Linda Dirven1, Martin J van den Bent2, Andrew Bottomley3, Nelly van der Meer4, Bronno van der Holt4, Maaike J Vos5, Annemiek M E Walenkamp6, Laurens V Beerepoot7, Monique C J Hanse8, Jaap C Reijneveld9, Aja Otten10, Filip Y F L de Vos11, Marion Smits12, Jacoline E C Bromberg2, Walter Taal2, Martin J B Taphoorn13. 1. VU University Medical Center, Department of Neurology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: l.dirven@vumc.nl. 2. Erasmus MC Cancer Institute, Department of Neuro-oncology, PO Box 5201, 3008 AE Rotterdam, The Netherlands. 3. European Organisation for Research and Treatment of Cancer, Quality of Life Department, Emmanuel Mounierlaan 83, 1200 Brussels, Belgium. 4. Erasmus MC Cancer Institute, Clinical Trial Center, PO Box 2040 3000 CA Rotterdam, The Netherlands. 5. Medical Center Haaglanden, Department of Neurology, PO Box 432, 2501 CK The Hague, The Netherlands. 6. University Medical Center Groningen, Department of Medical Oncology, PO Box 30.001, 9700 RB Groningen, The Netherlands. 7. St. Elisabeth Hospital, Department of Oncology, PO Box 90151 5000 LC Tilburg, The Netherlands. 8. Catharina Hospital Eindhoven, Department of Neurology, PO Box 1350, 5602 ZA Eindhoven, The Netherlands. 9. 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. 10. Isala Kliniek, Department of Neurology, PO Box 10400, 8000 GK Zwolle, The Netherlands. 11. University Medical Center Utrecht, Department of Medical Oncology, Utrecht clinical trial center, PO Box 85500, 3508 GA Utrecht, The Netherlands. 12. Erasmus MC - University Medical Center Rotterdam, Department of Radiology, PO Box 2040, 3000 CA Rotterdam, The Netherlands. 13. 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.
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.
RCT Entities:
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: Kathryn M Field; Madeleine T King; John Simes; David Espinoza; Elizabeth H Barnes; Kate Sawkins; Mark A Rosenthal; Lawrence Cher; Elizabeth Hovey; Helen Wheeler; Anna K Nowak Journal: J Neurooncol Date: 2017-05-22 Impact factor: 4.130
Authors: Jaishri O Blakeley; Stephen Joel Coons; John R Corboy; Nancy Kline Leidy; Tito R Mendoza; Jeffrey S Wefel Journal: Neuro Oncol Date: 2016-03 Impact factor: 12.300
Authors: Roberto Jose Diaz; Sheikh Ali; Mehreen Gull Qadir; Macarena I De La Fuente; Michael E Ivan; Ricardo J Komotar Journal: J Neurooncol Date: 2017-05-19 Impact factor: 4.130
Authors: A F Cardona; L Rojas; B Wills; A Ruiz-Patiño; L Abril; F Hakim; E Jiménez; N Useche; S Bermúdez; J A Mejía; J F Ramón; H Carranza; C Vargas; J Otero; P Archila; J Rodríguez; J Rodríguez; J Behaine; D González; J Jacobo; H Cifuentes; O Feo; P Penagos; D Pineda; L Ricaurte; L E Pino; C Vargas; J C Marquez; M I Mantilla; L D Ortiz; C Balaña; R Rosell; Z L Zatarain-Barrón; O Arrieta Journal: Clin Transl Oncol Date: 2019-02-23 Impact factor: 3.340
Authors: Linda Dirven; Mogens Groenvold; Martin J B Taphoorn; Thierry Conroy; Krzysztof A Tomaszewski; Teresa Young; Morten Aa Petersen Journal: Qual Life Res Date: 2017-07-13 Impact factor: 4.147
Authors: Linda Dirven; Martin Jb Taphoorn; Mogens Groenvold; Esther Jj Habets; Neil K Aaronson; Thierry Conroy; Jaap C Reijneveld; Teresa Young; Morten Aa Petersen Journal: Neurooncol Pract Date: 2017-01-19
Authors: Barbara Kiesewetter; Markus Raderer; Gerald W Prager; Thorsten Fuereder; Christine Marosi; Matthias Preusser; Michael Krainer; Gottfried J Locker; Thomas Brodowicz; Christoph C Zielinski Journal: ESMO Open Date: 2017-07-16