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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ESorafenib and lenvatinib can be effective for advanced differentiated thyroid cancer, and vandetanib and cabozantinib can be effective options for advanced medullary thyroid cancer. When first-line tyrosine kinase inhibitors fail for patients, evidence supports salvage therapy for differentiated thyroid cancer but is less compelling for medullary thyroid cancer.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Edifferentiated thyroid cancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emedullary thyroid cancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esorafenib\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Elenvatinib\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Evandetanib\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecabozantinib\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ethyroid disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EThe systemic therapies sorafenib and lenvatinib, which target the vascular endothelial growth factor (VEGF) pathway, are treatment options for advanced differentiated thyroid cancer (DTC). In advanced medullary thyroid cancer (MTC), vandetanib and cabozantinib are meaningful options. For patients who experience failure of a first-line tyrosine kinase inhibitor (TKI), salvage therapy is a reasonable strategy in DTC but has less evidence to support its use in MTC.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EManisha H. Shah, MD, Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA, discussed the recently approved targeted therapies for advanced DTC: sorafenib and lenvatinib. She explained that \u003Cem\u003EBRAF\u003C\/em\u003E is a key player in papillary thyroid cancer and that about 70% of patients in the clinical trial population have the \u003Cem\u003EBRAF\u003C\/em\u003E mutation.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ESorafenib is a \u003Cem\u003EBRAF\u003C\/em\u003E inhibitor that is a multikinase inhibitor (MKI) whose targets include the \u003Cem\u003EVEGF\u003C\/em\u003E receptors. The DECISION trial was a multicenter, international, double-blind, phase 3 trial that enrolled patients with DTC that was locally advanced or metastatic and iodine refractory and randomized them 1:1 to either sorafenib or placebo [Brose MS et al. \u003Cem\u003ELancet.\u003C\/em\u003E 2014]. The primary end point of median progression-free survival (PFS) was 10.8 months for patients receiving sorafenib (n\u2005=\u2005207) and 5.8 months for those receiving placebo (n\u2005=\u2005210; HR, 0.59; 95% CI, 0.45 to 0.76; \u003Cem\u003EP\u2005\u003C\/em\u003E\u0026lt;\u2005.0001; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The partial response (PR) rate was only 12%, with a median duration of about 10 months. Adverse events (AEs) led to dose reductions in 66% of patients and discontinuation in 18%. Hypocalcemia of grade 3 or 4 can occur with sorafenib, although it is preventable and quickly treatable. Keratoacanthoma is a notable class effect of \u003Cem\u003EBRAF\u003C\/em\u003E inhibitors.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/4\/25\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Progression-Free Survival in the DECISION Trial of Sorafenib vs PlaceboReprinted from Lancet, 384, Brose MS et al, Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomized, double-blind, phase 3 trial, 384:319-328, Copyright (2014), with permission from Elsevier.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2059722128\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Progression-Free Survival in the DECISION Trial of Sorafenib vs PlaceboReprinted from \u0026amp;lt;em\u0026amp;gt;Lancet\u0026amp;lt;\/em\u0026amp;gt;, 384, Brose MS et al, Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomized, double-blind, phase 3 trial, 384:319-328, Copyright (2014), with permission from Elsevier.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/4\/25\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/4\/25\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/4\/25\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16531\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-5\u0022 class=\u0022first-child\u0022\u003EProgression-Free Survival in the DECISION Trial of Sorafenib vs Placebo\u003C\/p\u003E\n               \u003Cp id=\u0022p-6\u0022\u003EReprinted from \u003Cem\u003ELancet\u003C\/em\u003E, 384, Brose MS et al, Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomized, double-blind, phase 3 trial, 384:319-328, Copyright (2014), with permission from Elsevier.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-7\u0022\u003ELenvatinib targets particular fibroblast growth factor receptors, which might evoke unique responses. The SELECT study was a phase 3 pivotal trial with a median PFS (the primary end point) of 18.3 months for the patients receiving lenvatinib (n\u2005=\u2005261) and 3.6 months for those receiving placebo (n\u2005=\u2005131; HR, 0.21; 99% CI, 0.14 to 0.31; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001) [Schlumberger M et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2015]. PRs were achieved by 63% of patients receiving lenvatinib, and complete responses were achieved by 2%. AEs led to dose reductions in 68% of patients and discontinuation in 14% of patients. Response to lenvatinib was not predicted by \u003Cem\u003ERAS\u003C\/em\u003E or \u003Cem\u003EBRAF\u003C\/em\u003E mutations.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003ENotably, treatment with MKIs with angiogenic targets can lead to the rare but dangerous and potentially fatal AEs of bowel perforation and fistulas, bleeding in the tumor or other organs, thromboembolism, and cardiac effects that can include arrhythmias, coronary artery disease, and LV dysfunction. These affect 1% to 2% of patients.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EEzra E.W. Cohen, MD, University of California San Diego, La Jolla, California, USA, discussed the treatment of MTC, which accounts for about 5% of thyroid cancers. Distant metastases carry a poor prognosis with a median overall survival (OS) of about 2 years. Among MTC, 75% are sporadic and about 65% are \u003Cem\u003ERET\u003C\/em\u003E mutated. Hereditary MTC is almost universally \u003Cem\u003ERET\u003C\/em\u003E mutated.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EPatients with metastatic or recurrent disease that is not curable do not necessarily require therapy and may be better served by observation. Ideally, therapy should be initiated when the patient has good performance status, no to minimal symptoms, and evidence of disease progression within the last 6 to 12 months. Patients who are symptomatic from their disease need systemic therapy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EThe MKIs vandetanib and cabozantinib offer meaningful therapeutic options for MTC. Vandetanib was approved as a result of a phase 3 trial that met its primary end point of PFS [Wells SA et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E. 2012]. Patients with a \u003Cem\u003ERET\u003C\/em\u003E mutation, particularly the \u003Cem\u003EM918T\u003C\/em\u003E mutation, had a tremendous benefit from vandetanib. Vandetanib has a black box warning about QTc prolongation that occurred in 8% of patients who received it.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003ECabozantinib is also approved for MTC, based on a phase 3 trial [Elisei R et al. \u003Cem\u003EJ Clin Oncol.\u003C\/em\u003E 2013]. Among 219 patients who received cabozantinib, 94% showed target lesion regression, whereas 27% of the 111 patients receiving placebo had target lesion regression. The median PFS was 11.2 months for cabozantinib vs 4.0 months for placebo (HR, 0.28; 95% CI, 0.19 to 0.40; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001). Patients with the \u003Cem\u003ERET M918T\u003C\/em\u003E mutation had a prolonged PFS relative to patients with other \u003Cem\u003ERET\u003C\/em\u003E mutations (HR, 0.15; 95% CI, 0.08 to 0.28) [Sherman SI et al. ASCO. 2013]. Patients with \u003Cem\u003ERAS\u003C\/em\u003E mutations also benefited from cabozantinib.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EMaria E. Cabanillas, MD, University of Texas MD Anderson Cancer Center, Houston, Texas, USA, discussed evidence to support salvage therapy after failure of a first-line kinase inhibitor in advanced thyroid cancer.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EA retrospective review of adult patients with metastatic DTC found that median OS was 24 months for patients treated with sorafenib alone (n\u2005=\u200535) and 63 months for those receiving salvage therapy (n\u2005=\u200525; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.013) [Dadu R et al. \u003Cem\u003EJ Clin Endocrinol Metab\u003C\/em\u003E. 2014]. PFS was 7.4 months (n\u2005=\u200515; 95% CI, 3.1 to 11.3) for all patients treated with sorafenib, and PFS was 11.3 months (n\u2005=\u200517; 95% CI, 5.3 to 24.4) for salvage therapy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EA phase 3 study of lenvatinib vs placebo in DTC found that patients who were TKI-na\u00efve had a PFS of 18.7 months with lenvatinib treatment (n\u2005=\u2005229; 95% CI, 16.4 to not estimable), while TKI-pretreated patients had a PFS of 15.1 months (n\u2005=\u200593; 95% CI, 8.8 to not estimable) [Schlumberger M et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2015].\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EA phase 2 trial of vemurafenib in patients with papillary thyroid cancer found that vascular endothelial growth factor receptor-2 inhibitor (VEGFR2i)-na\u00efve patients (n\u2005=\u20059) had a PR rate of 35%, median PFS of 15.6 months (95% CI, 11.2 to not reported), and OS not reached [Brose MS et al. \u003Cem\u003EEur J Cancer\u003C\/em\u003E. 2013; (abstr 28)]. The VEGFR2i-pretreated patients (n\u2005=\u20056) had a PR rate of 29%, median PFS of 6.3 months (95% CI, 5.39 to not reported), and median OS of 9.8 months (95% CI, 7.39 to not reached).\u003C\/p\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EA phase 1 study of cabozantinib in DTC found that patients previously treated with a VEGF pathway inhibitor still responded to cabozantinib [Cabanillas ME et al. \u003Cem\u003EThyroid\u003C\/em\u003E. 2014].\u003C\/p\u003E\n         \u003Cp id=\u0022p-18\u0022\u003EIn MTC, very little evidence exists for salvage therapy. A phase 3 trial comparing cabozantinib vs placebo in 330 patients with metastatic MTC found that 43% of previously treated patients (19 of 44 patients) achieved a PR with cabozantinib [Elisei R et al. \u003Cem\u003EJ Clin Oncol.\u003C\/em\u003E 2013]. A retrospective study found that changing to a different, but similar, TKI in MTC yielded responses that were quite variable with a brief median time to failure [Weitzman SP et al. ENDO. 2015].\u003C\/p\u003E\n         \u003Cp id=\u0022p-19\u0022\u003ERecent trials and drug approvals have led to new options for advanced DTC and advanced MTC. Salvage therapy can benefit patients whose first-line TKI has failed, with greater evidence of benefit in DTC than MTC.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/4\/25.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzln31\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzln31\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}