Concomitant chemoradiation using gemcitabine in locally advanced hepatocellular carcinoma

Abstract

e15611 Background: Hepatocellular carcinoma (HCC) is among the most common malignancies in Pakistan. There is currently no standard management for advanced HCC. Non-surgical modalities have demonstrated minimal improvements in survival. The aim of present study is to assess response rate and toxicity of concomitant gemcitabine and external radiation therapy (ERT) in locally advanced HCC. Methods: Thirty three biopsy proven advanced HCC patients having Okuda stage I and II disease were enrolled. 70 mg/m2 gemcitabine was given once weekly for three weeks during ERT. Partial liver ERT was delivered with 60Co upto 30 gray (Gy), 1.8 Gy/fraction and five fractions in a week. Tumor response was assessed by computed tomography (CT) eight weeks after completion of treatment. Response Evaluation Criteria in Solid Tumors (RECIST) was used to assess complete and partial response (CR, PR); progressive and stable disease (PD, SD). Hematological [neutropenia and thrombocytopenia], gastrointestinal (vomiting and diarrhea) and liver [encephalopathy, bilirubin, alanine and aspartate transferases (ALT and AST), and alkaline phosphatase (ALP)] toxicities were assessed weekly during treatment and then fortnightly upto 2 months according to Common Toxicity Criteria for Adverse Events version (3.0). Primary end point was to assess response rate at eight weeks after completion of treatment and Grade 3 or 4 toxicity during this period. Results: 28/33 patients were evaluable. No CR was seen. PR, SD and PD (%) were seen in 36, 39 and 25 of patients respectively. No grade 3 or 4 neutropenia was observed. 7/28 (25%) of patients developed grade 3 thrombocytopenia during treatment and needed a delay of one week for gemcitabine administration. Grade 3/4 toxicity (%) related to vomiting, diarrhea, encephalopathy, bilirubin, ALT, AST and ALP was seen in 18, 29, 21, 18, 14, 29 and 32 of the patients. Conclusions: The study showed that concomitant chemoradiation using 70mg/m2 gemcitabine is a feasible option with acceptable toxicity in locally advanced HCC. A larger study will be appropriate to define its definite role. No significant financial relationships to disclose.