Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: A randomized, double-blind, placebo-controlled trial

Neuro-Oncology

Volumn 15, Issue 10, 2013, Pages 1429-1437

  Brown, Paul D ^a,b   Pugh, Stephanie ^c   Laack, Nadia N ^b   Wefel, Jeffrey S ^a   Khuntia, Deepak ^d   Meyers, Christina ^a   Choucair, Ali ^e   Fox, Sherry ^f   Suh, John H ^g   Roberge, David ^h   Kavadi, Vivek ⁱ   Bentzen, Soren M ^j   Mehta, Minesh P ^k   Watkins Bruner, Deborah ^l  

^a UNIVERSITY OF TEXAS   (United States)

^b MAYO CLINIC   (United States)

^c RTOG Statistical Center   (United States)

^d SUTTER HEALTH   (United States)

^e Norton Healthcare   (United States)

^f Bon Secours Richmond Health System   (United States)

^g LERNER RESEARCH INSTITUTE   (United States)

^h MCGILL UNIVERSITY   (Canada)

ⁱ US Oncology   (United States)

^j UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^k NORTHWESTERN UNIVERSITY   (United States)

^l EMORY UNIVERSITY   (United States)

more..

Author keywords

brain metastases; cognition; memantine; neuroprotective agents; radiotherapy

Indexed keywords

MEMANTINE;

ADULT; AGED; ALOPECIA; ARTICLE; BRAIN METASTASIS; BRAIN RADIATION; COGNITIVE DEFECT; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG INDUCED HEADACHE; EVENING DOSAGE; EXECUTIVE FUNCTION; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; NAUSEA; PATIENT COMPLIANCE; RANDOMIZED CONTROLLED TRIAL; VELOCITY; WHOLE BRAIN RADIOTHERAPY;

BRAIN METASTASES; COGNITION; MEMANTINE; NEUROPROTECTIVE AGENTS; RADIOTHERAPY;

ADULT; AGED; AGED, 80 AND OVER; BRAIN NEOPLASMS; COGNITION DISORDERS; CRANIAL IRRADIATION; DOUBLE-BLIND METHOD; EXCITATORY AMINO ACID ANTAGONISTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MEMANTINE; MIDDLE AGED; NEOPLASM STAGING; NEUROPSYCHOLOGICAL TESTS; PROGNOSIS; SURVIVAL RATE;

EID: 84884999605     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/not114     Document Type: Article

References (34)

1. Laack NN, Brown PD. Cognitive sequelae of brain radiation in adults. Semin Oncol. 2004;31:702-713. (Pubitemid 39389022)
2. Monje ML, Palmer T. Radiation injury and neurogenesis. Curr Opin Neurol. 2003;16:129-134. (Pubitemid 36521196)
3. Belka C, Budach W, Kortmann RD, et al. Radiation induced CNS toxicity-molecular and cellular mechanisms. Br J Cancer. 2001;85: 1233-1239. (Pubitemid 33081913)
4. KhuntiaD,BrownP, Li J, et al.Whole-brainradiotherapy inthemanagement of brain metastasis. J ClinOncol. 2006;24:1295-1304.
5. Orrego F, Villanueva S. The chemical nature of the main central excitatory transmitter: a critical appraisal based upon release studies and synaptic vesicle localization. Neuroscience. 1993;56:539-555. (Pubitemid 23290570)
6. DanyszW, Parsons CG, Karcz-Kubicha M, et al. GlycineB antagonists as potential therapeutic agents. Previous hopes and present reality. Amino Acids. 1998;14:235-239.
7. Lancelot E, Beal MF. Glutamate toxicity in chronic neurodegenerative disease. Prog Brain Res. 1998;116:331-347. (Pubitemid 28526944)
8. Chen HS, Pellegrini JW, Aggarwal SK, et al. Open-channel block of N-methyl-D-aspartate (NMDA) responses by memantine: therapeutic advantage against NMDA receptor-mediated neurotoxicity. J Neurosci. 1992;12:4427-4436.
9. Chen HS, Lipton SA. Mechanism of memantine block of NMDA-activated channels in rat retinal ganglion cells:uncompetitive antagonism. J Physiol. 1997;499:27-46. (Pubitemid 27098863)
10. Pellegrini JW, Lipton SA. Delayed administration of memantine prevents N-methyl-D-aspartate receptor-mediated neurotoxicity. Ann Neurol. 1993;33:403-407. (Pubitemid 23103976)
11. Orgogozo JM, Rigaud AS, Stoffler A, et al. Efficacy and safety of memantine in patients with mild to moderate vascular dementia: a randomized, placebo-controlled trial (MMM 300). Stroke. 2002;33: 1834-1839. (Pubitemid 34761071)
12. Wilcock G, Mobius HJ, Stoffler A, et al. A double-blind, placebocontrolled multicentre study of memantine in mild to moderate vascular dementia (MMM500). Int Clin Psychopharmacol. 2002;17:297-305. (Pubitemid 35283717)
13. Gaspar L, Scott C, Rotman M, et al. Recursive partitioning analysis (RPA) of prognostic factors in three Radiation Therapy Oncology Group (RTOG) brain metastases trials. Int J Radiat Oncol Biol Phys. 1997;37:745-751. (Pubitemid 27181303)
14. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Diseases. 1974;27:365-375.
15. Meyers CA, Brown PD. Role and relevance of neurocognitive assessment in clinical trials of patients with CNS tumors. J Clin Oncol. 2006;24: 1305-1309. (Pubitemid 46622034)
16. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189-198.
17. Li J, Bentzen SM, RenschlerM, et al. Relationship between neurocognitive function and quality of life afterwhole-brain radiotherapy in patients with brain metastasis. Int J Radiat Oncol Biol Phys. 2008;71:64-70. (Pubitemid 351506468)
18. Johnson DR, Sawyer AM, Meyers CA, et al. Early measures of cognitive function predict survival in patients with newly diagnosed glioblastoma. Neuro Oncol. 2012;14:808-816.
19. Meyers CA, Hess KR, Yung WK, et al. Cognitive function as a predictor of survival in patients with recurrent malignant glioma. J Clin Oncol. 2000; 18:646-650. (Pubitemid 30078546)
20. Meyers CA, Smith JA, Bezjak A, et al. Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol. 2004;22:157-165. (Pubitemid 41095128)
21. Randles RH, Wolfe DA. Introduction to the Theory of Nonparametric Statistics. New York, NY: John Wiley & Sons; 1979.
22. Yuan YC. Multiple Imputation for Missing Data: Concepts and New Developments. Rockville, MD: SAS Institute Inc.; 2002.
23. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12-19.
24. Gray RJ. A class of K-sample test for comparing the cumulative incidence of a competing risk. Ann Statist. 1988;16:1141-1154.
25. Cox DR. Regression models and life tables. J R Stat Soc [B]. 1972;34: 187-220.
26. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
27. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemotherapy Reports-Part 1966; 50:163-170.
28. Brown PD, Jensen AW, Felten SJ, et al. Detrimental effects of tumor progression on cognitive function of patients with high-grade glioma. J Clin Oncol. 2006;24:5427-5433. (Pubitemid 46623176)
29. Sun A, Bae K, Gore EM, et al. Phase III trial of prophylactic cranial irradiation compared with observation in patients with locally advanced non-small-cell lung cancer: neurocognitive and quality-of-life analysis. J Clin Oncol. 2011;29:279-286.
30. Meyers CA,Weitzner MA, Valentine AD, et al. Methylphenidate therapy improves cognition, mood, and function of brain tumor patients. J Clin Oncol. 1998;16:2522-2527. (Pubitemid 28309050)
31. Shaw EG, Rosdhal R, D'Agostino RB Jr, et al. Phase II study of donepezil in irradiated brain tumor patients. Effect on cognitive function, mood, and quality of life. J Clin Oncol. 2006;24:1415-1420. (Pubitemid 46622007)
32. Wolfson AH, Bae K, Komaki R, et al. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limiteddisease small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011;81: 77-84.
33. Bae K, Bruner DW, Baek S, et al. Patterns of missing Mini Mental Status Exam (MMSE) in Radiation Therapy Oncology Group (RTOG) brain cancer trials. J Neurooncol. 2011;105:383-395.
34. Li J, Bentzen SM, Renschler M, et al. Regression after whole-brain radiation therapy for brain metastases correlates with survival and improved neurocognitive function. J Neurooncol. 2007;25: 1260-1266. (Pubitemid 46640573)