…of patients with primary MF may be appropriate for treatment with Jakafi†
…of patients with primary MF may be appropriate for treatment with Jakafi†
†Based on a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis.4
New or increasing splenomegaly is considered to be a marker of disease progression in myelofibrosis.6
IWG-MRT and ELN response criteria state that a palpable spleen extending ≥5 cm below the left costal margin constitutes progressive disease6§
- Splenomegaly can cause/exacerbate cytopenias due to splenic sequestration7
- Splenomegaly may cause pain, early satiety, abdominal discomfort, and other symptoms7,8
- In a pooled overall survival analysis of 528 patients from the COMFORT||¶ trials, larger baseline spleen volume was associated with incremental increases in the risk of death over 3 years, irrespective of treatment9#
In a study of 1,054 patients with primary myelofibrosis, approximately 90% of patients for whom data were available had palpable splenomegaly at diagnosis3**
In a study of 1,054 patients with primary myelofibrosis, approximately 90% of patients for whom data were available had palpable splenomegaly at diagnosis3**
§Progressive disease assignment for splenomegaly requires confirmation by CT or MRI showing a ≥25% increase in spleen volume from baseline. Baseline values for both physical examination and imaging studies refer to pretreatment baseline and not to posttreatment measurements.6
||COMFORT-I (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-I) was a randomized, double-blind, placebo-controlled phase 3 study with 309 patients with intermediate-2–risk or high-risk myelofibrosis. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline to week 24 as measured by CT or MRI.10,11
¶COMFORT-II (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-II) was a randomized, open-label phase 3 study with 219 patients with intermediate-2–risk or high-risk myelofibrosis. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline at week 48 as measured by CT or MRI.10,12
#14% increase in risk of death for each additional 5 dL of spleen volume at baseline (hazard ratio, 1.14; 95% confidence interval, 1.07-1.21).9
**Data were available for 768 patients, 681 of whom had palpable spleen.3