title: The impact of bevacizumab on health-related quality of life in patients treated for recurrent glioblastoma: results of the randomised controlled phase 2 BELOB trial.
abstract: BACKGROUND
  The BELOB study, a randomised controlled phase 2 trial comparing lomustine, bevacizumab and combined lomustine and bevacizumab in patients with recurrent glioblastoma, showed that the 9-month overall survival rate was most promising in the combination arm. Here we report the health-related quality of life (HRQoL) results, a secondary trial end-point.
  
  
  METHODS
  HRQoL was measured at baseline and every 6weeks until progression using the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and brain module (QLQ-BN20). HRQoL was assessed over time for five preselected scales (global health (GH), physical (PF) and social functioning (SF), motor dysfunction (MD) and communication deficit (CD)). Moreover, mean changes in HRQoL from baseline until progression were determined.
  
  
  RESULTS
  138/148 patients with at least a baseline HRQoL assessment were analysed. Over time, HRQoL remained relatively stable in all treatment arms for all five scales, at least during the first three treatment cycles. More than half (54-61%) of the patients showed stable (<10 point change) or improved (⩾10 point change) HRQoL during their progression-free time, except for SF (43%), irrespective of treatment arm. Deterioration of mean HRQoL was most profound at disease progression for all scales except SF, which deteriorated earlier in disease course. Compared to baseline, 40% of patients had clinically relevant (⩾10 points) worse GH, PF and SF, while 44% and 31% had increased MD and CD at disease progression, irrespective of treatment arm.
  
  
  CONCLUSIONS
  Bevacizumab, whether or not in combination with lomustine, did not negatively affect HRQoL in patients treated for recurrent glioblastoma in this randomised study.
authors.affiliation: VU University Medical Center, Department of Neurology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: l.dirven@vumc.nl.
authors.forename: Linda
authors.initials: L
authors.lastname: Dirven
authors.affiliation: Erasmus MC Cancer Institute, Department of Neuro-oncology, PO Box 5201, 3008 AE Rotterdam, The Netherlands.
authors.forename: Martin J
authors.initials: MJ
authors.lastname: van den Bent
authors.affiliation: European Organisation for Research and Treatment of Cancer, Quality of Life Department, Emmanuel Mounierlaan 83, 1200 Brussels, Belgium.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.affiliation: Erasmus MC Cancer Institute, Clinical Trial Center, PO Box 2040 3000 CA Rotterdam, The Netherlands.
authors.forename: Nelly
authors.initials: N
authors.lastname: van der Meer
authors.affiliation: Erasmus MC Cancer Institute, Clinical Trial Center, PO Box 2040 3000 CA Rotterdam, The Netherlands.
authors.forename: Bronno
authors.initials: B
authors.lastname: van der Holt
authors.affiliation: Medical Center Haaglanden, Department of Neurology, PO Box 432, 2501 CK The Hague, The Netherlands.
authors.forename: Maaike J
authors.initials: MJ
authors.lastname: Vos
authors.affiliation: University Medical Center Groningen, Department of Medical Oncology, PO Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: Annemiek M E
authors.initials: AM
authors.lastname: Walenkamp
authors.affiliation: St. Elisabeth Hospital, Department of Oncology, PO Box 90151 5000 LC Tilburg, The Netherlands.
authors.forename: Laurens V
authors.initials: LV
authors.lastname: Beerepoot
authors.affiliation: Catharina Hospital Eindhoven, Department of Neurology, PO Box 1350, 5602 ZA Eindhoven, The Netherlands.
authors.forename: Monique C J
authors.initials: MC
authors.lastname: Hanse
authors.affiliation: VU University Medical Center, Department of Neurology, PO Box 7057, 1007 MB Amsterdam, The Netherlands; Academic Medical Center, Department of Neurology, PO Box 22660, 1100 DD Amsterdam, The Netherlands.
authors.forename: Jaap C
authors.initials: JC
authors.lastname: Reijneveld
authors.affiliation: Isala Kliniek, Department of Neurology, PO Box 10400, 8000 GK Zwolle, The Netherlands.
authors.forename: Aja
authors.initials: A
authors.lastname: Otten
authors.affiliation: University Medical Center Utrecht, Department of Medical Oncology, Utrecht clinical trial center, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: Filip Y F L
authors.initials: FY
authors.lastname: de Vos
authors.affiliation: Erasmus MC - University Medical Center Rotterdam, Department of Radiology, PO Box 2040, 3000 CA Rotterdam, The Netherlands.
authors.forename: Marion
authors.initials: M
authors.lastname: Smits
authors.affiliation: Erasmus MC Cancer Institute, Department of Neuro-oncology, PO Box 5201, 3008 AE Rotterdam, The Netherlands.
authors.forename: Jacoline E C
authors.initials: JE
authors.lastname: Bromberg
authors.affiliation: Erasmus MC Cancer Institute, Department of Neuro-oncology, PO Box 5201, 3008 AE Rotterdam, The Netherlands.
authors.forename: Walter
authors.initials: W
authors.lastname: Taal
authors.affiliation: VU University Medical Center, Department of Neurology, PO Box 7057, 1007 MB Amsterdam, The Netherlands; Medical Center Haaglanden, Department of Neurology, PO Box 432, 2501 CK The Hague, The Netherlands.
authors.forename: Martin J B
authors.initials: MJ
authors.lastname: Taphoorn
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D001932:Brain Neoplasms / Q000188:drug therapy*; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy*; D006801:Humans; D008130:Lomustine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D015996:Survival Rate; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D008130:Lomustine
keywords: Bevacizumab; Brain tumour; Health-related quality of life; Randomised controlled trial; Recurrent glioblastoma