Abstract
IntroductionBesides data reported in a Phase-III trial, data on sunitinib in pancreatic Neuroendocrine Tumors (panNETs) are scanty. AimTo evaluate sunitinib efficacy and tolerability in panNETs patients treated in a real-world setting. Patients and methodsRetrospective 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). ResultsEighty 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. ConclusionsThe 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.
Highlights
Besides data reported in a Phase-III trial, data on sunitinib in pancreatic Neuroendocrine Tumors are scanty
Sunitinib activity in pancreatic Neuroendocrine Tumors (panNETs) has been definitively confirmed in a multicenter Phase III trial in 2011 [9] which showed, without significantly affecting patients' quality of life [11], a doubling in median progression-free survival (PFS) of 11.4 months in patients receiving sunitinib compared to those treated with placebo, a figure that has recently been confirmed by the updated data analysis [12]
This is an Italian nationwide retrospective analysis of patients with sporadic panNETs who received sunitinib based on compassionate use or local regulatory authority approval, with the following inclusion criteria: age >18 years, histologically proven diagnosis of panNET with well-differentiated morphology, locally advanced unresectable or metastatic disease, progressive disease (PD) documented by radiological examinations, ECOG performance status 2, availability of follow-up data collected according to the European Neuroendocrine Tumors Society (ENETS) guidelines [13]
Summary
Besides data reported in a Phase-III trial, data on sunitinib in pancreatic Neuroendocrine Tumors (panNETs) are scanty. The therapeutic scenario of panNETs has dramatically changed during the last few years, after the introduction of targeted agents everolimus and sunitinib which are effective in patients with advanced, well-differentiated progressive tumors [8,9]. Sunitinib activity in panNETs has been definitively confirmed in a multicenter Phase III trial in 2011 [9] which showed, without significantly affecting patients' quality of life [11], a doubling in median progression-free survival (PFS) of 11.4 months in patients receiving sunitinib compared to those treated with placebo, a figure that has recently been confirmed by the updated data analysis [12]
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