OnCo
trialsTrialPositive

EF-14

The trial that made a wearable electric-field device part of glioblastoma care, extending median survival by about five months.

695 patients, open-label. Median OS 20.9 vs 16.0 months (HR 0.63); 5-year OS 13% vs 5%. Stopped early for efficacy at interim analysis. Benefit correlated with device usage. Debated for lack of a sham control; NCCN category 1.

Setting
Newly diagnosed glioblastoma after chemoradiation: TTFields + maintenance temozolomide vs temozolomide alone
Phase
Phase 3
Sponsor
Novocure
Registry
Headline result
OS 20.9 vs 16.0 months, HR 0.63.
Reported
2015
Enrolled
695
Replication
Single pivotal trial without a sham control; no independent randomised replication.

Outcomes

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In plain words
What these results mean for people, not percentages
695 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 6.7 vs 4 months with TTFields + temozolomide compared with Temozolomide; 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 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.52 to 0.76).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
  • Median 20.9 vs 16 months with TTFields + temozolomide compared with Temozolomide; about 4.9 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 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.53 to 0.76).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Newly diagnosed glioblastoma after chemoradiation: TTFields + maintenance temozolomide vs temozolomide alone. 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.

695 participants enrolled.

Progression-free survivalprimary
HR 0.63 (0.52–0.76) · p <0.001
TTFields + temozolomide
6.7 mo
Temozolomide
4 mo
Source
Overall survival
HR 0.63 (0.53–0.76)
TTFields + temozolomide
20.9 mo
Temozolomide
16 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryTTFields + temozolomide4666.7 months0.63 (0.52–0.76)<0.001link
Temozolomide2294 months
Overall survivalTTFields + temozolomide20.9 months0.63 (0.53–0.76)link
Temozolomide16 months
Replication
Single pivotal trial without a sham control; no independent randomised replication.

Connected

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