An update on the safety of lanreotide autogel for the treatment of patients with neuroendocrine tumors

References

• Basu B, Sirohi B, Corrie P. Systemic therapy for neuroendocrine tumours of gastroenteropancreatic origin. Endocr Relat Cancer. 2010;17(1):R75–90. doi: 10.1677/ERC-09-0108
   PubMed Web of Science ®Google Scholar
• Scalettar BA, Jacobs C, Fulwiler A, et al. Hindered submicron mobility and long-term storage of presynaptic dense-core granules revealed by single-particle tracking. Dev Neurobiol. 2012;72(9):1181–1195. doi: 10.1002/dneu.20984
   PubMed Web of Science ®Google Scholar
• Kaltsas GA, Besser GM, Grossman AB. The diagnosis and medical management of advanced neuroendocrine tumors. Endocr Rev. 2004;25(3):458–511. doi: 10.1210/er.2003-0014
   PubMed Web of Science ®Google Scholar
• Pavel M, Öberg K, Falconi M, et al. Gastroenteropancreatic neuroendocrine neoplasms: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(7):844–860. doi: 10.1016/j.annonc.2020.03.304
   PubMed Web of Science ®Google Scholar
• Baudin E, Caplin M, Garcia-Carbonero R, et al. Lung and thymic carcinoids: ESMO clinical practice guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(4):439–451. doi: 10.1016/j.annonc.2021.01.003
   PubMed Web of Science ®Google Scholar
• Taal BG, Visser O. Epidemiology of neuroendocrine tumours. Neuroendocrinology. 2004;80(Suppl. 1):3–7. doi: 10.1159/000080731
   PubMedGoogle Scholar
• Oronsky B, Ma PC, Morgensztern D, et al. Nothing but NET: a review of neuroendocrine tumors and carcinomas. Neoplasia N Y N. 2017;19(12):991–1002. doi: 10.1016/j.neo.2017.09.002
   PubMed Web of Science ®Google Scholar
• Dasari A, Shen C, Halperin D, et al. Trends in the incidence, prevalence, and survival outcomes in patients with neuroendocrine tumors in the United States. JAMA Oncol. 2017;3(10):1335. doi: 10.1001/jamaoncol.2017.0589
   PubMed Web of Science ®Google Scholar
• Di Domenico A, Wiedmer T, Marinoni I, et al. Genetic and epigenetic drivers of neuroendocrine tumours (NET). Endocr Relat Cancer. 2017;24(9):R315–R334. doi: 10.1530/ERC-17-0012
   PubMed Web of Science ®Google Scholar
• Gut P, Komarowska H, Czarnywojtek A, et al. Familial syndromes associated with neuroendocrine tumours. Contemp OncolContemp Oncol Poznan Pol. 2015;19:176–183. doi: 10.5114/wo.2015.52710
   PubMed Web of Science ®Google Scholar
• Insabato L, Del Basso De Caro M, Caramanna E, et al. Pathology of neuroendocrine tumours. Front Biosci Landmark Ed. 2009;14:4712–4718. doi: 10.2741/3562
   PubMed Web of Science ®Google Scholar
• Rossi RE, Massironi S. The increasing incidence of neuroendocrine neoplasms worldwide: current knowledge and open issues. J Clin Med. 2022;11(13):3794. doi: 10.3390/jcm11133794
   PubMed Web of Science ®Google Scholar
• Zhang JY, Kunz PL. Making sense of a complex disease: a practical approach to managing neuroendocrine tumors. JCO Oncol Pract. 2022;18(4):258–264. doi: 10.1200/OP.21.00240
   PubMedGoogle Scholar
• Modica R, Liccardi A, Minotta R, et al. Therapeutic strategies for patients with neuroendocrine neoplasms: current perspectives. Expert Rev Endocrinol Metab. 2022;17(5):389–403. doi: 10.1080/17446651.2022.2099840
   PubMed Web of Science ®Google Scholar
• Modlin IM, Pavel M, Kidd M, et al. Review article: somatostatin analogues in the treatment of gastroenteropancreatic neuroendocrine (carcinoid) tumours. Aliment Pharmacol Ther. 2010;31(2):169–188. doi: 10.1111/j.1365-2036.2009.04174.x
   PubMed Web of Science ®Google Scholar
• Ricci S, Antonuzzo A, Galli L, et al. Long-acting depot lanreotide in the treatment of patients with advanced neuroendocrine tumors. Am J Clin Oncol. 2000;23(4):412–415. doi: 10.1097/00000421-200008000-00020
   PubMed Web of Science ®Google Scholar
• Saif MW, Fu J, Smith MH, et al. Treatment with lanreotide depot following octreotide long-acting release among patients with gastroenteropancreatic neuroendocrine tumors. J Pancreat Cancer. 2018;4:64–71. doi: 10.1089/pancan.2018.0013
   PubMedGoogle Scholar
• Öberg K, Lamberts SWJ. Somatostatin analogues in acromegaly and gastroenteropancreatic neuroendocrine tumours: past, present and future. Endocr Relat Cancer. 2016;23(12):R551–R566. doi: 10.1530/ERC-16-0151
   PubMed Web of Science ®Google Scholar
• Johanson V, Wilson B, Abrahamsson A, et al. Randomized crossover study in patients with neuroendocrine tumors to assess patient preference for lanreotide Autogel(®) given by either self/partner or a health care professional. Patient Prefer Adherence. 2012;6:703–710. doi: 10.2147/PPA.S34337
   PubMedGoogle Scholar
• Strosberg J, Kvols L. Antiproliferative effect of somatostatin analogs in gastroenteropancreatic neuroendocrine tumors. WJG. 2010;16(24):2963–2970. doi: 10.3748/wjg.v16.i24.2963
   PubMed Web of Science ®Google Scholar
• Sciammarella C, Luce A, Riccardi F, et al. Lanreotide induces cytokine modulation in intestinal neuroendocrine tumors and overcomes resistance to everolimus. Front Oncol [Internet].10. 2020 [cited 2023 Dec 13]; Available from: https://www.frontiersin.org/articles/10.3389/fonc.2020.01047
   PubMed Web of Science ®Google Scholar
• Buil-Bruna N, Garrido MJ, Dehez M, et al. Population pharmacokinetic analysis of lanreotide autogel®/Depot in the treatment of neuroendocrine tumors: pooled analysis of four clinical trials. Clin Pharmacokinet. 2016;55(4):461–473. doi: 10.1007/s40262-015-0329-4
   PubMed Web of Science ®Google Scholar
• U.S Food and Drug Administration. SOMATULINE® DEPOT (lanreotide) injection, for subcutaneous use Initial U.S. Approval. 2007 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022074s026lbl.pd
   Google Scholar
• Hummelshøj NE, Dam G, Pedersen LH, et al. First-generation somatostatin ligand receptor treatment in a pregnant patient with a neuroendocrine tumor with liver metastases. Endocrinol Diabetes Metab Case Rep. 2021;2021:21–0126. doi: 10.1530/EDM-21-0126
   PubMedGoogle Scholar
• Clinical review of somatuline autogel (lanreotide acetate).Pdf [Internet]. [cited 2023 Oct 17]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022074s000_MedR_P3.pdf
   Google Scholar
• Brighi N, Panzuto F, Modica R, et al. Biliary stone disease in patients with neuroendocrine tumors treated with somatostatin analogs: a multicenter study. Oncology. 2020;25(3):259–265. doi: 10.1634/theoncologist.2019-0403
   Google Scholar
• Godara A, Siddiqui NS, Byrne MM, et al. The safety of lanreotide for neuroendocrine tumor. Expert Opin Drug Saf. 2019;18(1):1–10. doi: 10.1080/14740338.2019.1559294
   PubMed Web of Science ®Google Scholar
• Naraev BG, Halland M, Halperin DM, et al. Management of diarrhea in patients with carcinoid syndrome. Pancreas. 2019;48(8):961–972. doi: 10.1097/MPA.0000000000001384
   PubMed Web of Science ®Google Scholar
• Lamarca A, McCallum L, Nuttall C, et al. Somatostatin analogue-induced pancreatic exocrine insufficiency in patients with neuroendocrine tumors: results of a prospective observational study. Expert Rev Gastroenterol Hepatol. 2018;12(7):723–731. doi: 10.1080/17474124.2018.1489232
   PubMed Web of Science ®Google Scholar
• Norlén O, Hessman O, Stålberg P, et al. Prophylactic cholecystectomy in midgut carcinoid patients. World J Surg. 2010;34(6):1361–1367. doi: 10.1007/s00268-010-0428-1
   PubMed Web of Science ®Google Scholar
• La Salvia A, Modica R, Rossi RE, et al. Targeting neuroendocrine tumors with octreotide and lanreotide: key points for clinical practice from NET specialists. Cancer Treat Rev. 2023;117:102560. doi: 10.1016/j.ctrv.2023.102560
   PubMed Web of Science ®Google Scholar
• Raj N, Cruz E, O’Shaughnessy S, et al. A randomized trial evaluating patient experience and preference between octreotide long-acting release and lanreotide for treatment of well-differentiated neuroendocrine tumors. JCO Oncol Pract. 2022;18(9):e1533–e1541. doi: 10.1200/OP.22.00055
   PubMedGoogle Scholar
• O’Toole D, Kunz PL, Webb SM, et al. PRESTO 2: an international survey to evaluate patients’ injection experiences with the latest devices/formulations of long-acting somatostatin analog therapies for neuroendocrine tumors or acromegaly. Adv Ther. 2023;40(2):671–690. doi: 10.1007/s12325-022-02360-6
   PubMed Web of Science ®Google Scholar
• Adelman D, Truong Thanh X-M, Feuilly M, et al. Evaluation of nurse preferences between the lanreotide autogel new syringe and the octreotide long-acting release syringe: an international simulated-use study (PRESTO). Adv Ther. 2020;37(4):1608–1619. doi: 10.1007/s12325-020-01255-8
   PubMed Web of Science ®Google Scholar
• Martín-Richard M, Massutí B, Pineda E, et al. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study. BMC Cancer. 2013;13(1):427. doi: 10.1186/1471-2407-13-427
   PubMedGoogle Scholar
• Caplin ME, Pavel M, Ćwikła JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3):224–233. doi: 10.1056/NEJMoa1316158
   PubMed Web of Science ®Google Scholar
• Caplin ME, Pavel M, Phan AT, et al. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021;71(2):502–513. doi: 10.1007/s12020-020-02475-2
   PubMed Web of Science ®Google Scholar
• Pavel M, Ćwikła JB, Lombard-Bohas C, et al. Efficacy and safety of high-dose lanreotide autogel in patients with progressive pancreatic or midgut neuroendocrine tumours: CLARINET FORTE phase 2 study results. Eur J Cancer Oxf Engl. 1990. 2021;157:403–414. doi: 10.1016/j.ejca.2021.06.056
   Google Scholar
• Vinik AI, Wolin EM, Liyanage N, et al. evaluation of lanreotide depot/autogel efficacy and safety as a carcinoid syndrome treatment (elect): a randomized, double-blind, placebo-controlled trial. Endocr PractOff J Am Coll Endocrinol Am Assoc Clin Endocrinol. 2016;22:1068–1080. doi: 10.4158/EP151172.OR
   Google Scholar
• Ferolla P, Berruti A, Spada F, et al. Efficacy and safety of lanreotide autogel and temozolomide combination therapy in progressive thoracic neuroendocrine tumors (carcinoid): results from the phase 2 ATLANT study. Neuroendocrinology. 2023;113(3):332–342. doi: 10.1159/000526811
   PubMed Web of Science ®Google Scholar
• Lepage C, Phelip J-M, Lievre A, et al. Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: an international double-blind, placebo-controlled randomised phase II trial - Prodige 31 REMINET: An FFCD study. Eur J Cancer Oxf Engl. 1990. 2022;175:31–40. doi: 10.1016/j.ejca.2022.07.033
   Google Scholar
• Pavel M, Lahner H, Hörsch D, et al. Combined lanreotide autogel and temozolomide treatment of progressive pancreatic and intestinal neuroendocrine tumors: the phase II sonnet study. Oncologist. 2024;29(5):e643–e654. doi: 10.1093/oncolo/oyad325
   PubMedGoogle Scholar
• Ruszniewski P, Valle JW, Lombard-Bohas C, et al. Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: an international observational study. Dig Liver Dis Off J Ital Soc Gastroenterol Ital Assoc Study Liver. 2016;48(5):552–558. doi: 10.1016/j.dld.2015.12.013
   Google Scholar
• Rinke A, Maintz C, Müller L, et al. Multicenter, observational study of lanreotide autogel for the treatment of patients with neuroendocrine tumors in routine clinical practice in Germany and Austria. Exp Clin Endocrinol DiabetesExp Clin Endocrinol Diabetes Off J Ger Soc Endocrinol Ger Diabetes Assoc. 2021;129(7):500–509. doi: 10.1055/a-1342-2755
   PubMed Web of Science ®Google Scholar
• Faggiano A, Modica R, Lo Calzo F, et al. Lanreotide Therapy vs Active Surveillance in MEN1-related pancreatic neuroendocrine Tumors < 2 Centimeters. J Clin Endocrinol Metab. 2020;105:dgz007. doi: 10.1210/clinem/dgz007
   PubMed Web of Science ®Google Scholar
• Siddiqui Z, Marginean H, Leung M, et al. Real world use of lanreotide in neuroendocrine tumors. J Gastrointest Oncol. 2023;14(3):1488–1495. doi: 10.21037/jgo-22-1182
   PubMed Web of Science ®Google Scholar
• Lamberti G, Faggiano A, Brighi N, et al. Nonconventional doses of somatostatin analogs in patients with progressing well-differentiated neuroendocrine tumor. J Clin Endocrinol Metab. 2020;105(1):194–200. doi: 10.1210/clinem/dgz035
   Web of Science ®Google Scholar
• Diamantopoulos LN, Laskaratos F-M, Kalligeros M, et al. Antiproliferative effect of above-label doses of somatostatin analogs for the management of gastroenteropancreatic neuroendocrine tumors. Neuroendocrinology. 2020;111(7):650–659. doi: 10.1159/000509420
   PubMed Web of Science ®Google Scholar
• Kunz PL, Reidy-Lagunes D, Anthony LB, et al. Consensus guidelines for the management and treatment of neuroendocrine tumors. Pancreas. 2013;42(4):557–577. doi: 10.1097/MPA.0b013e31828e34a4
   PubMed Web of Science ®Google Scholar
• Pavel M, Baudin E, Couvelard A, et al. ENETS consensus guidelines for the management of patients with liver and other distant metastases from neuroendocrine neoplasms of foregut, midgut, hindgut, and unknown primary. Neuroendocrinology. 2012;95(2):157–176. doi: 10.1159/000335597
   PubMed Web of Science ®Google Scholar