Guidelines on radioiodine therapy for differentiated thyroid carcinoma^[*]

Summary

Aim: For the examination of the impact on clinical practice of the guidelines for differentiated thyroid carcinoma (DTC), treatment data from the ongoing Multicenter Study Differentiated Thyroid Carcinoma (MSDS) were analyzed. Patients, methods: Patients were randomized to adjuvant external beam radiotherapy (RTx) or no RTx in addition to standard therapy in TNM stages pT4 pN0/1/x M0/x (UICC, 5th ed. 1997). All patients were to receive the same treatment regimen consisting of thyroidectomy, ablative radioiodine therapy (RIT), and a diagnostic ¹³¹I whole-body scintigraphy (WBS) 3-4 months after RIT. Results: Of 339 eligible patients enrolled between January 2000 and March 2004, 273 could be analyzed. Guideline recommendations by the German Society for Nuclear Medicine from 1999 and 1992 were complied with within 28% and 82% with regard to the interval between surgery and RIT (4 vs. 4–6 weeks), in 33% and 84% with regard to ¹³¹I activity for RIT (1-3 vs. 1-4 GBq; ± 10%), and in 16% and 60% with regard to ¹³¹I activity for WBS (15319-300 vs. 15319-400 MBq; ± 10%). Conclusions: The 1999 guideline revision appears to have had little impact on clinical practice. Further follow-up will reveal if guideline compliance had an effect on outcomes.

Zusammenfassung

Ziel: Um den Effekt der Leitlinien zur Therapie des differenzierten Schilddrüsenkarzinoms (DTC) zu untersuchen, wurden die Behandlungsdaten der laufenden Multizentrischen Studie Differenziertes Schilddrüsenkarzinom (MSDS) analysiert. Patienten, Methoden: Patienten in den TNM-Stadien pT4 pN0/1/x M0/x (UICC, 5. Aufl. 1997) erhielten per Randomisierung eine perkutane Strahlentherapie (RTx) oder keine RTx zusätzlich zur Standardtherapie. Letztere bestand aus Thyroidektomie, ablativer Radioiodtherapie (RIT) und einer diagnostischen ¹³¹I-Ganzkörperszintigraphie (WBS) 3-4 Monate nach RIT. Ergebnisse: Von 339 Patienten zwischen 1/2000 und 3/2004 konnten 273 ausgewertet werden. Die Leitlinien der Deutschen Gesellschaft für Nuklearmedizin von 1999 und 1992 wurden befolgt in 28% und 82% in Bezug auf den Zeitraum zwischen Operation und RIT (4 bzw. 4-6 Wochen), in 33% und 84% in Bezug auf die ¹³¹I-Aktivität für die RIT (1-3 bzw. 1-4 GBq; ± 10%) und 16% bzw. 60% in Bezug auf die ¹³¹I-Aktivität für die Ganzkörperszintigraphie (15319-300 bzw. 15319-400 MBq; ± 10%). Schlussfolgerung: Die Revision der Leitlinien von 1999 hatte wenig Effekt auf die klinische Praxis. Die Nachbeobachtung des Studienkollektivs wird zeigen, ob die Umsetzung der Leitlinien Einfluss auf die Behandlungsergebnisse nimmt.

Keywords

Thyroid carcinoma - clinical practice guideline - radioiodine therapy - iodine-131

Schlüsselwörter

Schilddrüsenkarzinom - klinische Leitlinien - Radioiodtherapie - Iod-131

^* Results have been presented in part at the Annual Meeting of the European Association on August 25, 2003.

^** MSDS study group

• References

• 1 Alexander C, Bader JB, Schaefer A. et al. Intermediate and long-term side effects of high-dose radioiodine therapy for thyroid carcinoma. J Nucl Med 1998; 39: 1551-4.
• 2 Balasubramanian SP, Murrow S, Holt S. et al. Audit of compliance to adjuvant chemotherapy and radiotherapy guidelines in breast cancer in a cancer network. Breast 2003; 12: 136-41.
• 3 Becker D, Charkes ND, Dworkin H. et al. Procedure guideline for extended scintigraphy for differentiated thyroid cancer: 1.0. Society of Nuclear Medicine. J Nucl Med 1996; 37: 1269-71.
• 4 Becker DV, Charkes ND, Hurley JR. et al. Society of Nuclear Medicine Procedure Guideline for Extended Scintigraphy for Differentiated Thyroid Cancer (Version 2.0). Society of Nuclear Medicine Procedure Guidelines Manual 2002; 19-22.
• 5 Belin RM, Ladenson PW, Robinson KA. et al. Development and use of evidence-based clinical practice guidelines for thyroid disease. Endocrinol Metab Clin North Am 2002; 31: 795-817.
• 6 Bennett CL, Somerfield MR, Pfister DG. et al. Perspectives on the value of American Society of Clinical Oncology clinical guidelines as reported by oncologists and health maintenance organizations. J Clin Oncol 2003; 21: 937-41.
• 7 Biermann M, Pixberg M, Riemann B. et al. Radioiodine therapy of thyroid cancinoma. Onkologe 2005; 11: 70-7.
• 8 Biermann M, Pixberg M, Schuck A. et al. External beam radiotherapy. In: Biersack H-J, Grünwald F. (eds). Thyroid cancer. Heidelberg: Springer; 2005: 139-61.
• 9 Biermann M, Pixberg MK, Schober O. Changing Patterns of Care for Locally Advanced Differentiated Thyroid Carcinoma (DTC) in German-speaking Europe since 1996. Eur J Nucl Med 2003; 30: S155.
• 10 Biermann M, Pixberg MK, Schober O. Impact of the 1996 guidelines for the treatment of differentiated thyroid carcinoma (DTC) on medical practice in Germany. Eur J Nucl Med 2003; 30: S261.
• 11 Biermann M, Pixberg MK, Schuck A. et al. Multicenter Study Differentiated Thyroid Carcinoma (MSDS): Diminished acceptance of adjuvant external beam radiotherapy for differentiated thyroid carcinoma. Nuklearmedizin 2003; 42: 244-50.
• 12 Biermann M, Schober O. GCP-compliant management of the Multicentric Study Differentiated Thyroid Carcinoma (MSDS) with a relational database under Oracle 8i. Inform Biom Epidemiol Med Biol 2002; 33: 441-59.
• 13 Biermann M, Schober O. Should High hTG levels in absence of iodine uptake be treated?. Eur J Nucl Med 2003; 30: 160-3.
• 14 British Thyroid Association. Guidelines for the managment of thyroid cancer in adults. www.british-thyroid-association.org/guidelines.htm 2001
• 15 Cabana MD, Ebel BE, Cooper-Patrick L. et al. Barriers pediatricians face when using asthma practice guidelines. Arch Pediatr Adolesc Med 2000; 154: 685-93.
• 16 Deutsche Krebsgesellschaft. Malignant goiter. In: Junginger T, Hossfeld DK, Müller R-P. (eds). Guidelines for the diagnosis and therapy of tumors of the gastrointestinal tract and the thyroid gland. Stuttgart: Thieme; 1999: 204-13.
• 17 Deutsche Krebsgesellschaft. Malignant thyroid tumors. Concise interdisciplinary guidelines 2000. Germering: Zuckschwerdt; 2000: 92-106.
• 18 Deutsche Krebsgesellschaft. Malignant thyroid tumors. Concise interdisciplinary guidelines 2002. Germering: Zuckschwerdt; 2002
• 19 Dietlein M, Dressler J, Eschner W. et al. Procedure guideline for iodine-131 whole-body scintigraphy for differentiated thyroid cancer. Nuklearmedizin 1999; 38: 213-4.
• 20 Dietlein M, Dressler J, Eschner W. et al. Procedure guideline for thyroid uptake measurement. Nuklearmedizin 1999; 38: 211-2.
• 21 Dietlein M, Dressler J, Eschner W. et al. Procedure guideline for iodine-131 whole-body scintigraphy for differentiated thyroid cancer (version 2). Nuklearmedizin 2003; 42: 123-5.
• 22 Dietlein M, Dressler J, Farahati J. et al. Procedure guidelines for radioiodine therapy of differentiated thyroid cancer (version 2). Nuklearmedizin 2004; 43: 115-20.
• 23 Dietlein M, Dressler J, Farahati J. et al. Guidelines for radioiodine therapy (RIT) in differentiated thyroid cancer. Nuklearmedizin 1999; 38: 221-2.
• 24 Dietlein M, Dressler J, Grunwald F. et al. Guideline for in vivo- and in vitro procedures for thyroid diseases (version 2). Nuklearmedizin 2003; 42: 109-15.
• 25 Dietlein M, Schober O, Schicha H. Overtherapy or undertherapy for papillary thyroid microcarcinoma? Therapeutic considerations for radioiodine ablation. Nuklearmedizin 2004; 43: 107-14.
• 26 Dralle H, Machens A, Brauckhoff M. et al. Surgery of thyroid cancer: Should the surgical guidelines be revised following the introduction of the new TNM classification?. Onkologe 2005; 11: 58-69.
• 27 Eichhorn W, Tabler H, Lippold R. et al. Prognostic factors determining long-term survival in welldifferentiated thyroid cancer: an analysis of four hundred eighty-four patients undergoing therapy and aftercare at the same institution. Thyroid 2003; 13: 949-58.
• 28 Field MJ, Lohr KN. Clinical practice guidelines: Directions for a new program. Washington, D. C.: National Academy Press; 1990
• 29 Georgi P, Emrich D, Heidenreich P. et al. Radioiodine therapy of differentiated thyroid cancer. Recommendations of the Therapy Study Group of the German Society of Nuclear Medicine. Nuklearmedizin 1992; 31: 151-3.
• 30 Gordon AJ, Macpherson DS. Guideline chaos: conflicting recommendations for preoperative cardiac assessment. Am J Cardiol 2003; 91: 1299-303.
• 31 Graham ID, Evans WK, Logan D. et al. Canadian oncologists and clinical practice guidelines: a national survey of attitudes and reported use. Provincial Lung Disease Site Group of Cancer Care Ontario. Oncology 2000; 59: 283-90.
• 32 Hölzer S, Steiner D, Bauer R. et al. Current practice of radioiodine treatment in the management of differentiated thyroid cancer in Germany. Eur J Nucl Med 2000; 27: 1465-72.
• 33 Junginger T, Hartel W. Leitlinien der Therapie maligner Schilddrüsentumoren. Mitteilungen der Deutschen Gesellschaft für Chirurgie 1996; 3/1996.
• 34 Junginger T, Hossfeld DK, Müller R-P. Leitlinien zur Diagnostik und Therapie von Tumoren des Gastrointestinaltrakts und der Schilddrüse. Stuttgart: Thieme; 1999
• 35 Karges W, Dralle H, Raue F. et al. Calcitonin measurement to detect medullary thyroid carcinoma in nodular goiter: german evidence-based consensus recommendation. Exp Clin Endocrinol Diabetes 2004; 112: 52-8.
• 36 Klein E, Heinze HG, Hoffmann G. et al. Therapy of thyroid neoplasms. Synopsis of guideline from section thyroid gland of the German Society for Endocrinology. Dtsch Med Wochenschr 1976; 101: 835-59.
• 37 Koch W, Rosa F, Knesewitsch P. et al. Guideline on radiation protection in medicine requires documentation of radioiodine therapy and follow-up: What are the benefits of an electronic database?. Nuklearmedizin 2005; 44: 49-55.
• 38 Lees W, Mansberg R, Roberts J. et al. The clinical effects of thyroid stunning after diagnostic wholebody scanning with 185 MBq ¹³¹I. Eur J Nucl Med Mol Imaging 2002; 29: 1421-7.
• 39 Lerch H, Schober O, Kuwert T. et al. Survival of differentiated thyroid carcinoma studied in 500 patients. J Clin Oncol 1997; 15: 2067-75.
• 40 Meier DA, Brill DR, Becker DV. et al. Procedure guideline for therapy of thyroid disease with (131)iodine. J Nucl Med 2002; 43: 856-61.
• 41 MSDS study group. Multicentric Study Differentiated Thyroid Carcinoma (MSDS): A prospective randomized trial on the benefits of percutaneous radiotherapy for differentiated thyroid carcinoma (DTC) pT4 pN0/1/x M0 R0–1. Protocol v. 1.0 ff. http://msds-studie.uni-muenster.de 1999
• 42 National Comprehensive Cancer Network. Clinical practice guidelines in oncology. Thyroid Carcinoma v. 1.2005. http://www.nccn.org 2005
• 43 Ottevanger PB, De Mulder PH, Grol RP. et al. Adherence to the guidelines of the CCCE in the treatment of node-positive breast cancer patients. Eur J Cancer 2004; 40: 198-204.
• 44 Schmoor C, Olschewski M, Schumacher M. Randomized and non-randomized patients in clinical trials: experiences with comprehensive cohort studies. Stat Med 1996; 15: 263-71.
• 45 Schuck A, Biermann M, Pixberg MK. et al. Acute toxicity of adjuvant radiotherapy in locally advanced differentiated thyroid cancer: First results of the Multicenter Study Differentiated Thyroid Cancer (MSDS). Strahlenther Onkol 2003; 179: 821-7.
• 46 Seegenschmiedt MH, Sautter-Bihl ML, Schmitt G. et al. Guidelines in radiooncology. External beam radiotherapy of malignant struma. AWMF-Guideline registry no. 052/001. www.awmf-online.de 1998
• 47 Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA 1999; 281: 1900-5.
• 48 Sherman SI, Brierley JD, Sperling M. et al. Prospective multicenter study of thyroid carcinoma treatment: initial analysis of staging and outcome. National Thyroid Cancer Treatment Cooperative Study Registry Group. Cancer 1998; 83: 1012-21.
• 49 Singer PA, Cooper DS, Daniels GH. et al. Treatment guidelines for patients with thyroid nodules and well-differentiated thyroid cancer. American Thyroid Association. Arch Intern Med 1996; 156: 2165-72.
• 50 Thyroid Carcinoma Task Force. AACE/AAES medical/surgical guidelines for clinical practice: management of thyroid carcinoma. Endocr Pract 2001; 7: 203-18.
• 51 Van Tol KM, Jager PL, de Vries EG. et al. Outcome in patients with differentiated thyroid cancer with negative diagnostic whole-body scanning and detectable stimulated thyroglobulin. Eur J Endocrinol 2003; 148: 589-96.
• 52 Verkooijen RB, Stokkel MP, Smit JW. et al. Radioiodine- 131 in differentiated thyroid cancer: a retrospective analysis of an uptake-related ablation strategy. Eur J Nucl Med Mol Imaging 2004; 31: 499-506.
• 53 Wieler H, Bartenstein P, Becker HP. et al. Guideline for therapy of malignant thyroid tumours: pleading for an actualization. Nuklearmedizin 2004; 43: 121-3.
• 54 Wittekind C, Meyer HJ, Bootz F. TNM classification of malignant tumors. 6th ed. Berlin: Springer; 2002
• 55 Wittekind C, Wagner G. TNM classification of malignant tumors. 5th ed. Berlin: Springer; 1997
• 56 Woolf SH, Grol R, Hutchinson A. et al. Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines. Br Med J 1999; 318: 527-30.
• 57 Wyckoff HO, Allisy A, Liden K. The new special names of SI units in the field of ionizing radiations. Radiology 1976; 118: 233-4.