Multicentre phase II studies evaluating imatinib plus hydroxyurea in patients with progressive glioblastoma

DA Reardon; G Dresemann; S Taillibert; M Campone; Martin van den Bent; P Clement; E Blomquist; L Gordower; H Schultz; J Raizer; P Hau; J Easaw; M Gil; J Tonn; AA Gijtenbeek; U Schlegel; P Bergstrom; S Green; Adam Weir; Z Nikolova

doi:10.1038/sj.bjc.6605411

Multicentre phase II studies evaluating imatinib plus hydroxyurea in patients with progressive glioblastoma

DA Reardon
, G Dresemann
, S Taillibert
, M Campone
, Martin van den Bent
, P Clement
, E Blomquist
, L Gordower
, H Schultz
, J Raizer
, P Hau
, J Easaw
, M Gil
, J Tonn
, AA Gijtenbeek
, U Schlegel
, P Bergstrom
, S Green
, Adam Weir
, Z Nikolova

Neurology

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Research output: Contribution to journal › Article › Academic › peer-review

119 Citations (Scopus)

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Abstract

BACKGROUND: We evaluated the efficacy of imatinib mesylate in addition to hydroxyurea in patients with recurrent glioblastoma (GBM) who were either on or not on enzyme-inducing anti-epileptic drugs (EIAEDs). METHODS: A total of 231 patients with GBM at first recurrence from 21 institutions in 10 countries were enrolled. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 600 mg per day for patients not on EIAEDs and at 500 mg twice a day if on EIAEDs. The primary end point was radiographic response rate and secondary end points were safety, progression-free survival at 6 months (PFS-6), and overall survival (OS). RESULTS: The radiographic response rate after centralised review was 3.4%. Progression-free survival at 6 months and median OS were 10.6% and 26.0 weeks, respectively. Outcome did not appear to differ based on EIAED status. The most common grade 3 or greater adverse events were fatigue (7%), neutropaenia (7%), and thrombocytopaenia (7%). CONCLUSION: Imatinib in addition to hydroxyurea was well tolerated among patients with recurrent GBM but did not show clinically meaningful anti-tumour activity. British Journal of Cancer (2009) 101, 1995-2004. doi: 10.1038/sj.bjc.6605411 www.bjcancer.com Published online 10 November 2009 (C) 2009 Cancer Research UK

Original language	Undefined/Unknown
Pages (from-to)	1995-2004
Number of pages	10
Journal	British Journal of Cancer
Volume	101
Issue number	12
DOIs	https://doi.org/10.1038/sj.bjc.6605411
Publication status	Published - 2009

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Research programs

EMC MM-03-44-06

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10.1038/sj.bjc.6605411

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http://hdl.handle.net/1765/24592

Cite this

Reardon, DA., Dresemann, G., Taillibert, S., Campone, M., van den Bent, M., Clement, P., Blomquist, E., Gordower, L., Schultz, H., Raizer, J., Hau, P., Easaw, J., Gil, M., Tonn, J., Gijtenbeek, AA., Schlegel, U., Bergstrom, P., Green, S., Weir, A., & Nikolova, Z. (2009). Multicentre phase II studies evaluating imatinib plus hydroxyurea in patients with progressive glioblastoma. British Journal of Cancer, 101(12), 1995-2004. https://doi.org/10.1038/sj.bjc.6605411

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title = "Multicentre phase II studies evaluating imatinib plus hydroxyurea in patients with progressive glioblastoma",

abstract = "BACKGROUND: We evaluated the efficacy of imatinib mesylate in addition to hydroxyurea in patients with recurrent glioblastoma (GBM) who were either on or not on enzyme-inducing anti-epileptic drugs (EIAEDs). METHODS: A total of 231 patients with GBM at first recurrence from 21 institutions in 10 countries were enrolled. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 600 mg per day for patients not on EIAEDs and at 500 mg twice a day if on EIAEDs. The primary end point was radiographic response rate and secondary end points were safety, progression-free survival at 6 months (PFS-6), and overall survival (OS). RESULTS: The radiographic response rate after centralised review was 3.4\%. Progression-free survival at 6 months and median OS were 10.6\% and 26.0 weeks, respectively. Outcome did not appear to differ based on EIAED status. The most common grade 3 or greater adverse events were fatigue (7\%), neutropaenia (7\%), and thrombocytopaenia (7\%). CONCLUSION: Imatinib in addition to hydroxyurea was well tolerated among patients with recurrent GBM but did not show clinically meaningful anti-tumour activity. British Journal of Cancer (2009) 101, 1995-2004. doi: 10.1038/sj.bjc.6605411 www.bjcancer.com Published online 10 November 2009 (C) 2009 Cancer Research UK",

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Reardon, DA, Dresemann, G, Taillibert, S, Campone, M, van den Bent, M, Clement, P, Blomquist, E, Gordower, L, Schultz, H, Raizer, J, Hau, P, Easaw, J, Gil, M, Tonn, J, Gijtenbeek, AA, Schlegel, U, Bergstrom, P, Green, S, Weir, A & Nikolova, Z 2009, 'Multicentre phase II studies evaluating imatinib plus hydroxyurea in patients with progressive glioblastoma', British Journal of Cancer, vol. 101, no. 12, pp. 1995-2004. https://doi.org/10.1038/sj.bjc.6605411

TY - JOUR

T1 - Multicentre phase II studies evaluating imatinib plus hydroxyurea in patients with progressive glioblastoma

AU - Reardon, DA

AU - Dresemann, G

AU - Taillibert, S

AU - Campone, M

AU - van den Bent, Martin

AU - Clement, P

AU - Blomquist, E

AU - Gordower, L

AU - Schultz, H

AU - Raizer, J

AU - Hau, P

AU - Easaw, J

AU - Gil, M

AU - Tonn, J

AU - Gijtenbeek, AA

AU - Schlegel, U

AU - Bergstrom, P

AU - Green, S

AU - Weir, Adam

AU - Nikolova, Z

PY - 2009

Y1 - 2009

N2 - BACKGROUND: We evaluated the efficacy of imatinib mesylate in addition to hydroxyurea in patients with recurrent glioblastoma (GBM) who were either on or not on enzyme-inducing anti-epileptic drugs (EIAEDs). METHODS: A total of 231 patients with GBM at first recurrence from 21 institutions in 10 countries were enrolled. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 600 mg per day for patients not on EIAEDs and at 500 mg twice a day if on EIAEDs. The primary end point was radiographic response rate and secondary end points were safety, progression-free survival at 6 months (PFS-6), and overall survival (OS). RESULTS: The radiographic response rate after centralised review was 3.4%. Progression-free survival at 6 months and median OS were 10.6% and 26.0 weeks, respectively. Outcome did not appear to differ based on EIAED status. The most common grade 3 or greater adverse events were fatigue (7%), neutropaenia (7%), and thrombocytopaenia (7%). CONCLUSION: Imatinib in addition to hydroxyurea was well tolerated among patients with recurrent GBM but did not show clinically meaningful anti-tumour activity. British Journal of Cancer (2009) 101, 1995-2004. doi: 10.1038/sj.bjc.6605411 www.bjcancer.com Published online 10 November 2009 (C) 2009 Cancer Research UK

AB - BACKGROUND: We evaluated the efficacy of imatinib mesylate in addition to hydroxyurea in patients with recurrent glioblastoma (GBM) who were either on or not on enzyme-inducing anti-epileptic drugs (EIAEDs). METHODS: A total of 231 patients with GBM at first recurrence from 21 institutions in 10 countries were enrolled. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 600 mg per day for patients not on EIAEDs and at 500 mg twice a day if on EIAEDs. The primary end point was radiographic response rate and secondary end points were safety, progression-free survival at 6 months (PFS-6), and overall survival (OS). RESULTS: The radiographic response rate after centralised review was 3.4%. Progression-free survival at 6 months and median OS were 10.6% and 26.0 weeks, respectively. Outcome did not appear to differ based on EIAED status. The most common grade 3 or greater adverse events were fatigue (7%), neutropaenia (7%), and thrombocytopaenia (7%). CONCLUSION: Imatinib in addition to hydroxyurea was well tolerated among patients with recurrent GBM but did not show clinically meaningful anti-tumour activity. British Journal of Cancer (2009) 101, 1995-2004. doi: 10.1038/sj.bjc.6605411 www.bjcancer.com Published online 10 November 2009 (C) 2009 Cancer Research UK

U2 - 10.1038/sj.bjc.6605411

DO - 10.1038/sj.bjc.6605411

M3 - Article

C2 - 19904263

SN - 0007-0920

VL - 101

SP - 1995

EP - 2004

JO - British Journal of Cancer

JF - British Journal of Cancer

IS - 12

ER -