1. Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours
- Author
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Yali Shen, Jozef Sufliarsky, Wenhui Lou, Shailesh V. Shrikhande, Adina E. Croitoru, Liqun Jia, Antonio Cubillo, Lin Shen, Salvatore Galdy, Xianjun Yu, Mustafa Khasraw, Eva Sedlackova, Paul Ruff, Ivan Borbath, Paul E. Oberstein, Shukui Qin, Espen Thiis-Evensen, Kathrine C. Fernandez, Brad Rosbrook, Jiri Tomasek, Gazala Khan, Nicola Fazio, Matthew H. Kulke, Eric Raymond, Reza Khosravan, Jianming Xu, Michael Schenker, Chigusa Morizane, Tetsuhide Ito, and Pascal Hammel
- Subjects
Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Antineoplastic Agents ,Neutropenia ,Placebo ,Phase IV Trial ,Gastroenterology ,Disease-Free Survival ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,0302 clinical medicine ,Endocrinology ,Internal medicine ,Sunitinib ,medicine ,Clinical endpoint ,Humans ,Progression-free survival ,Adverse effect ,Aged ,Leukopenia ,Endocrine and Autonomic Systems ,business.industry ,Middle Aged ,medicine.disease ,3. Good health ,Pancreatic Neoplasms ,Survival Rate ,Neuroendocrine Tumors ,030104 developmental biology ,030220 oncology & carcinogenesis ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
Background: In a phase III study, sunitinib led to a significant increase in progression-free survival (PFS) versus placebo in patients with pancreatic neuroendocrine tumours (panNETs). This study was a post-marketing commitment to support the phase III data. Methods: In this ongoing, open-label, phase IV trial (NCT01525550), patients with progressive, advanced unresectable/metastatic, well-differentiated panNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to those of the phase III study. The primary endpoint was investigator-assessed PFS per Response Evaluation Criteria in Solid Tumours v1.0 (RECIST). Other endpoints included PFS per Choi criteria, overall survival (OS), objective response rate (ORR), and adverse events (AEs). Results: Sixty-one treatment-naive and 45 previously treated patients received sunitinib. By March 19, 2016, 82 (77%) patients had discontinued treatment, mainly due to disease progression. Median treatment duration was 11.7 months. Investigator-assessed median PFS per RECIST (95% confidence interval [CI]) was 13.2 months (10.9–16.7): 13.2 (7.4–16.8) and 13.0 (9.2–20.4) in treatment-naive and previously treated patients, respectively. ORR (95% CI) per RECIST was 24.5% (16.7–33.8) in the total population: 21.3% (11.9–33.7) in treatment-naive and 28.9% (16.4–44.3) in previously treated patients. Median OS, although not yet mature, was 37.8 months (95% CI, 33.0–not estimable). The most common treatment-related AEs were neutropenia (53.8%), diarrhoea (46.2%), and leukopenia (43.4%). Conclusions: This phase IV trial confirms sunitinib as an efficacious and safe treatment option in patients with advanced/metastatic, well-differentiated, unresectable panNETs, and supports the phase III study outcomes. AEs were consistent with the known safety profile of sunitinib.
- Published
- 2018
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