OnCo
trialsTrialPositive

ToGA

The trial that brought the breast-cancer drug Herceptin to stomach cancer, the first targeted therapy to improve survival in this disease.

OS 13.8 vs 11.1 months (HR 0.74; Lancet 2010); 16.0 months in IHC3+ or IHC2+/FISH+ tumours. Established HER2 testing for all advanced gastric cancers and the trastuzumab-chemotherapy backbone that KEYNOTE-811 (pembrolizumab added) and HERIZON-GEA-01 (zanidatamab) have since built on.

Setting
First-line HER2-positive advanced gastric/GEJ adenocarcinoma: trastuzumab + cisplatin/fluoropyrimidine vs chemotherapy
Phase
Phase 3
Sponsor
Roche
Registry
Headline result
OS 13.8 vs 11.1 months, HR 0.74.
Reported
2010
Enrolled
594
Replication
Effect confirmed in real-world cohorts and as the control arm of HERIZON-GEA-01 (median PFS 8.1 months).

Outcomes

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In plain words
What these results mean for people, not percentages
594 people took part
Overall survivalprimarysurvival endpoint
  • Median 13.8 vs 11.1 months with Trastuzumab + chemotherapy compared with Chemotherapy; about 2.7 months longer 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 26 percent lower chance of the event at any given time (hazard ratio 0.74, likely range 0.6 to 0.91).
  • 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: First-line HER2-positive advanced gastric/GEJ adenocarcinoma: trastuzumab + cisplatin/fluoropyrimidine vs chemotherapy. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.

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.

594 participants enrolled.

Overall survivalprimary
HR 0.74 (0.6–0.91)
Trastuzumab + chemotherapy
13.8 mo
Chemotherapy
11.1 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryTrastuzumab + chemotherapy29413.8 months0.74 (0.6–0.91)link
Chemotherapy29011.1 months
Replication
Effect confirmed in real-world cohorts and as the control arm of HERIZON-GEA-01 (median PFS 8.1 months).

Connected

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