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Author Notes:

Corresponding author: Ruben A. Mesa, MD, Division of Hematology-Oncology, Mayo Clinic Arizona, 13400 E. Shea Blvd, Scottsdale, AZ 85259; e-mail: mesa.ruben@mayo.edu.

Conception and design: Ruben A. Mesa, Vikas Gupta, Susan Erickson-Viitanen, William Sun, Richard S. Levy, Srdan Verstovsek

Provision of study materials or patients: Ruben A. Mesa, Jason Gotlib, Vikas Gupta, John V. Catalano, Michael W. Deininger, Alan L. Shields, Carole B. Miller, Richard T. Silver, Moshe Talpaz, Elliott F. Winton, Jimmie H. Harvey, Hagop M. Kantarjian, Srdan Verstovsek

Collection and assembly of data: Ruben A. Mesa, Jason Gotlib, Vikas Gupta, John V. Catalano, Michael W. Deininger, Alan L. Shields, Carole B. Miller, Richard T. Silver, Moshe Talpaz, Elliott F. Winton, Jimmie H. Harvey, Thomas Hare, Victor Sandor, Hagop M. Kantarjian, Srdan Verstovsek

Data analysis and interpretation: Ruben A. Mesa, Vikas Gupta, John V. Catalano, Alan L. Shields, Richard T. Silver, Elliott F. Winton, Jimmie H. Harvey, Susan Erickson-Viitanen, William Sun, Victor Sandor, Hagop M. Kantarjian

Manuscript writing: All authors

Final approval of manuscript: All authors

We thank Susan Kralian, PhD, of the Curry Rockefeller Group for medical writing assistance and Hema Gowda and Kelly Reith of Incyte for additional editorial support.

Please see original article for full disclosure of conflicts of interest

Subjects:

Research Funding:

Supported by Incyte.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Oncology
  • ONCOLOGY
  • QUALITY-OF-LIFE
  • ASSESSMENT FORM
  • MYELOPROLIFERATIVE NEOPLASMS
  • CLINICAL-TRIALS
  • JAK2 INHIBITOR
  • IMPROVEMENT
  • INCB018424
  • DISORDERS
  • SYSTEM

Effect of Ruxolitinib Therapy on Myelofibrosis-Related Symptoms and Other Patient-Reported Outcomes in COMFORT-I: A Randomized, Double-Blind, Placebo-Controlled Trial

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Journal Title:

Journal of Clinical Oncology

Volume:

Volume 31, Number 10

Publisher:

, Pages 1285-1292

Type of Work:

Article | Final Publisher PDF

Abstract:

Purpose: To assess the effects of ruxolitinib on symptom burden and quality of life (QoL) and to evaluate the ability of the modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 to measure meaningful changes in myelofibrosis-related symptoms in patients with myelofibrosis. Patients and Methods: COMFORT-I (Controlled Myelofibrosis Study With Oral JAK Inhibitor Treatment-I) is a double-blind, placebo-controlled phase III study evaluating ruxolitinib in patients with intermediate-2 or high-risk myelofibrosis. Exploratory analyses were conducted on the following patient-reported outcomes (PROs) assessments: modified MFSAF v2.0 (individual symptoms and Total Symptom Score [TSS]), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, and Patient Global Impression of Change (PGIC). Results: Patients receiving ruxolitinib experienced improvements in individual myelofibrosis-related symptoms, although patients receiving placebo experienced worsening (P < .001). The majority (91%) of ruxolitinib-treated patients designated as ≥ 50% TSS responders (≥ 50% TSS improvement) self-reported their condition as either "Much improved" or "Very much improved" on the PGIC. These patients achieved significant improvements in the EORTC QLQ-C30 functional domains and Global Health Status/QoL versus patients receiving placebo, who experienced worsening on these measures (P ≤ .0135). Ruxolitinib-treated patients with a lesser degree of symptom improvement (< 50% TSS responders) also achieved improvements over placebo on these measures. The degree of spleen volume reduction with ruxolitinib correlated with improvements in TSS, PGIC, PROMIS Fatigue Scale, and EORTC Global Health Status/QoL. Ruxolitinib-treated patients who achieved a ≥ 35% reduction in spleen volume experienced the greatest improvements in these PROs. Conclusion: Ruxolitinib-treated patients achieved clinically meaningful improvements in myelofibrosis-related symptoms and QoL, but patients receiving placebo reported worsening of symptoms and other PROs. © 2013 by American Society of Clinical Oncology.

Copyright information:

© 2013 by American Society of Clinical Oncology

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