Juan W Valle1, Ivan Borbath2, Brad Rosbrook3, Kathrine Fernandez4, Eric Raymond5. 1. Division of Cancer Sciences/Department of Medical Oncology, The Christie NHS Foundation Trust, University of Manchester, Manchester M20 4BX, UK. 2. Department of Hepato-Gastroenterology, Cliniques Universitaires Saint-Luc, Av Hippocrate, 10 - 1200 Brussels, Belgium. 3. Pfizer Inc., 10646 Science Center Dr, San Diego, CA 92121, USA. 4. Pfizer Inc., 1 Portland St, Cambridge, MA 02139, USA. 5. Paris Saint-Joseph Hospital Group, 185 Rue Raymond Losserand, Paris 75014, France.
Abstract
AIM: To describe the long-term safety of sunitinib in patients with progressive, well-differentiated, advanced/metastatic pancreatic neuroendocrine tumors. PATIENTS & METHODS:Sunitinib- and placebo-treated patients from the Phase III study continued to receive sunitinib (37.5 mg on a continuous daily-dosing regimen) in two open-label extension studies. RESULTS: Median (range) treatment exposure: 30.2 (0.7-269.4) and 87.1 (3.9-319.4) weeks for medium-term (n = 41) and long-term-treated (n = 61) populations, respectively. All patients experienced ≥1 adverse event (AE); 47 (45.6%) reported serious AEs. Common all-causality AEs: diarrhea (63.1%); neutropenia (43.7%); abdominal pain (40.8%). Fifteen (14.6%) patients discontinued treatment due to treatment-related AEs. CONCLUSION: The safety of extended sunitinib treatment was consistent with the known safety profile of sunitinib in pancreatic neuroendocrine tumors.
RCT Entities:
AIM: To describe the long-term safety of sunitinib in patients with progressive, well-differentiated, advanced/metastatic pancreatic neuroendocrine tumors. PATIENTS & METHODS:Sunitinib- and placebo-treated patients from the Phase III study continued to receive sunitinib (37.5 mg on a continuous daily-dosing regimen) in two open-label extension studies. RESULTS: Median (range) treatment exposure: 30.2 (0.7-269.4) and 87.1 (3.9-319.4) weeks for medium-term (n = 41) and long-term-treated (n = 61) populations, respectively. All patients experienced ≥1 adverse event (AE); 47 (45.6%) reported serious AEs. Common all-causality AEs: diarrhea (63.1%); neutropenia (43.7%); abdominal pain (40.8%). Fifteen (14.6%) patients discontinued treatment due to treatment-related AEs. CONCLUSION: The safety of extended sunitinib treatment was consistent with the known safety profile of sunitinib in pancreatic neuroendocrine tumors.
Authors: Xavier M Keutgen; Kimberly J Ornell; Alyx Vogle; Olga Lakiza; Jelani Williams; Paul Miller; Katelyn S Mistretta; Namrata Setia; Ralph R Weichselbaum; Jeannine M Coburn Journal: Ann Surg Oncol Date: 2021-06-05 Impact factor: 5.344
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