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Azim HA, Omar A, Atef H, et al. Sorafenib plus tegafur-uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study). J Hepatocell Carcinoma. 2018;5:109-119doi: 10.2147/JHC.S169285.
Azim, H. A., Omar, A., Atef, H., Zawahry, H., Shaker, M. K., Abdelmaksoud, A. K., EzzElarab, M., Abdel-Rahman, O., Ismail, M., Kassem, L., & Waked, I. (2018). 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, 5109-119. https://doi.org/10.2147/JHC.S169285
Azim, Hamdy A, et al. "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 vol. 5 (2018): 109-119. doi: https://doi.org/10.2147/JHC.S169285
Azim HA, Omar A, Atef H, Zawahry H, Shaker MK, Abdelmaksoud AK, 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). J Hepatocell Carcinoma. 2018 Nov 19;5:109-119. doi: 10.2147/JHC.S169285. eCollection 2018. PMID: 30510922; PMCID: PMC6250115.
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J Hepatocell Carcinoma. 2018 Nov 19;5:109-119. doi: 10.2147/JHC.S169285. eCollection 2018.

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

Hamdy A Azim, Ashraf Omar, Hesham Atef, Heba Zawahry, Mohamed K Shaker, Ah Kamel Abdelmaksoud, Mohamed EzzElarab, Omar Abdel-Rahman, Mohamed Ismail, Loay Kassem, Imam Waked

Affiliations

  1. Department of Clinical Oncology, Faculty of Medicine, Cairo University, Cairo, Egypt, [email protected], [email protected].
  2. Department of Gastroenterology, Faculty of Medicine, Cairo University, Cairo, Egypt.
  3. Department of Medical Oncology, National Cancer Institute, Cairo, Egypt.
  4. Tropical Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
  5. Department of Diagnostic and Intervention Radiology, Cairo University, Cairo, Egypt.
  6. National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
  7. Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
  8. Clinical Oncology Department, Cairo Oncology Center, Cairo, Egypt.
  9. Institute of Liver Disease, Menoufiya University, Menoufiya, Egypt.

PMID: 30510922 PMCID: PMC6250115 DOI: 10.2147/JHC.S169285

Abstract

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/m

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;

CONCLUSION: In patients with advanced HCC, adding UFT to sorafenib is feasible, but it did not improve efficacy outcome over sorafenib monotherapy.

Keywords: Egypt; advanced hepatocellular carcinoma; sorafenib; tegafur/uracil

Conflict of interest statement

Disclosure IW received grants/research supports from: Abbvie, Gilead, Janssen, Pharco, Mylan, Onxio and participated in company sponsored speaker’s bureau of Abbvie, Eva-Pharma, Gilead, Janssen, Marcy

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