Optimal Jakafi Dosing Associated With Improved Outcomes in Myelofibrosis

Optimal dosing of Jakafi (ruxolitinib) was associated with improved efficacy and manageable safety in patients with myelofibrosis, according to study findings from the ongoing, observational, multicenter ROMEI study, which were published in the journal, Cancer. Notably, this is an Italian-based clinical study.

“To ensure optimal treatment with [Jakafi], patients should be started on appropriate [Jakafi] doses and maintain the highest tolerated dose for maximum effectiveness. Patients who received the recommended doses showed a better trend in response. … Timely [Jakafi] treatment results in maximum patient benefits such as spleen size reduction, symptom relief, and improved [overall survival],” co-first author, Dr. Massimo Breccia, and colleagues wrote in the journal.

Breccia is part of the Department of Translational and Precision Medicine, at Azienda Ospedaliero-Universitaria Policlinico Umberto I Viale del Policlinico, at the Sapienza University, located in Rome, Italy.

The real-world study — meaning it was research conducted outside of a clinical trial setting — analyzed Jakafi dosing patterns and associated clinical outcomes among patients with myelofibrosis over a 12-month period. Notably, the study enrolled 508 adult patients.

The current interim analysis included two groups of patients: 174 who received the expected dose of Jakafi and 132 patients who received lower than the expected dose of Jakafi, with expected doses based on platelet count class.

Researchers noted that 43.7% of patients were started on 20 milligrams of Jakafi twice daily,

20.6% were started on 15 milligrams twice daily, 22.3% on 10 milligrams twice daily and 12% on 5 mg twice daily, with the remaining 1.4% of patients on a different dosage. Researchers found that 43% of patients were started at a lower-than-expected dose of Jakafi, but both groups of patients exhibited a reduction in average daily Jakafi doses over a 12-month period.

In the as-expected dosing group, the mean daily dose during the first month was 36 milligrams a day and then decreased and stabilized with small fluctuations from the second month at 31 milligrams per day to the twelfth month at 25.3 milligrams per day. Contrarily, in the less-than-expected dosing group, the mean daily dose slightly decreased from 20.7 milligrams per day in the first month to 17.6 milligrams per day in the twelfth month.

At week 48, symptom response rates were 40.8% in the as-expected dosing group and 40.9% in lower-than-expected dosing group. However, the former group showed higher spleen response rates at 24 weeks (50% versus 30.2%) and 48 weeks (57.7% versus 45.8%), with median times to response of 3.3 months versus 1.1 months.

Regarding overall survival, 23 (13.2%) and 27 (20.5%) patients in the as-expected and less-than-expected dosing groups had died by time of data cut-off; the estimated overall survival time was not estimable in the former group and 4.7 years in the latter group.

Researchers noted that in both groups, a slight improvement in all dimensions of reported quality of life was observed at 24 and 48 weeks compared with baseline scores.

Concerning safety, side effects were reported in 87.4% and 84.9% of patients, respectively. Common side effects included blood and lymphatic system disorders (63.8%; 51.5%), anemia (50.6.%; 40.9%) and thrombocytopenia (29.9%; 25.8%).

Reference

“Dosing and clinical outcomes of ruxolitinib in patients with myelofibrosis in a real-world setting: Interim results of the Italian observational study (ROMEI)” by Dr. Massimo Breccia et al., Cancer.

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