title: Neurocognitive functioning and quality of life in patients with recurrent malignant gliomas treated on a phase Ib trial evaluating topotecan by convection-enhanced delivery.
abstract: BACKGROUND
  Malignant gliomas are highly proliferative, invasive tumors that are resistant to conventional treatment, and disease progression is often accompanied by physical and mental debilitation. Neurocognitive functioning (NCF) and quality of life (QoL) were evaluated as part of a prospective phase Ib dose-escalation study of topotecan by convection-enhanced delivery (CED) for adult patients with recurrent malignant gliomas.
  
  
  METHODS
  Sixteen patients were enrolled, and NCF and QoL were evaluated using the Cognitive Stability Index and SF-36 at baseline and monthly for 4 months post treatment. Descriptive analyses included the reliable change index for serial evaluations and correlations for associations between outcome variables and age, tumor volume, total topotecan dose, and treatment effect.
  
  
  RESULTS
  Individual classifications of response to treatment indicated that a majority of patients reported stable scores over the follow-up period. Demographic and treatment-related variables were not associated with outcomes. Baseline processing speed scores were invalid for 6 subjects. Higher rates of valid scores were observed on subsequent administrations.
  
  
  CONCLUSIONS
  As the first study to use CED of any kind to evaluate the impact of CED on NCF or QoL, there was no evidence of severe detriment to either outcome. Long-term evaluation is necessary to track changes in NCF and QoL related to disease progression. Invalid scores suggest that computer-based assessments may not be suitable for all patients with malignant gliomas, especially those with cognitive deficits secondary to their disease. Future trials should include a wider range of sensitive measures to assess the impact of CED on patient NCF and QoL.
authors.affiliation: Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation , Columbia University Medical Center , New York , New York (J.A.O., A.N.D., S.A.S.); Department of Neurological Surgery , Columbia University Medical Center , New York , New York (J.N.B.).
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Oberg
authors.affiliation: Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation , Columbia University Medical Center , New York , New York (J.A.O., A.N.D., S.A.S.); Department of Neurological Surgery , Columbia University Medical Center , New York , New York (J.N.B.).
authors.forename: Amie N
authors.initials: AN
authors.lastname: Dave
authors.affiliation: Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation , Columbia University Medical Center , New York , New York (J.A.O., A.N.D., S.A.S.); Department of Neurological Surgery , Columbia University Medical Center , New York , New York (J.N.B.).
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Bruce
authors.affiliation: Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation , Columbia University Medical Center , New York , New York (J.A.O., A.N.D., S.A.S.); Department of Neurological Surgery , Columbia University Medical Center , New York , New York (J.N.B.).
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Sands
keywords: acute effects; glioma; neurocognition; quality of life; topotecan by convection-enhanced delivery