Response assessment criteria for brain metastases: proposal from the RANO group

Nancy U. Lin; Eudocia Q. Lee; Hidefumi Aoyama; Igor J. Barani; Daniel P. Barboriak; Brigitta G. Baumert; Martin Bendszus; Paul D. Brown; D. Ross Camidge; Susan M. Chang; Janet Dancey; Elisabeth G. E. de Vries; Laurie E. Gaspar; Gordon J. Harris; F. Stephen Hodi; Steven N. Kalkanis; Mark E. Linskey; David R. Macdonald; Kim Margolin; Minesh P. Mehta; David Schiff; Riccardo Soffietti; John H. Suh; Martin J. van den Bent; Michael A. Vogelbaum; Patrick Y. Wen; Response Assessment Neuro-Oncology

doi:10.1016/S1470-2045(15)70057-4

Response assessment criteria for brain metastases: proposal from the RANO group

Nancy U. Lin^*, Eudocia Q. Lee, Hidefumi Aoyama, Igor J. Barani, Daniel P. Barboriak, Brigitta G. Baumert, Martin Bendszus, Paul D. Brown, D. Ross Camidge, Susan M. Chang, Janet Dancey, Elisabeth G. E. de Vries, Laurie E. Gaspar, Gordon J. Harris, F. Stephen Hodi, Steven N. Kalkanis, Mark E. Linskey, David R. Macdonald, Kim Margolin, Minesh P. MehtaDavid Schiff, Riccardo Soffietti, John H. Suh, Martin J. van den Bent, Michael A. Vogelbaum, Patrick Y. Wen, Response Assessment Neuro-Oncology

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

801 Citations (Scopus)

Abstract

CNS metastases are the most common cause of malignant brain tumours in adults. Historically, patients with brain metastases have been excluded from most clinical trials, but their inclusion is now becoming more common. The medical literature is difficult to interpret because of substantial variation in the response and progression criteria used across clinical trials. The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group is an international, multidisciplinary effort to develop standard response and progression criteria for use in clinical trials of treatment for brain metastases. Previous efforts have focused on aspects of trial design, such as patient population, variations in existing response and progression criteria, and challenges when incorporating neurological, neuro-cognitive, and quality-of-life endpoints into trials of patients with brain metastases. Here, we present our recommendations for standard response and progression criteria for the assessment of brain metastases in clinical trials. The proposed criteria will hopefully facilitate the development of novel approaches to this difficult problem by providing more uniformity in the assessment of CNS metastases across trials.

Original language	English
Pages (from-to)	E270-E278
Number of pages	9
Journal	Lancet Oncology
Volume	16
Issue number	6
DOIs	https://doi.org/10.1016/S1470-2045(15)70057-4
Publication status	Published - Jun-2015

Keywords

GAMMA-KNIFE RADIOSURGERY
VOLUMETRIC DATA ERRORS
SOLID TUMORS
CLINICAL-TRIALS
BREAST-CANCER
PHASE-II
GUIDELINES
MR

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Lin, N. U., Lee, E. Q., Aoyama, H., Barani, I. J., Barboriak, D. P., Baumert, B. G., Bendszus, M., Brown, P. D., Camidge, D. R., Chang, S. M., Dancey, J., de Vries, E. G. E., Gaspar, L. E., Harris, G. J., Hodi, F. S., Kalkanis, S. N., Linskey, M. E., Macdonald, D. R., Margolin, K., ... Response Assessment Neuro-Oncology (2015). Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncology, 16(6), E270-E278. https://doi.org/10.1016/S1470-2045(15)70057-4

@article{39bc6f3ae0a44d2890c93bad0f08f58f,

title = "Response assessment criteria for brain metastases: proposal from the RANO group",

abstract = "CNS metastases are the most common cause of malignant brain tumours in adults. Historically, patients with brain metastases have been excluded from most clinical trials, but their inclusion is now becoming more common. The medical literature is difficult to interpret because of substantial variation in the response and progression criteria used across clinical trials. The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group is an international, multidisciplinary effort to develop standard response and progression criteria for use in clinical trials of treatment for brain metastases. Previous efforts have focused on aspects of trial design, such as patient population, variations in existing response and progression criteria, and challenges when incorporating neurological, neuro-cognitive, and quality-of-life endpoints into trials of patients with brain metastases. Here, we present our recommendations for standard response and progression criteria for the assessment of brain metastases in clinical trials. The proposed criteria will hopefully facilitate the development of novel approaches to this difficult problem by providing more uniformity in the assessment of CNS metastases across trials.",

keywords = "GAMMA-KNIFE RADIOSURGERY, VOLUMETRIC DATA ERRORS, SOLID TUMORS, CLINICAL-TRIALS, BREAST-CANCER, PHASE-II, GUIDELINES, MR",

author = "Lin, {Nancy U.} and Lee, {Eudocia Q.} and Hidefumi Aoyama and Barani, {Igor J.} and Barboriak, {Daniel P.} and Baumert, {Brigitta G.} and Martin Bendszus and Brown, {Paul D.} and Camidge, {D. Ross} and Chang, {Susan M.} and Janet Dancey and {de Vries}, {Elisabeth G. E.} and Gaspar, {Laurie E.} and Harris, {Gordon J.} and Hodi, {F. Stephen} and Kalkanis, {Steven N.} and Linskey, {Mark E.} and Macdonald, {David R.} and Kim Margolin and Mehta, {Minesh P.} and David Schiff and Riccardo Soffietti and Suh, {John H.} and {van den Bent}, {Martin J.} and Vogelbaum, {Michael A.} and Wen, {Patrick Y.} and {Response Assessment Neuro-Oncology}",

year = "2015",

month = jun,

doi = "10.1016/S1470-2045(15)70057-4",

language = "English",

volume = "16",

pages = "E270--E278",

journal = "Lancet Oncology",

issn = "1470-2045",

publisher = "ELSEVIER SCIENCE INC",

number = "6",

}

Lin, NU, Lee, EQ, Aoyama, H, Barani, IJ, Barboriak, DP, Baumert, BG, Bendszus, M, Brown, PD, Camidge, DR, Chang, SM, Dancey, J, de Vries, EGE, Gaspar, LE, Harris, GJ, Hodi, FS, Kalkanis, SN, Linskey, ME, Macdonald, DR, Margolin, K, Mehta, MP, Schiff, D, Soffietti, R, Suh, JH, van den Bent, MJ, Vogelbaum, MA, Wen, PY & Response Assessment Neuro-Oncology 2015, 'Response assessment criteria for brain metastases: proposal from the RANO group', Lancet Oncology, vol. 16, no. 6, pp. E270-E278. https://doi.org/10.1016/S1470-2045(15)70057-4

TY - JOUR

T1 - Response assessment criteria for brain metastases

T2 - proposal from the RANO group

AU - Lin, Nancy U.

AU - Lee, Eudocia Q.

AU - Aoyama, Hidefumi

AU - Barani, Igor J.

AU - Barboriak, Daniel P.

AU - Baumert, Brigitta G.

AU - Bendszus, Martin

AU - Brown, Paul D.

AU - Camidge, D. Ross

AU - Chang, Susan M.

AU - Dancey, Janet

AU - de Vries, Elisabeth G. E.

AU - Gaspar, Laurie E.

AU - Harris, Gordon J.

AU - Hodi, F. Stephen

AU - Kalkanis, Steven N.

AU - Linskey, Mark E.

AU - Macdonald, David R.

AU - Margolin, Kim

AU - Mehta, Minesh P.

AU - Schiff, David

AU - Soffietti, Riccardo

AU - Suh, John H.

AU - van den Bent, Martin J.

AU - Vogelbaum, Michael A.

AU - Wen, Patrick Y.

AU - Response Assessment Neuro-Oncology

PY - 2015/6

Y1 - 2015/6

N2 - CNS metastases are the most common cause of malignant brain tumours in adults. Historically, patients with brain metastases have been excluded from most clinical trials, but their inclusion is now becoming more common. The medical literature is difficult to interpret because of substantial variation in the response and progression criteria used across clinical trials. The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group is an international, multidisciplinary effort to develop standard response and progression criteria for use in clinical trials of treatment for brain metastases. Previous efforts have focused on aspects of trial design, such as patient population, variations in existing response and progression criteria, and challenges when incorporating neurological, neuro-cognitive, and quality-of-life endpoints into trials of patients with brain metastases. Here, we present our recommendations for standard response and progression criteria for the assessment of brain metastases in clinical trials. The proposed criteria will hopefully facilitate the development of novel approaches to this difficult problem by providing more uniformity in the assessment of CNS metastases across trials.

AB - CNS metastases are the most common cause of malignant brain tumours in adults. Historically, patients with brain metastases have been excluded from most clinical trials, but their inclusion is now becoming more common. The medical literature is difficult to interpret because of substantial variation in the response and progression criteria used across clinical trials. The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group is an international, multidisciplinary effort to develop standard response and progression criteria for use in clinical trials of treatment for brain metastases. Previous efforts have focused on aspects of trial design, such as patient population, variations in existing response and progression criteria, and challenges when incorporating neurological, neuro-cognitive, and quality-of-life endpoints into trials of patients with brain metastases. Here, we present our recommendations for standard response and progression criteria for the assessment of brain metastases in clinical trials. The proposed criteria will hopefully facilitate the development of novel approaches to this difficult problem by providing more uniformity in the assessment of CNS metastases across trials.

KW - GAMMA-KNIFE RADIOSURGERY

KW - VOLUMETRIC DATA ERRORS

KW - SOLID TUMORS

KW - CLINICAL-TRIALS

KW - BREAST-CANCER

KW - PHASE-II

KW - GUIDELINES

KW - MR

U2 - 10.1016/S1470-2045(15)70057-4

DO - 10.1016/S1470-2045(15)70057-4

M3 - Review article

SN - 1470-2045

VL - 16

SP - E270-E278

JO - Lancet Oncology

JF - Lancet Oncology

IS - 6

ER -

Response assessment criteria for brain metastases: proposal from the RANO group

Abstract

Keywords

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