Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study
Background: Sorafenib, a multi-kinase inhibitor, is approved for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). This study evaluated the efficacy and safety of sorafenib in real-world clinical practice and compared the results to those of the...
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| Veröffentlicht in: | Thyroid (New York, N.Y.) N.Y.), 2018-03, Vol.28 (3), p.34-348 |
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| creator | Kim, Mijin Kim, Tae Hyuk Shin, Dong Yeob Lim, Dong Jun Kim, Eui Young Kim, Won Bae Chung, Jae Hoon Shong, Young Kee Kim, Bo Hyun Kim, Won Gu |
| description | Background:
Sorafenib, a multi-kinase inhibitor, is approved for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). This study evaluated the efficacy and safety of sorafenib in real-world clinical practice and compared the results to those of the DECISION trial. The clinical features associated with better clinical outcomes after sorafenib treatment were also evaluated.
Methods:
This multicenter, retrospective cohort study evaluated 98 patients with progressive RAI-refractory DTC who were treated with sorafenib in six tertiary hospitals in Korea. The primary objective was the progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors v1.1. Overall survival, response rate (defined as the best objective response according to Response Evaluation Criteria In Solid Tumors v1.1), and safety were also evaluated.
Results:
The median PFS was 9.7 months; median overall survival was not reached during follow-up. Partial responses and stable disease were achieved in 25 (25%) and 64 (65%) patients, respectively. Stable disease of >6 months was achieved in 41 (42%) patients. Subgroup analyses identified several prognostic indicators of a better PFS: absence of disease-related symptoms (hazard ratio [HR] = 0.5;
p
= 0.041), lung-only metastasis (HR = 0.4;
p
= 0.048), a daily maintenance dose ≥600 mg (HR = 0.3;
p
= 0.005), and a thyroglobulin reduction ≥60% (HR = 0.4;
p
= 0.012). The mean daily dose of sorafenib was 666 ± 114 mg, and drug withdrawals due to adverse events (AEs) occurred in 13% of patients. AEs and serious AEs were reported in 93 (95%) and 40 (41%) patients, respectively. The most frequent AE was hand-foot skin reaction (76%).
Conclusions:
The PFS of progressive RAI-refractory DTC patients treated with sorafenib was consistent with the findings of the DECISION trial. Disease-related symptoms, lung-only metastasis, a daily maintenance dose, and thyroglobulin reduction were significantly associated with PFS. These results suggest that sorafenib is an effective treatment option for patients with progressive RAI-refractory DTC. |
| doi_str_mv | 10.1089/thy.2017.0356 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6225595</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1989604570</sourcerecordid><originalsourceid>FETCH-LOGICAL-c497t-398d8da7cd2f8b30204a95ee14bf604524aac31bcc3beab3685bd0a9aca9d61a3</originalsourceid><addsrcrecordid>eNqFkcFu1DAURSMEoqWwZIu8ZJPBjuMkZoFUDQUqikDtsLZe7JeOUWIPtlMxn8Lf4mjaiq66suV3dN-VT1G8ZnTFaCffpe1-VVHWrigXzZPimAnRlpK27dN8p4KWbSWao-JFjL8oZU3X8ufFUSW5oIzK4-LvBkOyEPZkDQHJ2Z8dBotOI_EDufIBBnS2J9aRtEWyCQhpQpeW6Y_grwPGaG-QXIKx3npjHZaXOATQyefMj3YYMGTeQkJDNtt98NYsq7R1foL35JR89TnUkW_zmKzOKAZylWazf1k8G2CM-Or2PCl-fjrbrL-UF98_n69PL0pdyzaVXHamM9BqUw1dz2lFa5ACkdX90NBaVDWA5qzXmvcIPW860RsKEjRI0zDgJ8WHQ-5u7ic0S4UAo9oFO-VvUR6sejhxdquu_Y1qqkoIKXLA29uA4H_PGJOabNQ4juDQz1Ex2cmlSUszWh5QHXyMAYf7NYyqRafKOtWiUy06M__m_2739J2_DPADsDyDc6PFPgt9JPYfvL2ySA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1989604570</pqid></control><display><type>article</type><title>Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study</title><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Kim, Mijin ; Kim, Tae Hyuk ; Shin, Dong Yeob ; Lim, Dong Jun ; Kim, Eui Young ; Kim, Won Bae ; Chung, Jae Hoon ; Shong, Young Kee ; Kim, Bo Hyun ; Kim, Won Gu</creator><creatorcontrib>Kim, Mijin ; Kim, Tae Hyuk ; Shin, Dong Yeob ; Lim, Dong Jun ; Kim, Eui Young ; Kim, Won Bae ; Chung, Jae Hoon ; Shong, Young Kee ; Kim, Bo Hyun ; Kim, Won Gu ; Korean Thyroid Cancer Study Group (KTCSG) ; on behalf of Korean Thyroid Cancer Study Group (KTCSG)</creatorcontrib><description>Background:
Sorafenib, a multi-kinase inhibitor, is approved for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). This study evaluated the efficacy and safety of sorafenib in real-world clinical practice and compared the results to those of the DECISION trial. The clinical features associated with better clinical outcomes after sorafenib treatment were also evaluated.
Methods:
This multicenter, retrospective cohort study evaluated 98 patients with progressive RAI-refractory DTC who were treated with sorafenib in six tertiary hospitals in Korea. The primary objective was the progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors v1.1. Overall survival, response rate (defined as the best objective response according to Response Evaluation Criteria In Solid Tumors v1.1), and safety were also evaluated.
Results:
The median PFS was 9.7 months; median overall survival was not reached during follow-up. Partial responses and stable disease were achieved in 25 (25%) and 64 (65%) patients, respectively. Stable disease of >6 months was achieved in 41 (42%) patients. Subgroup analyses identified several prognostic indicators of a better PFS: absence of disease-related symptoms (hazard ratio [HR] = 0.5;
p
= 0.041), lung-only metastasis (HR = 0.4;
p
= 0.048), a daily maintenance dose ≥600 mg (HR = 0.3;
p
= 0.005), and a thyroglobulin reduction ≥60% (HR = 0.4;
p
= 0.012). The mean daily dose of sorafenib was 666 ± 114 mg, and drug withdrawals due to adverse events (AEs) occurred in 13% of patients. AEs and serious AEs were reported in 93 (95%) and 40 (41%) patients, respectively. The most frequent AE was hand-foot skin reaction (76%).
Conclusions:
The PFS of progressive RAI-refractory DTC patients treated with sorafenib was consistent with the findings of the DECISION trial. Disease-related symptoms, lung-only metastasis, a daily maintenance dose, and thyroglobulin reduction were significantly associated with PFS. These results suggest that sorafenib is an effective treatment option for patients with progressive RAI-refractory DTC.</description><identifier>ISSN: 1050-7256</identifier><identifier>EISSN: 1557-9077</identifier><identifier>DOI: 10.1089/thy.2017.0356</identifier><identifier>PMID: 29350109</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Aged ; Antineoplastic Agents - therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Progression-Free Survival ; Republic of Korea ; Retrospective Studies ; Sorafenib - therapeutic use ; Survival Analysis ; Survival Rate ; Tertiary Healthcare ; Thyroid Cancer and Nodules ; Thyroid Neoplasms - drug therapy ; Thyroid Neoplasms - mortality ; Thyroid Neoplasms - pathology ; Treatment Outcome</subject><ispartof>Thyroid (New York, N.Y.), 2018-03, Vol.28 (3), p.34-348</ispartof><rights>2018, Mary Ann Liebert, Inc.</rights><rights>Copyright 2018, Mary Ann Liebert, Inc., publishers 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c497t-398d8da7cd2f8b30204a95ee14bf604524aac31bcc3beab3685bd0a9aca9d61a3</citedby><cites>FETCH-LOGICAL-c497t-398d8da7cd2f8b30204a95ee14bf604524aac31bcc3beab3685bd0a9aca9d61a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29350109$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Mijin</creatorcontrib><creatorcontrib>Kim, Tae Hyuk</creatorcontrib><creatorcontrib>Shin, Dong Yeob</creatorcontrib><creatorcontrib>Lim, Dong Jun</creatorcontrib><creatorcontrib>Kim, Eui Young</creatorcontrib><creatorcontrib>Kim, Won Bae</creatorcontrib><creatorcontrib>Chung, Jae Hoon</creatorcontrib><creatorcontrib>Shong, Young Kee</creatorcontrib><creatorcontrib>Kim, Bo Hyun</creatorcontrib><creatorcontrib>Kim, Won Gu</creatorcontrib><creatorcontrib>Korean Thyroid Cancer Study Group (KTCSG)</creatorcontrib><creatorcontrib>on behalf of Korean Thyroid Cancer Study Group (KTCSG)</creatorcontrib><title>Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study</title><title>Thyroid (New York, N.Y.)</title><addtitle>Thyroid</addtitle><description>Background:
Sorafenib, a multi-kinase inhibitor, is approved for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). This study evaluated the efficacy and safety of sorafenib in real-world clinical practice and compared the results to those of the DECISION trial. The clinical features associated with better clinical outcomes after sorafenib treatment were also evaluated.
Methods:
This multicenter, retrospective cohort study evaluated 98 patients with progressive RAI-refractory DTC who were treated with sorafenib in six tertiary hospitals in Korea. The primary objective was the progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors v1.1. Overall survival, response rate (defined as the best objective response according to Response Evaluation Criteria In Solid Tumors v1.1), and safety were also evaluated.
Results:
The median PFS was 9.7 months; median overall survival was not reached during follow-up. Partial responses and stable disease were achieved in 25 (25%) and 64 (65%) patients, respectively. Stable disease of >6 months was achieved in 41 (42%) patients. Subgroup analyses identified several prognostic indicators of a better PFS: absence of disease-related symptoms (hazard ratio [HR] = 0.5;
p
= 0.041), lung-only metastasis (HR = 0.4;
p
= 0.048), a daily maintenance dose ≥600 mg (HR = 0.3;
p
= 0.005), and a thyroglobulin reduction ≥60% (HR = 0.4;
p
= 0.012). The mean daily dose of sorafenib was 666 ± 114 mg, and drug withdrawals due to adverse events (AEs) occurred in 13% of patients. AEs and serious AEs were reported in 93 (95%) and 40 (41%) patients, respectively. The most frequent AE was hand-foot skin reaction (76%).
Conclusions:
The PFS of progressive RAI-refractory DTC patients treated with sorafenib was consistent with the findings of the DECISION trial. Disease-related symptoms, lung-only metastasis, a daily maintenance dose, and thyroglobulin reduction were significantly associated with PFS. These results suggest that sorafenib is an effective treatment option for patients with progressive RAI-refractory DTC.</description><subject>Aged</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Progression-Free Survival</subject><subject>Republic of Korea</subject><subject>Retrospective Studies</subject><subject>Sorafenib - therapeutic use</subject><subject>Survival Analysis</subject><subject>Survival Rate</subject><subject>Tertiary Healthcare</subject><subject>Thyroid Cancer and Nodules</subject><subject>Thyroid Neoplasms - drug therapy</subject><subject>Thyroid Neoplasms - mortality</subject><subject>Thyroid Neoplasms - pathology</subject><subject>Treatment Outcome</subject><issn>1050-7256</issn><issn>1557-9077</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFu1DAURSMEoqWwZIu8ZJPBjuMkZoFUDQUqikDtsLZe7JeOUWIPtlMxn8Lf4mjaiq66suV3dN-VT1G8ZnTFaCffpe1-VVHWrigXzZPimAnRlpK27dN8p4KWbSWao-JFjL8oZU3X8ufFUSW5oIzK4-LvBkOyEPZkDQHJ2Z8dBotOI_EDufIBBnS2J9aRtEWyCQhpQpeW6Y_grwPGaG-QXIKx3npjHZaXOATQyefMj3YYMGTeQkJDNtt98NYsq7R1foL35JR89TnUkW_zmKzOKAZylWazf1k8G2CM-Or2PCl-fjrbrL-UF98_n69PL0pdyzaVXHamM9BqUw1dz2lFa5ACkdX90NBaVDWA5qzXmvcIPW860RsKEjRI0zDgJ8WHQ-5u7ic0S4UAo9oFO-VvUR6sejhxdquu_Y1qqkoIKXLA29uA4H_PGJOabNQ4juDQz1Ex2cmlSUszWh5QHXyMAYf7NYyqRafKOtWiUy06M__m_2739J2_DPADsDyDc6PFPgt9JPYfvL2ySA</recordid><startdate>20180301</startdate><enddate>20180301</enddate><creator>Kim, Mijin</creator><creator>Kim, Tae Hyuk</creator><creator>Shin, Dong Yeob</creator><creator>Lim, Dong Jun</creator><creator>Kim, Eui Young</creator><creator>Kim, Won Bae</creator><creator>Chung, Jae Hoon</creator><creator>Shong, Young Kee</creator><creator>Kim, Bo Hyun</creator><creator>Kim, Won Gu</creator><general>Mary Ann Liebert, Inc</general><general>Mary Ann Liebert, Inc., publishers</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20180301</creationdate><title>Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study</title><author>Kim, Mijin ; Kim, Tae Hyuk ; Shin, Dong Yeob ; Lim, Dong Jun ; Kim, Eui Young ; Kim, Won Bae ; Chung, Jae Hoon ; Shong, Young Kee ; Kim, Bo Hyun ; Kim, Won Gu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c497t-398d8da7cd2f8b30204a95ee14bf604524aac31bcc3beab3685bd0a9aca9d61a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Progression-Free Survival</topic><topic>Republic of Korea</topic><topic>Retrospective Studies</topic><topic>Sorafenib - therapeutic use</topic><topic>Survival Analysis</topic><topic>Survival Rate</topic><topic>Tertiary Healthcare</topic><topic>Thyroid Cancer and Nodules</topic><topic>Thyroid Neoplasms - drug therapy</topic><topic>Thyroid Neoplasms - mortality</topic><topic>Thyroid Neoplasms - pathology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Mijin</creatorcontrib><creatorcontrib>Kim, Tae Hyuk</creatorcontrib><creatorcontrib>Shin, Dong Yeob</creatorcontrib><creatorcontrib>Lim, Dong Jun</creatorcontrib><creatorcontrib>Kim, Eui Young</creatorcontrib><creatorcontrib>Kim, Won Bae</creatorcontrib><creatorcontrib>Chung, Jae Hoon</creatorcontrib><creatorcontrib>Shong, Young Kee</creatorcontrib><creatorcontrib>Kim, Bo Hyun</creatorcontrib><creatorcontrib>Kim, Won Gu</creatorcontrib><creatorcontrib>Korean Thyroid Cancer Study Group (KTCSG)</creatorcontrib><creatorcontrib>on behalf of Korean Thyroid Cancer Study Group (KTCSG)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Thyroid (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Mijin</au><au>Kim, Tae Hyuk</au><au>Shin, Dong Yeob</au><au>Lim, Dong Jun</au><au>Kim, Eui Young</au><au>Kim, Won Bae</au><au>Chung, Jae Hoon</au><au>Shong, Young Kee</au><au>Kim, Bo Hyun</au><au>Kim, Won Gu</au><aucorp>Korean Thyroid Cancer Study Group (KTCSG)</aucorp><aucorp>on behalf of Korean Thyroid Cancer Study Group (KTCSG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study</atitle><jtitle>Thyroid (New York, N.Y.)</jtitle><addtitle>Thyroid</addtitle><date>2018-03-01</date><risdate>2018</risdate><volume>28</volume><issue>3</issue><spage>34</spage><epage>348</epage><pages>34-348</pages><issn>1050-7256</issn><eissn>1557-9077</eissn><abstract>Background:
Sorafenib, a multi-kinase inhibitor, is approved for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). This study evaluated the efficacy and safety of sorafenib in real-world clinical practice and compared the results to those of the DECISION trial. The clinical features associated with better clinical outcomes after sorafenib treatment were also evaluated.
Methods:
This multicenter, retrospective cohort study evaluated 98 patients with progressive RAI-refractory DTC who were treated with sorafenib in six tertiary hospitals in Korea. The primary objective was the progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors v1.1. Overall survival, response rate (defined as the best objective response according to Response Evaluation Criteria In Solid Tumors v1.1), and safety were also evaluated.
Results:
The median PFS was 9.7 months; median overall survival was not reached during follow-up. Partial responses and stable disease were achieved in 25 (25%) and 64 (65%) patients, respectively. Stable disease of >6 months was achieved in 41 (42%) patients. Subgroup analyses identified several prognostic indicators of a better PFS: absence of disease-related symptoms (hazard ratio [HR] = 0.5;
p
= 0.041), lung-only metastasis (HR = 0.4;
p
= 0.048), a daily maintenance dose ≥600 mg (HR = 0.3;
p
= 0.005), and a thyroglobulin reduction ≥60% (HR = 0.4;
p
= 0.012). The mean daily dose of sorafenib was 666 ± 114 mg, and drug withdrawals due to adverse events (AEs) occurred in 13% of patients. AEs and serious AEs were reported in 93 (95%) and 40 (41%) patients, respectively. The most frequent AE was hand-foot skin reaction (76%).
Conclusions:
The PFS of progressive RAI-refractory DTC patients treated with sorafenib was consistent with the findings of the DECISION trial. Disease-related symptoms, lung-only metastasis, a daily maintenance dose, and thyroglobulin reduction were significantly associated with PFS. These results suggest that sorafenib is an effective treatment option for patients with progressive RAI-refractory DTC.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>29350109</pmid><doi>10.1089/thy.2017.0356</doi><tpages>315</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1050-7256 |
| ispartof | Thyroid (New York, N.Y.), 2018-03, Vol.28 (3), p.34-348 |
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| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Aged Antineoplastic Agents - therapeutic use Female Humans Male Middle Aged Progression-Free Survival Republic of Korea Retrospective Studies Sorafenib - therapeutic use Survival Analysis Survival Rate Tertiary Healthcare Thyroid Cancer and Nodules Thyroid Neoplasms - drug therapy Thyroid Neoplasms - mortality Thyroid Neoplasms - pathology Treatment Outcome |
| title | Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study |
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