ATA Guidelines Tools

31 95. Patients should be considered for referral to participate in prospective therapeutic clinical trials based upon specific eligibility requirements for given studies and the likelihood that the patient may or may not benefit from study participation. Clinicians considering referral of patients for trials should review available treatment options and eligibility criteria, preferably through discussions with trial center personnel and review of trial materials at the website www.clinicaltrials.org. (SR-M) 96. A) Kinase inhibitor therapy should be considered in RAI-refractory DTC patients with metastatic, rapidly progressive, symptomatic and/ or imminently threatening disease not otherwise amenable to local control using other approaches. Kinase inhibitors that are FDA- approved for differentiated thyroid carcinoma, or other available kinase inhibitors (preferably within the context of therapeutic clinical trials), can be considered since the impact of these agents on overall survival and quality of life remains to be defined. (WR-M) (B) Patients who are candidates for kinase inhibitor therapy should be thoroughly counseled on the potential risks and benefits of this therapy as well as alternative therapeutic approaches including best supportive care. Appropriate informed consent should be obtained and documented in the medical record prior to initiation of any therapy, regardless of whether the patient is being treated in the context of a clinical trial. (SR-L) 97. Patients who have disease progression while on initial kinase inhibitor therapy without prohibitive adverse effects should be considered for second-line kinase inhibitor therapy. Ideally, such therapy should be undertaken within the context of therapeutic clinical trials. (WR-L) 98. Active surveillance: Proactive monitoring and timely intervention in response to emergent toxicities are critical components of management in patients receiving kinase inhibitor therapy. (SR-L) 99. Agents without established efficacy in DTC should be used only primarily within the context of therapeutic clinical trials. (SR-L) 100. Cytotoxic chemotherapy can be considered in RAI-refractory DTC patients with metastatic, rapidly progressive, symptomatic, and/or imminently threatening disease not otherwise amenable to control through other approaches including kinase inhibitors. Too few data exist to recommend specific cytotoxic regimens, and use within the context of a therapeutic clinical trial is preferred. (WR-L) 101. Bisphosphonate or denosumab therapy should be considered in patients with diffuse and/or symptomatic bone metastases from RAI-refractory DTC, either alone or concomitantly with other systemic therapies. Adequate renal function (bisphosphonates) and calcium and vitamin D25 level (bisphosphonates and denosumab) should be documented prior to each dose, and dental evaluation should take place before initial use. (SR-M)

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