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Effect of neo-adjuvant chemotherapy on long-term neurological function, health state, behaviour, and quality of life in the PNET3 randomized controlled trial of treatment for primitive neuro-ectodermal tumour

Effect of neo-adjuvant chemotherapy on long-term neurological function, health state, behaviour, and quality of life in the PNET3 randomized controlled trial of treatment for primitive neuro-ectodermal tumour
Effect of neo-adjuvant chemotherapy on long-term neurological function, health state, behaviour, and quality of life in the PNET3 randomized controlled trial of treatment for primitive neuro-ectodermal tumour
Objective: To assess systematically the effect on quality of sur- vival (QoS) of the addition of chemotherapy to craniospinal irradiation (CSI) for treatment of primitive neuro-ectoder- ma1 tumour (PNET). Methods: We undertook a cross-sectional multi-informant questionnaire to assess QoS in UK children previously enrolled in the International Society for Paediatric Oncology PNET3 ran- domized controlled trial (RCT) of CSI (35Gy plus 2OGy boost to posterior fossa) versus CSI plus neo-adjuvant chemotherapy (Vincristine, Carboplatin, Etoposide, and Cyclophospha- mide) . When comparing the survivors assessed in the present follow-up study, pre- and postsurgical evaluation of neurologi- cal function, undertaken at the time of diagnosis, had shown no difference between children in the two treatment arms. Age-appropriate measures of outcome, as assessed by patients, parents, and health professionals, were compared between the treatment arms, using x2, student t-test, or Mann-Whitney U test, in 127/170 (75 %) of survivors at a mean (SD) age of 15.4 (4.0) years and 7 (2.25) years from diagnosis. These are given here for 69 12-17-year-olds for whom the following assess- ments were employed: (1) neurological assessment by a med- ical examination form and also by responses of parents to a questionnaire; (2) self-report and proxy- (i.e. principal carer) rated scores for both health status (Health Utilities Index MU [HUI3]), and behavioural problems (the Strengths and Diffi- culties Questionnaire [ SDQ]); and (3) quality of life (Paediatric Quality of Life questionnaire [ PedsQL]). Results: In 12-17-year-olds allocated to the CSI + chemo arm, relative to the CSI alone arm: (1) Neurological function was more impaired, particularly with respect to physical restriction of activity (n=69, x2 = 10.78,p=0.001); (2) HUI scores were significantly lower both on self-assessment (n=63, U=300.5, p=O.OOS) and proxy assessment (n=63, U=344,p=0.04), explained by differences in the domain of cognition and dexterity; (3)'Total difficulties' scores on the SDQ were higher (n=63, t=2.l,p=0.04) on parental assess- ment with more emotional symptoms. There was a similar trend on self-assessment; and (4) PedsQL scores were signifi- cantly lower both on self-assessment (n=63, U=345.0, p=0.045) and proxy-assessment (n=63, t=-2.829, p=0.006) with lower scores for physical health. Differences between treatment arms, showed a similar pattern of significant differences in the 18-24-year-olds (n=38) but not in the 6-11-year-olds (n=20). There were clear relationships between HUI, SDQ, and PedsQL group scores. Conclusions: The addition of chemotherapy to 'standard dose' CSI may adversely affect health status, behaviour, and quality of life. The effect on these measures of reducing the dose of CSI and simultaneously adding chemotherapy (e.g. in the current PNET4 RCT) requires further investigation.
controlled trial, controlled-trial, trial, quality-of-life, treatment, randomized controlled trial, health
0012-1622
37-37
Bull, K.
751f8b25-29ba-4d4f-96e2-6c339a83a47f
Kennedy, C.
7c3aff62-0a86-4b44-b7d7-4bc01f23ec93
Bull, K.
751f8b25-29ba-4d4f-96e2-6c339a83a47f
Kennedy, C.
7c3aff62-0a86-4b44-b7d7-4bc01f23ec93

Bull, K. and Kennedy, C. (2006) Effect of neo-adjuvant chemotherapy on long-term neurological function, health state, behaviour, and quality of life in the PNET3 randomized controlled trial of treatment for primitive neuro-ectodermal tumour. Developmental Medicine and Child Neurology., 48 (s104), 37-37. (doi:10.1111/j.1469-8749.2006.tb12577.x).

Record type: Meeting abstract

Abstract

Objective: To assess systematically the effect on quality of sur- vival (QoS) of the addition of chemotherapy to craniospinal irradiation (CSI) for treatment of primitive neuro-ectoder- ma1 tumour (PNET). Methods: We undertook a cross-sectional multi-informant questionnaire to assess QoS in UK children previously enrolled in the International Society for Paediatric Oncology PNET3 ran- domized controlled trial (RCT) of CSI (35Gy plus 2OGy boost to posterior fossa) versus CSI plus neo-adjuvant chemotherapy (Vincristine, Carboplatin, Etoposide, and Cyclophospha- mide) . When comparing the survivors assessed in the present follow-up study, pre- and postsurgical evaluation of neurologi- cal function, undertaken at the time of diagnosis, had shown no difference between children in the two treatment arms. Age-appropriate measures of outcome, as assessed by patients, parents, and health professionals, were compared between the treatment arms, using x2, student t-test, or Mann-Whitney U test, in 127/170 (75 %) of survivors at a mean (SD) age of 15.4 (4.0) years and 7 (2.25) years from diagnosis. These are given here for 69 12-17-year-olds for whom the following assess- ments were employed: (1) neurological assessment by a med- ical examination form and also by responses of parents to a questionnaire; (2) self-report and proxy- (i.e. principal carer) rated scores for both health status (Health Utilities Index MU [HUI3]), and behavioural problems (the Strengths and Diffi- culties Questionnaire [ SDQ]); and (3) quality of life (Paediatric Quality of Life questionnaire [ PedsQL]). Results: In 12-17-year-olds allocated to the CSI + chemo arm, relative to the CSI alone arm: (1) Neurological function was more impaired, particularly with respect to physical restriction of activity (n=69, x2 = 10.78,p=0.001); (2) HUI scores were significantly lower both on self-assessment (n=63, U=300.5, p=O.OOS) and proxy assessment (n=63, U=344,p=0.04), explained by differences in the domain of cognition and dexterity; (3)'Total difficulties' scores on the SDQ were higher (n=63, t=2.l,p=0.04) on parental assess- ment with more emotional symptoms. There was a similar trend on self-assessment; and (4) PedsQL scores were signifi- cantly lower both on self-assessment (n=63, U=345.0, p=0.045) and proxy-assessment (n=63, t=-2.829, p=0.006) with lower scores for physical health. Differences between treatment arms, showed a similar pattern of significant differences in the 18-24-year-olds (n=38) but not in the 6-11-year-olds (n=20). There were clear relationships between HUI, SDQ, and PedsQL group scores. Conclusions: The addition of chemotherapy to 'standard dose' CSI may adversely affect health status, behaviour, and quality of life. The effect on these measures of reducing the dose of CSI and simultaneously adding chemotherapy (e.g. in the current PNET4 RCT) requires further investigation.

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Published date: January 2006
Keywords: controlled trial, controlled-trial, trial, quality-of-life, treatment, randomized controlled trial, health

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Local EPrints ID: 62338
URI: http://eprints.soton.ac.uk/id/eprint/62338
ISSN: 0012-1622
PURE UUID: 3cd04309-91e4-4deb-ac20-547f18349e9f
ORCID for K. Bull: ORCID iD orcid.org/0000-0002-5541-4556

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Date deposited: 12 Feb 2009
Last modified: 27 Apr 2019 00:36

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Author: K. Bull ORCID iD
Author: C. Kennedy

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