Sunitinib in patients with pre-treated pancreatic neuroendocrine tumors: A real-world study

Maria Rinzivillo, Nicola Fazio, Sara Pusceddu, Andrea Spallanzani, Toni Ibrahim, Davide Campana, Riccardo Marconicini, Stefano Partelli, Giuseppe Badalamenti, Maria Pia Brizzi, Laura Catena, Giovanni Schinzari, Carlo Carnaghi, Rossana Berardi, Antongiulio Faggiano, Lorenzo Antonuzzo, Francesca Spada, Sara Gritti, Daniela Femia, Fabio GelsominoAlberto Bongiovanni, Sergio Ricci, Nicole Brighi, Massimo Falconi, Gianfranco Delle Fave, Francesco Panzuto

Research output: Contribution to journalArticle

Abstract

INTRODUCTION: Besides data reported in a Phase-III trial, data on sunitinib in pancreatic Neuroendocrine Tumors (panNETs) are scanty.

AIM: To evaluate sunitinib efficacy and tolerability in panNETs patients treated in a real-world setting.

PATIENTS AND METHODS: Retrospective analysis of progressive panNETs treated with sunitinib. Efficacy was assessed by evaluating progression-free survival, overall survival, and disease control (DC) rate (stable disease (SD) + partial response + complete response). Data are reported as median (25th-75th IQR).

RESULTS: Eighty patients were included. Overall, 71.1% had NET G2, 26.3% had NET G1, and 2.6% had NET G3 neoplasms. A total of 53 patients (66.3%) had received three or more therapeutic regimens before sunitinib, with 24 patients (30%) having been treated with four previous treatments. Median PFS was 10 months. Similar risk of progression was observed between NET G1 and NET G2 tumors (median PFS 11 months and 8 months, respectively), and between patients who had received ≥ 3 vs ≤ 2 therapeutic approaches before sunitinib (median PFS 9 months and 10 months, respectively). DC rate was 71.3% and SD was the most frequent observed response, occurring in 43 pts (53.8%). Overall, 59 pts (73.8%) experienced AEs, which were grade 1-2 in 43 of them (72.9%), grade 3 in 15 pts (25.4%), and grade 4 in one patient (1.7%). Six pts (7.5%) stopped treatment due to toxicity.

CONCLUSIONS: The present real-world experience shows that sunitinib is a safe and effective treatment for panNETs, even in the clinical setting of heavily pre-treated, progressive diseases.

Original languageEnglish
Pages (from-to)198-203
Number of pages6
JournalPancreatology
Volume18
Issue number2
DOIs
Publication statusPublished - Mar 2018

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Neuroendocrine Tumors
Therapeutics
Disease-Free Survival
sunitinib
Neoplasms
Survival

Keywords

  • Adult
  • Aged
  • Antineoplastic Agents/adverse effects
  • Humans
  • Indoles/adverse effects
  • Italy/epidemiology
  • Middle Aged
  • Neuroendocrine Tumors/drug therapy
  • Pancreatic Neoplasms/drug therapy
  • Pyrroles/adverse effects
  • Retrospective Studies
  • Sunitinib
  • Treatment Outcome

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Sunitinib in patients with pre-treated pancreatic neuroendocrine tumors : A real-world study. / Rinzivillo, Maria; Fazio, Nicola; Pusceddu, Sara; Spallanzani, Andrea; Ibrahim, Toni; Campana, Davide; Marconicini, Riccardo; Partelli, Stefano; Badalamenti, Giuseppe; Brizzi, Maria Pia; Catena, Laura; Schinzari, Giovanni; Carnaghi, Carlo; Berardi, Rossana; Faggiano, Antongiulio; Antonuzzo, Lorenzo; Spada, Francesca; Gritti, Sara; Femia, Daniela; Gelsomino, Fabio; Bongiovanni, Alberto; Ricci, Sergio; Brighi, Nicole; Falconi, Massimo; Delle Fave, Gianfranco; Panzuto, Francesco.

In: Pancreatology, Vol. 18, No. 2, 03.2018, p. 198-203.

Research output: Contribution to journalArticle

Rinzivillo, M, Fazio, N, Pusceddu, S, Spallanzani, A, Ibrahim, T, Campana, D, Marconicini, R, Partelli, S, Badalamenti, G, Brizzi, MP, Catena, L, Schinzari, G, Carnaghi, C, Berardi, R, Faggiano, A, Antonuzzo, L, Spada, F, Gritti, S, Femia, D, Gelsomino, F, Bongiovanni, A, Ricci, S, Brighi, N, Falconi, M, Delle Fave, G & Panzuto, F 2018, 'Sunitinib in patients with pre-treated pancreatic neuroendocrine tumors: A real-world study', Pancreatology, vol. 18, no. 2, pp. 198-203. https://doi.org/10.1016/j.pan.2018.01.005
Rinzivillo, Maria ; Fazio, Nicola ; Pusceddu, Sara ; Spallanzani, Andrea ; Ibrahim, Toni ; Campana, Davide ; Marconicini, Riccardo ; Partelli, Stefano ; Badalamenti, Giuseppe ; Brizzi, Maria Pia ; Catena, Laura ; Schinzari, Giovanni ; Carnaghi, Carlo ; Berardi, Rossana ; Faggiano, Antongiulio ; Antonuzzo, Lorenzo ; Spada, Francesca ; Gritti, Sara ; Femia, Daniela ; Gelsomino, Fabio ; Bongiovanni, Alberto ; Ricci, Sergio ; Brighi, Nicole ; Falconi, Massimo ; Delle Fave, Gianfranco ; Panzuto, Francesco. / Sunitinib in patients with pre-treated pancreatic neuroendocrine tumors : A real-world study. In: Pancreatology. 2018 ; Vol. 18, No. 2. pp. 198-203.
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abstract = "INTRODUCTION: Besides data reported in a Phase-III trial, data on sunitinib in pancreatic Neuroendocrine Tumors (panNETs) are scanty.AIM: To evaluate sunitinib efficacy and tolerability in panNETs patients treated in a real-world setting.PATIENTS AND METHODS: Retrospective analysis of progressive panNETs treated with sunitinib. Efficacy was assessed by evaluating progression-free survival, overall survival, and disease control (DC) rate (stable disease (SD) + partial response + complete response). Data are reported as median (25th-75th IQR).RESULTS: Eighty patients were included. Overall, 71.1{\%} had NET G2, 26.3{\%} had NET G1, and 2.6{\%} had NET G3 neoplasms. A total of 53 patients (66.3{\%}) had received three or more therapeutic regimens before sunitinib, with 24 patients (30{\%}) having been treated with four previous treatments. Median PFS was 10 months. Similar risk of progression was observed between NET G1 and NET G2 tumors (median PFS 11 months and 8 months, respectively), and between patients who had received ≥ 3 vs ≤ 2 therapeutic approaches before sunitinib (median PFS 9 months and 10 months, respectively). DC rate was 71.3{\%} and SD was the most frequent observed response, occurring in 43 pts (53.8{\%}). Overall, 59 pts (73.8{\%}) experienced AEs, which were grade 1-2 in 43 of them (72.9{\%}), grade 3 in 15 pts (25.4{\%}), and grade 4 in one patient (1.7{\%}). Six pts (7.5{\%}) stopped treatment due to toxicity.CONCLUSIONS: The present real-world experience shows that sunitinib is a safe and effective treatment for panNETs, even in the clinical setting of heavily pre-treated, progressive diseases.",
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author = "Maria Rinzivillo and Nicola Fazio and Sara Pusceddu and Andrea Spallanzani and Toni Ibrahim and Davide Campana and Riccardo Marconicini and Stefano Partelli and Giuseppe Badalamenti and Brizzi, {Maria Pia} and Laura Catena and Giovanni Schinzari and Carlo Carnaghi and Rossana Berardi and Antongiulio Faggiano and Lorenzo Antonuzzo and Francesca Spada and Sara Gritti and Daniela Femia and Fabio Gelsomino and Alberto Bongiovanni and Sergio Ricci and Nicole Brighi and Massimo Falconi and {Delle Fave}, Gianfranco and Francesco Panzuto",
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TY - JOUR

T1 - Sunitinib in patients with pre-treated pancreatic neuroendocrine tumors

T2 - A real-world study

AU - Rinzivillo, Maria

AU - Fazio, Nicola

AU - Pusceddu, Sara

AU - Spallanzani, Andrea

AU - Ibrahim, Toni

AU - Campana, Davide

AU - Marconicini, Riccardo

AU - Partelli, Stefano

AU - Badalamenti, Giuseppe

AU - Brizzi, Maria Pia

AU - Catena, Laura

AU - Schinzari, Giovanni

AU - Carnaghi, Carlo

AU - Berardi, Rossana

AU - Faggiano, Antongiulio

AU - Antonuzzo, Lorenzo

AU - Spada, Francesca

AU - Gritti, Sara

AU - Femia, Daniela

AU - Gelsomino, Fabio

AU - Bongiovanni, Alberto

AU - Ricci, Sergio

AU - Brighi, Nicole

AU - Falconi, Massimo

AU - Delle Fave, Gianfranco

AU - Panzuto, Francesco

N1 - Copyright © 2018 IAP and EPC. Published by Elsevier B.V. All rights reserved.

PY - 2018/3

Y1 - 2018/3

N2 - INTRODUCTION: Besides data reported in a Phase-III trial, data on sunitinib in pancreatic Neuroendocrine Tumors (panNETs) are scanty.AIM: To evaluate sunitinib efficacy and tolerability in panNETs patients treated in a real-world setting.PATIENTS AND METHODS: Retrospective analysis of progressive panNETs treated with sunitinib. Efficacy was assessed by evaluating progression-free survival, overall survival, and disease control (DC) rate (stable disease (SD) + partial response + complete response). Data are reported as median (25th-75th IQR).RESULTS: Eighty patients were included. Overall, 71.1% had NET G2, 26.3% had NET G1, and 2.6% had NET G3 neoplasms. A total of 53 patients (66.3%) had received three or more therapeutic regimens before sunitinib, with 24 patients (30%) having been treated with four previous treatments. Median PFS was 10 months. Similar risk of progression was observed between NET G1 and NET G2 tumors (median PFS 11 months and 8 months, respectively), and between patients who had received ≥ 3 vs ≤ 2 therapeutic approaches before sunitinib (median PFS 9 months and 10 months, respectively). DC rate was 71.3% and SD was the most frequent observed response, occurring in 43 pts (53.8%). Overall, 59 pts (73.8%) experienced AEs, which were grade 1-2 in 43 of them (72.9%), grade 3 in 15 pts (25.4%), and grade 4 in one patient (1.7%). Six pts (7.5%) stopped treatment due to toxicity.CONCLUSIONS: The present real-world experience shows that sunitinib is a safe and effective treatment for panNETs, even in the clinical setting of heavily pre-treated, progressive diseases.

AB - INTRODUCTION: Besides data reported in a Phase-III trial, data on sunitinib in pancreatic Neuroendocrine Tumors (panNETs) are scanty.AIM: To evaluate sunitinib efficacy and tolerability in panNETs patients treated in a real-world setting.PATIENTS AND METHODS: Retrospective analysis of progressive panNETs treated with sunitinib. Efficacy was assessed by evaluating progression-free survival, overall survival, and disease control (DC) rate (stable disease (SD) + partial response + complete response). Data are reported as median (25th-75th IQR).RESULTS: Eighty patients were included. Overall, 71.1% had NET G2, 26.3% had NET G1, and 2.6% had NET G3 neoplasms. A total of 53 patients (66.3%) had received three or more therapeutic regimens before sunitinib, with 24 patients (30%) having been treated with four previous treatments. Median PFS was 10 months. Similar risk of progression was observed between NET G1 and NET G2 tumors (median PFS 11 months and 8 months, respectively), and between patients who had received ≥ 3 vs ≤ 2 therapeutic approaches before sunitinib (median PFS 9 months and 10 months, respectively). DC rate was 71.3% and SD was the most frequent observed response, occurring in 43 pts (53.8%). Overall, 59 pts (73.8%) experienced AEs, which were grade 1-2 in 43 of them (72.9%), grade 3 in 15 pts (25.4%), and grade 4 in one patient (1.7%). Six pts (7.5%) stopped treatment due to toxicity.CONCLUSIONS: The present real-world experience shows that sunitinib is a safe and effective treatment for panNETs, even in the clinical setting of heavily pre-treated, progressive diseases.

KW - Adult

KW - Aged

KW - Antineoplastic Agents/adverse effects

KW - Humans

KW - Indoles/adverse effects

KW - Italy/epidemiology

KW - Middle Aged

KW - Neuroendocrine Tumors/drug therapy

KW - Pancreatic Neoplasms/drug therapy

KW - Pyrroles/adverse effects

KW - Retrospective Studies

KW - Sunitinib

KW - Treatment Outcome

U2 - 10.1016/j.pan.2018.01.005

DO - 10.1016/j.pan.2018.01.005

M3 - Article

C2 - 29361429

VL - 18

SP - 198

EP - 203

JO - Pancreatology

JF - Pancreatology

SN - 1424-3903

IS - 2

ER -