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Neuroendocrinology. 2018;107(3):237-245. doi: 10.1159/000491999. Epub 2018 Jul 10.

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

Author information

1
Department of Medical Oncology, Paris Saint-Joseph Hospital Group, Paris, France.
2
Program in Neuroendocrine and Carcinoid Tumors, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
3
PLA Cancer Center, Nanjing Bayi Hospital, Nanjing, China.
4
Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
5
Centrul de Oncologie Sf. Nectarie, Oncologie Medicala, Craiova, Romania.
6
Hospital Universitario Madrid Sanchinarro, Centro Integral Oncológico Clara Campal, Madrid, Spain.
7
Zhongshan Hospital, Fudan University, Shanghai, China.
8
Faculty of Medicine, Masaryk Memorial Cancer Institute, Masaryk University, Brno, Czech Republic.
9
Department of Gastroenterology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
10
No. 307 Hospital, Academy of Military Medical Sciences, Beijing, China.
11
Department of Medical Oncology, Fundeni Clinical Institute, Bucharest, Romania.
12
Andrew Love Cancer Center, Geelong Hospital, Victoria, Victoria, Australia.
13
Všeobecné Fakultní Nemocnice v Praze Onkologická Klinika, Prague, Czech Republic.
14
Hepato-Gastroenterology Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
15
Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
16
Division of Hematology/Oncology, Columbia University Medical Center, New York, New York, USA.
17
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
18
China-Japan Friendship Hospital, Beijing, China.
19
Service d'Oncologie Digestive, Hôpital Beaujon, Clichy, France.
20
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of GI Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
21
GI and HPB Surgical Oncology, Tata Memorial Hospital, Mumbai, India.
22
West China Hospital of Sichuan University, Chengdu, China.
23
2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovakia.
24
Henry Ford Health System, Detroit, Michigan, USA.
25
National Cancer Center, Tokyo, Japan.
26
Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, Milan, Italy.
27
Pfizer Oncology, Pfizer Inc., San Diego, California, USA.
28
Pfizer Oncology, Pfizer Inc., Cambridge, Massachusetts, USA.
29
Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, Milan, Italynicola.fazio@ieo.it.

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.

KEYWORDS:

Overall survival; Pancreatic neuroendocrine tumour; Progression-free survival; Safety; Sunitinib

PMID:
29991024
DOI:
10.1159/000491999
[Indexed for MEDLINE]

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