@article{db56666b5570410b8bea508bd794a242,
title = "Sunitinib in patients with pre-treated pancreatic neuroendocrine tumors: A real-world study",
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. {\textcopyright} 2018 IAP and EPC",
keywords = "Neuroendocrine tumors, Pancreas, Progressive disease, Sunitinib, Target therapy, antineoplastic agent, everolimus, somatostatin derivative, sunitinib, indole derivative, pyrrole derivative, adult, aged, Article, asthenia, cancer staging, cancer survival, diarrhea, disease control, drug efficacy, drug safety, drug withdrawal, female, fever, hand foot syndrome, human, hypertension, major clinical study, male, mucosa inflammation, neutropenia, overall survival, pancreas islet cell tumor, priority journal, progression free survival, radioisotope therapy, retrospective study, stomatitis, thrombocytopenia, Italy, middle aged, neuroendocrine tumor, pancreas tumor, treatment outcome, Adult, Aged, Antineoplastic Agents, Humans, Indoles, Middle Aged, Neuroendocrine Tumors, Pancreatic Neoplasms, Pyrroles, Retrospective Studies, Treatment Outcome",
author = "M. Rinzivillo and N. Fazio and S. Pusceddu and A. Spallanzani and T. Ibrahim and D. Campana and R. Marconicini and S. Partelli and G. Badalamenti and M.P. Brizzi and L. Catena and G. Schinzari and C. Carnaghi and R. Berardi and A. Faggiano and L. Antonuzzo and F. Spada and S. Gritti and D. Femia and F. Gelsomino and A. Bongiovanni and S. Ricci and N. Brighi and M. Falconi and {Delle Fave}, G. and F. Panzuto",
note = "Cited By :1 Export Date: 5 February 2019 CODEN: PANCC Correspondence Address: Panzuto, F.; Digestive and Liver Disease, ENETS Center of Excellence at Sant'Andrea Hospital – Sapienza University of Rome, Ospedale Sant'Andrea, Via di Grottarossa 1035, Italy; email: fpanzuto@ospedalesantandrea.it Chemicals/CAS: everolimus, 159351-69-6; sunitinib, 341031-54-7, 557795-19-4; Antineoplastic Agents; Indoles; Pyrroles; sunitinib References: Dasari, A., Shen, C., Halperin, D., Zhao, B., Zhou, S., Xu, Y., Trends in the incidence, prevalence, and survival outcomes in patients with neuroendocrine tumors in the United States (2017) JAMA Oncol; Fraenkel, M., Kim, M., Faggiano, A., de Herder, W.W., Valk, G.D., Incidence of gastroenteropancreatic neuroendocrine tumours: a systematic review of the literature (2014) Endocr Relat Canc, 21, pp. R153-R163; Lloyd, R.V., Osamura, R.Y., Kl{\"o}ppel, G., Rosai, J., Neoplasms of the neuroendocrine pancreas (2017) WHO classification of tumours of endocrine organs, 10, pp. 209-239. , fourth ed. WHO/IARC Classification of Tumours; Coriat, R., Walter, T., Terris, B., Couvelard, A., Ruszniewski, P., Gastroenteropancreatic well-differentiated grade 3 neuroendocrine tumors: review and position statement (2016) Oncologist, 21, pp. 1191-1199; Panzuto, F., Boninsegna, L., Fazio, N., Campana, D., Brizzi, M.P., Capurso, G., Metastatic and locally advanced pancreatic endocrine carcinomas: analysis of factors associated with disease progression (2011) J Clin Oncol, 29, pp. 2372-2377; Bettini, R., Boninsegna, L., Mantovani, W., Capelli, P., Bassi, C., Pederzoli, P., Prognostic factors at diagnosis and value of WHO classification in a mono-institutional series of 180 non-functioning pancreatic endocrine tumours (2008) Ann Oncol, 19, pp. 903-908; Panzuto, F., Merola, E., Rinzivillo, M., Partelli, S., Campana, D., Iannicelli, E., Advanced digestive neuroendocrine tumors: metastatic pattern is an independent factor affecting clinical outcome (2014) Pancreas, 43, pp. 212-218; Yao, J.C., Shah, M.H., Ito, T., Bohas, C.L., Wolin, E.M., Van Cutsem, E., Everolimus for advanced pancreatic neuroendocrine tumors (2011) N Engl J Med, 364, pp. 514-523; Raymond, E., Dahan, L., Raoul, J.L., Bang, Y.J., Borbath, I., Lombard-Bohas, C., Sunitinib malate for the treatment of pancreatic neuroendocrine tumors (2011) N Engl J Med, 364, pp. 501-513; Kulke, M.H., Lenz, H.J., Meropol, N.J., Posey, J., Ryan, D.P., Picus, J., Activity of sunitinib in patients with advanced neuroendocrine tumors (2008) J Clin Oncol, 26, pp. 3403-3410; Vinik, A., Bottomley, A., Korytowsky, B., Bang, Y.J., Raoul, J.L., Valle, J.W., Patient-reported outcomes and quality of life with sunitinib versus placebo for pancreatic neuroendocrine tumors: results from an international phase III trial (2016) Target Oncol, 11, pp. 815-824; Faivre, S., Niccoli, P., Castellano, D., Valle, J.W., Hammel, P., Raoul, J.L., Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study (2017) Ann Oncol, 28, pp. 339-343; Knigge, U., Capdevila, J., Bartsch, D.K., Baudin, E., Falkerby, J., Kianmanesh, R., ENETS consensus guidelines for the standards of care in neuroendocrine tumors: follow-up and documentation (2017) Neuroendocrinology, 105, pp. 310-319; http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500057834, [Accessed 4 August 2017]; https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf, [Accessed 4 August 2017]; Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, L., New guidelines to evaluate the response to treatment in solid tumors (2000) J Natl Cancer Inst, 92, pp. 205-216; https://www.cancer.gov/about-cancer/treatment/drugs/fda-sunitinib-malate, [Accessed 4 August 2017]; https://www.cancer.gov/about-cancer/treatment/drugs/fda-everolimus, [Accessed 4 August 2017]; http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001038/human_med_000633.jsp&mid=WC0b01ac058001d124, [Accessed 4 August 2017]; Ito, T., Okusaka, T., Nishida, T., Yamao, K., Igarashi, H., Morizane, C., Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor (2013) Invest N Drugs, 31, pp. 1265-1274; Yoo, C., Cho, H., Song, M.J., Hong, S.M., Kim, K.P., Chang, H.M., Efficacy and safety of everolimus and sunitinib in patients with gastroenteropancreatic neuroendocrine tumor (2017) Canc Chemother Pharmacol, 79, pp. 139-146; Wang, Y., Jin, K., Tan, H., Zhang, P., Yang, Q., Wang, W., Sunitinib is effective and tolerable in Chinese patients with advanced pancreatic neuroendocrine tumors: a multicenter retrospective study in China (2017) Canc Chemother Pharmacol; Raymond, E., Kulke, M., Qin, S., Schenker, M., Cubillo, A., Lou, W., The efficacy and safety of sunitinib in patients with advanced well-differentiated pancreatic neuroendocrine tumors (2017) J Clin Oncol, 35 (4), p. 380; Panzuto, F., Rinzivillo, M., Fazio, N., de Braud, F., Luppi, G., Zatelli, M.C., Real-world study of everolimus in advanced progressive neuroendocrine tumors (2014) Oncologist, 19, pp. 966-974; Capdevila, J., Sevilla, I., Alonso, V., Ant{\'o}n Aparicio, L., Jim{\'e}nez Fonseca, P., Grande, E., Evaluation of the efficacy and safety of lanreotide in combination with targeted therapies in patients with neuroendocrine tumours in clinical practice: a retrospective cross-sectional analysis (2015) BMC Canc, 15, p. 495; Sevilla, I., Segura, {\'A}., Capdevila, J., L{\'o}pez, C., Garc{\'i}a-Carbonero, R., Grande, E., GETNE (Spanish Group of NeuroEndocrine Tumors). Management of controversial gastroenteropancreatic neuroendocrine tumour clinical situations with somatostatin analogues: results of a Delphi questionnaire panel from the NETPraxis program (2016) BMC Canc, 16, p. 858; Yao, J.C., Lombard-Bohas, C., Baudin, E., Kvols, L.K., Rougier, P., Ruszniewski, P., Daily oral everolimus activity in patients with metastatic pancreatic neuroendocrine tumors after failure of cytotoxic chemotherapy: a phase II trial (2010) J Clin Oncol, 28, pp. 69-76; Kulke, M.H., Ruszniewski, P., Van Cutsem, E., Lombard-Bohas, C., Valle, J.W., De Herder, W.W., A randomized, open-label, phase 2 study of everolimus in combination with pasireotide LAR or everolimus alone in advanced, well-differentiated, progressive pancreatic neuroendocrine tumors: COOPERATE-2 trial (2017) Ann Oncol, 28, pp. 1309-1315; Pavel, M.E., Becerra, C., Grosch, K., Cheung, W., Hasskarl, J., Yao, J.C., Effect of everolimus on the pharmacokinetics of octreotide long-acting repeatable in patients with advanced neuroendocrine tumors: an analysis of the randomized phase III RADIANT-2 trial (2017) Clin Pharmacol Ther, 101, pp. 462-468",
year = "2018",
doi = "10.1016/j.pan.2018.01.005",
language = "English",
volume = "18",
pages = "198--203",
journal = "Pancreatology",
issn = "1424-3903",
publisher = "Elsevier B.V.",
number = "2",
}