Imatinib mesylate confers large QOL benefit in CML

PharmacoEconomics & Outcomes News 419 - 5 Jul 2003 Imatinib mesylate confers large QOL benefit in CML Imatinib mesylate offers "clear QOL advantages" over interferon (IFN)-α plus cytarabine for the first-line treatment of chronic myeloid leukaemia (CML), says a multinational team of investigators. Furthermore, patients who cross over to imatinib mesylate therapy from IFN-α plus cytarabine "experience a significant improvement in their QOL", compared with those remaining on IFN-α plus cytarabine therapy, they add. The International Randomized IFN versus ST1571 (IRIS) Study was a prospective, multicentre study conducted in an outpatient setting, in which patients with newly-diagnosed treatment-naive CML were randomised to receive either SC IFN-α plus low-dose cytarabine or oral imatinib mesylate 400mg daily; crossover to the other treatment arm was allowed in the event of intolerance or lack of efficacy. * QOL was assessed using the FACT-BRM, the TOI, ** and the EuroQoL-5D at baseline and at 12 months. The differences in QOL observed between the two treatment arms during the study period were "statistically significant (P < .05) and clinically important", say the investigators. IFN-α plus cytarabine recipients demonstrated a "large decline" in TOI scores after 1 month of treatment, they note. In contrast, mean TOI scores for imatinib mesylate recipients "changed very little" during treatment, comment the investigators. Moreover, patients who crossed over to imatinib mesylate from IFN-α plus cytarabine experienced a significant improvement from baseline in mean TOI scores, compared with patients who remained on IFN-α plus cytarabine. Indeed, at month 12, mean TOI scores for patients who crossed over to imatinib mesylate were similar to those for patients who had been initially randomised to imatinib mesylate therapy, the investigators state. * The study was supported by Novartis Pharma, with which the researchers were affiliated. ** FACT-BRM = Functional Assessment of Cancer Therapy-Biologic Response Modifiers; TOI = Trial Outcome Index (the primary QOL endpoint) Hahn EA, et al. 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 21: 2138-2146, 1 Jun 2003 800946789 1 PharmacoEconomics & Outcomes News 5 Jul 2003 No. 419 1173-5503/10/0419-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Transcript of Imatinib mesylate confers large QOL benefit in CML

PharmacoEconomics & Outcomes News 419 - 5 Jul 2003

Imatinib mesylate confers largeQOL benefit in CML

Imatinib mesylate offers "clear QOL advantages" overinterferon (IFN)-α plus cytarabine for the first-linetreatment of chronic myeloid leukaemia (CML), says amultinational team of investigators. Furthermore,patients who cross over to imatinib mesylate therapyfrom IFN-α plus cytarabine "experience a significantimprovement in their QOL", compared with thoseremaining on IFN-α plus cytarabine therapy, they add.

The International Randomized IFN versus ST1571(IRIS) Study was a prospective, multicentre studyconducted in an outpatient setting, in which patientswith newly-diagnosed treatment-naive CML wererandomised to receive either SC IFN-α plus low-dosecytarabine or oral imatinib mesylate 400mg daily;crossover to the other treatment arm was allowed in theevent of intolerance or lack of efficacy.* QOL wasassessed using the FACT-BRM, the TOI,** and theEuroQoL-5D at baseline and at 12 months.

The differences in QOL observed between the twotreatment arms during the study period were"statistically significant (P < .05) and clinically important",say the investigators. IFN-α plus cytarabine recipientsdemonstrated a "large decline" in TOI scores after 1month of treatment, they note. In contrast, mean TOIscores for imatinib mesylate recipients "changed verylittle" during treatment, comment the investigators.Moreover, patients who crossed over to imatinibmesylate from IFN-α plus cytarabine experienced asignificant improvement from baseline in mean TOIscores, compared with patients who remained on IFN-αplus cytarabine. Indeed, at month 12, mean TOI scoresfor patients who crossed over to imatinib mesylate weresimilar to those for patients who had been initiallyrandomised to imatinib mesylate therapy, theinvestigators state.* The study was supported by Novartis Pharma, with which theresearchers were affiliated.** FACT-BRM = Functional Assessment of Cancer Therapy-BiologicResponse Modifiers; TOI = Trial Outcome Index (the primary QOLendpoint)

Hahn EA, et al. Quality of life in patients with newly diagnosed chronic phasechronic myeloid leukemia on imatinib versus interferon alfa plus low-dosecytarabine: results from the IRIS Study. Journal of Clinical Oncology 21:2138-2146, 1 Jun 2003 800946789