COMFORT-II
COMFORT-II was the European companion to COMFORT-I: ruxolitinib shrank the spleen by more than a third in 28 percent of people with myelofibrosis after nearly a year, while not one patient on the best treatment their doctor could otherwise offer achieved that, and symptoms and quality of life improved.
Overview
COMFORT-II was an open-label phase 3 trial in Europe that randomised 219 patients with intermediate-2 or high-risk myelofibrosis two to one to ruxolitinib or best available therapy, which for most patients meant hydroxycarbamide or no treatment. The primary endpoint was a spleen volume reduction of at least 35 percent at week 48 on MRI or CT, with the same reduction at week 24 as the key secondary endpoint.
At week 48, 28 percent of the ruxolitinib group had reached the spleen endpoint against none on best available therapy, responses were durable, and role functioning and quality-of-life scores improved. Toxicity was modest, mainly anaemia and thrombocytopenia. The trial supported the European approval of ruxolitinib in 2012, and pooled long-term analyses with COMFORT-I later suggested a survival advantage.
- 28 vs 0 out of 100 reached this endpoint with Ruxolitinib compared with Best available therapy; 28 more per 100.
- Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 28.5 vs 0 out of 100 reached this endpoint with Ruxolitinib compared with Best available therapy; 28.5 more per 100.
- Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Intermediate-2 or high-risk primary myelofibrosis, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis: open-label ruxolitinib against best available therapy chosen by the physician, with spleen volume at 48 weeks as the primary endpoint. 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.
219 enrolled.
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