New research reveals that optimal dosing of Jakafi (ruxolitinib) can lead to better outcomes for patients with myelofibrosis, particularly regarding efficacy and manageable safety. This insight comes from the ongoing ROMEI clinical trial, which examined dosing patterns and clinical results among 508 patients with myelofibrosis.
Dr. Massimo Breccia, one of the co-authors of the study published in the journal Cancer, emphasizes the importance of starting patients on the appropriate Jakafi doses and maintaining the highest tolerated levels. The results indicate that patients who adhered to the recommended doses experienced greater benefits, including significant reductions in spleen size, symptom relief, and improved overall survival rates.
Study Highlights:
- The ROMEI study analyzed patient results over a 12-month period and included two dosing groups: those receiving the expected doses of Jakafi (174 patients) and those starting with lower-than-expected doses (132 patients).
- Of the patients, 43.7% began treatment on 20 mg of Jakafi taken twice daily. Others started on doses ranging from 5 mg to 15 mg, with 43% receiving lower-than-expected doses.
- There was a notable trend where the mean daily dose adjusted throughout the study. For patients on expected doses, it started at 36 mg daily and stabilized around 25.3 mg by month twelve. In the lower-than-expected group, the average dose decreased from 20.7 mg to 17.6 mg over the same period.
Response Rates:
- After 48 weeks, symptom response rates were similar in both dosing groups, at around 40%.
- However, the group receiving expected dosing showed significantly better spleen response rates, achieving 57.7% compared to 45.8% in the lower-than-expected group.
- While 13.2% of patients in the expected dosing group died during the study, this was higher in the lower-than-expected dosing group at 20.5%. The estimated overall survival time for patients on the lower doses was about 4.7 years.
Quality of Life Improvements:
Both groups reported improvements in their quality of life at 24 and 48 weeks, reflecting better management of myelofibrosis symptoms throughout the study period.
Safety Considerations:
Side effects were reported widely in both groups, with 87.4% of patients in the expected dosing group and 84.9% in the lower dosing group experiencing some adverse effects. Common side effects included:
- Blood and lymphatic system disorders (63.8% in expected group vs. 51.5% in lower group)
- Anemia (50.6% vs. 40.9%)
- Thrombocytopenia (low platelet count) at rates of 29.9% and 25.8%, respectively.
This research highlights the importance of optimal Jakafi dosing for improving treatment outcomes in myelofibrosis patients, reinforcing the need for individualized treatment plans to maximize benefits while managing safety concerns.
More Reading
Early Jakafi (Ruxolitinib) Treatment Boosts Spleen Response Rates in Myelofibrosis
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Reference:
Breccia M, Palandri F, Martelli M, et al. Dosing and clinical outcomes of ruxolitinib in patients with myelofibrosis in a real-world setting: Interim results of the Italian observational study (ROMEI). Cancer. 2025 Apr 1;131(7):e35801.
