Efficacy of low dose sorafenib and capecitabine in the management of hepatocellular cancer.

Abstract

e16117 Background: Hepatocellular cancer (HCC) is one of the commonest cancers in Pakistan due to endemic hepatitis B and C diseases. Its incidence is continuously rising due to lack of public awareness and lack of routine screening of the affected population. Most of the patients present in advanced stage of the disease excluding option for curative surgical options. These patients are mostly not fit enough to tolerate systemic therapies in full doses. So, we have to adapt ourselves to lower dosage so that it can be tolerated without many untoward side effects. Methods: This study was aimed to assess the efficacy of low dose sorafenib (400 mg daily in two divided doses) and capecitabine (1000 mg daily in two divided doses) in advanced hepatocellular carcinoma. Patients were prescribed this treatment for six months and then response was assessed using computed tomography or ultrasound and alpha fetoprotein (AFP) levels. Progression-free survival (PFS) and overall survival (OS) were also assessed. Results: Total of one-hundred fifty-five patients were enrolled. One hundred thirteen patients completed the treatment for six months and were evaluated for response. A total of 28 (25%) of patients progressed during treatment and were shifted to other treatment options. Nine patients (8%) had complete response, thirty-four (30%) had partial response, forty-two (37%) had stable disease and twenty-eight (25%) had progressive disease. Seventy-four patients (65%) showed significant reduction in AFP levels. A total of 85/113 (75%) patients were available for assessment of PFS and OS. Two-year PFS and OS were 32% and 43% respectively. Mean and median PFS (year) were 1.82 ±0.19 (95% confidence interval 1.48 to 2.17) and 1.27±0.16 (95% confidence interval 0.94 to 1.57) respectively. Mean and median OS (year) were 2.73 ±0.24 (95% confidence interval 2.39 to 3.16) and 2.27±0.13 (confidence interval 2.02 to 2.54) respectively. Twenty-six patients had one or more episode of grade 2 diarrhea, eleven patients developed encephalopathy, thirteen patients developed hand foot syndrome and nineteen patients showed grade 2 thrombocytopenia. Conclusions: Low dose sorafenib and capecitabine is effective in the treatment of advanced HCC with excellent tolerability and minimal toxicity.