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Cytoreductive therapy
Source: Myeloproliferative Neoplasms Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: September 27, 2024 · Captured 2026-09-09.
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Context: Treatment of Primary Myelofibrosis / Treatment Options for PMF
Ruxolitinib, an inhibitor of JAK1 and JAK2, can reduce the splenomegaly and debilitating symptoms of weight loss, fatigue, and night sweats for patients with JAK2-positive or JAK2-negative PMF, post–essential thrombocythemia myelofibrosis, or post-PV myelofibrosis.[55]
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Evidence (cytoreductive therapy):
In two prospective randomized trials, 528 higher-risk patients were randomly assigned to ruxolitinib or to either placebo (COMFORT-I [NCT00952289]) or best-available therapy (COMFORT-II [NCT00934544]).[37,38]
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In two prospective randomized trials, 528 higher-risk patients were randomly assigned to ruxolitinib or to either placebo (COMFORT-I [NCT00952289]) or best-available therapy (COMFORT-II [NCT00934544]).[37,38]
At 48 weeks, patients who received ruxolitinib had a decrease of 30% to 40% in mean spleen volume compared with an increase of 7% to 8% in the control patients.[37,38][Level of evidence B3]
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In two prospective randomized trials, 528 higher-risk patients were randomly assigned to ruxolitinib or to either placebo (COMFORT-I [NCT00952289]) or best-available therapy (COMFORT-II [NCT00934544]).[37,38]
Ruxolitinib also improved overall quality-of-life measures, with low toxic effects in both studies, but with no benefit in overall survival in the initial reports.
In two prospective randomized trials, 528 higher-risk patients were randomly assigned to ruxolitinib or to either placebo (COMFORT-I [NCT00952289]) or best-available therapy (COMFORT-II [NCT00934544]).[37,38]
Additional follow-up in both studies (5 years in COMFORT-I and in COMFORT-II) showed a survival benefit (statistically significant only for COMFORT-I) among patients who received ruxolitinib compared with control patients (COMFORT-I hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.50–0.96; P = .025; and COMFORT-II HR, 0.67; 95% CI, 0.44–1.02; P = .06).[56,57][Level of evidence A1]
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In two prospective randomized trials, 528 higher-risk patients were randomly assigned to ruxolitinib or to either placebo (COMFORT-I [NCT00952289]) or best-available therapy (COMFORT-II [NCT00934544]).[37,38]
Clinical benefits were observed across a wide variety of clinical subgroups.[58,59]
Discontinuation of ruxolitinib results in a rapid worsening of splenomegaly and the recurrence of systemic symptoms.[37-39] Ruxolitinib does not reverse bone marrow fibrosis or induce histological or cytogenetic remissions. Aggressive B-cell lymphomas have occurred among patients treated with ruxolitinib when a preexisting clonal B-cell population was identified at diagnosis in conjunction with myelofibrosis.[60]
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Preserved source evidence · Not medical advice