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

J 2018

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

RAYMOND, Eric, Matthew H. KULKE, Shukui QIN, Xianjun YU, Mchael SCHENKER et. al.

Základní údaje

Originální název

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

Autoři

RAYMOND, Eric (250 Francie), Matthew H. KULKE (840 Spojené státy), Shukui QIN (156 Čína), Xianjun YU (156 Čína), Mchael SCHENKER (642 Rumunsko), Antonio CUBILLO (724 Španělsko), Wenhui LOU (156 Čína), Jiří TOMÁŠEK (203 Česká republika, domácí), Espen THIIS-EVENSEN (578 Norsko), Jian-Ming XU (156 Čína), Adina E. CROITORU (642 Rumunsko), Mustafa KHASRAW (36 Austrálie), Eva SEDLACKOVA (203 Česká republika), Ivan BORBATH (56 Belgie), Paul RUFF (710 Jižní Afrika), Paul E. OBERSTEIN (840 Spojené státy), Tetsuhide ITO (392 Japonsko), Li Quin JIA (156 Čína), Pascal HAMMEL (250 Francie), Lin SHEN (156 Čína), Shailesh V. SHRIKHANDE (356 Indie), Yali SHEN (156 Čína), Jozef SUFLIARSKY (703 Slovensko), Gazala N. KHAN (840 Spojené státy), Chigusa MORIZANE (392 Japonsko), Salvatore GALDY (380 Itálie), Reza KHOSRAVAN (840 Spojené státy), Kathrine C. FERNANDEZ (840 Spojené státy), Brad ROSBROOK (840 Spojené státy) a Nicola FAZIO (380 Itálie)

Vydání

NEUROENDOCRINOLOGY, BASEL, KARGER, 2018, 0028-3835

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30103 Neurosciences

Stát vydavatele

Švýcarsko

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 6.804

Kód RIV

RIV/00216224:14110/18:00106277

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1159/000491999

UT WoS

000456060200004

Klíčová slova anglicky

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

Štítky

14110811, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 21. 2. 2019 13:52, Soňa Böhmová

Anotace

V originále

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

Citovat

RAYMOND, Eric, Matthew H. KULKE, Shukui QIN, Xianjun YU, Mchael SCHENKER, Antonio CUBILLO, Wenhui LOU, Jiří TOMÁŠEK, Espen THIIS-EVENSEN, Jian-Ming XU, Adina E. CROITORU, Mustafa KHASRAW, Eva SEDLACKOVA, Ivan BORBATH, Paul RUFF, Paul E. OBERSTEIN, Tetsuhide ITO, Li Quin JIA, Pascal HAMMEL, Lin SHEN, Shailesh V. SHRIKHANDE, Yali SHEN, Jozef SUFLIARSKY, Gazala N. KHAN, Chigusa MORIZANE, Salvatore GALDY, Reza KHOSRAVAN, Kathrine C. FERNANDEZ, Brad ROSBROOK a Nicola FAZIO. Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours. NEUROENDOCRINOLOGY. BASEL: KARGER, 2018, roč. 107, č. 3, s. 237-245. ISSN 0028-3835. Dostupné z: https://dx.doi.org/10.1159/000491999.

@article{1499356,
   author = {Raymond, Eric and Kulke, Matthew H. and Qin, Shukui and Yu, Xianjun and Schenker, Mchael and Cubillo, Antonio and Lou, Wenhui and Tomášek, Jiří and ThiisandEvensen, Espen and Xu, JianandMing and Croitoru, Adina E. and Khasraw, Mustafa and Sedlackova, Eva and Borbath, Ivan and Ruff, Paul and Oberstein, Paul E. and Ito, Tetsuhide and Jia, Li Quin and Hammel, Pascal and Shen, Lin and Shrikhande, Shailesh V. and Shen, Yali and Sufliarsky, Jozef and Khan, Gazala N. and Morizane, Chigusa and Galdy, Salvatore and Khosravan, Reza and Fernandez, Kathrine C. and Rosbrook, Brad and Fazio, Nicola},
   article_location = {BASEL},
   article_number = {3},
   doi = {http://dx.doi.org/10.1159/000491999},
   keywords = {Pancreatic neuroendocrine tumour; Progression-free survival; Overall survival; Safety; Sunitinib},
   language = {eng},
   issn = {0028-3835},
   journal = {NEUROENDOCRINOLOGY},
   title = {Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours},
   volume = {107},
   year = {2018}
}

TY  - JOUR
ID  - 1499356
AU  - Raymond, Eric - Kulke, Matthew H. - Qin, Shukui - Yu, Xianjun - Schenker, Mchael - Cubillo, Antonio - Lou, Wenhui - Tomášek, Jiří - Thiis-Evensen, Espen - Xu, Jian-Ming - Croitoru, Adina E. - Khasraw, Mustafa - Sedlackova, Eva - Borbath, Ivan - Ruff, Paul - Oberstein, Paul E. - Ito, Tetsuhide - Jia, Li Quin - 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
PY  - 2018
TI  - Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours
JF  - NEUROENDOCRINOLOGY
VL  - 107
IS  - 3
SP  - 237-245
EP  - 237-245
PB  - KARGER
SN  - 00283835
KW  - Pancreatic neuroendocrine tumour
KW  - Progression-free survival
KW  - Overall survival
KW  - Safety
KW  - Sunitinib
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 (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
ER  -

RAYMOND, Eric, Matthew H. KULKE, Shukui QIN, Xianjun YU, Mchael SCHENKER, Antonio CUBILLO, Wenhui LOU, Jiří TOMÁŠEK, Espen THIIS-EVENSEN, Jian-Ming XU, Adina E. CROITORU, Mustafa KHASRAW, Eva SEDLACKOVA, Ivan BORBATH, Paul RUFF, Paul E. OBERSTEIN, Tetsuhide ITO, Li Quin JIA, Pascal HAMMEL, Lin SHEN, Shailesh V. SHRIKHANDE, Yali SHEN, Jozef SUFLIARSKY, Gazala N. KHAN, Chigusa MORIZANE, Salvatore GALDY, Reza KHOSRAVAN, Kathrine C. FERNANDEZ, Brad ROSBROOK a Nicola FAZIO. Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours. \textit{NEUROENDOCRINOLOGY}. BASEL: KARGER, 2018, roč.~107, č.~3, s.~237-245. ISSN~0028-3835. Dostupné z: https://dx.doi.org/10.1159/000491999.

Podrobný výpis o publikaci