title: The value of 4-month neurocognitive function as an endpoint in brain metastases trials.
abstract: To investigate whether the neurocognitive function at 4 months could be a relevant primary endpoint in clinical trials dealing with brain metastases, we created a Japanese neurocognitive battery and examined the changes in patients' neurocognitive function for 1 year after their brain radiotherapy. In this prospective pilot study, we enrolled 27 patients (20 patients who received whole-brain radiation therapy [WBRT] and seven who received stereotactic irradiation [STI] alone) between March 2009 and December 2010. The follow-up neurocognitive data at 4, 8 and 12 months were available in 22 (17 WBRT, 5 STI), 19 patients (14 WBRT, 5 STI) and 13 patients (9 WBRT, 4 STI), respectively. Among the patients who received WBRT, significant deterioration in delayed memory compared to the baseline (p = 0.04) was observed at 4 months, and at 8 months, significant improvements were observed in immediate memory compared to the baseline (p = 0.008) and 4-months scores (p = 0.005). At 12 months, however, the immediate memory scores had returned to the baseline. Similar trends were observed in other functions (delayed memory, attention and executive functions). In these patients, the correlations between 4-months scores of neurocognitive functions and 12-months scores were significant in immediate memory (γ = 0.68, p = 0.004), delayed memory (γ = 0.738, p = 0.023) and attention (γ = 0.817, p = 0.007). Among the patients who received STI, no significant changes were observed in any functions. These results suggest that 4-months changes in neurocognitive functions were transient but could also be a premonitory index for predicting the neurocognitive function 1 year or later after brain radiation therapy.
authors.affiliation: Department of Radiation Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Onodera
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Aoyama
authors.forename: Khin Khin
authors.initials: KK
authors.lastname: Tha
authors.forename: Naoki
authors.initials: N
authors.lastname: Hashimoto
authors.forename: Atsuhito
authors.initials: A
authors.lastname: Toyomaki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Terae
authors.forename: Hiroki
authors.initials: H
authors.lastname: Shirato
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001932:Brain Neoplasms / Q000523:psychology / Q000532:radiotherapy* / Q000556:secondary / Q000601:surgery; D003071:Cognition / Q000528:radiation effects*; D003131:Combined Modality Therapy; D016371:Cranial Irradiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008568:Memory / Q000528:radiation effects*; D008875:Middle Aged; D060787:Neoplasm Grading; D009483:Neuropsychological Tests; D010865:Pilot Projects; D011379:Prognosis; D011446:Prospective Studies; D016634:Radiosurgery; D055815:Young Adult