Marianne Pavel1, Nicole Unger2, Ivan Borbath3, Sergio Ricci4, Tsann-Long Hwang5, Thomas Brechenmacher6, Jinhee Park7, Fabian Herbst8, Jennifer L Beaumont9, Oliver Bechter10. 1. Department of Hepatology and Gastroenterology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany. Marianne.Pavel@charite.de. 2. University of Duisburg-Essen, Essen, Germany. 3. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium. 4. Presidio Ospedaliero Santa Chiara, Pisa, Italy. 5. Chang Gung Memorial Hospital, Chang Gung University, Lin-Kou, Taiwan. 6. Novartis Pharma S.A.S., Rueil-Malmaison, France. 7. Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA. 8. Novartis Pharma AG, Basel, Switzerland. 9. Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 10. University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.
Abstract
BACKGROUND/AIMS: An open-label, multi-center, expanded access study was conducted in patients with advanced neuroendocrine tumors (NET) treated with everolimus (10 mg/day) to assess safety and health-related quality of life (HRQOL). METHODS: Of the 246 patients enrolled, 126 have pancreatic NET (pNET) and 120 have non-pNET. Patients continued treatment until disease progression, unacceptable toxicity, death, until commercial availability of everolimus, or May 2012, whichever came first. Adverse events (AEs) were analyzed according to Common Terminology Criteria version 4.0. HRQOL was assessed at baseline, for three 28-day cycles, and then at every three cycles until end of treatment (EOT) with EQ-5D, EORTC QLQ-C30, and EORTC QLQ-GINET21 instruments. RESULTS: The most common grade 3 or 4 AEs included hyperglycemia, infections, stomatitis, fatigue, and abdominal pain. In patients with pNET, mean (± SD) EQ VAS score remained stable at EOT (baseline, 68.8 ± 19.9 vs. EOT, 66.5 ± 20.6) without clinically significant change in QLQ-C30 global health status (change from baseline, - 3.9; n = 86). For patients with non-pNET, a reduction in EQ VAS score (63.9 ± 19.0 vs. 55.3 ± 23.0) with clinically significant changes in QLQ-C30 global health status (-13.0; n = 69) was seen by EOT. EQ-5D utility scores remained stable in patients with pNET and a moderate decrease was reported by patients with non-pNET. CONCLUSIONS: The safety profile of everolimus was consistent with the previous studies without adversely affecting HRQOL in pNET. Lower baseline HRQOL scores and more frequent comorbidities might have contributed to the worse outcomes in non-pNET. TRIAL REGISTRATION: EudraCT no. 2010-023032-17.
BACKGROUND/AIMS: An open-label, multi-center, expanded access study was conducted in patients with advanced neuroendocrine tumors (NET) treated with everolimus (10 mg/day) to assess safety and health-related quality of life (HRQOL). METHODS: Of the 246 patients enrolled, 126 have pancreatic NET (pNET) and 120 have non-pNET. Patients continued treatment until disease progression, unacceptable toxicity, death, until commercial availability of everolimus, or May 2012, whichever came first. Adverse events (AEs) were analyzed according to Common Terminology Criteria version 4.0. HRQOL was assessed at baseline, for three 28-day cycles, and then at every three cycles until end of treatment (EOT) with EQ-5D, EORTCQLQ-C30, and EORTCQLQ-GINET21 instruments. RESULTS: The most common grade 3 or 4 AEs included hyperglycemia, infections, stomatitis, fatigue, and abdominal pain. In patients with pNET, mean (± SD) EQ VAS score remained stable at EOT (baseline, 68.8 ± 19.9 vs. EOT, 66.5 ± 20.6) without clinically significant change in QLQ-C30 global health status (change from baseline, - 3.9; n = 86). For patients with non-pNET, a reduction in EQ VAS score (63.9 ± 19.0 vs. 55.3 ± 23.0) with clinically significant changes in QLQ-C30 global health status (-13.0; n = 69) was seen by EOT. EQ-5D utility scores remained stable in patients with pNET and a moderate decrease was reported by patients with non-pNET. CONCLUSIONS: The safety profile of everolimus was consistent with the previous studies without adversely affecting HRQOL in pNET. Lower baseline HRQOL scores and more frequent comorbidities might have contributed to the worse outcomes in non-pNET. TRIAL REGISTRATION: EudraCT no. 2010-023032-17.
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