REFLECT
Lenvatinib matched sorafenib on survival with more tumour shrinkage, giving a second first-line option after a decade.
OS 13.6 vs 12.3 months (HR 0.92; non-inferiority met); PFS 7.4 vs 3.7 months; ORR 24% vs 9% (mRECIST). First positive first-line trial since SHARP.
Setting
First-line unresectable HCC: lenvatinib vs sorafenib (non-inferiority)
Phase
Phase 3
Sponsor
Eisai
Registry
Headline result
OS 13.6 vs 12.3 months, non-inferior (HR 0.92).
Reported
2018
Enrolled
954
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 13.6 vs 12.3 months with Lenvatinib compared with Sorafenib; about 1.3 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 8 percent lower chance of the event at any given time (hazard ratio 0.92, likely range 0.79 to 1.06).
- 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.
Progression-free survivalsurrogate endpoint
- Median 7.4 vs 3.7 months with Lenvatinib compared with Sorafenib; about 3.7 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 34 percent lower chance of the event at any given time (hazard ratio 0.66).
- 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.
Be careful
- These results apply to the people the trial enrolled: First-line unresectable HCC: lenvatinib vs sorafenib (non-inferiority). 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.
954 participants enrolled.
Overall survivalprimary
HR 0.92 (0.79–1.06)
Lenvatinib
13.6 mo
Sorafenib
12.3 mo
Progression-free survival
HR 0.66
Lenvatinib
7.4 mo
Sorafenib
3.7 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Lenvatinib | 478 | 13.6 months | 0.92 (0.79–1.06) | — | — |
| Sorafenib | 476 | 12.3 months | ||||
| Progression-free survival | Lenvatinib | — | 7.4 months | 0.66 | — | — |
| Sorafenib | — | 3.7 months |