ACT IV
A double-blind test of a promising glioblastoma vaccine that showed no benefit, and taught the field how misleading historical-control comparisons can be.
745 randomised. Median OS 20.1 vs 20.0 months in the minimal-residual-disease population. Both arms outperformed historical expectations, and EGFRvIII was lost at recurrence in most patients irrespective of arm. Lancet Oncology 2017.
- Median 20.1 vs 20 months with Rindopepimut + temozolomide compared with Control + temozolomide; about 0.1 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 1 percent higher chance of the event at any given time (hazard ratio 1.01, likely range 0.79 to 1.3).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- 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: Newly diagnosed EGFRvIII+ glioblastoma with minimal residual disease: rindopepimut + temozolomide vs control (KLH) + temozolomide. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFRvIII); the result should not be assumed for people whose cancer does not have it.
- Not significant.
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.
745 participants enrolled.
Not significant
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, minimal residual disease populationprimary | Rindopepimut + temozolomide | 371 | 20.1 months | 1.01 (0.79–1.3) | — | link |
| Control + temozolomide | 374 | 20 months |
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not linked directly; found by shared links- TrialINDIGO
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