1. Observational Study to Assess Quality of Life in Patients with Pancreatic Neuroendocrine Tumors Receiving Treatment with Everolimus: The OBLIQUE Study (UK Phase IV Trial)
- Author
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Andrea Frilling, Ruby Saharan, Tim Meyer, Juan W. Valle, Olusola Olusesan Faluyi, John Ramage, Pankaj Punia, and Dr. Heinz-Horst Deichmann Stiftung
- Subjects
Male ,Health-related quality of life ,Endocrinology, Diabetes and Metabolism ,Neuroendocrine tumors ,030218 nuclear medicine & medical imaging ,Pancreatic neuroendocrine tumours ,0302 clinical medicine ,Endocrinology ,Quality of life ,Surveys and Questionnaires ,Clinical endpoint ,Medicine ,Manchester Cancer Research Centre ,Real-world study ,Middle Aged ,humanities ,Survival Rate ,Disease Progression ,Female ,Life Sciences & Biomedicine ,medicine.drug ,Adult ,medicine.medical_specialty ,Antineoplastic Agents ,030209 endocrinology & metabolism ,Phase IV Trial ,Disease-Free Survival ,Endocrinology & Metabolism ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,Internal medicine ,Humans ,In patient ,Everolimus ,Aged ,Science & Technology ,Endocrine and Autonomic Systems ,business.industry ,ResearchInstitutes_Networks_Beacons/mcrc ,Disease progression ,Neurosciences ,1103 Clinical Sciences ,medicine.disease ,Pancreatic Neoplasms ,Quality of Life ,Observational study ,Neurosciences & Neurology ,1109 Neurosciences ,business - Abstract
Background/Aims: To assess health-related quality of life (HRQoL), treatment patterns, and clinical outcomes of adult (≥18 years) patients with advanced (unresectable or metastatic) pancreatic neuroendocrine neoplasms (PanNENs) treated with everolimus in routine clinical practice. Methods: In a prospective, non-interventional, multi-center study patients administered at least one 10 mg dose of everolimus were evaluated for change in HRQoL (EORTC QLQ-C30 Global Health Status scale) from baseline after 6 months treatment (primary endpoint). Secondary endpoints included disease-specific HRQoL measures (EORTC QLQ-G.I.NET21), clinical outcomes, everolimus treatment patterns, and safety. Results: Forty-eight patients were recruited (between August 2013 and March 2015); the median treatment duration was 27.8 months. EORTC QLQ-C30 Global Health score was not significantly different from baseline after 6 months of treatment (mean difference –1.9 points, p = 0.660, n = 30). In pairwise analyses, the only significant changes in HRQoL from baseline were for EORTC QLQ-C30 physical functioning score at month 3 (adjusted mean difference –8.8 points, p = 0.002, n = 36) and the EORTC QLQ-G.I.NET21 disease-related worries scores at months 1 and 2 (adjusted mean differences: –11.5 points [p = 0.001, n = 44] and –8.8 points [p = 0.017, n = 43], respectively). Disease progression or death was recorded in 44.4% (n = 20/45) patients during follow-up; median progression-free survival was 25.1 months and the cumulative survival rate at 3 years was 71%. No new safety signals were detected. Conclusions: The OBLIQUE study demonstrates that HRQoL is maintained in patients with PanNENs during treatment with everolimus in a UK real-world setting. This study adds to the limited HRQoL data available in this patient group.
- Published
- 2019
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