Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases

Minesh P. Mehta, Patrick Rodrigus, C. H J Terhaard, Aroor Rao, John Suh, Wilson Roa, Luis Souhami, Andrea Bezjak, Mark Leibenhaut, Ritsuko Komaki, Christopher Schultz, Robert Timmerman, Walter Curran, Jennifer Smith, See Chun Phan, Richard A. Miller, Markus F. Renschler

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344 Citations (Scopus)

Abstract

Purpose: This phase III randomized trial evaluated survival as well as neurologic and neurocognitive function in patients with brain metastases from solid tumors receiving whole-brain radiation therapy (WBRT) with or without motexafin gadolinium (MGd). Patients and Methods: Patients were randomly assigned to 30 Gy of WBRT ± 5 mg/kg/d MGd. Survival and time to neurologic progression determined by a blinded events review committee (ERC) were coprimary end points. Standardized investigator neurologic assessment and neurocognitive testing were evaluated. Results: Four hundred one (251 non-small-cell lung cancer) patients were enrolled. There was no significant difference by treatment arm in survival (median, 5.2 months for MGd v 4.9 months for WBRT; P = .48) or time to neurologic progression (median, 9.5 months for MGd v 8.3 months for WBRT; P = .95). Treatment with MGd improved time to neurologic progression in patients with lung cancer (median, not reached for MGd v 7.4 months for WBRT; P = .048, unadjusted). By investigator, MGd improved time to neurologic progression in all patients (median, 4.3 months for MGd v 3.8 months for WBRT; P = .018) and in lung cancer patients (median, 5.5 months for MGd v 3.7 months for WBRT; P = .025). MGd improved neurocognitive function in lung cancer patients. Conclusion: The overall results did not demonstrate significant differences by treatment arm for survival and ERC time to neurologic progression. Investigator neurologic assessments demonstrated an MGd treatment benefit in all patients. In lung cancer patients, ERC- and investigator- determined time to neurologic progression demonstrated an MGd treatment benefit. MGd may improve time to neurologic and neurocognitive progression in lung cancer.

Original languageEnglish (US)
Pages (from-to)2529-2536
Number of pages8
JournalJournal of Clinical Oncology
Volume21
Issue number13
DOIs
StatePublished - Jul 1 2003

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Nervous System
Radiotherapy
Neoplasm Metastasis
Survival
Brain
Lung Neoplasms
Advisory Committees
Research Personnel
motexafin gadolinium
Therapeutics
Non-Small Cell Lung Carcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases. / Mehta, Minesh P.; Rodrigus, Patrick; Terhaard, C. H J; Rao, Aroor; Suh, John; Roa, Wilson; Souhami, Luis; Bezjak, Andrea; Leibenhaut, Mark; Komaki, Ritsuko; Schultz, Christopher; Timmerman, Robert; Curran, Walter; Smith, Jennifer; Phan, See Chun; Miller, Richard A.; Renschler, Markus F.

In: Journal of Clinical Oncology, Vol. 21, No. 13, 01.07.2003, p. 2529-2536.

Research output: Contribution to journalArticle

Mehta, MP, Rodrigus, P, Terhaard, CHJ, Rao, A, Suh, J, Roa, W, Souhami, L, Bezjak, A, Leibenhaut, M, Komaki, R, Schultz, C, Timmerman, R, Curran, W, Smith, J, Phan, SC, Miller, RA & Renschler, MF 2003, 'Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases', Journal of Clinical Oncology, vol. 21, no. 13, pp. 2529-2536. https://doi.org/10.1200/JCO.2003.12.122
Mehta, Minesh P. ; Rodrigus, Patrick ; Terhaard, C. H J ; Rao, Aroor ; Suh, John ; Roa, Wilson ; Souhami, Luis ; Bezjak, Andrea ; Leibenhaut, Mark ; Komaki, Ritsuko ; Schultz, Christopher ; Timmerman, Robert ; Curran, Walter ; Smith, Jennifer ; Phan, See Chun ; Miller, Richard A. ; Renschler, Markus F. / Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 13. pp. 2529-2536.
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abstract = "Purpose: This phase III randomized trial evaluated survival as well as neurologic and neurocognitive function in patients with brain metastases from solid tumors receiving whole-brain radiation therapy (WBRT) with or without motexafin gadolinium (MGd). Patients and Methods: Patients were randomly assigned to 30 Gy of WBRT ± 5 mg/kg/d MGd. Survival and time to neurologic progression determined by a blinded events review committee (ERC) were coprimary end points. Standardized investigator neurologic assessment and neurocognitive testing were evaluated. Results: Four hundred one (251 non-small-cell lung cancer) patients were enrolled. There was no significant difference by treatment arm in survival (median, 5.2 months for MGd v 4.9 months for WBRT; P = .48) or time to neurologic progression (median, 9.5 months for MGd v 8.3 months for WBRT; P = .95). Treatment with MGd improved time to neurologic progression in patients with lung cancer (median, not reached for MGd v 7.4 months for WBRT; P = .048, unadjusted). By investigator, MGd improved time to neurologic progression in all patients (median, 4.3 months for MGd v 3.8 months for WBRT; P = .018) and in lung cancer patients (median, 5.5 months for MGd v 3.7 months for WBRT; P = .025). MGd improved neurocognitive function in lung cancer patients. Conclusion: The overall results did not demonstrate significant differences by treatment arm for survival and ERC time to neurologic progression. Investigator neurologic assessments demonstrated an MGd treatment benefit in all patients. In lung cancer patients, ERC- and investigator- determined time to neurologic progression demonstrated an MGd treatment benefit. MGd may improve time to neurologic and neurocognitive progression in lung cancer.",
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T1 - Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases

AU - Mehta, Minesh P.

AU - Rodrigus, Patrick

AU - Terhaard, C. H J

AU - Rao, Aroor

AU - Suh, John

AU - Roa, Wilson

AU - Souhami, Luis

AU - Bezjak, Andrea

AU - Leibenhaut, Mark

AU - Komaki, Ritsuko

AU - Schultz, Christopher

AU - Timmerman, Robert

AU - Curran, Walter

AU - Smith, Jennifer

AU - Phan, See Chun

AU - Miller, Richard A.

AU - Renschler, Markus F.

PY - 2003/7/1

Y1 - 2003/7/1

N2 - Purpose: This phase III randomized trial evaluated survival as well as neurologic and neurocognitive function in patients with brain metastases from solid tumors receiving whole-brain radiation therapy (WBRT) with or without motexafin gadolinium (MGd). Patients and Methods: Patients were randomly assigned to 30 Gy of WBRT ± 5 mg/kg/d MGd. Survival and time to neurologic progression determined by a blinded events review committee (ERC) were coprimary end points. Standardized investigator neurologic assessment and neurocognitive testing were evaluated. Results: Four hundred one (251 non-small-cell lung cancer) patients were enrolled. There was no significant difference by treatment arm in survival (median, 5.2 months for MGd v 4.9 months for WBRT; P = .48) or time to neurologic progression (median, 9.5 months for MGd v 8.3 months for WBRT; P = .95). Treatment with MGd improved time to neurologic progression in patients with lung cancer (median, not reached for MGd v 7.4 months for WBRT; P = .048, unadjusted). By investigator, MGd improved time to neurologic progression in all patients (median, 4.3 months for MGd v 3.8 months for WBRT; P = .018) and in lung cancer patients (median, 5.5 months for MGd v 3.7 months for WBRT; P = .025). MGd improved neurocognitive function in lung cancer patients. Conclusion: The overall results did not demonstrate significant differences by treatment arm for survival and ERC time to neurologic progression. Investigator neurologic assessments demonstrated an MGd treatment benefit in all patients. In lung cancer patients, ERC- and investigator- determined time to neurologic progression demonstrated an MGd treatment benefit. MGd may improve time to neurologic and neurocognitive progression in lung cancer.

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