Qol-07description of Clinical and Patient Reported Outcomes Assessments From a Phase 3, Multicenter, Randomized Trial Evaluating Nivolumab Monotherapy Versus Bevacizumab in Recurrent Glioblastoma: Checkmate-143
Year: 2015
Type: article
Abstract: Advances in therapy for glioblastoma (GBM) have provided limited survival and health-related quality of life (HRQoL) benefit. Symptom management and maintaining HRQoL are important metrics for assessing treatment benefit. To inform on these metrics, both clinician- and patient-reported outcome measures to evaluate HRQoL and neurocognitive impairment were included as exploratory endpoints in the randomized cohort 2 of CHECKMATE-143, evaluating nivolumab monotherapy versus bevacizumab in adult patients with recurrent GBM. Clinician assessment of neurologic function will be done using the Neurologic Assessment in Neuro-Oncology (NANO) scale, which includes nine major domains (gait, strength, ataxia, sensation, visual field, facial strength, language, level of consciousness, and behaviour). The Cogstate assessment, consisting of a computerized battery of neurocognitive tests of approximately 15 minutes in duration, was used to evaluate neurocognitive functioning, cognitive deficits and/or executive functioning at baseline, and on day 1 of weeks 13, 21, 45, and 69, and at the time of treatment discontinuation. Patient-reported HRQoL was determined using the EORTC QLQ-C30, an assessment commonly used in oncology studies and comprising six functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning, role functioning, and global QoL) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and the QLQ-BN20, a brain tumor-specific instrument evaluating four domains (future uncertainty, visual disorder, communication deficit, and motor dysfunction). The standardized EuroQoL-5D will be used for self-assessment of general health status across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety) and includes a visual analog rating scale. Scoring by using the NANO scale and assessment with the EORTC QLQ-C30, QLQ-BN20 and EQ5D will be done at baseline, weeks 7, 13, and every 8 weeks thereafter until treatment discontinuation. Methodology and baseline information regarding the use of these patient and clinician scales will be reported.
Source: Neuro-Oncology
Authors: Lakshmi Nayak, Alba Brandes, Antonio Omuro, Johannes Rieger, Antje Wick, Surasak Phuphanich, Ashley Sumrall, Solmaz Sahebjam, Manmeet Ahluwalia, Paul de Souza, Juan Manuel Sepulveda, Michele Maio, Oliver Grauer, Gordana Vlahovic, Joachim Baehring, Homa Dastani, Robert Latek, Vlad Coric, David Reardon
Institutions: Harvard University, Dana-Farber Cancer Institute, Dana-Farber/Harvard Cancer Center, Istituto delle Scienze Neurologiche di Bologna, Memorial Sloan Kettering Cancer Center, Goethe University Frankfurt, University Hospital Frankfurt, Heidelberg University, University Hospital Heidelberg, National Center for Tumor Diseases, Cedars-Sinai Medical Center, Levine Cancer Institute, Moffitt Cancer Center, Cleveland Clinic, Western Sydney University, Hospital Universitario 12 De Octubre, University of Siena, University of Münster, University Hospital Münster, Duke Medical Center, Yale University, Bristol-Myers Squibb (United States)
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2339609108