanned – were randomized. The study was terminated early because of futility. This is the final analysis of the study, after a median follow-up of 10.2 months and death of 86% of randomized patients (n=64). Median TTP was 7.5 months and 8.2 months in arms 1 and 2 respectively (HR: 1.07; 95% CI, 0.52–2.22; P=0.855), while the median overall survival was 8.2 months and 10.5 months respectively (HR: 1.58; 95% CI: 0.90–2.76, P=0.112). Nine patients (25%) in the combination arm discontinued treatment because of toxicity vs eight patients (21.1%) in the sorafenib monotherapy arm (P=0.899).Conclusion: In patients with advanced HCC, adding UFT to sorafenib is feasible, but it did not improve efficacy outcome over sorafenib monotherapy. Keywords: advanced hepatocellular carcinoma, sorafenib, tegafur/uracil, Egypthttps://www.dovepress.com/sorafenib-plus-tegafur-uracil-uft-versus-sorafenib-as-first-line-syste-peer-reviewed-article-JHCAdvanced hepatocellular carcinomasorafenibTegafur/uracilEgypt |
| spellingShingle | Azim HA Omar A Atef H Zawahry H Shaker MK Abdelmaksoud AHK EzzElarab M Abdel-Rahman O Ismail M Kassem L Waked I Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study) Journal of Hepatocellular Carcinoma Advanced hepatocellular carcinoma sorafenib Tegafur/uracil Egypt |
| title | Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study) |
| title_full | Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study) |
| title_fullStr | Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study) |
| title_full_unstemmed | Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study) |
| title_short | Sorafenib plus tegafur–uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study) |
| title_sort | sorafenib plus tegafur ndash uracil uft versus sorafenib as first line systemic treatment for patients with advanced stage hcc a phase ii trial eslc01 study |
| topic | Advanced hepatocellular carcinoma sorafenib Tegafur/uracil Egypt |
| url | https://www.dovepress.com/sorafenib-plus-tegafur-uracil-uft-versus-sorafenib-as-first-line-syste-peer-reviewed-article-JHC |
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