Enhancing Radioiodine Incorporation into Radioiodine-Refractory Thyroid Cancer with MAPK Inhibition (ERRITI): A Single-Center Prospective Two-Arm Study
Restoration of iodine incorporation (redifferentiation) by MAPK inhibition was achieved in previously radioiodine-refractory, unresectable thyroid carcinoma (RR-TC). However, results were unsatisfactory in BRAFV600E-mutant (BRAF-MUT) RR-TC. Here we assess safety and efficacy of redifferentiation the...
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| Veröffentlicht in: | Clinical cancer research 2022-10, Vol.28 (19), p.4194-4202 |
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| creator | Weber, Manuel Kersting, David Riemann, Burkhard Brandenburg, Tim Führer-Sakel, Dagmar Grünwald, Frank Kreissl, Michael C Dralle, Henning Weber, Frank Schmid, Kurt Werner Herrmann, Ken Jentzen, Walter Grafe, Hong Rischpler, Christoph Theurer, Sarah Bockisch, Andreas Nagarajah, James Fendler, Wolfgang P |
| description | Restoration of iodine incorporation (redifferentiation) by MAPK inhibition was achieved in previously radioiodine-refractory, unresectable thyroid carcinoma (RR-TC). However, results were unsatisfactory in BRAFV600E-mutant (BRAF-MUT) RR-TC. Here we assess safety and efficacy of redifferentiation therapy through genotype-guided MAPK-modulation in patients with BRAF-MUT or wildtype (BRAF-WT) RR-TC.
In this prospective single-center, two-arm phase II study, patients received trametinib (BRAF-WT) or trametinib + dabrafenib (BRAF-MUT) for 21 ± 3 days. Redifferentiation was assessed by 123I-scintigraphy. In case of restored radioiodine uptake, 124I-guided 131I therapy was performed. Primary endpoint was the redifferentiation rate. Secondary endpoints were treatment response (thyroglobulin, RECIST 1.1) and safety. Parameters predicting successful redifferentiation were assessed using a receiver operating characteristic analysis and Youden J statistic.
Redifferentiation was achieved in 7 of 20 (35%) patients, 2 of 6 (33%) in the BRAF-MUT and 5 of 14 (36%) in the BRAF-WT arm. Patients received a mean (range) activity of 300.0 (273.0-421.6) mCi for 131I therapy. Any thyroglobulin decline was seen in 57% (4/7) of the patients, RECIST 1.1 stable/partial response/progressive disease in 71% (5/7)/14% (1/7)/14% (1/7). Peak standardized uptake value (SUVpeak) < 10 on 2[18F]fluoro-2-deoxy-D-glucose (FDG)-PET was associated with successful redifferentiation (P = 0.01). Transient pyrexia (grade 3) and rash (grade 4) were noted in one patient each.
Genotype-guided MAPK inhibition was safe and resulted in successful redifferentiation in about one third of patients in each arm. Subsequent 131I therapy led to a thyroglobulin (Tg) decline in more than half of the treated patients. Low tumor glycolytic rate as assessed by FDG-PET is predictive of redifferentiation success. See related commentary by Cabanillas et al., p. 4164. |
| doi_str_mv | 10.1158/1078-0432.CCR-22-0437 |
| format | Article |
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In this prospective single-center, two-arm phase II study, patients received trametinib (BRAF-WT) or trametinib + dabrafenib (BRAF-MUT) for 21 ± 3 days. Redifferentiation was assessed by 123I-scintigraphy. In case of restored radioiodine uptake, 124I-guided 131I therapy was performed. Primary endpoint was the redifferentiation rate. Secondary endpoints were treatment response (thyroglobulin, RECIST 1.1) and safety. Parameters predicting successful redifferentiation were assessed using a receiver operating characteristic analysis and Youden J statistic.
Redifferentiation was achieved in 7 of 20 (35%) patients, 2 of 6 (33%) in the BRAF-MUT and 5 of 14 (36%) in the BRAF-WT arm. Patients received a mean (range) activity of 300.0 (273.0-421.6) mCi for 131I therapy. Any thyroglobulin decline was seen in 57% (4/7) of the patients, RECIST 1.1 stable/partial response/progressive disease in 71% (5/7)/14% (1/7)/14% (1/7). Peak standardized uptake value (SUVpeak) < 10 on 2[18F]fluoro-2-deoxy-D-glucose (FDG)-PET was associated with successful redifferentiation (P = 0.01). Transient pyrexia (grade 3) and rash (grade 4) were noted in one patient each.
Genotype-guided MAPK inhibition was safe and resulted in successful redifferentiation in about one third of patients in each arm. Subsequent 131I therapy led to a thyroglobulin (Tg) decline in more than half of the treated patients. Low tumor glycolytic rate as assessed by FDG-PET is predictive of redifferentiation success. See related commentary by Cabanillas et al., p. 4164.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-22-0437</identifier><identifier>PMID: 35594174</identifier><language>eng</language><publisher>United States: American Association for Cancer Research</publisher><subject>Clinical Trials: Targeted Therapy ; Fluorodeoxyglucose F18 ; Humans ; Iodine Radioisotopes - therapeutic use ; Prospective Studies ; Protein Kinase Inhibitors - adverse effects ; Proto-Oncogene Proteins B-raf - antagonists & inhibitors ; Thyroglobulin - genetics ; Thyroid Neoplasms - drug therapy ; Thyroid Neoplasms - genetics ; Thyroid Neoplasms - radiotherapy</subject><ispartof>Clinical cancer research, 2022-10, Vol.28 (19), p.4194-4202</ispartof><rights>2022 The Authors; Published by the American Association for Cancer Research.</rights><rights>2022 The Authors; Published by the American Association for Cancer Research 2022 American Association for Cancer Research</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c463t-fdb823748fc839b38612cce5793c6096b77c33fcda9fa2b13e256119f5bdab663</citedby><cites>FETCH-LOGICAL-c463t-fdb823748fc839b38612cce5793c6096b77c33fcda9fa2b13e256119f5bdab663</cites><orcidid>0000-0001-5905-6015 ; 0000-0002-8649-5977 ; 0000-0002-3555-0809 ; 0000-0002-8451-1830 ; 0000-0002-5545-8487</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,3356,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35594174$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Weber, Manuel</creatorcontrib><creatorcontrib>Kersting, David</creatorcontrib><creatorcontrib>Riemann, Burkhard</creatorcontrib><creatorcontrib>Brandenburg, Tim</creatorcontrib><creatorcontrib>Führer-Sakel, Dagmar</creatorcontrib><creatorcontrib>Grünwald, Frank</creatorcontrib><creatorcontrib>Kreissl, Michael C</creatorcontrib><creatorcontrib>Dralle, Henning</creatorcontrib><creatorcontrib>Weber, Frank</creatorcontrib><creatorcontrib>Schmid, Kurt Werner</creatorcontrib><creatorcontrib>Herrmann, Ken</creatorcontrib><creatorcontrib>Jentzen, Walter</creatorcontrib><creatorcontrib>Grafe, Hong</creatorcontrib><creatorcontrib>Rischpler, Christoph</creatorcontrib><creatorcontrib>Theurer, Sarah</creatorcontrib><creatorcontrib>Bockisch, Andreas</creatorcontrib><creatorcontrib>Nagarajah, James</creatorcontrib><creatorcontrib>Fendler, Wolfgang P</creatorcontrib><title>Enhancing Radioiodine Incorporation into Radioiodine-Refractory Thyroid Cancer with MAPK Inhibition (ERRITI): A Single-Center Prospective Two-Arm Study</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>Restoration of iodine incorporation (redifferentiation) by MAPK inhibition was achieved in previously radioiodine-refractory, unresectable thyroid carcinoma (RR-TC). However, results were unsatisfactory in BRAFV600E-mutant (BRAF-MUT) RR-TC. Here we assess safety and efficacy of redifferentiation therapy through genotype-guided MAPK-modulation in patients with BRAF-MUT or wildtype (BRAF-WT) RR-TC.
In this prospective single-center, two-arm phase II study, patients received trametinib (BRAF-WT) or trametinib + dabrafenib (BRAF-MUT) for 21 ± 3 days. Redifferentiation was assessed by 123I-scintigraphy. In case of restored radioiodine uptake, 124I-guided 131I therapy was performed. Primary endpoint was the redifferentiation rate. Secondary endpoints were treatment response (thyroglobulin, RECIST 1.1) and safety. Parameters predicting successful redifferentiation were assessed using a receiver operating characteristic analysis and Youden J statistic.
Redifferentiation was achieved in 7 of 20 (35%) patients, 2 of 6 (33%) in the BRAF-MUT and 5 of 14 (36%) in the BRAF-WT arm. Patients received a mean (range) activity of 300.0 (273.0-421.6) mCi for 131I therapy. Any thyroglobulin decline was seen in 57% (4/7) of the patients, RECIST 1.1 stable/partial response/progressive disease in 71% (5/7)/14% (1/7)/14% (1/7). Peak standardized uptake value (SUVpeak) < 10 on 2[18F]fluoro-2-deoxy-D-glucose (FDG)-PET was associated with successful redifferentiation (P = 0.01). Transient pyrexia (grade 3) and rash (grade 4) were noted in one patient each.
Genotype-guided MAPK inhibition was safe and resulted in successful redifferentiation in about one third of patients in each arm. Subsequent 131I therapy led to a thyroglobulin (Tg) decline in more than half of the treated patients. Low tumor glycolytic rate as assessed by FDG-PET is predictive of redifferentiation success. See related commentary by Cabanillas et al., p. 4164.</description><subject>Clinical Trials: Targeted Therapy</subject><subject>Fluorodeoxyglucose F18</subject><subject>Humans</subject><subject>Iodine Radioisotopes - therapeutic use</subject><subject>Prospective Studies</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Proto-Oncogene Proteins B-raf - antagonists & inhibitors</subject><subject>Thyroglobulin - genetics</subject><subject>Thyroid Neoplasms - drug therapy</subject><subject>Thyroid Neoplasms - genetics</subject><subject>Thyroid Neoplasms - radiotherapy</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkd1KxDAQhYMo_j-Ckku9iOanaVovhKWsuqi41PU6pGlqI7vJklZln8TXNXVV9GoOzJwzM3wAHBF8RgjPzgkWGcIJo2dFUSJKBy02wC7hXCBGU74Z9c_MDtjruheMSUJwsg12GOd5QkSyCz7GrlVOW_cMS1Vbb31tnYETp31Y-qB66x20rvd_26g0TVC692EFZ-0qeFvDIqaYAN9t38L70fQ2RrS2sl_-k3FZTmaT0ws4go9x1dygwrg-jk-D75ZG9_bNwNm7R6OwgI_9a706AFuNmnfm8Lvug6er8ay4QXcP15NidId0krIeNXWVUSaSrNEZyyuWpYRqbbjImU5xnlZCaMYaXau8UbQizFCeEpI3vKpVlaZsH1yuc5ev1cLUOp4V1Fwug12osJJeWfm_42wrn_2bzDkVHJMYwNcBOr7SBdP8egmWAyk5UJADBRlJSUoHLaLv-O_iX9cPGvYJkh-SoQ</recordid><startdate>20221003</startdate><enddate>20221003</enddate><creator>Weber, Manuel</creator><creator>Kersting, David</creator><creator>Riemann, Burkhard</creator><creator>Brandenburg, Tim</creator><creator>Führer-Sakel, Dagmar</creator><creator>Grünwald, Frank</creator><creator>Kreissl, Michael C</creator><creator>Dralle, Henning</creator><creator>Weber, Frank</creator><creator>Schmid, Kurt Werner</creator><creator>Herrmann, Ken</creator><creator>Jentzen, Walter</creator><creator>Grafe, Hong</creator><creator>Rischpler, Christoph</creator><creator>Theurer, Sarah</creator><creator>Bockisch, Andreas</creator><creator>Nagarajah, James</creator><creator>Fendler, Wolfgang P</creator><general>American Association for Cancer Research</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-5905-6015</orcidid><orcidid>https://orcid.org/0000-0002-8649-5977</orcidid><orcidid>https://orcid.org/0000-0002-3555-0809</orcidid><orcidid>https://orcid.org/0000-0002-8451-1830</orcidid><orcidid>https://orcid.org/0000-0002-5545-8487</orcidid></search><sort><creationdate>20221003</creationdate><title>Enhancing Radioiodine Incorporation into Radioiodine-Refractory Thyroid Cancer with MAPK Inhibition (ERRITI): A Single-Center Prospective Two-Arm Study</title><author>Weber, Manuel ; Kersting, David ; Riemann, Burkhard ; Brandenburg, Tim ; Führer-Sakel, Dagmar ; Grünwald, Frank ; Kreissl, Michael C ; Dralle, Henning ; Weber, Frank ; Schmid, Kurt Werner ; Herrmann, Ken ; Jentzen, Walter ; Grafe, Hong ; Rischpler, Christoph ; Theurer, Sarah ; Bockisch, Andreas ; Nagarajah, James ; Fendler, Wolfgang P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c463t-fdb823748fc839b38612cce5793c6096b77c33fcda9fa2b13e256119f5bdab663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Clinical Trials: Targeted Therapy</topic><topic>Fluorodeoxyglucose F18</topic><topic>Humans</topic><topic>Iodine Radioisotopes - therapeutic use</topic><topic>Prospective Studies</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Proto-Oncogene Proteins B-raf - antagonists & inhibitors</topic><topic>Thyroglobulin - genetics</topic><topic>Thyroid Neoplasms - drug therapy</topic><topic>Thyroid Neoplasms - genetics</topic><topic>Thyroid Neoplasms - radiotherapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Weber, Manuel</creatorcontrib><creatorcontrib>Kersting, David</creatorcontrib><creatorcontrib>Riemann, Burkhard</creatorcontrib><creatorcontrib>Brandenburg, Tim</creatorcontrib><creatorcontrib>Führer-Sakel, Dagmar</creatorcontrib><creatorcontrib>Grünwald, Frank</creatorcontrib><creatorcontrib>Kreissl, Michael C</creatorcontrib><creatorcontrib>Dralle, Henning</creatorcontrib><creatorcontrib>Weber, Frank</creatorcontrib><creatorcontrib>Schmid, Kurt Werner</creatorcontrib><creatorcontrib>Herrmann, Ken</creatorcontrib><creatorcontrib>Jentzen, Walter</creatorcontrib><creatorcontrib>Grafe, Hong</creatorcontrib><creatorcontrib>Rischpler, Christoph</creatorcontrib><creatorcontrib>Theurer, Sarah</creatorcontrib><creatorcontrib>Bockisch, Andreas</creatorcontrib><creatorcontrib>Nagarajah, James</creatorcontrib><creatorcontrib>Fendler, Wolfgang P</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Weber, Manuel</au><au>Kersting, David</au><au>Riemann, Burkhard</au><au>Brandenburg, Tim</au><au>Führer-Sakel, Dagmar</au><au>Grünwald, Frank</au><au>Kreissl, Michael C</au><au>Dralle, Henning</au><au>Weber, Frank</au><au>Schmid, Kurt Werner</au><au>Herrmann, Ken</au><au>Jentzen, Walter</au><au>Grafe, Hong</au><au>Rischpler, Christoph</au><au>Theurer, Sarah</au><au>Bockisch, Andreas</au><au>Nagarajah, James</au><au>Fendler, Wolfgang P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Enhancing Radioiodine Incorporation into Radioiodine-Refractory Thyroid Cancer with MAPK Inhibition (ERRITI): A Single-Center Prospective Two-Arm Study</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2022-10-03</date><risdate>2022</risdate><volume>28</volume><issue>19</issue><spage>4194</spage><epage>4202</epage><pages>4194-4202</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>Restoration of iodine incorporation (redifferentiation) by MAPK inhibition was achieved in previously radioiodine-refractory, unresectable thyroid carcinoma (RR-TC). However, results were unsatisfactory in BRAFV600E-mutant (BRAF-MUT) RR-TC. Here we assess safety and efficacy of redifferentiation therapy through genotype-guided MAPK-modulation in patients with BRAF-MUT or wildtype (BRAF-WT) RR-TC.
In this prospective single-center, two-arm phase II study, patients received trametinib (BRAF-WT) or trametinib + dabrafenib (BRAF-MUT) for 21 ± 3 days. Redifferentiation was assessed by 123I-scintigraphy. In case of restored radioiodine uptake, 124I-guided 131I therapy was performed. Primary endpoint was the redifferentiation rate. Secondary endpoints were treatment response (thyroglobulin, RECIST 1.1) and safety. Parameters predicting successful redifferentiation were assessed using a receiver operating characteristic analysis and Youden J statistic.
Redifferentiation was achieved in 7 of 20 (35%) patients, 2 of 6 (33%) in the BRAF-MUT and 5 of 14 (36%) in the BRAF-WT arm. Patients received a mean (range) activity of 300.0 (273.0-421.6) mCi for 131I therapy. Any thyroglobulin decline was seen in 57% (4/7) of the patients, RECIST 1.1 stable/partial response/progressive disease in 71% (5/7)/14% (1/7)/14% (1/7). Peak standardized uptake value (SUVpeak) < 10 on 2[18F]fluoro-2-deoxy-D-glucose (FDG)-PET was associated with successful redifferentiation (P = 0.01). Transient pyrexia (grade 3) and rash (grade 4) were noted in one patient each.
Genotype-guided MAPK inhibition was safe and resulted in successful redifferentiation in about one third of patients in each arm. Subsequent 131I therapy led to a thyroglobulin (Tg) decline in more than half of the treated patients. Low tumor glycolytic rate as assessed by FDG-PET is predictive of redifferentiation success. See related commentary by Cabanillas et al., p. 4164.</abstract><cop>United States</cop><pub>American Association for Cancer Research</pub><pmid>35594174</pmid><doi>10.1158/1078-0432.CCR-22-0437</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-5905-6015</orcidid><orcidid>https://orcid.org/0000-0002-8649-5977</orcidid><orcidid>https://orcid.org/0000-0002-3555-0809</orcidid><orcidid>https://orcid.org/0000-0002-8451-1830</orcidid><orcidid>https://orcid.org/0000-0002-5545-8487</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Clinical Trials: Targeted Therapy Fluorodeoxyglucose F18 Humans Iodine Radioisotopes - therapeutic use Prospective Studies Protein Kinase Inhibitors - adverse effects Proto-Oncogene Proteins B-raf - antagonists & inhibitors Thyroglobulin - genetics Thyroid Neoplasms - drug therapy Thyroid Neoplasms - genetics Thyroid Neoplasms - radiotherapy |
| title | Enhancing Radioiodine Incorporation into Radioiodine-Refractory Thyroid Cancer with MAPK Inhibition (ERRITI): A Single-Center Prospective Two-Arm Study |
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