Download PDF
Nuklearmedizin 2015; 54(01): 01-11
DOI: 10.1055/s-0037-1616604
DGN-Handlungsempfehlung
Schattauer GmbH

Peptide receptor radionuclide therapy for patients with somatostatin receptor expressing tumours

German Guideline (S1)[*] Article in several languages: deutsch | English
T. D. Poeppel
1   Klinik für Nuklearmedizin, Universitätsklinikum Essen
,
C. Boy
1   Klinik für Nuklearmedizin, Universitätsklinikum Essen
,
A. Bockisch
1   Klinik für Nuklearmedizin, Universitätsklinikum Essen
,
J. Kotzerke
2   Klinik und Poliklinik für Nuklearmedizin, Universitätsklinikum Dresden
,
I. Buchmann
3   Klinik für Radiologie und Nuklearmedizin, Universitäts klinikum Schleswig Holstein, Campus Lübeck
,
S. Ezziddin
4   Klinik für Nuklearmedizin, Universitätsklinikum des Saarlandes
,
K. Scheidhauer
5   Klinik für Nuklearmedizin, Klinikum rechts der Isar, Technische Universität München
,
B. J. Krause
6   Klinik und Poliklinik für Nuklearmedizin, Universitätsklinikum Rostock
,
D. Schmidt
7   Klinik für Nuklearmedizin, Universitätsklinikum Erlangen
,
H. Amthauer
8   Klinik für Radiologie und Nuklearmedizin, Universitäts klinikum Magdeburg
,
F. Rösch
9   Institut für Kernchemie, Johannes Gutenberg Universität Mainz
,
J. Nagarajah
1   Klinik für Nuklearmedizin, Universitätsklinikum Essen
,
D. Führer
10   Klinik für Endokrinologie und Stoffwechselerkrankungen, Universitätsklinikum Essen
,
H. Lahner
10   Klinik für Endokrinologie und Stoffwechselerkrankungen, Universitätsklinikum Essen
,
G. Pöpperl
11   Klinik für Nuklearmedizin, Katharinenhospital Stuttgart
,
D. Hörsch
11   Klinik für Innere Medizin/Gastroenterologie und Endokrinologie, Zentralklinik Bad Berka
,
M. A. Walter
1   Klinik für Nuklearmedizin, Universitätsklinikum Essen
,
R. P. Baum
1   Klinik für Nuklearmedizin, Universitätsklinikum Essen
› Author Affiliations
Further Information

Publication History

20 November 2014

Publication Date:
10 January 2018 (online)

    Permissions and Reprints

Summary

This document describes the guideline for peptide receptor radionuclide therapy (PRRT) published by the German Society of Nuclear Medicine (DGN) and accepted by the Association of the Scientific Medical Societies in Germany (AWMF) to be included in the official AWMF Guideline Registry. These recommendations are a prerequisite for the quality management in the treatment of patients with somatostatin receptor expressing tumours using PRRT. They are aimed at guiding nuclear medicine specialists in selecting likely candidates to receive PRRT and to deliver the treatment in a safe and effective manner. The recommendations are based on an interdisciplinary consensus. The document contains background information and definitions and covers the rationale, indications and contraindications for PRRT. Essential topics are the requirements for institutions performing the therapy, e. g. presence of an expert for medical physics, intense cooperation with all colleagues involved in the treatment of a patient, and a certificate of instruction in radiochemical labelling and quality control are required. Furthermore, it is specified which patient data have to be available prior to performance of therapy and how treatment has to be carried out technically. Here, quality control and documentation of labelling are of great importance. After treatment, clinical quality control is mandatory (work-up of therapy data and follow-up of patients). Essential elements of follow-up are specified in detail. The complete treatment inclusive after-care has to be realised in close cooperation with the involved medical disciplines. Generally, the decision for PRRT should be undertaken within the framework of a multidisciplinary tumour board.

Keywords

Neuroendocrine tumour - NET - NEN - peptide receptor radionuclide therapy - PRRT - guideline - DOTATOC - DOTATATE

* Stand: 12/2013

* AWMF-Registernummer: 031-045


 

  • Literatur

  • 1 Salazar R, Wiedenmann B, Rindi G, Ruszniewski P. ENETS 2011 Consensus Guidelines for the Management of Patients with Digestive Neuroendocrine Tumors: an update. Neuroendocrinology 2012; 95: 71-73.
    CrossrefPubMedGoogle Scholar
  • 2 Öberg K, Hellman P, Ferolla P, Papotti M. Group obotEGW. Neuroendocrine bronchial and thymic tumors: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012; 23: vii120-vii123.
    PubMedGoogle Scholar
  • 3 Öberg K, Knigge U, Kwekkeboom D, Perren A. Group obotEGW. Neuroendocrine gastro-entero-pancreatic tumors: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012; 23: vii124-vii130.
    CrossrefPubMedGoogle Scholar
  • 4 Zaknun JJ, Bodei L, Mueller-Brand J. et al. The joint IAEA, EANM, and SNMMI practical guidance on peptide receptor radionuclide therapy in neuroendocrine tumors. Eur J Nucl Med Mol Imaging 2013; 40: 800-816.
    CrossrefPubMedGoogle Scholar
  • 5 International Atomic Energy Agency. (Ed) Practical Guidance on Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumours. www-pub.iaea.org/MTCD/Publications/PDF/P1560_web.pdf
    Google Scholar
  • 6 Reubi JC, Schar JC, Waser B. et al. Affinity profiles for human somatostatin receptor subtypes SST1-SST5 of somatostatin radiotracers selected for scintigraphic and radiotherapeutic use. Eur J Nucl Med 2000; 27: 273-282.
    CrossrefPubMedGoogle Scholar
  • 7 Anlauf M, Gerlach P, Raffel A. et al. Neuroendokrine Neoplasien des gastroenteropankreatischen Systems. Der Onkologe 2011; 17: 572-582.
    CrossrefGoogle Scholar
  • 8 HÖrsch D, Grabowski P, Schneider CP. et al. Current treatment options for neuroendocrine tumors. Drugs Today (Barc) 2011; 47: 773-786.
    CrossrefPubMedGoogle Scholar
  • 9 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: 4656-4663.
    CrossrefPubMedGoogle Scholar
  • 10 Raymond E, Dahan L, Raoul JL. et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 2011; 364: 501-513.
    CrossrefPubMedGoogle Scholar
  • 11 Yao JC, Shah MH, Ito T. et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011; 364: 514-523.
    CrossrefPubMedGoogle Scholar
  • 12 Kwekkeboom DJ, de Herder WW, Kam BL. et al. Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival. J Clin Oncol 2008; 26: 2124-2130.
    CrossrefPubMedGoogle Scholar
  • 13 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: 2416-2423.
    CrossrefPubMedGoogle Scholar
  • 14 Bushnell Jr. DL, O'Dorisio TM, O'Dorisio MS. et al. 90Y-edotreotide for metastatic carcinoid refractory to octreotide. J Clin Oncol 2010; 28: 1652-1659.
    CrossrefPubMedGoogle Scholar
  • 15 Khan S, Krenning EP, van Essen M. et al. Quality of life in 265 patients with gastroenteropancreatic or bronchial neuroendocrine tumors treated with [177Lu-DOTA0,Tyr3]octreotate. J Nucl Med 2011; 52: 1361-1368.
    CrossrefPubMedGoogle Scholar
  • 16 Caplin M, Sundin A, Nillson O. et al. ENETS Consensus Guidelines for the management of patients with digestive neuroendocrine neoplasms: colorectal neuroendocrine neoplasms. Neuroendocrinology 2012; 95: 88-97.
    CrossrefPubMedGoogle Scholar
  • 17 Delle Fave G, Kwekkeboom DJ, Van Cutsem E. et al. ENETS Consensus Guidelines for the management of patients with gastroduodenal neoplasms. Neuroendocrinology 2012; 95: 74-87.
    CrossrefPubMedGoogle Scholar
  • 18 Falconi M, Bartsch DK, Eriksson B. et al. ENETS Consensus Guidelines for the management of patients with digestive neuroendocrine neoplasms of the digestive system: well-differentiated pancreatic non-functioning tumors. Neuroendocrinology 2012; 95: 120-134.
    CrossrefPubMedGoogle Scholar
  • 19 Jensen RT, Cadiot G, Brandi ML. et al. ENETS Consensus Guidelines for the management of patients with digestive neuroendocrine neoplasms: functional pancreatic endocrine tumor syndromes. Neuroendocrinology 2012; 95: 98-119.
    CrossrefPubMedGoogle Scholar
  • 20 Kwekkeboom DJ, Krenning EP, Lebtahi R. et al. ENETS Consensus Guidelines for the Standards of Care in Neuroendocrine Tumors: peptide receptor radionuclide therapy with radiolabeled somatostatin analogs. Neuroendocrinology 2009; 90: 220-226.
    CrossrefPubMedGoogle Scholar
  • 21 Pape UF, Perren A, Niederle B. et al. ENETS Consensus Guidelines for the management of patients with neuroendocrine neoplasms from the jejuno-ileum and the appendix including goblet cell carcinomas. Neuroendocrinology 2012; 95: 135-156.
    CrossrefPubMedGoogle Scholar
  • 22 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: 157-176.
    CrossrefPubMedGoogle Scholar
  • 23 Baum RP, Kulkarni HR. THERANOSTICS: From molecular imaging using Ga-68 labeled tracers and PET/CT to personalized radionuclide therapy - The Bad Berka Experience. Theranostics 2012; 2: 437-447.
    CrossrefPubMedGoogle Scholar
  • 24 Kwekkeboom DJ, Teunissen JJ, Bakker WH. et al. Radiolabeled somatostatin analog [177Lu-DOTA0,Tyr3]octreotate in patients with endocrine gastroenteropancreatic tumors. J Clin Oncol 2005; 23: 2754-2762.
    CrossrefPubMedGoogle Scholar
  • 25 Boy C, Heusner TA, Poeppel TD. et al. 68Ga-DOTATOC PET/CT and somatostatin receptor (sst1-sst5) expression in normal human tissue: correlation of sst2 mRNA and SUVmax. Eur J Nucl Med Mol Imaging 2011; 38: 1224-1236.
    CrossrefPubMedGoogle Scholar
  • 26 Campana D, Ambrosini V, Pezzilli R. et al. Standardized uptake values of 68Ga-DOTANOC PET: A promising prognostic tool in neuroendocrine tumors. J Nucl Med 2010; 51: 353-359.
    CrossrefPubMedGoogle Scholar
  • 27 Ezziddin S, Opitz M, Attassi M. et al. Impact of the Ki-67 proliferation index on response to peptide receptor radionuclide therapy. Eur J Nucl Med Mol Imaging 2011; 38: 459-466.
    CrossrefPubMedGoogle Scholar
  • 28 Bodei L, Cremonesi M, Ferrari M. et al. Long-term evaluation of renal toxicity after peptide receptor radionuclide therapy with 90Y-DOTATOC and 177Lu-DOTATATE: the role of associated risk factors. Eur J Nucl Med Mol Imaging 2008; 35: 1847-1856.
    CrossrefPubMedGoogle Scholar
  • 29 Bartolomei M, Bodei L, De Cicco C. et al. Peptide receptor radionuclide therapy with 90Y-DOTATOC in recurrent meningioma. Eur J Nucl Med Mol Imaging 2009; 36: 1407-1416.
    CrossrefPubMedGoogle Scholar
  • 30 Ferrari M, Cremonesi M, Bartolomei M. et al. Dosimetric model for locoregional treatments of brain tumors with 90Y-conjugates: clinical application with 90Y-DOTATOC. J Nucl Med 2006; 47: 105-112.
    PubMedGoogle Scholar
  • 31 Kwekkeboom DJ, Mueller-Brand J, Paganelli G. et al. Overview of results of peptide receptor radionuclide therapy with 3 radiolabeled somatostatin analogs. J Nucl Med 2005; 46 (Suppl 1) 62S-66S.
    PubMedGoogle Scholar
  • 32 Valkema R, Pauwels SA, Kvols LK. et al. Long-term follow-up of renal function after peptide receptor radiation therapy with 90Y-DOTA(0),Tyr(3)-octreotide and 177Lu-DOTA(0), Tyr(3)-octreotate. J Nucl Med 2005; 46 (Suppl 1) 83S-91S.
    PubMedGoogle Scholar
  • 33 van Essen M, Krenning EP, Kam BL. et al. Report on short-term side effects of treatments with 177Lu-octreotate in combination with capecitabine in seven patients with gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging 2008; 35: 743-748.
    CrossrefPubMedGoogle Scholar
  • 34 Rolleman EJ, Melis M, Valkema R. et al. Kidney protection during peptide receptor radionuclide therapy with somatostatin analogues. Eur J Nucl Med Mol Imaging 2010; 37: 1018-1031.
    CrossrefPubMedGoogle Scholar
  • 35 Vegt E, de Jong M, Wetzels JF. et al. Renal toxicity of radiolabeled peptides and antibody fragments: mechanisms, impact on radionuclide therapy, and strategies for prevention. J Nucl Med 2010; 51: 1049-1058.
    CrossrefPubMedGoogle Scholar
  • 36 B. Braun Melsungen AG: Gelafundin 4 % InfusionslÖsung – Fachinformation. Juli 2008
    PubMedGoogle Scholar
  • 37 Kratochwil C, Giesel FL, Lopez-Benitez R. et al. Intraindividual comparison of selective arterial versus venous 68Ga-DOTATOC PET/CT in patients with gastroenteropancreatic neuroendocrine tumors. Clin Cancer Res 2010; 16: 2899-2905.
    CrossrefPubMedGoogle Scholar
  • 38 Baum RP, Kulkarni HR, Carreras C. Peptides and receptors in image-guided therapy: theranostics for neuroendocrine neoplasms. Semin Nucl Med 2012; 42: 190-207.
    CrossrefPubMedGoogle Scholar
  • 39 Villard L, Romer A, Marincek N. et al. Cohort study of somatostatin-based radiopeptide therapy with [90Y-DOTA]-TOC versus [90Y-DOTA]-TOC plus [177Lu-DOTA]-TOC in neuroendocrine cancers. J Clin Oncol 2012; 30: 1100-1106.
    CrossrefPubMedGoogle Scholar
  • 40 Cremonesi M, Ferrari M, Bodei L. et al. Dosimetry in Peptide radionuclide receptor therapy: a review. J Nucl Med 2006; 47: 1467-1475.
    PubMedGoogle Scholar
  • 41 Cremonesi M, Ferrari M, Zoboli S. et al. Biokinetics and dosimetry in patients administered with 111In-DOTA-Tyr(3)-octreotide: implications for internal radiotherapy with 90Y-DOTATOC. Eur J Nucl Med 1999; 26: 877-886.
    CrossrefPubMedGoogle Scholar
  • 42 Kwekkeboom DJ, Bakker WH, Kooij PP. et al. [177Lu-DOTAOTyr3]octreotate: comparison with [111In-DTPAo]octreotide in patients. Eur J Nucl Med 2001; 28: 1319-1325.
    CrossrefPubMedGoogle Scholar
  • 43 Forrer F, Uusijarvi H, Waldherr C. et al. A comparison of 111In-DOTATOC and 111In-DOTATATE: biodistribution and dosimetry in the same patients with metastatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging 2004; 31: 1257-1262.
    PubMedGoogle Scholar
  • 44 Wehrmann C, Senftleben S, Zachert C. et al. Results of individual patient dosimetry in peptide receptor radionuclide therapy with 177Lu DOTA-TATE and 177Lu DOTA-NOC. Cancer Biother Radiopharm 2007; 22: 406-416.
    CrossrefPubMedGoogle Scholar
  • 45 Rodrigues M, Traub-Weidinger T, Li S. et al. Comparison of 111In-DOTA-DPhe1-Tyr3-octreotide and 111In-DOTA-lanreotide scintigraphy and dosimetry in patients with neuroendocrine tumours. Eur J Nucl Med Mol Imaging 2006; 33: 532-540.
    CrossrefPubMedGoogle Scholar
  • 46 Forrer F, Krenning EP, Kooij PP. et al. Bone marrow dosimetry in peptide receptor radionuclide therapy with [177Lu-DOTA(0),Tyr(3)]octreotate. Eur J Nucl Med Mol Imaging 2009; 36: 1138-1146.
    CrossrefPubMedGoogle Scholar
  • 47 Forster GJ, Engelbach MJ, Brockmann JJ. et al. Preliminary data on biodistribution and dosimetry for therapy planning of somatostatin receptor positive tumours: comparison of 86Y-DOTATOC and 111In-DTPA-octreotide. Eur J Nucl Med 2001; 28: 1743-1750.
    CrossrefPubMedGoogle Scholar
  • 48 Helisch A, Forster GJ, Reber H. et al. Pre-therapeutic dosimetry and biodistribution of 86Y-DOTA-Phe1-Tyr3-octreotide versus 111In-pentetreotide in patients with advanced neuroendocrine tumours. Eur J Nucl Med Mol Imaging 2004; 31: 1386-1392.
    PubMedGoogle Scholar
  • 49 Menda Y, O'Dorisio MS, Kao S. et al. Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors. J Nucl Med 2010; 51: 1524-1531.
    CrossrefPubMedGoogle Scholar
  • 50 Kwekkeboom DJ, Kooij PP, Bakker WH. et al. Comparison of 111In-DOTA-Tyr3-octreotide and 111In-DTPA-octreotide in the same patients: biodistribution, kinetics, organ and tumor uptake. J Nucl Med 1999; 40: 762-767.
    PubMedGoogle Scholar
  • 51 Hindorf C, Chittenden S, Causer L. et al. Dosimetry for 90Y-DOTATOC therapies in patients with neuroendocrine tumors. Cancer Biother Radiopharm 2007; 22: 130-135.
    CrossrefPubMedGoogle Scholar
  • 52 Sandstrom M, Garske U, Granberg D. et al. Individualized dosimetry in patients undergoing therapy with 177Lu-DOTA-D-Phe (1)-Tyr (3)-octreotate. Eur J Nucl Med Mol Imaging 2010; 37: 212-225.
    CrossrefPubMedGoogle Scholar
  • 53 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: 510-518.
    CrossrefPubMedGoogle Scholar
  • 54 Arnold R, Chen YJ, Costa F. et al. ENETS Consensus Guidelines for the Standards of Care in Neuroendocrine Tumors: follow-up and documentation. Neuroendocrinology 2009; 90: 227-233.
    CrossrefPubMedGoogle Scholar
  • 55 Ruf J, Schiefer J, Furth C. et al. 68Ga-DOTATOC PET/CT of neuroendocrine tumors: spotlight on the CT phases of a triple-phase protocol. J Nucl Med 2011; 52: 697-704.
    CrossrefPubMedGoogle Scholar