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  • Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma.

    (Taphoorn MJ, Henriksson R, Bottomley, et al.)

  • 출처
    J Clin Oncol
  • 등재일
    2015 Jul 1
  • 저널이슈번호
    33(19):2166-75
  • 내용

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    [Abstract]


    PURPOSE:  

    As glioblastoma progresses, patients experience a decline in health-related quality of life (HRQoL). Delaying this decline is an important treatment goal. In newly diagnosed glioblastoma, progression-free survival was prolonged when bevacizumab was added to radiotherapy plus temozolomide (RT/TMZ) versus placebo plus RT/TMZ (phase III AVAglio study; hazard ratio, 0.64; 95% CI, 0.55 to 0.74; P < .001). To ensure that addition of bevacizumab to standard-of-care therapy was not associated with HRQoL detriment, HRQoL assessment was a secondary objective.

     

    PATIENTS AND METHODS:

    Patients completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires C30 and BN20 at each tumor assessment (Appendix Table A1, online only). Raw scores were converted to a 100-point scale and mean changes from baseline scores were evaluated (stable: < 10-point change; clinically relevant deterioration/improvement: ≥ 10-point change). Deterioration-free survival was the time to deterioration/progression/death; time to deterioration was the time to deterioration/death.

     

    RESULTS:

    Most evaluable patients who had not progressed (> 74%) completed all HRQoL assessments for at least 1 year of treatment, and almost all completed at least one HRQoL assessment at baseline (98.3% and 97.6%, bevacizumab and placebo arms, respectively). Mean changes from baseline did not reach a clinically relevant difference between arms for most items. HRQoL declined at progression in both arms. The addition of bevacizumab to RT/TMZ resulted in statistically longer (P < .001) deterioration-free survival across all items. Time to deterioration was not statistically longer in the placebo plus RT/TMZ arm (v bevacizumab) for any HRQoL item.

     

    CONCLUSION:

    The addition of bevacizumab to standard-of-care treatment for newly diagnosed glioblastoma had no impact on HRQoL during the progression-free period.

     

    © 2015 by American Society of Clinical Oncology.

     

    [Author information]

     

    Taphoorn MJ1, Henriksson R2, Bottomley A2, Cloughesy T2, Wick W2, Mason WP2, Saran F2, Nishikawa R2, Hilton M2, Theodore-Oklota C2, Ravelo A2, Chinot OL2.

     

    1 Martin J.B. Taphoorn, Medical Center Haaglanden, the Hague, and VU University Medical Center, Amsterdam, the Netherlands; Roger Henriksson, Cancer Center Stockholm Gotland, Karolinska, Stockholm, and Umeå University, Umeå, Sweden; Andrew Bottomley, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Timothy Cloughesy, University of California, Los Angeles, Los Angeles; Christina Theodore-Oklota and Arliene Ravelo, Genentech, South San Francisco, CA; Wolfgang Wick, University Hospital of Heidelberg, Heidelberg, Germany; Warren Mason, Princess Margaret Hospital, Toronto, Ontario, Canada; Frank Saran, The Royal Marsden National Health Service Foundation Trust, Surrey, United Kingdom; Ryo Nishikawa, Saitama Medical University, Saitama, Japan; Magalie Hilton, F. Hoffmann-La Roche, Basel, Switzerland; Olivier L. Chinot, Service de Neuro-Oncologie, Aix-Marseille University, Assistance Publique- Hôpitaux de Marseille, Centre Hospitalier Universitaire Timone, Marseille, France. m.taphoorn@mchaaglanden.nl.
    2 Martin J.B. Taphoorn, Medical Center Haaglanden, the Hague, and VU University Medical Center, Amsterdam, the Netherlands; Roger Henriksson, Cancer Center Stockholm Gotland, Karolinska, Stockholm, and Umeå University, Umeå, Sweden; Andrew Bottomley, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Timothy Cloughesy, University of California, Los Angeles, Los Angeles; Christina Theodore-Oklota and Arliene Ravelo, Genentech, South San Francisco, CA; Wolfgang Wick, University Hospital of Heidelberg, Heidelberg, Germany; Warren Mason, Princess Margaret Hospital, Toronto, Ontario, Canada; Frank Saran, The Royal Marsden National Health Service Foundation Trust, Surrey, United Kingdom; Ryo Nishikawa, Saitama Medical University, Saitama, Japan; Magalie Hilton, F. Hoffmann-La Roche, Basel, Switzerland; Olivier L. Chinot, Service de Neuro-Oncologie, Aix-Marseille University, Assistance Publique- Hôpitaux de Marseille, Centre Hospitalier Universitaire Timone, Marseille, France.​

     

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    good research

    2015-07-03 23:19:44

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