Login Register Cart 0
Generic placeholder image

Current Drug Delivery

Editor-in-Chief

ISSN (Print): 1567-2018
ISSN (Online): 1875-5704

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Mini-Review Article

Preparation of Long-Acting Somatostatin and GnRH Analogues and Their Applications in Tumor Therapy

Author(s): Fang Yu*, Tingting Zhang, Fenghua Fu, Aiping Wang and Xinyong Liu

Volume 19, Issue 1, 2022

Published on: 10 January, 2022

Page: [5 - 16] Pages: 12

DOI: 10.2174/1567201819666211224113311

Price: $65

Abstract

Hormonal drugs are essential treatment options for some hormone-dependent or hormone- sensitive tumors. The common dosage forms of hormonal drugs have a short half-life. Hence, frequent administration is needed, which results in poor patient compliance. Nevertheless, using drug delivery technology, somatostatin analogues (SSAs) and gonadotropin-releasing hormone (GnRH) analogues are prepared into long-acting formulations that can significantly prolong the action time of these drugs, reducing medication frequency and increasing patient compliance. Such drugs are advantageous when treating acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), breast cancer, prostate cancer, and other diseases having a relatively long course. SSAs and GnRH analogues are two typical hormonal drugs, the long-acting formulations of which are essential in clinical practice. This review summarized the preparation methods and clinical application of long-acting formulations in cancer. Further, the action mechanism and new research of SSAs and GnRH analogues were discussed, and suggestions related to the development of long-acting SSAs and GnRH analogues were provided.

Keywords: Hormonal drugs, long-acting analogues, somatostatin analogues, GnRH analogues, tumor therapy, hormone-sensitive tumors.

« Previous Next »
Graphical Abstract

[1]
Karpuz, M.; Silindir-Gunay, M.; Ozer, A.Y. Current and future approaches for effective cancer imaging and treatment. Cancer Biother. Radiopharm., 2018, 33(2), 39-51.
[http://dx.doi.org/10.1089/cbr.2017.2378] [PMID: 29634415]
[2]
Stokes, Z.; Chan, S. Principles of cancer treatment by hormone therapy. Surgery, 2009, 27(4), 165-168.
[http://dx.doi.org/10.1016/j.mpsur.2009.01.004]
[3]
Cakir, M.; Dworakowska, D.; Grossman, A. Somatostatin receptor biology in neuroendocrine and pituitary tumours: Part 1-molecular pathways. J. Cell. Mol. Med., 2010, 14(11), 2570-2584.
[http://dx.doi.org/10.1111/j.1582-4934.2010.01125.x] [PMID: 20629989]
[4]
Stueven, A.K.; Kayser, A.; Wetz, C.; Amthauer, H.; Wree, A.; Tacke, F.; Wiedenmann, B.; Roderburg, C.; Jann, H. Somatostatin analogues in the treatment of neuroendocrine tumors: Past, present and future. Int. J. Mol. Sci., 2019, 20(12), 3049-3052.
[http://dx.doi.org/10.3390/ijms20123049] [PMID: 31234481]
[5]
Rai, U.; Thrimawithana, T.R.; Valery, C.; Young, S.A. Therapeutic uses of somatostatin and its analogues: Current view and potential applications. Pharmacol. Ther., 2015, 152, 98-110.
[http://dx.doi.org/10.1016/j.pharmthera.2015.05.007] [PMID: 25956467]
[6]
Chalabi, M.; Duluc, C.; Caron, P.; Vezzosi, D.; Guillermet-Guibert, J.; Pyronnet, S.; Bousquet, C. Somatostatin analogs: Does pharmacology impact antitumor efficacy? Trends Endocrinol. Metab., 2014, 25(3), 115-127.
[http://dx.doi.org/10.1016/j.tem.2013.11.003] [PMID: 24405892]
[7]
Gadelha, M.R.; Gu, F.; Bronstein, M.D.; Brue, T.C.; Fleseriu, M.; Shimon, I.; van der Lely, A.J.; Ravichandran, S.; Kandra, A.; Pedroncelli, A.M.; Colao, A.A.L. Risk factors and management of pasireotide-associated hyperglycemia in acromegaly. Endocr. Connect., 2020, 9(12), 1178-1190.
[http://dx.doi.org/10.1530/EC-20-0361] [PMID: 33434154]
[8]
Lamberts, S.W.J.; Hofland, L.J. Anniversary review: Octreotide, 40 years later. Eur. J. Endocrinol., 2019, 181(5), R173-R183.
[http://dx.doi.org/10.1530/EJE-19-0074] [PMID: 31398712]
[9]
de Herder, W.W.; Hofland, L.J.; van der Lely, A.J.; Lamberts, S.W.J. Somatostatin receptors in gastroentero-pancreatic neuroendocrine tumours. Endocr. Relat. Cancer, 2003, 10(4), 451-458.
[http://dx.doi.org/10.1677/erc.0.0100451] [PMID: 14713257]
[10]
Theodoropoulou, M.; Stalla, G.K. Somatostatin receptors: From signaling to clinical practice. Front. Neuroendocrinol., 2013, 34(3), 228-252.
[http://dx.doi.org/10.1016/j.yfrne.2013.07.005] [PMID: 23872332]
[11]
Sidéris, L.; Dubé, P.; Rinke, A. Antitumor effects of somatostatin analogs in neuroendocrine tumors. Oncologist, 2012, 17(6), 747-755.
[http://dx.doi.org/10.1634/theoncologist.2011-0458] [PMID: 22628056]
[12]
Bodmer, D.; Fong, J.W.; Kissel, T.; Maulding, H.V.; Nagele, O.; Pearson, J.E. Sustained release formulations of water soluble peptides. US Patent 005538739, 1996.
[13]
Jain, R.A. The manufacturing techniques of various drug loaded biodegradable poly(lactide-co-glycolide) (PLGA) devices. Biomaterials, 2000, 21(23), 2475-2490.
[http://dx.doi.org/10.1016/S0142-9612(00)00115-0] [PMID: 11055295]
[14]
Awwad, S.; Day, R.M.; Khaw, P.T.; Brocchini, S.; Fadda, H.M. Sustained release ophthalmic dexamethasone: In vitroin vivo correlations derived from the PK-Eye. Int. J. Pharm., 2017, 522(1-2), 119-127.
[http://dx.doi.org/10.1016/j.ijpharm.2017.02.047] [PMID: 28232270]
[15]
Astruc, B.; Marbach, P.; Bouterfa, H.; Denot, C.; Safari, M.; Vitaliti, A.; Sheppard, M. Long-acting octreotide and prolonged-release lanreotide formulations have different pharmacokinetic profiles. J. Clin. Pharmacol., 2005, 45(7), 836-844.
[http://dx.doi.org/10.1177/0091270005277936] [PMID: 15951474]
[16]
Enzler, T.; Fojo, T. Long-acting somatostatin analogues in the treatment of unresectable/metastatic neuroendocrine tumors. Semin. Oncol., 2017, 44(2), 141-156.
[http://dx.doi.org/10.1053/j.seminoncol.2017.07.001] [PMID: 28923213]
[17]
Petersen, H.; Bizec, J.C.; Schuetz, H.; Delporte, M-L. Pharmacokinetic and technical comparison of Sandostatin® LAR® and other formulations of long-acting octreotide. BMC Res. Notes, 2011, 4, 344-352.
[http://dx.doi.org/10.1186/1756-0500-4-344] [PMID: 21906300]
[18]
Roland Cherif-Cheikh. Sustained release of peptides from pharmaceutical compositions. US Patent 005595760, 1997.
[19]
Lightman, S. Somatuline Autogel: An extended release lanreotide formulation. Hosp. Med., 2002, 63(3), 162-165.
[http://dx.doi.org/10.12968/hosp.2002.63.3.2062] [PMID: 11933820]
[20]
Bronstein, M.; Musolino, N.; Jallad, R.; Cendros, J.M.; Ramis, J.; Obach, R.; Leselbaum, A.; Catus, F. Pharmacokinetic profile of lanreotide Autogel in patients with acromegaly after four deep subcutaneous injections of 60, 90 or 120 mg every 28 days. Clin. Endocrinol. (Oxf.), 2005, 63(5), 514-519.
[http://dx.doi.org/10.1111/j.1365-2265.2005.02372.x] [PMID: 16268802]
[21]
Olivier, L.; Marc, R.; Vitomir, V. Extended-release composition comprising a somatostatin derivative in microparticles. US Patent 009351923, 2016.
[22]
Petersenn, S.; Hu, K.; Maldonado, M.; Zhang, Y.; Lasher, J.; Bouillaud, E.; Wang, Y.; Mann, K.; Unger, N. Tolerability and dose proportional pharmacokinetics of pasireotide administered as a single dose or two divided doses in healthy male volunteers: A single-center, open-label, ascending-dose study. Clin. Ther., 2012, 34(3), 677-688.
[http://dx.doi.org/10.1016/j.clinthera.2012.01.015] [PMID: 22364824]
[23]
Dietrich, H.; Hu, K.; Ruffin, M.; Song, D.; Bouillaud, E.; Wang, Y.; Hasskarl, J. Safety, tolerability, and pharmacokinetics of a single dose of pasireotide long-acting release in healthy volunteers: A single-center Phase I study. Eur. J. Endocrinol., 2012, 166(5), 821-828.
[http://dx.doi.org/10.1530/EJE-11-0773] [PMID: 22383336]
[24]
Gomes-Porras, M.; Cárdenas-Salas, J.; Álvarez-Escolá, C. Somatostatin analogs in clinical practice: A review. Int. J. Mol. Sci., 2020, 21(5), 1682-1708.
[http://dx.doi.org/10.3390/ijms21051682] [PMID: 32121432]
[25]
Pusceddu, S.; Prinzi, N.; Raimondi, A.; Corti, F.; Buzzoni, R.; Di Bartolomeo, M.; Seregni, E.; Maccauro, M.; Coppa, J.; Milione, M.; Mazzaferro, V.; de Braud, F. Entering the third decade of experience with octreotide LAR in neuroendocrine tumors: A review of current knowledge. Tumori, 2019, 105(2), 113-120.
[http://dx.doi.org/10.1177/0300891618765362] [PMID: 29714658]
[26]
Jimenez-Fonseca, P.; Carmona-Bayonas, A.; Lamarca, A. External validity of somatostatin analogues trials in advanced neuroendocrine neoplasms: The GETNE-TRASGU study. Neuroendocrinology, 2021. Available from: https://pubmed.ncbi.nlm.nih.gov/33508849/
[http://dx.doi.org/10.1159/000514808]
[27]
Rinke, A.; Müller, H.H.; Schade-Brittinger, C.; Klose, K.J.; Barth, P.; Wied, M.; Mayer, C.; Aminossadati, B.; Pape, U.F.; Bläker, M.; Harder, J.; Arnold, C.; Gress, T.; Arnold, R. 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.
[http://dx.doi.org/10.1200/JCO.2009.22.8510] [PMID: 19704057]
[28]
Caplin, M.E.; Pavel, M.; Ćwikła, J.B.; Phan, A.T.; Raderer, M.; Sedláčková, E.; Cadiot, G.; Wolin, E.M.; Capdevila, J.; Wall, L.; Rindi, G.; Langley, A.; Martinez, S.; Blumberg, J.; Ruszniewski, P. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N. Engl. J. Med., 2014, 371(3), 224-233.
[http://dx.doi.org/10.1056/NEJMoa1316158] [PMID: 25014687]
[29]
Mohamed, A.; Blanchard, M.P.; Albertelli, M.; Barbieri, F.; Brue, T.; Niccoli, P.; Delpero, J.R.; Monges, G.; Garcia, S.; Ferone, D.; Florio, T.; Enjalbert, A.; Moutardier, V.; Schonbrunn, A.; Gerard, C.; Barlier, A.; Saveanu, A. Pasireotide and octreotide antiproliferative effects and sst2 trafficking in human pancreatic neuroendocrine tumor cultures. Endocr. Relat. Cancer, 2014, 21(5), 691-704.
[http://dx.doi.org/10.1530/ERC-14-0086] [PMID: 25012983]
[30]
Walls, G.V.; Stevenson, M.; Soukup, B.S.; Lines, K.E.; Grossman, A.B.; Schmid, H.A.; Thakker, R.V. Pasireotide therapy of multiple endocrine neoplasia type 1-associated neuroendocrine tumors in female mice deleted for an men1 allele improves survival and reduces tumor progression. Endocrinology, 2016, 157(5), 1789-1798.
[http://dx.doi.org/10.1210/en.2015-1965] [PMID: 26990064]
[31]
Quinn, T.J.; Yuan, Z.; Adem, A.; Geha, R.; Vrikshajanani, C.; Koba, W.; Fine, E.; Hughes, D.T.; Schmid, H.A.; Libutti, S.K. Pasireotide (SOM230) is effective for the treatment of pancreatic neuroendocrine tumors (PNETs) in a multiple endocrine neoplasia type 1 (MEN1) conditional knockout mouse model. Surgery, 2012, 152(6), 1068-1077.
[http://dx.doi.org/10.1016/j.surg.2012.08.021] [PMID: 23102680]
[32]
Wolin, E.M.; Jarzab, B.; Eriksson, B.; Walter, T.; Toumpanakis, C.; Morse, M.A.; Tomassetti, P.; Weber, M.M.; Fogelman, D.R.; Ramage, J.; Poon, D.; Gadbaw, B.; Li, J.; Pasieka, J.L.; Mahamat, A.; Swahn, F.; Newell-Price, J.; Mansoor, W.; Öberg, K. Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues. Drug Des. Devel. Ther., 2015, 9, 5075-5086.
[http://dx.doi.org/10.2147/DDDT.S84177] [PMID: 26366058]
[33]
Broder, M.S.; Beenhouwer, D.; Strosberg, J.R.; Neary, M.P.; Cherepanov, D. Gastrointestinal neuroendocrine tumors treated with high dose octreotide-LAR: A systematic literature review. World J. Gastroenterol., 2015, 21(6), 1945-1955.
[http://dx.doi.org/10.3748/wjg.v21.i6.1945] [PMID: 25684964]
[34]
Pavel, M.; Wika, J.B.; Lombard-Bohas, C.; Borbath, I.; Ruszniewski, P. Efficacy and safety of lanreotide autogel (LAN) 120 mg every 14 days in progressive pancreatic or midgut neuroendocrine tumours (NETs): CLARINET FORTE study results. Ann. Oncol., 2020, 31, S773.
[http://dx.doi.org/10.1016/j.annonc.2020.08.1375]
[35]
Lamberti, G.; Faggiano, A.; Brighi, N.; Tafuto, S.; Ibrahim, T.; Brizzi, M.P.; Pusceddu, S.; Albertelli, M.; Massironi, S.; Panzuto, F.; Badalamenti, G.; Riccardi, F.; Butturini, G.; Gelsomino, F.; De Divitiis, C.; Modica, R.; Bongiovanni, A.; La Salvia, A.; Torchio, M.; Colao, A.; Ferone, D.; Campana, D. Non-conventional doses of somatostatin analogs in patients with progressing well differentiated neuroendocrine tumor. J. Clin. Endocrinol. Metab., 2020, 105(1), 194-200.
[http://dx.doi.org/10.1210/clinem/dgz035] [PMID: 31545377]
[36]
Berruti, A.; Fazio, N.; Ferrero, A.; Brizzi, M.P.; Volante, M.; Nobili, E.; Tozzi, L.; Bodei, L.; Torta, M.; D’Avolio, A.; Priola, A.M.; Birocco, N.; Amoroso, V.; Biasco, G.; Papotti, M.; Dogliotti, L. Bevacizumab plus octreotide and metronomic capecitabine in patients with metastatic well-to-moderately differentiated neuroendocrine tumors: The XELBEVOCT study. BMC Cancer, 2014, 14, 184-194.
[http://dx.doi.org/10.1186/1471-2407-14-184] [PMID: 24628963]
[37]
Yordanova, A.; Wicharz, M.M.; Mayer, K.; Brossart, P.; Gonzalez-Carmona, M.A.; Strassburg, C.P.; Fimmers, R.; Essler, M.; Ahmadzadehfar, H. The role of adding somatostatin analogues to peptide receptor radionuclide therapy as a combination and maintenance therapy. Clin. Cancer Res., 2018, 24(19), 4672-4679.
[http://dx.doi.org/10.1158/1078-0432.CCR-18-0947] [PMID: 29950352]
[38]
Prasad, V.; Srirajaskanthan, R.; Toumpanakis, C.; Grana, C.M.; Baldari, S.; Shah, T.; Lamarca, A.; Courbon, F.; Scheidhauer, K.; Baudin, E.; Truong Thanh, X.M.; Houchard, A.; Dromain, C.; Bodei, L. Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: A need for standardised practice. Eur. J. Nucl. Med. Mol. Imaging, 2020, 47(10), 2358-2371.
[http://dx.doi.org/10.1007/s00259-020-04712-2] [PMID: 32062681]
[39]
Junsheng, W. Therapeutic effect of traditional Chinese medicine combined with somatostatin analogues on advanced gastroenteropancreatic neuroendocrine tumors. J. Clin. Med., 2018, 5(54), 135-136.
[40]
Pusceddu, S.; Facciorusso, A.; Giacomelli, L.; Prinzi, N.; Corti, F.; Niger, M.; Milione, M.; Coppa, J.; Cascella, T.; Pulice, I.; Biamonte, L.; Papa, S.; Di Bartolomeo, M.; Shah, A.; Sacco, R.; de Braud, F. Target therapies plus somatostatin analogs in NETs: A network meta-analysis. Endocr. Relat. Cancer, 2021, 28(7), 467-479.
[http://dx.doi.org/10.1530/ERC-20-0492] [PMID: 33979777]
[41]
Simó, M.; Argyriou, A.A.; Macià, M.; Plans, G.; Majós, C.; Vidal, N.; Gil, M.; Bruna, J. Recurrent high-grade meningioma: A phase II trial with somatostatin analogue therapy. Cancer Chemother. Pharmacol., 2014, 73(5), 919-923.
[http://dx.doi.org/10.1007/s00280-014-2422-z] [PMID: 24619496]
[42]
Wu, W.; Zhou, Y.; Wang, Y.; Liu, L.; Lou, J.; Deng, Y.; Zhao, P.; Shao, A. Clinical significance of somatostatin receptor (SSTR) 2 in meningioma. Front. Oncol., 2020, 10, 1633-1666.
[http://dx.doi.org/10.3389/fonc.2020.01633] [PMID: 33014821]
[43]
Giardino, E.; Catalano, R.; Mangili, F.; Barbieri, A.M.; Treppiedi, D.; Elli, F.M.; Dolci, A.; Contarino, A.; Spada, A.; Arosio, M.; Mantovani, G.; Peverelli, E. Octreotide and pasireotide effects on medullary thyroid carcinoma (MTC) cells growth, migration and invasion. Mol. Cell. Endocrinol., 2021, 520, 111092.
[http://dx.doi.org/10.1016/j.mce.2020.111092] [PMID: 33248230]
[44]
Dasgupta, P.; Gűnther, T.; Schulz, S. Pharmacological characterization of veldoreotide as a somatostatin receptor 4 agonist. Life (Basel), 2021, 11(10), 1075-1086.
[http://dx.doi.org/10.3390/life11101075] [PMID: 34685446]
[45]
Pavel, M.; Borson-Chazot, F.; Cailleux, A.; Hörsch, D.; Lahner, H.; Pivonello, R.; Tauchmanova, L.; Darstein, C.; Olsson, H.; Tiberg, F.; Ferone, D. Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: A phase 2, multicenter study. Cancer Chemother. Pharmacol., 2019, 83(2), 375-385.
[http://dx.doi.org/10.1007/s00280-018-3734-1] [PMID: 30535537]
[46]
Vitale, G.; Dicitore, A.; Sciammarella, C.; Di Molfetta, S.; Rubino, M.; Faggiano, A.; Colao, A. Pasireotide in the treatment of neuroendocrine tumors: A review of the literature. Endocr. Relat. Cancer, 2018, 25(6), R351-R364.
[http://dx.doi.org/10.1530/ERC-18-0010] [PMID: 29643113]
[47]
Bolton, E.M.; Lynch, T. Are all gonadotrophin-releasing hormone agonists equivalent for the treatment of prostate cancer? A systematic review. BJU Int., 2018, 122(3), 371-383.
[http://dx.doi.org/10.1111/bju.14168] [PMID: 29438592]
[48]
Naor, Z.; Harris, D.; Shacham, S. Mechanism of GnRH receptor signaling: Combinatorial cross-talk of Ca2+ and protein kinase C. Front. Neuroendocrinol., 1998, 19(1), 1-19.
[http://dx.doi.org/10.1006/frne.1997.0162] [PMID: 9465287]
[49]
Sealfon, S.C.; Weinstein, H.; Millar, R.P. Molecular mechanisms of ligand interaction with the gonadotropin-releasing hormone receptor. Endocr. Rev., 1997, 18(2), 180-205.
[http://dx.doi.org/10.1210/edrv.18.2.0295] [PMID: 9101136]
[50]
Emons, G.; Schally, A.V. The use of luteinizing hormone releasing hormone agonists and antagonists in gynaecological cancers. Hum. Reprod., 1994, 9(7), 1364-1379.
[http://dx.doi.org/10.1093/oxfordjournals.humrep.a138714] [PMID: 7962452]
[51]
Huhtaniemi, I.; White, R.; McArdle, C.A.; Persson, B.E. Will GnRH antagonists improve prostate cancer treatment? Trends Endocrinol. Metab., 2009, 20(1), 43-50.
[http://dx.doi.org/10.1016/j.tem.2008.09.003] [PMID: 19008119]
[52]
Miyamoto, H.; Messing, E.M.; Chang, C. Androgen deprivation therapy for prostate cancer: Current status and future prospects. Prostate, 2004, 61(4), 332-353.
[http://dx.doi.org/10.1002/pros.20115] [PMID: 15389811]
[53]
Cheer, S.M.; Plosker, G.L.; Simpson, D.; Wagstaff, A.J. Goserelin: A review of its use in the treatment of early breast cancer in premenopausal and perimenopausal women. Drugs, 2005, 65(18), 2639-2655.
[http://dx.doi.org/10.2165/00003495-200565180-00011] [PMID: 16392882]
[54]
Tunn, U.W.; Gruca, D.; Bacher, P. Six-month leuprorelin acetate depot formulations in advanced prostate cancer: A clinical evaluation. Clin. Interv. Aging, 2013, 8, 457-464.
[http://dx.doi.org/10.2147/CIA.S27931] [PMID: 23637525]
[55]
Klotz, L. Pharmacokinetic and pharmacodynamic profile of degarelix for prostate cancer. Expert Opin. Drug Metab. Toxicol., 2015, 11(11), 1795-1802.
[http://dx.doi.org/10.1517/17425255.2015.1085506] [PMID: 26513436]
[56]
Jinku, Z.; Jirui, S.; Sahar, B.; Waseem, H. Recent development and future prospects of molecular targeted therapy in prostate cancer. Curr. Mol. Pharmacol, 2021. Available from: https://pubmed.ncbi.nlm.nih.gov/34102978/
[57]
Jain, A.; Kunduru, K.R.; Basu, A.; Mizrahi, B.; Domb, A.J.; Khan, W. Injectable formulations of poly(lactic acid) and its copolymers in clinical use. Adv. Drug Deliv. Rev., 2016, 107, 213-227.
[http://dx.doi.org/10.1016/j.addr.2016.07.002] [PMID: 27423636]
[58]
Hutchinson, F.G.; Furr, B.J. Biodegradable polymers for the sustained release of peptides. Biochem. Soc. Trans., 1985, 13(2), 520-523.
[http://dx.doi.org/10.1042/bst0130520] [PMID: 3160619]
[59]
Francis, G. Continuous release pharmaceutical compositions. US Patent 005366734, 1994.
[60]
ZOLADEX (goserelin acetate implant) 3.6 mg. AstraZeneca plc: London, 2015.
[61]
Boccardo, F.; Rubagotti, A.; Amoroso, D.; Agostara, B.; Amadori, D.; Gallo, L.; Iacobelli, S.; Massidda, B.; Mesiti, M.; Pacini, P.; Tomao, S.; Paganuzzi, M.; Marroni, P. Endocrinological and clinical evaluation of two depot formulations of leuprolide acetate in pre- and perimenopausal breast cancer patients. Cancer Chemother. Pharmacol., 1999, 43(6), 461-466.
[http://dx.doi.org/10.1007/s002800050924] [PMID: 10321505]
[62]
Tsai, H.W.; Wang, P.H.; Huang, B.S.; Twu, N.F.; Yen, M.S.; Chen, Y.J. Low-dose add-back therapy during postoperative GnRH agonist treatment. Taiwan. J. Obstet. Gynecol., 2016, 55(1), 55-59.
[http://dx.doi.org/10.1016/j.tjog.2015.04.004] [PMID: 26927249]
[63]
Schmid, P.; Untch, M.; Kossé, V.; Bondar, G.; Vassiljev, L.; Tarutinov, V.; Lehmann, U.; Maubach, L.; Meurer, J.; Wallwiener, D.; Possinger, K. Leuprorelin acetate every-3-months depot versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with node-positive breast cancer: The TABLE study. J. Clin. Oncol., 2007, 25(18), 2509-2515.
[http://dx.doi.org/10.1200/JCO.2006.08.8534] [PMID: 17577027]
[64]
Alonso, M.J.; Gupta, R.K.; Min, C.; Siber, G.R.; Langer, R. Biodegradable microspheres as controlled-release tetanus toxoid delivery systems. Vaccine, 1994, 12(4), 299-306.
[http://dx.doi.org/10.1016/0264-410X(94)90092-2] [PMID: 8178550]
[65]
Periti, P.; Mazzei, T.; Mini, E. Clinical pharmacokinetics of depot leuprorelin. Clin. Pharmacokinet., 2002, 41(7), 485-504.
[http://dx.doi.org/10.2165/00003088-200241070-00003] [PMID: 12083977]
[66]
Lee, M.; Browneller, R.; Wu, Z.; Jung, A.; Ratanawong, C.; Sharifi, R. Therapeutic effects of leuprorelin microspheres in prostate cancer. Adv. Drug Deliv. Rev., 1997, 28(1), 121-138.
[http://dx.doi.org/10.1016/S0169-409X(97)00054-9] [PMID: 10837568]
[67]
Okada, H. One- and three-month release injectable microspheres of the LH-RH superagonist leuprorelin acetate. Adv. Drug Deliv. Rev., 1997, 28(1), 43-70.
[http://dx.doi.org/10.1016/S0169-409X(97)00050-1] [PMID: 10837564]
[68]
Sethi, R.; Sanfilippo, N. Six-month depot formulation of leuprorelin acetate in the treatment of prostate cancer. Clin. Interv. Aging, 2009, 4, 259-267.
[PMID: 19554097]
[69]
Mahboubian, A.; Hashemein, S.K.; Moghadam, S.; Atyabi, F.; Dinarvand, R. Preparation and in-vitro evaluation of controlled release PLGA microparticles containing triptoreline. Iran. J. Pharm. Res., 2010, 9(4), 369-378.
[PMID: 24381601]
[70]
Piero, O.; Rolland-Yves, M.; Romano, D. Sustained and controlled release of water insoluble polypeptieds. US Patent US005776885, 1998.
[71]
Zhao, Z.; Fu, W.; Liu, Z.P.; Zhou, Y.; Xu, Q. Biodegradable triptorelin microsphere prepared by hot-melt-extrusion. Chin J Mod Appl Pharm., 2016, 33(12), 1533-1538.
[72]
TRELSTAR (triptorelin pamoate for injectable suspension), for intramuscular use; Ipsen S.A.: France, 2018.
[73]
Taylor, C.W.; Green, S.; Dalton, W.S.; Martino, S.; Rector, D.; Ingle, J.N.; Robert, N.J.; Budd, G.T.; Paradelo, J.C.; Natale, R.B.; Bearden, J.D.; Mailliard, J.A.; Osborne, C.K. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: An intergroup study. J. Clin. Oncol., 1998, 16(3), 994-999.
[http://dx.doi.org/10.1200/JCO.1998.16.3.994] [PMID: 9508182]
[74]
Kim, H.A.; Lee, J.W.; Nam, S.J.; Park, B.W.; Im, S.A.; Lee, E.S.; Jung, Y.S.; Yoon, J.H.; Kang, S.S.; Lee, S.J.; Park, K.H.; Jeong, J.; Cho, S.H.; Kim, S.Y.; Kim, L.S.; Moon, B.I.; Lee, M.H.; Kim, T.H.; Park, C.; Jung, S.H.; Gwak, G.; Kim, J.; Kang, S.H.; Jin, Y.W.; Kim, H.J.; Han, S.H.; Han, W.; Hur, M.H.; Noh, W.C. Adding ovarian suppression to tamoxifen for premenopausal breast cancer: A randomized phase III trial. J. Clin. Oncol., 2020, 38(5), 434-443.
[http://dx.doi.org/10.1200/JCO.19.00126] [PMID: 31518174]
[75]
Francis, P.A.; Regan, M.M.; Fleming, G.F.; Láng, I.; Ciruelos, E.; Bellet, M.; Bonnefoi, H.R.; Climent, M.A.; Da Prada, G.A.; Burstein, H.J.; Martino, S.; Davidson, N.E.; Geyer, C.E., Jr; Walley, B.A.; Coleman, R.; Kerbrat, P.; Buchholz, S.; Ingle, J.N.; Winer, E.P.; Rabaglio-Poretti, M.; Maibach, R.; Ruepp, B.; Giobbie-Hurder, A.; Price, K.N.; Colleoni, M.; Viale, G.; Coates, A.S.; Goldhirsch, A.; Gelber, R.D. Adjuvant ovarian suppression in premenopausal breast cancer. N. Engl. J. Med., 2015, 372(5), 436-446.
[http://dx.doi.org/10.1056/NEJMoa1412379] [PMID: 25495490]
[76]
Carlson, R.W.; Theriault, R.; Schurman, C.M.; Rivera, E.; Chung, C.T.; Phan, S.C.; Arun, B.; Dice, K.; Chiv, V.Y.; Green, M.; Valero, V. Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J. Clin. Oncol., 2010, 28(25), 3917-3921.
[http://dx.doi.org/10.1200/JCO.2009.24.9565] [PMID: 20679610]
[77]
Nishimura, R.; Anan, K.; Yamamoto, Y.; Higaki, K.; Tanaka, M.; Shibuta, K.; Sagara, Y.; Ohno, S.; Tsuyuki, S.; Mase, T.; Teramukai, S. Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial. Oncol. Rep., 2013, 29(5), 1707-1713.
[http://dx.doi.org/10.3892/or.2013.2312] [PMID: 23446822]
[78]
Yao, S.; Xu, B.; Li, Q.; Zhang, P.; Yuan, P.; Wang, J.; Ma, F.; Fan, Y. Goserelin plus letrozole as first- or second-line hormonal treatment in premenopausal patients with advanced breast cancer. Endocr. J., 2011, 58(6), 509-516.
[http://dx.doi.org/10.1507/endocrj.K11E-020] [PMID: 21532215]
[79]
Sa-Nguanraksa, D.; Krisorakun, T.; Pongthong, W.; O-Charoenrat, P. Survival outcome of combined GnRH agonist and tamoxifen is comparable to that of sequential adriamycin and cyclophosphamide chemotherapy plus tamoxifen in premenopausal patients with early breast cancer. Mol. Clin. Oncol., 2019, 11(5), 517-522.
[http://dx.doi.org/10.3892/mco.2019.1913] [PMID: 31620283]
[80]
Jeong, J.H.; Kim, J.E.; Ahn, J.H.; Jung, K.H.; Koh, S.J.; Cheon, J.; Sohn, J.; Kim, G.M.; Lee, K.S.; Sim, S.H.; Park, I.H.; Kim, S.B. Leuprorelin combined with letrozole with/without everolimus in ovarian-suppressed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer: The LEO study. Eur. J. Cancer, 2021, 144, 341-350.
[http://dx.doi.org/10.1016/j.ejca.2020.11.044] [PMID: 33388491]
[81]
Frampton, J.E. Triptorelin: A review of its use as an adjuvant anticancer therapy in early breast cancer. Drugs, 2017, 77(18), 2037-2048.
[http://dx.doi.org/10.1007/s40265-017-0849-3] [PMID: 29177573]
[82]
Ferraro, E.; Trapani, D.; Marrucci, E.; Curigliano, G. Evaluating triptorelin as a treatment option for breast cancer. Expert Opin. Pharmacother., 2019, 20(15), 1809-1818.
[http://dx.doi.org/10.1080/14656566.2019.1650020] [PMID: 31500470]
[83]
Moore, H.C.F.; Unger, J.M.; Phillips, K-A.; Boyle, F.; Hitre, E.; Porter, D.; Francis, P.A.; Goldstein, L.J.; Gomez, H.L.; Vallejos, C.S.; Partridge, A.H.; Dakhil, S.R.; Garcia, A.A.; Gralow, J.; Lombard, J.M.; Forbes, J.F.; Martino, S.; Barlow, W.E.; Fabian, C.J.; Minasian, L.; Meyskens, F.L., Jr; Gelber, R.D.; Hortobagyi, G.N.; Albain, K.S. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N. Engl. J. Med., 2015, 372(10), 923-932.
[http://dx.doi.org/10.1056/NEJMoa1413204] [PMID: 25738668]
[84]
Wang, S.; Pei, L.; Hu, T.; Jia, M.; Wang, S. Protective effect of goserelin on ovarian reserve during (neo)adjuvant chemotherapy in young breast cancer patients: A prospective cohort study in China. Hum. Reprod., 2021, 36(4), 976-986.
[http://dx.doi.org/10.1093/humrep/deaa349] [PMID: 33411897]
[85]
Song, G.; Gao, H.; Yuan, Z. Effect of leuprolide acetate on ovarian function after cyclophosphamide-doxorubicin-based chemotherapy in premenopausal patients with breast cancer: Results from a phase II randomized trial. Med. Oncol., 2013, 30(3), 667.
[http://dx.doi.org/10.1007/s12032-013-0667-8] [PMID: 23904400]
[86]
Lambertini, M.; Boni, L.; Michelotti, A.; Gamucci, T.; Scotto, T.; Gori, S.; Giordano, M.; Garrone, O.; Levaggi, A.; Poggio, F.; Giraudi, S.; Bighin, C.; Vecchio, C.; Sertoli, M.R.; Pronzato, P.; Del Mastro, L. Ovarian suppression with triptorelin during adjuvant breast cancer chemotherapy and long-term ovarian function, pregnancies, and disease-free survival: A randomized clinical trial. JAMA, 2015, 314(24), 2632-2640.
[http://dx.doi.org/10.1001/jama.2015.17291] [PMID: 26720025]
[87]
Lee, J.H.; Choi, Y.S. The role of gonadotropin-releasing hormone agonists in female fertility preservation. Clin. Exp. Reprod. Med., 2021, 48(1), 11-26.
[http://dx.doi.org/10.5653/cerm.2020.04049] [PMID: 33648041]
[88]
Paluch-Shimon, S.; Cardoso, F.; Partridge, A.H.; Abulkhair, O.; Azim, H.A., Jr; Bianchi-Micheli, G.; Cardoso, M.J.; Curigliano, G.; Gelmon, K.A.; Harbeck, N.; Merschdorf, J.; Poortmans, P.; Pruneri, G.; Senkus, E.; Spanic, T.; Stearns, V.; Wengström, Y.; Peccatori, F.; Pagani, O. ESO-ESMO 4th international consensus guidelines for breast cancer in young women (BCY4). Ann. Oncol., 2020, 31(6), 674-696.
[http://dx.doi.org/10.1016/j.annonc.2020.03.284] [PMID: 32199930]
[89]
Yasmin, E.; Balachandren, N.; Davies, M.C.; Jones, G.L.; Lane, S.; Mathur, R.; Webber, L.; Anderson, R.A. Fertility preservation for medical reasons in girls and women: British fertility society policy and practice guideline. Hum. Fertil. (Camb.), 2018, 21(1), 3-26.
[http://dx.doi.org/10.1080/14647273.2017.1422297] [PMID: 29298394]
[90]
Karlsson, P.; Sun, Z.; Braun, D.; Price, K.N.; Castiglione-Gertsch, M.; Rabaglio, M.; Gelber, R.D.; Crivellari, D.; Collins, J.; Murray, E.; Zaman, K.; Colleoni, M.; Gusterson, B.A.; Viale, G.; Regan, M.M.; Coates, A.S.; Goldhirsch, A. Long-term results of International Breast Cancer Study Group Trial VIII: Adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer. Ann. Oncol., 2011, 22(10), 2216-2226.
[http://dx.doi.org/10.1093/annonc/mdq735] [PMID: 21325445]
[91]
Im, S.A.; Lu, Y.S.; Bardia, A.; Harbeck, N.; Colleoni, M.; Franke, F.; Chow, L.; Sohn, J.; Lee, K.S.; Campos-Gomez, S.; Villanueva- Vazquez, R.; Jung, K.H.; Chakravartty, A.; Hughes, G.; Gounaris, I.; Rodriguez-Lorenc, K.; Taran, T.; Hurvitz, S.; Tripathy, D. Overall survival with ribociclib plus endocrine therapy in breast cancer. N. Engl. J. Med., 2019, 381(4), 307-316.
[http://dx.doi.org/10.1056/NEJMoa1903765] [PMID: 31166679]
[92]
Tripathy, D.; Im, S.A.; Colleoni, M.; Franke, F.; Bardia, A.; Harbeck, N.; Hurvitz, S.A.; Chow, L.; Sohn, J.; Lee, K.S.; Campos- Gomez, S.; Villanueva Vazquez, R.; Jung, K.H.; Babu, K.G.; Wheatley-Price, P.; De Laurentiis, M.; Im, Y.H.; Kuemmel, S.; El-Saghir, N.; Liu, M.C.; Carlson, G.; Hughes, G.; Diaz-Padilla, I.; Germa, C.; Hirawat, S.; Lu, Y.S. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): A randomised phase 3 trial. Lancet Oncol., 2018, 19(7), 904-915.
[http://dx.doi.org/10.1016/S1470-2045(18)30292-4] [PMID: 29804902]
[93]
Kaisary, A.V.; Tyrrell, C.J.; Peeling, W.B.; Griffiths, K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br. J. Urol., 1991, 67(5), 502-508.
[http://dx.doi.org/10.1111/j.1464-410X.1991.tb15195.x] [PMID: 1828183]
[94]
Debruyne, F.M.; Dijkman, G.A. Advances and trends in hormonal therapy for advanced prostate cancer. Eur. Urol., 1995, 28(3), 177-188.
[http://dx.doi.org/10.1159/000475049] [PMID: 8536770]
[95]
Dias Silva, É.; Ferreira, U.; Matheus, W.; Faria, E.F.; Silva, G.D.; Saito, M.; de Souza, A.A.; Laranjo, A., Jr; Clark, O.; Magna, L.A.; Castilho, L.N.; Reis, L.O. Goserelin versus leuprolide in the chemical castration of patients with prostate cancer. Int. Urol. Nephrol., 2012, 44(4), 1039-1044.
[http://dx.doi.org/10.1007/s11255-012-0134-z] [PMID: 22315155]
[96]
Shim, M.; Bang, W.J.; Oh, C.Y.; Lee, Y.S.; Cho, J.S. Effectiveness of three different luteinizing hormone-releasing hormone agonists in the chemical castration of patients with prostate cancer: Goserelin versus triptorelin versus leuprolide. Investig. Clin. Urol., 2019, 60(4), 244-250.
[http://dx.doi.org/10.4111/icu.2019.60.4.244] [PMID: 31294133]
[97]
Roach, M., III; Izaguirre, A. Goserelin acetate in combination with radiotherapy for prostate cancer. Expert Opin. Pharmacother., 2007, 8(2), 257-264.
[http://dx.doi.org/10.1517/14656566.8.2.257] [PMID: 17257094]
[98]
Carrie, C.; Hasbini, A.; de Laroche, G.; Richaud, P.; Guerif, S.; Latorzeff, I.; Supiot, S.; Bosset, M.; Lagrange, J.L.; Beckendorf, V.; Lesaunier, F.; Dubray, B.; Wagner, J.P.; N’Guyen, T.D.; Suchaud, J.P.; Créhange, G.; Barbier, N.; Habibian, M.; Ferlay, C.; Fourneret, P.; Ruffion, A.; Dussart, S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): A randomised, multicentre, open-label phase 3 trial. Lancet Oncol., 2016, 17(6), 747-756.
[http://dx.doi.org/10.1016/S1470-2045(16)00111-X] [PMID: 27160475]
[99]
Tan, J.; Zhou, Z.; Luo, Z. Efficacy and prognosis of goserelin acetate sustained-release implants combined with bicalutamide tablets in elderly patients with prostate cancer. Clinical Medical Engineering., 2021, 28(02), 173-174.
[100]
Montgomery, B.S.I.; Borwell, J.P.; Higgins, D.M. Does needle size matter? Patient experience of luteinising hormone-releasing hormone analogue injection. Prostate Cancer Prostatic Dis., 2005, 8(1), 66-68.
[http://dx.doi.org/10.1038/sj.pcan.4500778] [PMID: 15700050]
[101]
Lu, T. Nursing Experience of Injection Pain of Goserelin Sustained-release Implant. Inner Mongolia Traditional Chinese Medicine., 2014, 33(2), 164-165.
[102]
Williams, G.; Lindsay, S.; Bowsher, W.G. Randomised crossover trial to assess the tolerability of LHRH analogue administration. Prostate Cancer Prostatic Dis., 2003, 6(2), 187-189.
[http://dx.doi.org/10.1038/sj.pcan.4500625] [PMID: 12806381]
[103]
Kinoshita, H.; Kawa, G.; Hiura, Y.; Chizaki, R.; Matsuda, T. Effectiveness of skin icing in reducing pain associated with goserelin acetate injection. Int. J. Clin. Oncol., 2010, 15(5), 472-475.
[http://dx.doi.org/10.1007/s10147-010-0095-0] [PMID: 20544251]
[104]
Naya, Y.; Hagiwara, N.; Takeuchi, I.; Mori, M.; Inagaki, A.; Nakanouchi, T.; Mikami, K. Fifteen-second skin icing using a frozen gel pack is effective for reducing goserelin injection pain. Urol. Int., 2014, 93(2), 202-206.
[http://dx.doi.org/10.1159/000353917] [PMID: 24287721]
[105]
Huang, J.; Luo, Y.P. Nursing of abdominal subcutaneous injection of goserelin acetate sustained-release implant. Practical Clinical Medicine., 2014, 15(1), 124-139.
[106]
Shore, N.D.; Abrahamsson, P.A.; Anderson, J.; Crawford, E.D.; Lange, P. New considerations for ADT in advanced prostate cancer and the emerging role of GnRH antagonists. Prostate Cancer Prostatic Dis., 2013, 16(1), 7-15.
[http://dx.doi.org/10.1038/pcan.2012.25] [PMID: 22751146]
[107]
CAMCEVI (leuprolide) injectable emulsion, for subcutaneous use; Foresee Pharmaceuticals Co. Ltd.: Taiwan, 2021.
[108]
Easy and convenient long-acting treatment of prostate cancer­­CAM2032 prostate cancer. Available from: https://www.camurus.com/pipeline/

Rights & Permissions Print Cite
Article Metrics
31
1
© 2024 Bentham Science Publishers | Privacy Policy