Comparable OS with SIRT, sorafenib in Asia Pacific patients with HCC
Patients with locally advanced hepatocellular carcinoma (HCC) from the Asia Pacific region had comparable overall survival (OS) regardless of whether they were treated with selective internal radiation therapy (SIRT) or sorafenib. However, SIRT appeared to be more tolerable than sorafenib, according to results of the phase III SIRveNIB* trial.
“[SIRT] was neither superior nor detrimental compared with sorafenib in locally advanced HCC. However, tumour response rate [TRR] and adverse event [AE] frequency were improved with [SIRT] over sorafenib,” said study lead author Professor Pierce Chow from the National Cancer Centre Singapore and co-authors.
Researchers of this multinational (27 centres in 11 Asia Pacific countries), open-label trial randomized 360 adult patients with locally advanced HCC to undergo a single radioembolization treatment (SIRT with yttrium-90 resin microspheres; n=182) or continuous treatment with oral sorafenib (800 mg/day, median treatment duration 13.8 weeks; n=178). Of these, 28.6 and 9.0 percent of patients assigned to SIRT and sorafenib, respectively, did not undergo treatment, leaving 130 (mean age 60.9 years, 82.3 percent male) and 162 patients (mean age 57.5 years, 85.2 percent male) in the SIRT and sorafenib groups, respectively (treated population).
Results showed that median OS was comparable between patients who were treated with SIRT and sorafenib (8.8 vs 10.0 months, hazard ratio [HR], 1.12, 95 percent confidence interval, 0.9–1.4; p=0.36). [J Clin Oncol 2018;doi:10.1200/JCO.2017.76.0892]
Among patients in the treated population, those with Barcelona Clinic Liver Cancer stage C who received SIRT demonstrated greater OS than those who received sorafenib (9.2 vs 5.8 months, HR, 0.67; p=0.0475), though researchers pointed out that these findings warrant further research due to the limited number of patients with BCLC stage C (n=50 and 73 on SIRT and sorafenib, respectively).
In the treated population, SIRT-treated patients had better TRR compared with sorafenib-treated patients (23.1 percent vs 1.9 percent; p<0.001), as well as longer progression-free survival at any site (median, 6.3 vs 5.2 months, HR, 0.73; p=0.0128) and time to tumour progression at any site (median, 6.4 vs 5.4 months, HR, 0.73; p=0.0188).
There were 1,468 treatment-emergent AEs reported, 437 and 1,031 in patients treated with SIRT and sorafenib, respectively.
Grade ≥3 AEs occurred less frequently among SIRT-treated compared with sorafenib-treated patients (27.7 percent vs 50.6 percent; p<0.001), with ascites (3.8 percent vs 2.5 percent), abdominal pain (2.3 percent vs 1.2 percent), anaemia (0 percent vs 2.5 percent), and radiation hepatitis (1.5 percent vs 0 percent) the most common grade ≥3 AEs. Serious AEs also occurred less frequently among SIRT-treated than sorafenib-treated patients (20.8 percent vs 35.2 percent).
According to the researchers, despite sorafenib being the “reference treatment” for locally advanced or metastatic HCC, dose reduction or treatment discontinuation is often necessary due to AEs. [N Engl J Med 2008;359:378-390; Oncologist 2009;14:70-76]
As such, the improved AE profile with SIRT “may offer a better-tolerated alternative to sorafenib for patients with HCC”, they said.
A limitation of the study was the lack of radioembolization facilities in several of the participating countries. Thus, patients from five countries had to travel to Singapore for assessment and treatment which resulted in treatment delay and subsequent disease progression, death, or withdrawal from the study.