PMID- 29991024
OWN - NLM
STAT- MEDLINE
DCOM- 20190110
LR  - 20190110
IS  - 1423-0194 (Electronic)
IS  - 0028-3835 (Linking)
VI  - 107
IP  - 3
DP  - 2018
TI  - Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic 
      Neuroendocrine Tumours.
PG  - 237-245
LID - 10.1159/000491999 [doi]
AB  - 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.
CI  - (c) 2018 S. Karger AG, Basel.
FAU - Raymond, Eric
AU  - Raymond E
AD  - Department of Medical Oncology, Paris Saint-Joseph Hospital Group, Paris, France.
FAU - Kulke, Matthew H
AU  - Kulke MH
AD  - Program in Neuroendocrine and Carcinoid Tumors, Dana-Farber Cancer Institute, 
      Boston, Massachusetts, USA.
FAU - Qin, Shukui
AU  - Qin S
AD  - PLA Cancer Center, Nanjing Bayi Hospital, Nanjing, China.
FAU - Yu, Xianjun
AU  - Yu X
AD  - Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Schenker, Michael
AU  - Schenker M
AD  - Centrul de Oncologie Sf. Nectarie, Oncologie Medicala, Craiova, Romania.
FAU - Cubillo, Antonio
AU  - Cubillo A
AD  - Hospital Universitario Madrid Sanchinarro, Centro Integral Oncologico Clara 
      Campal, Madrid, Spain.
FAU - Lou, Wenhui
AU  - Lou W
AD  - Zhongshan Hospital, Fudan University, Shanghai, China.
FAU - Tomasek, Jiri
AU  - Tomasek J
AD  - Faculty of Medicine, Masaryk Memorial Cancer Institute, Masaryk University, Brno, 
      Czech Republic.
FAU - Thiis-Evensen, Espen
AU  - Thiis-Evensen E
AD  - Department of Gastroenterology, Oslo University Hospital, Rikshospitalet, Oslo, 
      Norway.
FAU - Xu, Jian-Ming
AU  - Xu JM
AD  - No. 307 Hospital, Academy of Military Medical Sciences, Beijing, China.
FAU - Croitoru, Adina E
AU  - Croitoru AE
AD  - Department of Medical Oncology, Fundeni Clinical Institute, Bucharest, Romania.
FAU - Khasraw, Mustafa
AU  - Khasraw M
AD  - Andrew Love Cancer Center, Geelong Hospital, Victoria, Victoria, Australia.
FAU - Sedlackova, Eva
AU  - Sedlackova E
AD  - Vseobecne Fakultni Nemocnice v Praze Onkologicka Klinika, Prague, Czech Republic.
FAU - Borbath, Ivan
AU  - Borbath I
AD  - Hepato-Gastroenterology Department, Cliniques Universitaires Saint-Luc, Brussels, 
      Belgium.
FAU - Ruff, Paul
AU  - Ruff P
AD  - Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South 
      Africa.
FAU - Oberstein, Paul E
AU  - Oberstein PE
AD  - Division of Hematology/Oncology, Columbia University Medical Center, New York, 
      New York, USA.
FAU - Ito, Tetsuhide
AU  - Ito T
AD  - Department of Medicine and Bioregulatory Science, Graduate School of Medical 
      Sciences, Kyushu University, Fukuoka, Japan.
FAU - Jia, Liqun
AU  - Jia L
AD  - China-Japan Friendship Hospital, Beijing, China.
FAU - Hammel, Pascal
AU  - Hammel P
AD  - Service d'Oncologie Digestive, Hopital Beaujon, Clichy, France.
FAU - Shen, Lin
AU  - Shen L
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education), Department of GI Oncology, Peking University Cancer Hospital and 
      Institute, Beijing, China.
FAU - Shrikhande, Shailesh V
AU  - Shrikhande SV
AD  - GI and HPB Surgical Oncology, Tata Memorial Hospital, Mumbai, India.
FAU - Shen, Yali
AU  - Shen Y
AD  - West China Hospital of Sichuan University, Chengdu, China.
FAU - Sufliarsky, Jozef
AU  - Sufliarsky J
AD  - 2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, 
      Slovakia.
FAU - Khan, Gazala N
AU  - Khan GN
AD  - Henry Ford Health System, Detroit, Michigan, USA.
FAU - Morizane, Chigusa
AU  - Morizane C
AD  - National Cancer Center, Tokyo, Japan.
FAU - Galdy, Salvatore
AU  - Galdy S
AD  - Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European 
      Institute of Oncology, IEO, Milan, Italy.
FAU - Khosravan, Reza
AU  - Khosravan R
AD  - Pfizer Oncology, Pfizer Inc., San Diego, California, USA.
FAU - Fernandez, Kathrine C
AU  - Fernandez KC
AD  - Pfizer Oncology, Pfizer Inc., Cambridge, Massachusetts, USA.
FAU - Rosbrook, Brad
AU  - Rosbrook B
AD  - Pfizer Oncology, Pfizer Inc., San Diego, California, USA.
FAU - Fazio, Nicola
AU  - Fazio N
AD  - Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European 
      Institute of Oncology, IEO, Milan, Italynicola.fazio@ieo.it.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180710
PL  - Switzerland
TA  - Neuroendocrinology
JT  - Neuroendocrinology
JID - 0035665
RN  - 0 (Antineoplastic Agents)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuroendocrine Tumors/*drug therapy/mortality/pathology
MH  - Pancreatic Neoplasms/*drug therapy/mortality/pathology
MH  - Sunitinib/adverse effects/*therapeutic use
MH  - Survival Rate
OTO - NOTNLM
OT  - Overall survival
OT  - Pancreatic neuroendocrine tumour
OT  - Progression-free survival
OT  - Safety
OT  - Sunitinib
EDAT- 2018/07/11 06:00
MHDA- 2019/01/11 06:00
CRDT- 2018/07/11 06:00
PHST- 2018/03/11 00:00 [received]
PHST- 2018/07/05 00:00 [accepted]
PHST- 2018/07/11 06:00 [pubmed]
PHST- 2019/01/11 06:00 [medline]
PHST- 2018/07/11 06:00 [entrez]
AID - 000491999 [pii]
AID - 10.1159/000491999 [doi]
PST - ppublish
SO  - Neuroendocrinology. 2018;107(3):237-245. doi: 10.1159/000491999. Epub 2018 Jul 
      10.