SELECT
Turned lenvatinib into the main drug for thyroid cancers that no longer take up radioactive iodine, quadrupling the time before the disease grew.
Overview
SELECT, trial NCT01321554 sponsored by Eisai and reported in 2015, turned lenvatinib into the main drug for differentiated thyroid cancers that no longer take up radioactive iodine, quadrupling the time before the disease grew. It randomised 392 patients with progressive radioiodine-refractory disease to lenvatinib or placebo, met its primary progression-free survival endpoint with a very large effect and a response rate near two-thirds against almost none on placebo, leading to FDA approval in February 2015; hypertension in about two-thirds and dose reductions in more than sixty percent drive management, and survival was confounded by crossover. Nuclide links it to thyroid cancer, kinase inhibitors and anti-angiogenic therapy, VEGF and RET as targets, the radioiodine-refractory term and Martin Schlumberger. When to start a drug this toxic in a slow disease is the open question.
- 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.
- 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.
- 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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Lenvatinib | - | 18.3 months | 0.21 | - | link |
| Placebo | - | 3.6 months | ||||
| Objective response rate | Lenvatinib | - | 64.8% | - | - | link |
| Placebo | - | 1.5% |