Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours
Year: 2018
Type: article
Study design: Clinical Trial
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.
Source: Neuroendocrinology
DOI: 10.1159/000491999
Authors: Eric Raymond, Matthew H. Kulke, Shukui Qin, Xianjun Yu, Michael Schenker, Antonio Cubillo, Wenhui Lou, Jiri Tomasek, Espen Thiis-Evensen, Jian-Ming Xu, Adina E. Croitoru, Mustafa Khasraw, Eva Sedlackova, Ivan Borbath, Paul Ruff, Paul E. Oberstein, Tetsuhide Ito, Liqun Jia, Pascal Hammel, Lin Shen, Shailesh V. Shrikhande, Yali Shen, Jozef Sufliarsky, Gazala N. Khan, Chigusa Morizane, Salvatore Galdy, Reza Khosravan, Kathrine C. Fernandez, Brad Rosbrook, Nicola Fazio
Institutions: Hôpital Paris Saint-Joseph, Dana-Farber Cancer Institute, 81th Hospital of PLA, Fudan University Shanghai Cancer Center, Hospital Universitario HM Sanchinarro, Fudan University, Zhongshan Hospital, Masaryk University, Masaryk Memorial Cancer Institute, Oslo University Hospital, Academy of Military Medical Sciences, Institutul Clinic Fundeni, Geelong Hospital, General University Hospital in Prague, Cliniques Universitaires Saint-Luc, University of the Witwatersrand, Columbia University Irving Medical Center, Kyushu University, China-Japan Friendship Hospital, Hôpital Beaujon, Peking University Cancer Hospital, Tata Memorial Hospital, West China Hospital of Sichuan University, Comenius University Bratislava, Henry Ford Health, European Institute of Oncology, Pfizer (United States)
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2819457658