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Randomized Controlled Trial Multicenter Study
Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma.
- Martin J B Taphoorn, Roger Henriksson, Andrew Bottomley, Timothy Cloughesy, Wolfgang Wick, Warren P Mason, Frank Saran, Ryo Nishikawa, Magalie Hilton, Christina Theodore-Oklota, Arliene Ravelo, and Olivier L Chinot.
- 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.
- J. Clin. Oncol. 2015 Jul 1; 33 (19): 2166-75.
PurposeAs 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 MethodsPatients 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.ResultsMost 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.ConclusionThe 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.
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