Skip to content
Bending the Curve Trial by Trial
?

SARAH

Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial

Phase 3N = 467NCT01482442

Population
Locally advanced or inoperable HCC (BCLC stage C), or HCC not eligible for surgery or ablation after a previous cure, or after two unsuccessful TACE rounds; ECOG 0 or 1; Child-Pugh A or B with a score of 7 or lower
Design
Multicentre, open-label, investigator-initiated, randomised (1:1) phase 3 trial at 25 centres in France: selective internal radiotherapy (SIRT) with yttrium-90 resin microspheres 2 to 5 weeks after randomisation versus continuous oral sorafenib 400 mg twice daily. Eligible patients had ECOG performance status 0 or 1, Child-Pugh class A or a B score of 7 or lower, and locally advanced HCC (BCLC stage C), or new HCC not eligible for resection, transplantation or thermal ablation after a previous cure, or HCC after two unsuccessful rounds of TACE. 467 were randomised; after eight patients withdrew consent, 237 were assigned to SIRT and 222 to sorafenib.
Primary endpoint
OS
Arms
  • SIRT with yttrium-90 (experimental, n = 237): Selective internal radiotherapy with yttrium-90 resin microspheres 2 to 5 weeks after randomisation
  • Sorafenib (control, n = 222): Continuous oral sorafenib 400 mg twice daily
People
Vilgrain V
OSHR 1.15 (95% CI 0.94–1.41)Δ median OS−1.9 months
Show the numbers
Results reported for SARAH
EndpointAnalysisSIRT with yttrium-90SorafenibEffect
OSOverall survival (primary end point), final resultsfinalVilgrain 2017median 8 months (6.7–9.9)median 9.9 months (8.7–11.4)HR 1.15 (95% CI 0.94–1.41)P=0.18Hazard ratio is for SIRT versus sorafenib. Median follow-up was 27.9 months (IQR 21.9-33.6) in the SIRT group and 28.1 months (20.0-35.3) in the sorafenib group.
Results reported for SARAH
EndpointAnalysisSIRT with yttrium-90SorafenibEffect
OSOverall survival (primary end point), final resultsfinalVilgrain 2017median 8 months (6.7–9.9)median 9.9 months (8.7–11.4)HR 1.15 (95% CI 0.94–1.41)P=0.18Hazard ratio is for SIRT versus sorafenib. Median follow-up was 27.9 months (IQR 21.9-33.6) in the SIRT group and 28.1 months (20.0-35.3) in the sorafenib group.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.150.94–1.41
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%05101520Months (modelled)
  • SIRT with yttrium-90 (experimental)
  • Sorafenib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSIRT with yttrium-90Sorafenib
0100.0%100.0%
659.5%65.7%
1235.4%43.2%
1919.3%26.4%
2511.5%17.4%
Primary publication: Vilgrain V, Pereira H, Assenat E, Guiu B, Ilonca AD, Pageaux GP, et al. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2017;18(12):1624-1636. PubMedDOI

Appears in

Sources

  1. Vilgrain V, Pereira H, Assenat E, Guiu B, Ilonca AD, Pageaux GP, et al. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2017;18(12):1624-1636.

    PubMedDOI