Journal of Postgraduate Medicine, Education and Research

Register      Login

VOLUME 46 , ISSUE 2 ( April-June, 2012 ) > List of Articles

RESEARCH ARTICLE

Prospective Single-Arm Study of Radioprotection by Amifostine in High Dose Radioactive Iodine Therapy for Thyroid Cancer

Ajay Sandhu, Vladimir Ioffe, Daniel Karakla, J Trad Wadsworth, April Mendoza, Nikhil Rao, Kathleen Dignan, Elizabeth Mason, Thomas E Goffman

Citation Information : Sandhu A, Ioffe V, Karakla D, Wadsworth JT, Mendoza A, Rao N, Dignan K, Mason E, Goffman TE. Prospective Single-Arm Study of Radioprotection by Amifostine in High Dose Radioactive Iodine Therapy for Thyroid Cancer. J Postgrad Med Edu Res 2012; 46 (2):90-94.

DOI: 10.5005/jp-journals-10028-1019

Published Online: 01-06-2012

Copyright Statement:  Copyright © 2012; The Author(s).


Abstract

Purpose

Xerostomia, sialoadenitis, taste dysfunction and nausea are well known toxicities following high dose radioactive iodine (RAI) treatment for well-differentiated thyroid cancer. This prospective study sought to determine the incidence rates for RAI adverse effects and to determine, whether the radioprotector, amifostine could decrease the duration of the adverse effects in single treatment patients.

Materials and methods

Patients with differentiated thyroid cancer received 150 mCi RAI after total thyroidectomy. All patients were pretreated with 1 mg granisetron and 4 mg dexamethasone. Patients in the amifostine arm (n = 27) were prospectively enrolled and received 500 mg amifostine subcutaneously. Adverse effects were scored based on the CTCAE at 1 month, 6 months, and yearly intervals using a physician administered questionnaire. The results were compared with a retrospective no amifostine cohort (n = 22) for whom data was collected with the identical questionnaire.

Results

The overall incidence of xerostomia, sialadenitis, taste dysfunction and nausea in the treatment group was 26, 22, 52 and 26% respectively. Only grades 1 and 2 adverse effects were observed. The mean duration (days) of xerostomia (control vs treatment)—37.3 vs 21.9 (F test, p = 0.016), taste dysfunction—45.5 vs 23.5 (F test, p = 0.001), sialadenitis— 16.8 vs 7.5 and nausea—18.7 vs 5.1.

Conclusion

In patients treated once with high dose RAI, who develop xerostomia, sialoadenitis, taste dysfunction, and/or nausea, the duration of symptoms appears to be reduced by pretreatment with 500 mg of subcutaneous amifostine without significant treatment related adverse effects.

How to cite this article

Sandhu A, Ioffe V, Karakla D, Wadsworth JT, Mendoza A, Rao N, Dignan K, Mason E, Goffman TE. Prospective Single-Arm Study of Radioprotection by Amifostine in High Dose Radioactive Iodine Therapy for Thyroid Cancer. J Postgrad Med Edu Res 2012;46(2):90-94.


PDF Share
  1. Cancer statistics. CA Cancer J Clin 2005;55:10-30.
  2. SEER cancer statistics review 1975-2001. Bethesda: National Cancer Institute 2004.
  3. An analysis of ablation of thyroid remnants with I-131 in 511 patients from 1947-1984: Experience at University of Michigan. J Nucl Med 1984;25:1287-93.
  4. Ablation of the thyroid remnant and 131I dose in differentiated thyroid cancer. Clin Endocrinol (Oxf) 2000;52:765-73.
  5. Pathological tumor-node-metastasis (pTNM) staging for papillary and follicular thyroid carcinomas: A retrospective analysis of 700 patients. J Clin Endocrinol Metab 1997;82:3553-62.
  6. Limitations and indications in the treatment of cancer of the thyroid with radioactive iodine. J Clin Endocrinol Metab 1951;11:1128-42.
  7. Radioiodine therapy for thyroid cancer. Endocrinol Metab Clin North Am 1995;24:803-39.
  8. Papillary carcinoma. In: Wartofsky L. Thyroid cancer: A comprehensive guide to clinical management. Totowa: Humana Press Inc 2000.
  9. Sialadenitis following I-131 therapy for thyroid carcinoma: Concise communication. J Nucl Med 1984;25:755-58.
  10. Sialoadenitis following I-131 therapy for thyroid carcinoma: Concise communication. J Nucl Med 1985;26:816
  11. Radioactive iodine and the salivary glands. Thyroid 2003;13:265-71.
  12. Radioprotection of salivary glands by S-2-(3-aminopropylamino)-ethylphosphorothioic (amifostine) obtained in a rabbit animal model. Int J Radiat Oncol Biol Phys 1999;45:181-86.
  13. Influence of intravenous amifostine on xerostomia, tumor control, and survival after radiotherapy for head-and-neck cancer: 2-year follow-up of a prospective, randomized, phase III trial. Int J Radiat Oncol Biol Phys 2005;63:985-90.
  14. Effect of amifostine on patient assessed clinical benefit in irradiated head and neck cancer. Int J Radiat Oncol Biol Phys 2000;48:1035-39.
  15. Salivary gland protection by amifostine in high-dose radioiodine treatment: Results of a double-blind placebo-controlled study. J Clin Oncol 1998;16:3542-49.
  16. Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol 2000;18:3339-45.
  17. Preliminary results of a pilot study using WR-2721 before fractionated irradiation of the head and neck to reduce salivary gland dysfunction. Int J Radiat Oncol Biol Phys 1994;29:747-54.
  18. Prophylactic use of amifostine to prevent radiochemotherapy-induced mucositis and xerostomia in head-and-neck cancer. Int J Radiat Oncol Biol Phys 2002;52:739-47.
  19. Amifostine in simultaneous radiochemotherapy of advanced head and neck cancer. Semin Radiat Oncol 2002;12:4-13.
  20. Selective cytoprotection with amifostine in concurrent radiochemotherapy for head and neck cancer. Ann Oncol 1998;9:505-09.
  21. Radiochemotherapy with amifostine cytoprotection for head and neck cancer. Support Care Cancer 1998;6:155-60.
  22. Amifostine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential as a radioprotector and cytotoxic chemoprotector. Drugs 1995;50:1001-31.
  23. Active versus passive absorption kinetics as the basis for selective protection of normal tissues by S-2-(3-aminopropylamino)-ethylphosphorothioic acid. Cancer Res 1980;40:1519-24.
  24. Synthesis, biodistribution, and autoradiography of radiolabeled S-2-(3-methylaminopropylamino) ethylphosphorothioic acid (WR-3689). Radiat Res 1986;106:366-79.
  25. Specific protection of different normal tissues. Pharmacol Ther 1988;39:33-43.
  26. Protection of normal tissues by WR2721 during fractionated irradiation. Int J Radiat Oncol Biol Phys 1976;1:699-703.
  27. Protection of normal tissue against late radiation injury by WR-2721. Radiat Res 1981;85:408-15.
  28. Distribution of WR-2721 in normal and malignant tissues of mice and rats bearing solid tumors: Dependence on tumor type, drug dose and species. Radiat Res 1974;59:475-83.
  29. Full Prescribing Information MO, Inc, Gaithersburg, MD 2003.
  30. Carboplatin combined with amifostine, a bone marrow protectant, in the treatment of non-small-cell lung cancer: A randomised phase II study. Br J Cancer 1995;72:1551-55.
  31. Phase I/II trials of WR-2721 and cis-platinum. Int J Radiat Oncol Biol Phys 1986;12:1509-12.
  32. Amifostine pretreatment for protection against cyclophosphamide-induced and cisplatininduced toxicities: Results of a randomized control trial in patients with advanced ovarian cancer. J Clin Oncol 1996;14: 2101-12.
  33. Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non-small-cell lung cancer: Report of a randomized comparative trial. Int J Radiat Oncol Biol Phys 2004;58:1369-77.
  34. Use of radiation with or without WR-2721 in advanced rectal cancer. Cancer 1992;69:2820-25.
  35. Amifostine, cisplatin, and vinblastine in metastatic non-small-cell lung cancer: A report of high response rates and prolonged survival. J Clin Oncol 1996;14:1913-21.
  36. Subcutaneous administration of amifostine during fractionated radiotherapy: A randomized phase II study. J Clin Oncol 2000;18:2226-33.
  37. Preliminary data of the GORTEC 2000-02 phase III trial comparing intravenous and subcutaneous administration of amifostine for head and neck tumors treated by external radiotherapy. Semin Oncol 2002;29:57-60.
  38. A phase II trial of subcutaneous amifostine and radiation therapy in patients with head and neck cancer. Semin Radiat Oncol 2002;12:18-19.
  39. Pilot study of subcutaneous amifostine in patients undergoing postoperative intensity modulated radiation therapy for head and neck cancer: Preliminary data. Semin Oncol 2003;30:96-100.
  40. Side effects of rational dose iodine-131 therapy for metastatic well-differentiated thyroid carcinoma. J Nucl Med 1986;27:1519-27.
  41. The long-term hazards of the treatment of thyroid cancer with radioiodine. Br J Radiol 1986;59:45-51.
  42. Quality of life with well-differentiated thyroid cancer: Treatment toxicities and their reduction. Thyroid 2004;14:133-40.
  43. Taste dysfunction in patients with thyroid cancer following treatment with 131I. J Nucl Med 1992;33:996
  44. Transient radiation effects following high dose 131I therapy for differentiated thyroid cancer (DTC). J Nucl Med 1994;35:15P.
  45. The radioiodine therapy in differentiated thyroid cancer: A nuclear medicine perspective. Clinical oncology 2010;22:430-37.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.