Efficacy and safety of sorafenib-gemcitabine combination therapy in advanced hepatocellular carcinoma: an open-label Phase II feasibility study

Hematology/oncology and Stem Cell Therapy
Naeem NaqiJavaid Khattak

Abstract

Sorafenib is considered a standard of care in advanced hepatocellular carcinoma (HCC). Its combination with gemcitabine, a pyrimidine analogue with limited friendly hepatic profile may prove beneficial in advanced HCC. The primary objective was to evaluate the efficacy and safety of a sorafenib and gemcitabine combination in patients with advanced HCC. This was a non-randomized, open-label, single-arm, multi-centric Phase II study conducted in Pakistan where 30 treatment-naive patients aged between 26 and 73 years with Child-Pugh score A or B were treated with sorafenib (400 mg oral) twice daily for 16 weeks along with gemcitabine (1000 mg/m(2) intravenous) administered on day 1 and day 8 of a four-week cycle for 16 weeks. Of the 18 patients (60%) who completed all four cycles of treatment, eight patients had stable disease, two had partial response, and eight had progressive disease. There was no complete response. The most common (≥10% patients) treatment-emergent adverse events were gemcitabine-related thrombocytopenia (40%) followed by sorafenib-related hand-foot skin reaction and anorexia (33% each). The efficacy of sorafenib gemcitabine combination therapy is similar to the sorafenib alone treatment. However, frequent dos...Continue Reading

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Citations

Mar 10, 2016·Gastroenterology Research and Practice·Abu Bakar Hafeez BhattiNajmul Hassan Shah
Oct 9, 2014·Asian Pacific Journal of Cancer Prevention : APJCP·Alvina MunafMaheshwari Bhunesh Kumar
Jun 11, 2020·Therapeutic Advances in Medical Oncology·Guanghan FanXiao Xu
Mar 6, 2021·Clinics and Research in Hepatology and Gastroenterology·Izabela ZarębskaŁukasz Szylberg

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