Addition of Y-90 radioembolization increases tumor response and local disease control in hepatocellular carcinoma patients receiving sorafenib

Abstract

Purpose To compare the treatment response and progression-free survival (PFS) in advanced hepatocellular carcinoma (HCC) patients who received sorafenib treatment either alone or combined with radioembolization (RE). Methods Follow-up images of the patients treated within a multicenter phase II trial (SORAMIC) were assessed by mRECIST. A total of 177 patients (73 combination arm [RE + sorafenib] and 104 sorafenib arm) were included in this post-hoc analysis. Response and progression characteristics were compared between treatment arms. Survival analyses were done to compare PFS and post-progression survival between treatment arms. Multivariate Cox regression analysis was used to compare survival with factors known to influence PFS in patients with HCC. Results The combination arm had significantly higher objective response rate (61.6% vs. 29.8%, p < 0.001), complete response rate (13.7% vs. 3.8%, p = 0.022), and a trend for higher disease control rate (79.2% vs. 72.1%, p = 0.075). Progression was encountered in 116 (65.5%) patients and was more common in the sorafenib arm (75% vs. 52.0%, p = 0.001). PFS (median 8.9 vs. 5.4 months, p = 0.022) and hepatic PFS were significantly better in the combination arm (9.0 vs. 5.7 months, p = 0.014). Multivariate analysis confirmed the treatment arm as an independent predictor of PFS. Conclusion In advanced HCC patients receiving sorafenib, combination with RE has an additive anticancer effect on sorafenib treatment resulting in a higher and longer tumor response. However, the enhanced response did not translate into prolonged survival. Better patient selection and superselective treatment could improve outcomes after combination therapy.

Recent advances in the management of hepatocellular carcinoma

“…Patients who received combination therapy had higher objective response rate (61.6% vs. 29.8%, P<0.001), complete response rate (13.7% vs. 3.8%, P=0.022), median PFS (8.9 vs. 5.4 months, P=0.022), and hepatic median PFS (9.0 vs. 5.7 months, P=0.014). 58 However, an improvement in OS was not seen in the combination arm. Similarly, the TACTICS trial evaluated TACE compared to TACE plus sorafenib in patients with unresectable HCC.…”

“…In the multicenter phase II SORAMIC trial, patients with advanced HCC received sorafenib either alone or in combination with radioembolization. Patients who received combination therapy had higher objective response rate (61.6% vs. 29.8%, P <0.001), complete response rate (13.7% vs. 3.8%, P =0.022), median PFS (8.9 vs. 5.4 months, P =0.022), and hepatic median PFS (9.0 vs. 5.7 months, P =0.014) [ 58 ]. However, an improvement in OS was not seen in the combination arm.…”