Practical Measures of Clinical Benefit With Ruxolitinib Therapy: An Exploratory Analysis of COMFORT-I

Carole B. Miller, Rami S. Komrokji, Ruben A. Mesa, William Sun, Michael Montgomery, Srdan Verstovsek

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: The phase III COMFORT (Controlled Myelofibrosis Study With Oral JAK inhibitor Treatment)-I and COMFORT-II trials in patients with intermediate-2 or high-risk myelofibrosis (MF) showed that ruxolitinib was superior to placebo and best available therapy, respectively, for improvements in spleen volume, MF-related symptoms, and overall survival (OS). However, patients managed in community settings might not have access to the methods used in the COMFORT trials. In this exploratory analysis we summarize efficacy findings of COMFORT-I using practical, community-oriented measures of patient outcomes. Patients and Methods: In this post hoc analysis of data from COMFORT-I we evaluated changes from baseline to week 12 in spleen size (palpable length and volume), patient-reported outcomes (Patient Global Impression of Change; Myelofibrosis Symptom Assessment Form; Patient-Reported Outcomes Measurement System Fatigue Scale), body weight, and serum albumin levels in 5 subgroups of ruxolitinib-treated patients on the basis of week 12 spleen length changes from baseline: (1-4) ≥ 50%, 25% to < 50%, 10% to < 25%, or < 10% reduction; and (5) worsening. OS was evaluated in ruxolitinib-treated patients with week 12 spleen length reductions from baseline ≥ 50%, 25% to < 50%, or < 25% (including worsening). Results: In all spleen length subgroups, including patients with worsening spleen length at week 12, ruxolitinib (n = 150) was associated with improvements in spleen volume, patient-reported symptom burden, body weight, and serum albumin levels. Greater reductions in spleen length were associated with prolonged OS. Conclusion: A variety of assessment methods beyond palpable spleen length that are easily accessible in the community setting might be useful in evaluating the clinical benefit of ruxolitinib over time in patients with MF.

Original languageEnglish (US)
JournalClinical Lymphoma, Myeloma and Leukemia
DOIs
StateAccepted/In press - Mar 10 2017

Fingerprint

Spleen
Primary Myelofibrosis
Therapeutics
Serum Albumin
Survival
Body Weight
INCB018424
Symptom Assessment
Fatigue
Placebos
Outcome Assessment (Health Care)

Keywords

  • Community hospitals
  • Janus kinases
  • Myelofibrosis
  • Myeloproliferative disorders
  • Splenomegaly

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Practical Measures of Clinical Benefit With Ruxolitinib Therapy : An Exploratory Analysis of COMFORT-I. / Miller, Carole B.; Komrokji, Rami S.; Mesa, Ruben A.; Sun, William; Montgomery, Michael; Verstovsek, Srdan.

In: Clinical Lymphoma, Myeloma and Leukemia, 10.03.2017.

Research output: Contribution to journalArticle

Miller, Carole B. ; Komrokji, Rami S. ; Mesa, Ruben A. ; Sun, William ; Montgomery, Michael ; Verstovsek, Srdan. / Practical Measures of Clinical Benefit With Ruxolitinib Therapy : An Exploratory Analysis of COMFORT-I. In: Clinical Lymphoma, Myeloma and Leukemia. 2017.
@article{222b265703a7414d8ef1c6155899ab97,
title = "Practical Measures of Clinical Benefit With Ruxolitinib Therapy: An Exploratory Analysis of COMFORT-I",
abstract = "Background: The phase III COMFORT (Controlled Myelofibrosis Study With Oral JAK inhibitor Treatment)-I and COMFORT-II trials in patients with intermediate-2 or high-risk myelofibrosis (MF) showed that ruxolitinib was superior to placebo and best available therapy, respectively, for improvements in spleen volume, MF-related symptoms, and overall survival (OS). However, patients managed in community settings might not have access to the methods used in the COMFORT trials. In this exploratory analysis we summarize efficacy findings of COMFORT-I using practical, community-oriented measures of patient outcomes. Patients and Methods: In this post hoc analysis of data from COMFORT-I we evaluated changes from baseline to week 12 in spleen size (palpable length and volume), patient-reported outcomes (Patient Global Impression of Change; Myelofibrosis Symptom Assessment Form; Patient-Reported Outcomes Measurement System Fatigue Scale), body weight, and serum albumin levels in 5 subgroups of ruxolitinib-treated patients on the basis of week 12 spleen length changes from baseline: (1-4) ≥ 50{\%}, 25{\%} to < 50{\%}, 10{\%} to < 25{\%}, or < 10{\%} reduction; and (5) worsening. OS was evaluated in ruxolitinib-treated patients with week 12 spleen length reductions from baseline ≥ 50{\%}, 25{\%} to < 50{\%}, or < 25{\%} (including worsening). Results: In all spleen length subgroups, including patients with worsening spleen length at week 12, ruxolitinib (n = 150) was associated with improvements in spleen volume, patient-reported symptom burden, body weight, and serum albumin levels. Greater reductions in spleen length were associated with prolonged OS. Conclusion: A variety of assessment methods beyond palpable spleen length that are easily accessible in the community setting might be useful in evaluating the clinical benefit of ruxolitinib over time in patients with MF.",
keywords = "Community hospitals, Janus kinases, Myelofibrosis, Myeloproliferative disorders, Splenomegaly",
author = "Miller, {Carole B.} and Komrokji, {Rami S.} and Mesa, {Ruben A.} and William Sun and Michael Montgomery and Srdan Verstovsek",
year = "2017",
month = "3",
day = "10",
doi = "10.1016/j.clml.2017.05.015",
language = "English (US)",
journal = "Clinical Lymphoma, Myeloma and Leukemia",
issn = "2152-2669",
publisher = "Cancer Media Group",

}

TY - JOUR

T1 - Practical Measures of Clinical Benefit With Ruxolitinib Therapy

T2 - An Exploratory Analysis of COMFORT-I

AU - Miller, Carole B.

AU - Komrokji, Rami S.

AU - Mesa, Ruben A.

AU - Sun, William

AU - Montgomery, Michael

AU - Verstovsek, Srdan

PY - 2017/3/10

Y1 - 2017/3/10

N2 - Background: The phase III COMFORT (Controlled Myelofibrosis Study With Oral JAK inhibitor Treatment)-I and COMFORT-II trials in patients with intermediate-2 or high-risk myelofibrosis (MF) showed that ruxolitinib was superior to placebo and best available therapy, respectively, for improvements in spleen volume, MF-related symptoms, and overall survival (OS). However, patients managed in community settings might not have access to the methods used in the COMFORT trials. In this exploratory analysis we summarize efficacy findings of COMFORT-I using practical, community-oriented measures of patient outcomes. Patients and Methods: In this post hoc analysis of data from COMFORT-I we evaluated changes from baseline to week 12 in spleen size (palpable length and volume), patient-reported outcomes (Patient Global Impression of Change; Myelofibrosis Symptom Assessment Form; Patient-Reported Outcomes Measurement System Fatigue Scale), body weight, and serum albumin levels in 5 subgroups of ruxolitinib-treated patients on the basis of week 12 spleen length changes from baseline: (1-4) ≥ 50%, 25% to < 50%, 10% to < 25%, or < 10% reduction; and (5) worsening. OS was evaluated in ruxolitinib-treated patients with week 12 spleen length reductions from baseline ≥ 50%, 25% to < 50%, or < 25% (including worsening). Results: In all spleen length subgroups, including patients with worsening spleen length at week 12, ruxolitinib (n = 150) was associated with improvements in spleen volume, patient-reported symptom burden, body weight, and serum albumin levels. Greater reductions in spleen length were associated with prolonged OS. Conclusion: A variety of assessment methods beyond palpable spleen length that are easily accessible in the community setting might be useful in evaluating the clinical benefit of ruxolitinib over time in patients with MF.

AB - Background: The phase III COMFORT (Controlled Myelofibrosis Study With Oral JAK inhibitor Treatment)-I and COMFORT-II trials in patients with intermediate-2 or high-risk myelofibrosis (MF) showed that ruxolitinib was superior to placebo and best available therapy, respectively, for improvements in spleen volume, MF-related symptoms, and overall survival (OS). However, patients managed in community settings might not have access to the methods used in the COMFORT trials. In this exploratory analysis we summarize efficacy findings of COMFORT-I using practical, community-oriented measures of patient outcomes. Patients and Methods: In this post hoc analysis of data from COMFORT-I we evaluated changes from baseline to week 12 in spleen size (palpable length and volume), patient-reported outcomes (Patient Global Impression of Change; Myelofibrosis Symptom Assessment Form; Patient-Reported Outcomes Measurement System Fatigue Scale), body weight, and serum albumin levels in 5 subgroups of ruxolitinib-treated patients on the basis of week 12 spleen length changes from baseline: (1-4) ≥ 50%, 25% to < 50%, 10% to < 25%, or < 10% reduction; and (5) worsening. OS was evaluated in ruxolitinib-treated patients with week 12 spleen length reductions from baseline ≥ 50%, 25% to < 50%, or < 25% (including worsening). Results: In all spleen length subgroups, including patients with worsening spleen length at week 12, ruxolitinib (n = 150) was associated with improvements in spleen volume, patient-reported symptom burden, body weight, and serum albumin levels. Greater reductions in spleen length were associated with prolonged OS. Conclusion: A variety of assessment methods beyond palpable spleen length that are easily accessible in the community setting might be useful in evaluating the clinical benefit of ruxolitinib over time in patients with MF.

KW - Community hospitals

KW - Janus kinases

KW - Myelofibrosis

KW - Myeloproliferative disorders

KW - Splenomegaly

UR - http://www.scopus.com/inward/record.url?scp=85020482537&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85020482537&partnerID=8YFLogxK

U2 - 10.1016/j.clml.2017.05.015

DO - 10.1016/j.clml.2017.05.015

M3 - Article

C2 - 28606598

AN - SCOPUS:85020482537

JO - Clinical Lymphoma, Myeloma and Leukemia

JF - Clinical Lymphoma, Myeloma and Leukemia

SN - 2152-2669

ER -