OnCo
trialsTrialNegative

SARAH and SIRveNIB

Two large trials found radioactive beads were gentler than sorafenib but did not help patients live longer.

SARAH (n=459): OS 8.0 vs 9.9 months (HR 1.15, not significant); SIRveNIB (n=360): OS 8.8 vs 10.0 months (HR 1.12). Better quality of life and response with Y-90. Interpreted as showing the need for personalised dosimetry and earlier-stage use rather than the failure of the modality.

Setting
Locally advanced HCC: yttrium-90 radioembolisation vs sorafenib
Phase
Phase 3
Sponsor
AP-HP (SARAH); NCC Singapore (SIRveNIB)
Registry
Headline result
OS not improved; fewer adverse events.
Reported
2017

Outcomes

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In plain words
What these results mean for people, not percentages
Overall survival (SARAH)primarysurvival endpoint
  • Median 8 vs 9.9 months with Y-90 SIRT compared with Sorafenib; about 1.9 months shorter for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 15 percent higher chance of the event at any given time (hazard ratio 1.15).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • These results apply to the people the trial enrolled: Locally advanced HCC: yttrium-90 radioembolisation vs sorafenib. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

Overall survival (SARAH)primary
HR 1.15
Y-90 SIRT
8 mo
Sorafenib
9.9 mo
EndpointArmnValueHR (95% CI)pSource
Overall survival (SARAH)primaryY-90 SIRT2378 months1.15
Sorafenib2229.9 months

Connected

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