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Published on: August 14, 2012
Sunitinib in patients with pre-treated pancreatic neuroendocrine tumors: A real-world study
Maria Rinzivillo1, Nicola Fazio2, Sara Pusceddu3
1Digestive and Liver Disease, ENETS Center of Excellence Sant'Andrea Hospital - Sapienza University of Rome, Italy.
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.
Insights
Sunitinib demonstrates safety and efficacy in treating pancreatic neuroendocrine tumors (panNETs) in a real-world setting. This study confirms its effectiveness even in patients with advanced, heavily pre-treated progressive disease.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Limited real-world data exists for sunitinib in pancreatic neuroendocrine tumors (panNETs) beyond Phase-III trial results.
- PanNETs represent a challenging subset of neuroendocrine tumors requiring effective treatment options.
Purpose of the Study:
- To assess the efficacy and tolerability of sunitinib in a real-world patient cohort with panNETs.
- To provide evidence for sunitinib's utility in progressive and heavily pre-treated panNETs cases.
Main Methods:
- Retrospective analysis of 80 patients with progressive panNETs treated with sunitinib.
- Efficacy endpoints included progression-free survival (PFS), overall survival, and disease control (DC) rate.
- Adverse events (AEs) and treatment discontinuation rates due to toxicity were also evaluated.
Main Results:
- Median PFS was 10 months, with similar progression risk across NET G1/G2 and prior treatment lines (≥3 vs ≤2).
- The overall disease control rate was 71.3%, with stable disease (SD) being the most common response (53.8%).
- 73.8% of patients experienced AEs, mostly grade 1-2 (72.9%), with only 7.5% discontinuing treatment due to toxicity.
Conclusions:
- Sunitinib is a safe and effective treatment for panNETs in a real-world setting.
- The drug shows promise even for patients with heavily pre-treated, progressive panNETs.
- Real-world data supports sunitinib's role in managing advanced panNETs.
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