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Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours.

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机构： [a]Department of Medical Oncology, Paris Saint-Joseph Hospital Group, Paris, France [b]Program in Neuroendocrine and Carcinoid Tumors, Dana-Farber Cancer Institute, Boston, MA, USA [c]PLA Cancer Center, Nanjing Bayi Hospital, Nanjing, China [d]Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China [e]Centrul de Oncologie Sf. Nectarie, Oncologie Medicala, Craiova, Romania [f]Hospital Universitario Madrid Sanchinarro, Centro Integral Oncológico Clara Campal, Madrid, Spain [g]Zhongshan Hospital, Fudan University, Shanghai, China [h]Faculty of Medicine, Masaryk Memorial Cancer Institute, Masaryk University, Brno, Czech Republic [i]Department of Gastroenterology, Oslo University Hospital, Rikshospitalet, Oslo, Norway [j]No. 307 Hospital, Academy of Military Medical Sciences, Beijing, China [k]Department of Medical Oncology, Fundeni Clinical Institute, Bucharest, Romania [l]Andrew Love Cancer Center, Geelong Hospital, Victoria, VIC, Australia [m]Všeobecné Fakultní Nemocnice v Praze Onkologická Klinika, Prague, Czech Republic [n]Hepato-Gastroenterology Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium [o]Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa [p]Division of Hematology/Oncology, Columbia University Medical Center, New York, NY, USA [q]Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan [r]China-Japan Friendship Hospital, Beijing, China [s]Service d’Oncologie Digestive, Hôpital Beaujon, Clichy, France [t]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of GI Oncology, Peking University Cancer Hospital and Institute, Beijing, China [u]GI and HPB Surgical Oncology, Tata Memorial Hospital, Mumbai, India [v]West China Hospital of Sichuan University, Chengdu, China [w]2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovakia [x]Henry Ford Health System, Detroit, MI, USA [y]National Cancer Center, Tokyo, Japan [z]Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, Milan, Italy [A]Pfizer Oncology, Pfizer Inc., San Diego, CA, USA [B]Pfizer Oncology, Pfizer Inc., Cambridge, MA, USA

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关键词： Pancreatic neuroendocrine tumour Progression-free survival Overall survival Safety Sunitinib

摘要：

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. 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). 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%). 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. © 2018 S. Karger AG, Basel.

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出版当年[2018]版：

大类 | 2 区医学

小类 | 3 区内分泌学与代谢 3 区神经科学

最新[2023]版：

大类 | 2 区医学

小类 | 2 区内分泌学与代谢 2 区神经科学

JCR分区：

出版当年[2018]版：

Q1 NEUROSCIENCES Q1 ENDOCRINOLOGY & METABOLISM

最新[2023]版：

Q2 ENDOCRINOLOGY & METABOLISM Q2 NEUROSCIENCES

影响因子： 3.2 最新[2023版] 3.6 最新五年平均 6.804 出版当年[2018版] 5 出版当年五年平均 5.024 出版前一年[2017版] 4.271 出版后一年[2019版]

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第一作者机构： [a]Department of Medical Oncology, Paris Saint-Joseph Hospital Group, Paris, France

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通讯作者：

通讯机构： [z]Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, Milan, Italy [*1]Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors European Institute of Oncology, IEO Via Ripamonti 435, IT–20143 Milan (Italy)

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Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours.

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