WEDNESDAY, Sept. 14 (HealthDay News) -- In patients with unresectable hepatocellular carcinoma (HCC), combined treatment with transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) and sorafenib is well tolerated and safe, according to a study published online Sept. 12 in the Journal of Clinical Oncology.
Timothy M. Pawlik, M.D., M.P.H., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues evaluated the safety and efficacy of DEB-TACE in combination with sorafenib (400 mg twice per day) in 35 patients (mean age, 63 years) with advanced HCC (mean index tumor size, 7.7 cm). In a phase II study, participants underwent 128 cycles of therapy with 60 cycles of sorafenib plus DEB-TACE, and 68 cycles of sorafenib alone. On average, every patient received two cycles of therapy with sorafenib treatment for an average of 71 days.
The investigators found that during cycle one, fatigue, anorexia, alterations in liver enzymes, and dermatologic adverse effects were the most common toxicities. Although most of the toxicities were mild (83 percent were grade 1 to 2 versus 17 percent that were grade 3 to 4), most patients experienced at least one grade 3 to 4 toxicity. Toxicity was decreased during cycle two. A total of 40 sorafenib dose interruptions and 25 sorafenib dose reductions were observed during the study. Sorafenib plus DEB-TACE was associated with a disease control rate of 95 percent, and an objective response of 58 percent.
"The combination of sorafenib and DEB-TACE in patients with unresectable HCC is well tolerated and safe, with most toxicities related to sorafenib," the authors write.
The study was supported in part by Bayer HealthCare, Onyx, and Biocompatibles; two authors disclosed financial relationships with these and other the pharmaceutical and health care companies.
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