单位：[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中山大学附属第二医院[v]West China Hospital of Sichuan University, Chengdu, China四川大学华西医院[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
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 (pan-NETs). 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 pan-NETs 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. (C) 2018 S. Karger AG, Basel
第一作者单位：[a]Department of Medical Oncology, Paris Saint-Joseph Hospital Group, Paris, France
共同第一作者：
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)
推荐引用方式(GB/T 7714)：
Eric Raymond,Matthew H. Kulke,Shukui Qin,et al.Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours[J].NEUROENDOCRINOLOGY.2018,107(3):237-245.doi:10.1159/000491999.
APA：
Eric Raymond,Matthew H. Kulke,Shukui Qin,Xianjun Yu,Michael Schenker...&Nicola Fazio.(2018).Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours.NEUROENDOCRINOLOGY,107,(3)
MLA：
Eric Raymond,et al."Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours".NEUROENDOCRINOLOGY 107..3(2018):237-245
