Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: Results from the IRIS study

Elizabeth A. Hahn, G. Alastair Glendenning, Mark V. Sorensen, Stacie A. Hudgens, Brian Druker, Francois Guilhot, Richard A. Larson, Stephen G. O'Brien, Deborah G. Dobrez, Martee L. Hensley, David Cella

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Abstract

Purpose: Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study. Patients and Methods: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over. Results: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P <.001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P <.001) differences were observed between patients who did and did not cross over in favor of imatinib. Conclusion: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.

Original languageEnglish (US)
Pages (from-to)2138-2146
Number of pages9
JournalJournal of Clinical Oncology
Volume21
Issue number11
DOIs
StatePublished - Jun 1 2003
Externally publishedYes

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Leukemia, Myeloid, Chronic Phase
Cytarabine
Interferon-alpha
Quality of Life
Imatinib Mesylate
Biological Therapy
Intention to Treat Analysis
Therapeutics
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine : Results from the IRIS study. / Hahn, Elizabeth A.; Glendenning, G. Alastair; Sorensen, Mark V.; Hudgens, Stacie A.; Druker, Brian; Guilhot, Francois; Larson, Richard A.; O'Brien, Stephen G.; Dobrez, Deborah G.; Hensley, Martee L.; Cella, David.

In: Journal of Clinical Oncology, Vol. 21, No. 11, 01.06.2003, p. 2138-2146.

Research output: Contribution to journalArticle

Hahn, EA, Glendenning, GA, Sorensen, MV, Hudgens, SA, Druker, B, Guilhot, F, Larson, RA, O'Brien, SG, Dobrez, DG, Hensley, ML & Cella, D 2003, 'Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: Results from the IRIS study', Journal of Clinical Oncology, vol. 21, no. 11, pp. 2138-2146. https://doi.org/10.1200/JCO.2003.12.154
Hahn, Elizabeth A. ; Glendenning, G. Alastair ; Sorensen, Mark V. ; Hudgens, Stacie A. ; Druker, Brian ; Guilhot, Francois ; Larson, Richard A. ; O'Brien, Stephen G. ; Dobrez, Deborah G. ; Hensley, Martee L. ; Cella, David. / Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine : Results from the IRIS study. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 11. pp. 2138-2146.
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abstract = "Purpose: Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study. Patients and Methods: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over. Results: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P <.001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P <.001) differences were observed between patients who did and did not cross over in favor of imatinib. Conclusion: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.",
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T1 - Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine

T2 - Results from the IRIS study

AU - Hahn, Elizabeth A.

AU - Glendenning, G. Alastair

AU - Sorensen, Mark V.

AU - Hudgens, Stacie A.

AU - Druker, Brian

AU - Guilhot, Francois

AU - Larson, Richard A.

AU - O'Brien, Stephen G.

AU - Dobrez, Deborah G.

AU - Hensley, Martee L.

AU - Cella, David

PY - 2003/6/1

Y1 - 2003/6/1

N2 - Purpose: Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study. Patients and Methods: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over. Results: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P <.001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P <.001) differences were observed between patients who did and did not cross over in favor of imatinib. Conclusion: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.

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