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SIRveNIB

SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma

Phase 3N = 360NCT01135056

Population
Locally advanced HCC, Asia-Pacific region
Design
Open-label, investigator-initiated, randomised (1:1) phase 3 trial in 11 countries in the Asia-Pacific region, a two-tailed study designed for superiority or detriment: yttrium-90 resin microspheres radioembolisation (RE) versus sorafenib 800 mg per day in patients with locally advanced HCC; stratified by centre and presence of portal vein thrombosis. Efficacy analyses were in the ITT population and safety analyses in the treated population.
Primary endpoint
OS
Arms
  • Radioembolisation with yttrium-90 (experimental, n = 182): Yttrium-90 resin microspheres radioembolisation (RE)
  • Sorafenib (control, n = 178): Sorafenib 800 mg per day
People
Chow PKH
OSHR 1.1 (95% CI 0.9–1.4)Δ median OS−1.2 months
Show the numbers
Results reported for SIRveNIB
EndpointAnalysisRadioembolisation with yttrium-90SorafenibEffect
OSOverall survival (primary end point)primaryChow 2018median 8.8 monthsmedian 10 monthsHR 1.1 (95% CI 0.9–1.4)P=0.36Hazard ratio is for radioembolisation versus sorafenib, as rounded in the abstract.
Results reported for SIRveNIB
EndpointAnalysisRadioembolisation with yttrium-90SorafenibEffect
OSOverall survival (primary end point)primaryChow 2018median 8.8 monthsmedian 10 monthsHR 1.1 (95% CI 0.9–1.4)P=0.36Hazard ratio is for radioembolisation versus sorafenib, as rounded in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.10.9–1.4
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Radioembolisation 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)
MonthsRadioembolisation with yttrium-90Sorafenib
0100.0%100.0%
662.3%66.0%
1335.9%40.6%
1922.4%26.8%
2514.0%17.7%
Primary publication: Chow PKH, Gandhi M, Tan SB, Khin MW, Khasbazar A, Ong J, et al. SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma. J Clin Oncol. 2018;36(19):1913-1921. PubMedDOI

Appears in

Sources

  1. Chow PKH, Gandhi M, Tan SB, Khin MW, Khasbazar A, Ong J, et al. SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma. J Clin Oncol. 2018;36(19):1913-1921.

    PubMedDOI