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Sorafenib, selective internal radiation yield similar survival in HCC

AMSTERDAM — Selective internal radiation therapy failed to best Nexavar in overall survival but did yield improvements in other parameters, including quality of life, in patients with hepatocellular carcinoma, according to data presented at the International Liver Congress.

“SIRT does not increase overall survival in patients with advanced and inoperable HCC compared to sorafenib,” Valerie Vilgrain, MD, of Hôpital Beaujon Service de Radiologie in Paris, said in a press conference. “Yet, SIRT offers a higher tumor response, a better tolerance with less treatment-related adverse events and a better quality of life over time and ... these issues are extremely important.”

Vilgrain said that although Nexavar (sorafenib, Bayer/Onyx Pharmaceuticals) is the backbone of care in HCC, selective internal radiation therapy (SIRT) at Y90 microspheres has shown efficacy in certain cohorts.

OS served as the primary endpoint in the current study, which was conducted at 25 centers in France. PFS, intrahepatic and extrahepatic progression, severity of disease and QOL were secondary endpoints. “The cohort included patients with locally advanced HCC who were not resectable,” Vilgrain said in her presentation.

The overall study population included 237 patients treated with SIRT and 222 patients treated with sorafenib. The data set included intention-to-treat (ITT), per protocol and safety populations.

Results of the ITT analysis showed that OS was 8 months in the SIRT group and 9.9 months for sorafenib (HR = 1.15; 95% CI, 0.94-1.41). For the per protocol analysis, the OS was 9.9 months in both groups (HR = 0.99; 95% CI, 0.79-1.24). “Subgroup analysis showed that OS was similar in subgroups like age, sex [and] severity of disease,” Vilgrain said. 

Secondary results indicated a median PFS duration of 4.1 months for SIRT and 3.7 months for sorafenib. Radiologic progression also was similar between the two groups.

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However, tumor response as assessed by Recist 1.1 criteria, which combined complete and partial response, showed a 19.0% rate for SIRT and an 11.6% rate for sorafenib (P = .042).

Safety was significantly better with SIRT, with 1,297 total adverse events occurring in that group and 2,837 occurring in the sorafenib group. Grade 3 events occurred in 230 patients in the SIRT group and 411 of those in the sorafenib group.

Treatment related adverse event rates were 20% for SIRT and 41% for sorafenib.

“Dermatologic complications and gastrointestinal complications like diarrhea or abdominal pain were higher in sorafenib,” Vilgrain said.

QOL also was significantly better in the SIRT group (P = .0005), according to Vilgrain. The per-protocol analysis showed a significantly better group QOL effect (P = .003).

Patients with Child-Pugh class A or B at 7 or less were included in the study, along with those with ECOG score 0-1, Recist criteria 1.1 and no extrahepatic manifestations at baseline. The two groups had similar baseline characteristics. The population was mostly male, with cirrhosis and alcohol misuse in most of the cases, according to Vilgrain. – by Rob Volansky

Reference: Vilgrain V, et al. GS-012. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.

Disclosure: Vilgrain reports receiving grants from Sirtex, consulting for Guerbet, delivering sponsored lectures for Bracco, Esga, JFR, Sirtex and Supersonic.