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Turned lenvatinib into the main drug for thyroid cancers that no longer take up radioactive iodine, quadrupling the time before the disease grew.

Median PFS 18.3 vs 3.6 months (HR 0.21); ORR 64.8% vs 1.5%. NEJM 2015; FDA approval February 2015. Hypertension in ~68% and a dose-reduction rate above 60% drive management; OS crossover-confounded.

Setting
Radioiodine-refractory differentiated thyroid cancer with progression: lenvatinib vs placebo
Phase
Phase 3
Sponsor
Eisai
Registry
Headline result
PFS 18.3 vs 3.6 months; HR 0.21.
Reported
2015
Enrolled
392
Replication
DECISION (sorafenib) showed the same direction with a smaller effect; class effect of VEGFR multikinase inhibitors is established.

Outcomes

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In plain words
What these results mean for people, not percentages
392 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 18.3 vs 3.6 months with Lenvatinib compared with Placebo; about 14.7 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 79 percent lower chance of the event at any given time (hazard ratio 0.21).
  • 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.
Objective response rateresponse endpoint
  • 64.8 vs 1.5 out of 100 had their tumour shrink with Lenvatinib compared with Placebo; 63.3 more per 100.
  • Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Be careful
  • These results apply to the people the trial enrolled: Radioiodine-refractory differentiated thyroid cancer with progression: lenvatinib vs placebo. 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.

392 participants enrolled.

Progression-free survivalprimary
HR 0.21
Lenvatinib
18.3 mo
Placebo
3.6 mo
Source
Objective response rate
Lenvatinib64.8 of 100
Placebo1.5 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryLenvatinib18.3 months0.21link
Placebo3.6 months
Objective response rateLenvatinib64.8%link
Placebo1.5%
Replication
DECISION (sorafenib) showed the same direction with a smaller effect; class effect of VEGFR multikinase inhibitors is established.

Connected

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