¹⁷⁷Lu-DOTATATE for the treatment of gastroenteropancreatic neuroendocrine tumors

References

• 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):1335–1342.
   PubMed Web of Science ®Google Scholar
• Oronsky B, Ma PC, Morgensztern D, et al. Nothing but NET: a review of neuroendocrine tumors and carcinomas. Neoplasia. 2017;19(12):991–1002.
   PubMed Web of Science ®Google Scholar
• Reubi JC. Somatostatin and other peptide receptors as tools for tumor diagnosis and treatment. Neuroendocrinology. 2004;80(Suppl 1):51–56.
   PubMedGoogle Scholar
• Rinke A, Muller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009;27(28):4656–4663.
   PubMed Web of Science ®Google Scholar
• Caplin ME, Pavel M, Cwikla JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3):224–233.
   PubMed Web of Science ®Google Scholar
• Yao JC, Shah MH, Ito T, et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011;364(6):514–523.
   PubMed Web of Science ®Google Scholar
• Yao JC, Fazio N, Singh S, et al. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016;387(10022):968–977.
   PubMed Web of Science ®Google Scholar
• Raymond E, Dahan L, Raoul JL, et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011;364(6):501–513.
   PubMed Web of Science ®Google Scholar
• Waldherr C, Pless M, Maecke HR, et al. The clinical value of [90Y-DOTA]-D-Phe1-Tyr3-octreotide (90Y-DOTATOC) in the treatment of neuroendocrine tumours: a clinical phase II study. Ann Oncol. 2001;12(7):941–945.
   PubMed Web of Science ®Google Scholar
• Otte A, Herrmann R, Heppeler A, et al. Yttrium-90 DOTATOC: first clinical results. Eur J Nucl Med. 1999;26(11):1439–1447.
   PubMedGoogle Scholar
• Valkema R, De Jong M, Bakker WH, et al. Phase I study of peptide receptor radionuclide therapy with [In-DTPA]octreotide: the Rotterdam experience. Semin Nucl Med. 2002;32(2):110–122.
   PubMed Web of Science ®Google Scholar
• Anthony LB, Woltering EA, Espenan GD, et al. Indium-111-pentetreotide prolongs survival in gastroenteropancreatic malignancies. Semin Nucl Med. 2002;32(2):123–132.
   PubMed Web of Science ®Google Scholar
• Barone R, Borson-Chazot F, Valkema R, et al. Patient-specific dosimetry in predicting renal toxicity with (90)Y-DOTATOC: relevance of kidney volume and dose rate in finding a dose-effect relationship. J Nucl Med. 2005;46(Suppl 1):99S–106S.
   PubMedGoogle Scholar
• Strosberg JR, Fine RL, Choi J, et al. First-line chemotherapy with capecitabine and temozolomide in patients with metastatic pancreatic endocrine carcinomas. Cancer. 2011;117(2):268–275.
   PubMed Web of Science ®Google Scholar
• Fine RL, Gulati AP, Krantz BA, et al. Capecitabine and temozolomide (CAPTEM) for metastatic, well-differentiated neuroendocrine cancers: the pancreas center at Columbia University experience. Cancer Chemother Pharmacol. 2013;71(3):663–670.
   PubMed Web of Science ®Google Scholar
• Owen DH, Alexander AJ, Konda B, et al. Combination therapy with capecitabine and temozolomide in patients with low and high grade neuroendocrine tumors, with an exploratory analysis of O(6)-methylguanine DNA methyltransferase as a biomarker for response. Oncotarget. 2017;8(61):104046–104056.
   PubMedGoogle Scholar
• Al-Toubah T, Morse B, Strosberg J. Capecitabine and temozolomide in advanced lung neuroendocrine neoplasms. Oncologist. 2019. pii: theoncologist.2019-0361. doi: 10.1634/theoncologist.2019-0361. [Epub ahead of print].
   PubMed Web of Science ®Google Scholar
• Papaxoinis G, Kordatou Z, McCallum L, et al. Capecitabine and temozolomide in patients with advanced pulmonary carcinoid tumours. Neuroendocrinology. 2019. doi: 10.1159/000502864. [Epub ahead of print].
   PubMedGoogle Scholar
• Chatzellis E, Angelousi A, Daskalakis K, et al. Activity and safety of standard and prolonged capecitabine/temozolomide administration in patients with advanced neuroendocrine neoplasms. Neuroendocrinology. 2019. doi: 10.1159/000500135. [Epub ahead of print].
   Web of Science ®Google Scholar
• Sahu A, Jefford M, Lai-Kwon J, et al. CAPTEM in metastatic well-differentiated intermediate to high grade neuroendocrine tumors: a single centre experience. J Oncol. 2019;2019:9032753.
   PubMedGoogle Scholar
• Rogowski W, Wachula E, Gorzelak A, et al. Capecitabine and temozolomide combination for treatment of high-grade well-differentiated neuroendocrine tumour and poorly-differentiated neuroendocrine carcinoma. Retrospective analysis. Endokrynol Pol. 2019;70:313–317.
   PubMed Web of Science ®Google Scholar
• Kam BL, Teunissen JJ, Krenning EP, et al. Lutetium-labelled peptides for therapy of neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2012;39(Suppl 1):S103–112.
   PubMedGoogle Scholar
• Esser JP, Krenning EP, Teunissen JJ, et al. Comparison of [(177)Lu-DOTA(0),Tyr(3)]octreotate and [(177)Lu-DOTA(0),Tyr(3)]octreotide: which peptide is preferable for PRRT? Eur J Nucl Med Mol Imaging. 2006;33(11):1346–1351.
   PubMed Web of Science ®Google Scholar
• Mettler F, Giberteau M. Essentials of nuclear medicine and molecular imaging. 7th ed. Elsevier: Philadelphia (PA); 2019.
   Google Scholar
• Jamar F, Barone R, Mathieu I, et al. 86Y-DOTA0-D-Phe1-Tyr3-octreotide (SMT487)–a phase 1 clinical study: pharmacokinetics, biodistribution and renal protective effect of different regimens of amino acid co-infusion. Eur J Nucl Med Mol Imaging. 2003;30(4):510–518.
   PubMed Web of Science ®Google Scholar
• Rolleman EJ, Valkema R, de Jong M, et al. Safe and effective inhibition of renal uptake of radiolabelled octreotide by a combination of lysine and arginine. Eur J Nucl Med Mol Imaging. 2003;30(1):9–15.
   PubMed Web of Science ®Google Scholar
• [cited 2019 Aug 20]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208700Orig1s000lbll.pdf.
   Google Scholar
• Kwekkeboom DJ, Bakker WH, Kooij PP, et al. [177Lu-DOTAOTyr3]octreotate: comparison with [111In-DTPAo]octreotide in patients. Eur J Nucl Med. 2001;28(9):1319–1325.
   PubMedGoogle Scholar
• Imhof A, Brunner P, Marincek N, et al. Response, survival, and long-term toxicity after therapy with the radiolabeled somatostatin analogue [90Y-DOTA]-TOC in metastasized neuroendocrine cancers. J Clin Oncol. 2011;29(17):2416–2423.
   PubMed Web of Science ®Google Scholar
• Bodei L, Kidd M, Paganelli G, et al. The failure of clinical factors to predict long-term toxicity after PRRT in >800 patients - Is a genetic screen needed?. J Nucl Med. 2014;55:1948.
   Google Scholar
• Kwekkeboom DJ, Bakker WH, Kam BL, et al. Treatment of patients with gastro-entero-pancreatic (GEP) tumours with the novel radiolabelled somatostatin analogue [177Lu-DOTA(0),Tyr3]octreotate. Eur J Nucl Med Mol Imaging. 2003;30(3):417–422.
   PubMed Web of Science ®Google Scholar
• Bodei L, Cremonesi M, Grana CM, et al. Peptide receptor radionuclide therapy with (1)(7)(7)Lu-DOTATATE: the IEO phase I-II study. Eur J Nucl Med Mol Imaging. 2011;38(12):2125–2135.
   PubMed Web of Science ®Google Scholar
• Delpassand E, Samarghandi A, Zamanian S, et al. Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor–expressing neuroendocrine tumors: the first US phase 2 experience. Pancreas. 2014;43(4):518–525.
   PubMed Web of Science ®Google Scholar
• Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125–135.
   PubMed Web of Science ®Google Scholar
• Strosberg JR, Wolin EM, Chasen BA, et al. First update on overall survival, progression-free survival, and health-related time-to-deterioration quality of life from the NETTER-1 study: 177Lu-Dotatate vs. high dose octreotide in progressive midgut neuroendocrine tumors. J Clin Oncol. 2018;36(15_suppl):4099.
   Web of Science ®Google Scholar
• Strosberg J, Wolin E, Chasen B, et al. Health-related quality of life in patients with progressive midgut neuroendocrine tumors treated with (177)Lu-Dotatate in the phase III NETTER-1 trial. J Clin Oncol. 2018;36(25):2578–2584.
   Google Scholar
• Brabander T, van der Zwan WA, Teunissen JJM, et al. Long-term efficacy, survival, and safety of [(177)Lu-DOTA(0),Tyr(3)]octreotate in patients with gastroenteropancreatic and bronchial neuroendocrine tumors. Clin Cancer Res. 2017;23(16):4617–4624.
   PubMed Web of Science ®Google Scholar
• Baum RP, Kulkarni HR, Singh A, et al. Results and adverse events of personalized peptide receptor radionuclide therapy with (90)Yttrium and (177)Lutetium in 1048 patients with neuroendocrine neoplasms. Oncotarget. 2018;9(24):16932–16950.
   PubMedGoogle Scholar
• Zhang J, Kulkarni HR, Singh A, et al. Peptide receptor radionuclide therapy (PRRT) in patients with progressive grade 3 neuroendocrine neoplasms (NEN). J Nucl Med. 2019;60(no supplement 1):560.
   Google Scholar
• Bodei L, Kidd MS, Singh A, et al. PRRT genomic signature in blood for prediction of (177)Lu-octreotate efficacy. Eur J Nucl Med Mol Imaging. 2018;45(7):1155–1169.
   PubMed Web of Science ®Google Scholar
• Forrer F, Uusijarvi H, Storch D, et al. Treatment with 177Lu-DOTATOC of patients with relapse of neuroendocrine tumors after treatment with 90Y-DOTATOC. J Nucl Med. 2005;46(8):1310–1316.
   PubMed Web of Science ®Google Scholar
• van Essen M, Krenning EP, Kam BL, et al. Salvage therapy with (177)Lu-octreotate in patients with bronchial and gastroenteropancreatic neuroendocrine tumors. J Nucl Med. 2010;51(3):383–390.
   PubMed Web of Science ®Google Scholar
• Severi S, Sansovini M, Ianniello A, et al. Feasibility and utility of re-treatment with (177)Lu-DOTATATE in GEP-NENs relapsed after treatment with (90)Y-DOTATOC. Eur J Nucl Med Mol Imaging. 2015;42(13):1955–1963.
   PubMed Web of Science ®Google Scholar
• Haug AR, Rominger A, Mustafa M, et al. Treatment with octreotide does not reduce tumor uptake of (68)Ga-DOTATATE as measured by PET/CT in patients with neuroendocrine tumors. J Nucl Med. 2011;52(11):1679–1683.
   PubMed Web of Science ®Google Scholar
• Cherk MH, Kong G, Hicks RJ, et al. Changes in biodistribution on (68)Ga-DOTA-Octreotate PET/CT after long acting somatostatin analogue therapy in neuroendocrine tumour patients may result in pseudoprogression. Cancer Imaging. 2018;18(1):3.
   PubMedGoogle Scholar
• Ayati N, Lee ST, Zakavi R, et al. Long-acting somatostatin analog therapy differentially alters (68)Ga-DOTATATE uptake in normal tissues compared with primary tumors and metastatic lesions. J Nucl Med. 2018;59(2):223–227.
   PubMed Web of Science ®Google Scholar
• Zhang J, Wang H, Jacobson O, et al. Safety, pharmacokinetics, and dosimetry of a long-acting radiolabeled somatostatin analog (177)Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. J Nucl Med. 2018;59(11):1699–1705.
   PubMed Web of Science ®Google Scholar
• Dalm SU, Nonnekens J, Doeswijk GN, et al. Comparison of the therapeutic response to treatment with a 177Lu-labeled somatostatin receptor agonist and antagonist in preclinical models. J Nucl Med. 2016;57(2):260–265.
   PubMed Web of Science ®Google Scholar
• Wild D, Fani M, Fischer R, et al. Comparison of somatostatin receptor agonist and antagonist for peptide receptor radionuclide therapy: a pilot study. J Nucl Med. 2014;55(8):1248–1252.
   PubMed Web of Science ®Google Scholar
• Reidy-Lagunes D, Pandit-Taskar N, O’Donoghue J, et al. Phase I trial of well-differentiated neuroendocrine tumors (NETs)with radiolabeled somatostatin antagonist 177 Lu-Satoreotide Tetraxetan. Clin Cancer Res. 2019. DOI:10.1158/1078-0432.CCR-19-1026.
   PubMedGoogle Scholar
• White BH, Whalen K, Kriksciukaite K, et al. Discovery of an SSTR2-targeting maytansinoid conjugate (PEN-221) with potent activity in vitro and in vivo. J Med Chem. 2019;62(5):2708–2719.
   PubMed Web of Science ®Google Scholar
• Johnson ML, Meyer T, Halperin DM, et al. First in human phase 1/2a study of PEN-221 somatostatin analog (SSA)-DM1 conjugate for patients (PTS) with advanced neuroendocrine tumor (NET) or small cell lung cancer (SCLC): phase 1 results. J Clin Oncol. 2018;36(15_suppl):4097.
   Web of Science ®Google Scholar