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.
| Original language | English |
|---|---|
| Pages (from-to) | 237-245 |
| Number of pages | 9 |
| Journal | Neuroendocrinology |
| Volume | 107 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Nov 1 2018 |
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Keywords
- Overall survival
- Pancreatic neuroendocrine tumour
- Progression-free survival
- Safety
- Sunitinib
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Endocrinology
- Endocrine and Autonomic Systems
- Cellular and Molecular Neuroscience
Cite this
Efficacy and safety of sunitinib in patients with well-differentiated pancreatic neuroendocrine tumours. / Raymond, Eric; Kulke, Matthew H.; Qin, Shukui; Yu, Xianjun; Schenker, Michael; Cubillo, Antonio; Lou, Wenhui; Tomasek, Jiri; Thiis-Evensen, Espen; Xu, Jian Ming; Croitoru, Adina E.; Khasraw, Mustafa; Sedlackova, Eva; Borbath, Ivan; Ruff, Paul; Oberstein, Paul E.; Ito, Tetsuhide; Jia, Liqun; Hammel, Pascal; Shen, Lin; Shrikhande, Shailesh V.; Shen, Yali; Sufliarsky, Jozef; Khan, Gazala N.; Morizane, Chigusa; Galdy, Salvatore; Khosravan, Reza; Fernandez, Kathrine C.; Rosbrook, Brad; Fazio, Nicola.
In: Neuroendocrinology, Vol. 107, No. 3, 01.11.2018, p. 237-245.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy and safety of sunitinib in patients with well-differentiated pancreatic neuroendocrine tumours
AU - Raymond, Eric
AU - Kulke, Matthew H.
AU - Qin, Shukui
AU - Yu, Xianjun
AU - Schenker, Michael
AU - Cubillo, Antonio
AU - Lou, Wenhui
AU - Tomasek, Jiri
AU - Thiis-Evensen, Espen
AU - Xu, Jian Ming
AU - Croitoru, Adina E.
AU - Khasraw, Mustafa
AU - Sedlackova, Eva
AU - Borbath, Ivan
AU - Ruff, Paul
AU - Oberstein, Paul E.
AU - Ito, Tetsuhide
AU - Jia, Liqun
AU - Hammel, Pascal
AU - Shen, Lin
AU - Shrikhande, Shailesh V.
AU - Shen, Yali
AU - Sufliarsky, Jozef
AU - Khan, Gazala N.
AU - Morizane, Chigusa
AU - Galdy, Salvatore
AU - Khosravan, Reza
AU - Fernandez, Kathrine C.
AU - Rosbrook, Brad
AU - Fazio, Nicola
PY - 2018/11/1
Y1 - 2018/11/1
N2 - 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.
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.
KW - Overall survival
KW - Pancreatic neuroendocrine tumour
KW - Progression-free survival
KW - Safety
KW - Sunitinib
UR - http://www.scopus.com/inward/record.url?scp=85056302332&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85056302332&partnerID=8YFLogxK
U2 - 10.1159/000491999
DO - 10.1159/000491999
M3 - Article
C2 - 29991024
AN - SCOPUS:85056302332
VL - 107
SP - 237
EP - 245
JO - Neuroendocrinology
JF - Neuroendocrinology
SN - 0028-3835
IS - 3
ER -