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Author Notes:

Correspondence: Professor Srdan Verstovsek, MD, PhD, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 418, Houston, TX 77030, USA. sverstov@mdanderson.org

S.V., R.A.M. and H.A.K. contributed to concept design, data acquisition, data analysis and data interpretation.

R.S.L. and V.S. contributed to concept design and data interpretation.

J.G., V.G., J.F.D., R.P., J.V.C., R.M.L., E.F.W., R.T.S., C.M. and E.H. contributed to data acquisition and data interpretation.

M.D., J.H.H., M.T., M.O.A and A.R. contributed to data acquisition.

W.S. performed the statistical analyses. K.V. contributed to concept design.

S.E.-V. contributed to data interpretation.

All authors assisted with manuscript development or revised it critically for intellectual content as well as approved the final draft of the manuscript.

We thank Monica Nicosia, PhD, from the Curry Rockefeller Group, LLC, and Melinda Ramsey, PhD, of Melinda Ramsey, LLC for providing medical writing assistance (funded by Incyte Corporation) with earlier drafts of the manuscript.

See publication for full list of disclosures.

Subjects:

Research Funding:

The COMFORT-I study was supported by Incyte Corporation.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Hematology
  • Myelofibrosis
  • ruxolitinib
  • subgroups
  • spleen volume
  • symptoms
  • INTERNATIONAL WORKING GROUP
  • WORLD-HEALTH-ORGANIZATION
  • MYELOPROLIFERATIVE NEOPLASMS
  • CRITERIA
  • CLASSIFICATION
  • DIAGNOSIS

The clinical benefit of ruxolitinib across patient subgroups: analysis of a placebo-controlled, Phase III study in patients with myelofibrosis

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Journal Title:

British Journal of Haematology

Volume:

Volume 161, Number 4

Publisher:

, Pages 508-516

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Myelofibrosis (MF) patients can present with a wide spectrum of disease characteristics. We analysed the consistency of ruxolitinib efficacy across patient subgroups in the COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment (COMFORT-I,) a double-blind trial, where patients with intermediate-2 or high-risk MF were randomized to twice-daily oral ruxolitinib (n=155) or placebo (n=154). Subgroups analysed included MF subtype (primary, post-polycythaemia vera, post-essential thrombocythaemia), age (≤65, > 65years), International Prognostic Scoring System risk group, baseline Eastern Cooperative Oncology Group performance status (0, 1, ≥2), JAK2 V617F mutation (positive, negative), baseline haemoglobin level (≥100, < 100g/l), baseline platelet count (100-200×10 9 /l, > 200×10 9 /l), baseline palpable spleen size (≤10, > 10cm), and baseline quartile of spleen volume and Total Symptom Score (TSS; Q1=lowest, Q4=highest). Mean percentage change from baseline to week 24 in spleen volume and TSS were calculated for ruxolitinib and placebo in each subgroup. Overall survival was estimated by Kaplan-Meier method according to original randomization group. In ruxolitinib-treated patients, reductions in spleen volume and TSS and evidence of improved survival relative to placebo across subgroups were consistent with those seen in the COMFORT-I population, confirming that ruxolitinib is an effective therapy for the spectrum of MF patients studied in COMFORT-I.

Copyright information:

© 2013 John Wiley & Sons Ltd.

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