Phase I study of combination chemotherapy using sorafenib and transcatheter arterial infusion with cisplatin for advanced hepatocellular carcinoma.
Bottom Line: The common drug-related adverse events that were of severity grade 3 or 4 included the elevation of aspartate aminotransferase (30%), alanine aminotransferase (20%), amylase (30%), and lipase (30%).The median overall survival and progression-free survival were 9.1 and 3.3 months, respectively.The combination of sorafenib at 800 mg/day with TAI of cisplatin at 65 mg/m(2) /cycle was determined to be the recommended regimen.
Affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Hepatology, Osaka City University Hospital, Osaka, Japan.Show MeSH
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Mentions: No patients had a complete response, five patients (25%) showed partial responses, and 12 patients (60%) showed stable disease. Progressive disease occurred in three patients (15%). During the treatment, the serum AFP level decreased in 12 patients (60%), and the serum DCP level decreased in nine patients (45%). All patients were included in the survival assessment. Of the 20 patients, one is still alive at the time of drafting this manuscript. He survived more than 40 months. He received six courses of combination chemotherapy of sorafenib with TAI of cisplatin. His HCC shrank partially, allowing for surgical resection, and no recurrence was seen. The other 19 patients did not survive. The cause of death was tumor progression in 18 of the patients and myocardial disease in one patient. The median OS and median PFS were 9.1 and 3.3 months, respectively (Fig.1).
Affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Hepatology, Osaka City University Hospital, Osaka, Japan.