Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial

CABARET/COGNO Investigators

Research output: Contribution to journalArticle

Abstract

Aim: Assessment of magnetic resonance imaging (MRI) in glioblastoma can be challenging. For patients with recurrent glioblastoma managed on the CABARET trial, we compared disease status assessed at hospitals and subsequent blinded central expert radiological review. Methods: MRI results and clinical status at specified time points were used for site and central assessment of disease status. Clinical status was determined by the site. Response Assessment in Neuro-Oncology (RANO) criteria were used for both assessments. Site and central assessments of progression-free survival (PFS) and response rates were compared. Inter-rater variability for central review progression dates was assessed. Results: Central review resulted in shorter PFS in 45% of 89 evaluable patients (n = 40). Median PFS was 3.6 (central) versus 3.9 months (site) (hazard ratio 1.5, 95% confidence interval 1.3–1.8, P < 0.001). Responses were documented more frequently by sites (n = 16, 18%) than centrally (n = 11, 12%). Seven of 120 patients continued on trial without site-determined progression for more than 6 months beyond the central review determination of progression. Of scans reviewed by all three central reviewers, 33% were fully concordant for progression date. Conclusion: While the difference between site and central PFS dates was statistically significant, the 0.3-month median difference is small. The variability within central review is consistent with previous studies, highlighting the challenges in MRI interpretation in this context. A small proportion of patients benefited from treatment well beyond the centrally determined progression date, reinforcing that clinical status together with radiology results are important determinants of whether a therapy is effective for an individual.

Original languageEnglish
Pages (from-to)e359-e365
JournalAsia-Pacific Journal of Clinical Oncology
Volume14
Issue number5
DOIs
Publication statusPublished - 1 Oct 2018

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Glioblastoma
Disease-Free Survival
Clinical Trials
Magnetic Resonance Imaging
Radiology
Survival Rate
Confidence Intervals
Therapeutics

Cite this

@article{61cdc59f86f94e2a9d230828060253b4,
title = "Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial",
abstract = "Aim: Assessment of magnetic resonance imaging (MRI) in glioblastoma can be challenging. For patients with recurrent glioblastoma managed on the CABARET trial, we compared disease status assessed at hospitals and subsequent blinded central expert radiological review. Methods: MRI results and clinical status at specified time points were used for site and central assessment of disease status. Clinical status was determined by the site. Response Assessment in Neuro-Oncology (RANO) criteria were used for both assessments. Site and central assessments of progression-free survival (PFS) and response rates were compared. Inter-rater variability for central review progression dates was assessed. Results: Central review resulted in shorter PFS in 45{\%} of 89 evaluable patients (n = 40). Median PFS was 3.6 (central) versus 3.9 months (site) (hazard ratio 1.5, 95{\%} confidence interval 1.3–1.8, P < 0.001). Responses were documented more frequently by sites (n = 16, 18{\%}) than centrally (n = 11, 12{\%}). Seven of 120 patients continued on trial without site-determined progression for more than 6 months beyond the central review determination of progression. Of scans reviewed by all three central reviewers, 33{\%} were fully concordant for progression date. Conclusion: While the difference between site and central PFS dates was statistically significant, the 0.3-month median difference is small. The variability within central review is consistent with previous studies, highlighting the challenges in MRI interpretation in this context. A small proportion of patients benefited from treatment well beyond the centrally determined progression date, reinforcing that clinical status together with radiology results are important determinants of whether a therapy is effective for an individual.",
keywords = "bevacizumab, carboplatin, clinical trial, glioblastoma, magnetic resonance imaging",
author = "{CABARET/COGNO Investigators} and Field, {Kathryn M.} and Greg Fitt and Rosenthal, {Mark A.} and John Simes and Nowak, {Anna K.} and Barnes, {Elizabeth H.} and Kate Sawkins and Christine Goh and Moffat, {Bradford A.} and Simon Salinas and Lawrence Cher and Helen Wheeler and Hovey, {Elizabeth J.} and Phal, {Pramit M.}",
year = "2018",
month = "10",
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doi = "10.1111/ajco.12806",
language = "English",
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pages = "e359--e365",
journal = "Asia–Pacific Journal of Clinical Oncology",
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}

Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial. / CABARET/COGNO Investigators.

In: Asia-Pacific Journal of Clinical Oncology, Vol. 14, No. 5, 01.10.2018, p. e359-e365.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial

AU - CABARET/COGNO Investigators

AU - Field, Kathryn M.

AU - Fitt, Greg

AU - Rosenthal, Mark A.

AU - Simes, John

AU - Nowak, Anna K.

AU - Barnes, Elizabeth H.

AU - Sawkins, Kate

AU - Goh, Christine

AU - Moffat, Bradford A.

AU - Salinas, Simon

AU - Cher, Lawrence

AU - Wheeler, Helen

AU - Hovey, Elizabeth J.

AU - Phal, Pramit M.

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Aim: Assessment of magnetic resonance imaging (MRI) in glioblastoma can be challenging. For patients with recurrent glioblastoma managed on the CABARET trial, we compared disease status assessed at hospitals and subsequent blinded central expert radiological review. Methods: MRI results and clinical status at specified time points were used for site and central assessment of disease status. Clinical status was determined by the site. Response Assessment in Neuro-Oncology (RANO) criteria were used for both assessments. Site and central assessments of progression-free survival (PFS) and response rates were compared. Inter-rater variability for central review progression dates was assessed. Results: Central review resulted in shorter PFS in 45% of 89 evaluable patients (n = 40). Median PFS was 3.6 (central) versus 3.9 months (site) (hazard ratio 1.5, 95% confidence interval 1.3–1.8, P < 0.001). Responses were documented more frequently by sites (n = 16, 18%) than centrally (n = 11, 12%). Seven of 120 patients continued on trial without site-determined progression for more than 6 months beyond the central review determination of progression. Of scans reviewed by all three central reviewers, 33% were fully concordant for progression date. Conclusion: While the difference between site and central PFS dates was statistically significant, the 0.3-month median difference is small. The variability within central review is consistent with previous studies, highlighting the challenges in MRI interpretation in this context. A small proportion of patients benefited from treatment well beyond the centrally determined progression date, reinforcing that clinical status together with radiology results are important determinants of whether a therapy is effective for an individual.

AB - Aim: Assessment of magnetic resonance imaging (MRI) in glioblastoma can be challenging. For patients with recurrent glioblastoma managed on the CABARET trial, we compared disease status assessed at hospitals and subsequent blinded central expert radiological review. Methods: MRI results and clinical status at specified time points were used for site and central assessment of disease status. Clinical status was determined by the site. Response Assessment in Neuro-Oncology (RANO) criteria were used for both assessments. Site and central assessments of progression-free survival (PFS) and response rates were compared. Inter-rater variability for central review progression dates was assessed. Results: Central review resulted in shorter PFS in 45% of 89 evaluable patients (n = 40). Median PFS was 3.6 (central) versus 3.9 months (site) (hazard ratio 1.5, 95% confidence interval 1.3–1.8, P < 0.001). Responses were documented more frequently by sites (n = 16, 18%) than centrally (n = 11, 12%). Seven of 120 patients continued on trial without site-determined progression for more than 6 months beyond the central review determination of progression. Of scans reviewed by all three central reviewers, 33% were fully concordant for progression date. Conclusion: While the difference between site and central PFS dates was statistically significant, the 0.3-month median difference is small. The variability within central review is consistent with previous studies, highlighting the challenges in MRI interpretation in this context. A small proportion of patients benefited from treatment well beyond the centrally determined progression date, reinforcing that clinical status together with radiology results are important determinants of whether a therapy is effective for an individual.

KW - bevacizumab

KW - carboplatin

KW - clinical trial

KW - glioblastoma

KW - magnetic resonance imaging

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U2 - 10.1111/ajco.12806

DO - 10.1111/ajco.12806

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SP - e359-e365

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SN - 1743-7555

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