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Review

Clinically meaningful end points in the evolving treatment paradigm for radioactive iodine-refractory differentiated thyroid cancer

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References

  • Pacini F, Ito Y, Luster M, et al. Radioactive iodine-refractory differentiated thyroid cancer: unmet needs and future directions. Expert Rev Endocrinol Metab 2012;7:541-54
  • Sacks W, Braunstein GD. Evolving approaches in managing radioactive iodine-refractory differentiated thyroid cancer. Endocr Pract 2014;20:263-75
  • Brose MS, Nutting CM, Jarzab B, et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet 2014;384:319-28
  • Gutman SI, Piper M, Grant MD, et al. Progression-free survival: what does it mean for psychological well-being or quality of life?. Agency for Healthcare Research and Quality; Rockville, MD: 2013
  • Park C, Perini J, Farmer RW, et al. Sorafenib and thyroid cancer. Expert Rev Endocrinol Metab 2014;9:561-70
  • Xing M. Molecular pathogenesis and mechanisms of thyroid cancer. Nat Rev Cancer 2013;13:184-99
  • Cooper DS, Doherty GM, Haugen BR, et al. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid 2009;19:1167-214
  • Sacks W, Fung CH, Chang JT, et al. The effectiveness of radioactive iodine for treatment of low-risk thyroid cancer: a systematic analysis of the peer-reviewed literature from 1966 to April 2008. Thyroid 2010;20:1235-45
  • Pfister DG, Fagin JA. Refractory thyroid cancer: a paradigm shift in treatment is not far off. J Clin Oncol 2008;26:4701-4
  • Durante C, Haddy N, Baudin E, et al. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab 2006;91:2892-9
  • Schlumberger M, Sherman SI. Approach to the patient with advanced differentiated thyroid cancer. Eur J Endocrinol 2012;166:5-11
  • Stanley K. Design of randomized controlled trials. Circulation 2007;115:1164-9
  • Di Leo A, Bleiberg H, Buyse M. Overall survival is not a realistic end point for clinical trials of new drugs in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancer. J Clin Oncol 2003;21:2045-7
  • O’Neill RT. Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance. Control Clin Trials 1997;18:550-6
  • US Food and Drug Administration. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. US Department of Health and Human Services; Rockville, MD: 2007
  • Sznol M. Reporting disease control rates or clinical benefit rates in early clinical trials of anticancer agents: useful endpoint or hype? Curr Opin Investig Drugs 2010;11:1340-1
  • Sherrill B, Kaye JA, Sandin R, et al. Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology. Onco Targets Ther 2012;5:287-96
  • Lebwohl D, Kay A, Berg W, et al. Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development. Cancer J 2009;15:386-94
  • Beckman M. More clinical cancer treatments judged by progression-free rather than overall survival. J Natl Cancer Inst 2007;99:1068-9
  • Panageas KS, Ben-Porat L, Dickler MN, et al. When you look matters: the effect of assessment schedule on progression-free survival. J Natl Cancer Inst 2007;99:428-32
  • Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-47
  • National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines®) thyroid carcinoma. Version 2. 2013. Available in:http://www.nccn.org/professionals/physician_gls/PDF/thyroid.pdf
  • Nishino M, Jagannathan JP, Krajewski KM, et al. Personalized tumor response assessment in the era of molecular medicine: cancer-specific and therapy-specific response criteria to complement pitfalls of RECIST. AJR Am J Roentgenol 2012;198:737-45
  • Zucchelli G, Iervasi A, Ferdeghini M, Iervasi G. Serum thyroglobulin measurement in the follow-up of patients treated for differentiated thyroid cancer. Q J Nucl Med Mol Imaging 2009;53:482-9
  • Spencer C, Fatemi S. Thyroglobulin antibody (TgAb) methods - Strengths, pitfalls and clinical utility for monitoring TgAb-positive patients with differentiated thyroid cancer. Best Pract Res Clin Endocrinol Metab 2013;27:701-12
  • Yamada O, Miyauchi A, Ito Y, et al. Changes in serum thyroglobulin antibody levels as a dynamic prognostic factor for early-phase recurrence of thyroglobulin antibody-positive papillary thyroid carcinoma after total thyroidectomy. Endocr J 2014;61:961-5
  • Tsushima Y, Miyauchi A, Ito Y, et al. Prognostic significance of changes in serum thyroglobulin antibody levels of pre- and post-total thyroidectomy in thyroglobulin antibody-positive papillary thyroid carcinoma patients. Endocr J 2013;60:871-6
  • Dadu R, Shah K, Busaidy NL, et al. Efficacy and tolerability of vemurafenib in patients with BRAFV600E-positive papillary thyroid cancer: M.D. Anderson Cancer Center off label experience. J Clin Endocrinol Metab 2015;100:E77-81
  • Brose MS, Smit J, Capdevila J, et al. Regional approaches to the management of patients with advanced, radioactive iodine-refractory differentiated thyroid carcinoma. Expert Rev Anticancer Ther 2012;12:1137-47
  • Brose MS, Nutting CM, Sherman SI, et al. Rationale and design of DECISION: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. BMC Cancer 2011;11:349
  • Eisai, Inc. A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of lenvatinib (E7080) in 131I-refractory differentiated thyroid cancer. Available from: www.clinicaltrials.gov
  • Schlumberger M, Tahara M, Wirth LJ, et al. A phase 3 multicenter double-blind placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT) [abstract]. J Clin Oncol 2014;32(15 Suppl):abstract LBA6008
  • Dabisch I, Dethling J, Dintsios CM, et al. Patient relevant endpoints in oncology: current issues in the context of early benefit assessment in Germany. Health Econ Rev 2014;4:2
  • Muhlbacher AC, Nubling M. Analysis of physicians’ perspectives versus patients’ preferences: direct assessment and discrete choice experiments in the therapy of multiple myeloma. Eur J Health Econ 2011;12:193-203
  • Herschbach P, Keller M, Knight L, et al. Psychological problems of cancer patients: a cancer distress screening with a cancer-specific questionnaire. Br J Cancer 2004;91:504-11
  • Cella D, Escudier B, Rini B, et al. Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. Br J Cancer 2013;108:1571-8
  • Silvestri G, Pritchard R, Welch HG. Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. BMJ 1998;317:771-5
  • Ho AL, Grewal RK, Leboeuf R, et al. Selumetinib-enhanced radioiodine uptake in advanced thyroid cancer. N Engl J Med 2013;368:623-32
  • Gild ML, Bullock M, Robinson BG, Clifton-Bligh R. Multikinase inhibitors: a new option for the treatment of thyroid cancer. Nat Rev Endocrinol 2011;7:617-24
  • Gainor JF, Shaw AT. Emerging paradigms in the development of resistance to tyrosine kinase inhibitors in lung cancer. J Clin Oncol 2013;31:3987-96
  • Krause DS, Van Etten RA. Tyrosine kinases as targets for cancer therapy. N Engl J Med 2005;353:172-87

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