A randomized multicenter phase II trial on the efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma
The purpose of this study was to investigate the usefulness of a hydrocolloid dressing containing ceramide for hand-foot skin reaction (HFSR) on the soles of the feet in metastatic renal cell carcinoma (RCC) patients treated with sorafenib. Patients with grade 1 HFSR on the soles of the feet were ra...
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| Veröffentlicht in: | Annals of oncology 2014-02, Vol.25 (2), p.472-476 |
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| creator | Shinohara, N. Nonomura, N. Eto, M. Kimura, G. Minami, H. Tokunaga, S. Naito, S. |
| description | The purpose of this study was to investigate the usefulness of a hydrocolloid dressing containing ceramide for hand-foot skin reaction (HFSR) on the soles of the feet in metastatic renal cell carcinoma (RCC) patients treated with sorafenib.
Patients with grade 1 HFSR on the soles of the feet were randomly assigned in to two groups. One group received a hydrocolloid dressing containing ceramide (arm A) and the other received 10% urea cream (arm B). Patients in both groups applied treatment to the affected sites on the soles of the feet, but not to the hands. The primary end point was the incidence of grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks.
Thirty-three patients were assessed (17 in arm A and 16 in arm B), and there were no significant differences in baseline characteristics between the two groups. During the observation period of this study, grade 2 or 3 HFSR on the soles of the feet was found in 29% of patients in arm A and was significantly less than the 69% in arm B (P = 0.03). The incidence of HFSR on the hands, however, was similar in both arms. The median time to grade 2 or 3 HFSR on the soles of the feet was also significantly longer in arm A than in arm B (P = 0.03).
These results indicate that a hydrocolloid dressing containing ceramide prevented the worsening of HFSR caused by sorafenib in metastatic RCC patients.
UMIN000002016. |
| doi_str_mv | 10.1093/annonc/mdt541 |
| format | Article |
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Patients with grade 1 HFSR on the soles of the feet were randomly assigned in to two groups. One group received a hydrocolloid dressing containing ceramide (arm A) and the other received 10% urea cream (arm B). Patients in both groups applied treatment to the affected sites on the soles of the feet, but not to the hands. The primary end point was the incidence of grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks.
Thirty-three patients were assessed (17 in arm A and 16 in arm B), and there were no significant differences in baseline characteristics between the two groups. During the observation period of this study, grade 2 or 3 HFSR on the soles of the feet was found in 29% of patients in arm A and was significantly less than the 69% in arm B (P = 0.03). The incidence of HFSR on the hands, however, was similar in both arms. The median time to grade 2 or 3 HFSR on the soles of the feet was also significantly longer in arm A than in arm B (P = 0.03).
These results indicate that a hydrocolloid dressing containing ceramide prevented the worsening of HFSR caused by sorafenib in metastatic RCC patients.
UMIN000002016.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdt541</identifier><identifier>PMID: 24351402</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Aged ; Antineoplastic agents ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Bandages, Hydrocolloid ; Biological and medical sciences ; Carcinoma, Renal Cell - drug therapy ; Carcinoma, Renal Cell - secondary ; ceramide ; Ceramides - administration & dosage ; Female ; hand-foot skin reaction ; Hand-Foot Syndrome - therapy ; Humans ; hydrocolloid dressing ; Kaplan-Meier Estimate ; Kidney Neoplasms - drug therapy ; Kidney Neoplasms - pathology ; Kidneys ; Male ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Nephrology. Urinary tract diseases ; Niacinamide - adverse effects ; Niacinamide - analogs & derivatives ; Niacinamide - therapeutic use ; Pharmacology. Drug treatments ; Phenylurea Compounds - adverse effects ; Phenylurea Compounds - therapeutic use ; renal cell carcinoma ; Sorafenib ; Surface Properties ; Treatment Outcome ; Tumors ; Tumors of the urinary system</subject><ispartof>Annals of oncology, 2014-02, Vol.25 (2), p.472-476</ispartof><rights>2014 European Society for Medical Oncology</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-30ff0a5326d27012e2ec78c913cc651067283e55ef41d38156409d9b7b5032e43</citedby><cites>FETCH-LOGICAL-c410t-30ff0a5326d27012e2ec78c913cc651067283e55ef41d38156409d9b7b5032e43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28168515$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24351402$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shinohara, N.</creatorcontrib><creatorcontrib>Nonomura, N.</creatorcontrib><creatorcontrib>Eto, M.</creatorcontrib><creatorcontrib>Kimura, G.</creatorcontrib><creatorcontrib>Minami, H.</creatorcontrib><creatorcontrib>Tokunaga, S.</creatorcontrib><creatorcontrib>Naito, S.</creatorcontrib><title>A randomized multicenter phase II trial on the efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>The purpose of this study was to investigate the usefulness of a hydrocolloid dressing containing ceramide for hand-foot skin reaction (HFSR) on the soles of the feet in metastatic renal cell carcinoma (RCC) patients treated with sorafenib.
Patients with grade 1 HFSR on the soles of the feet were randomly assigned in to two groups. One group received a hydrocolloid dressing containing ceramide (arm A) and the other received 10% urea cream (arm B). Patients in both groups applied treatment to the affected sites on the soles of the feet, but not to the hands. The primary end point was the incidence of grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks.
Thirty-three patients were assessed (17 in arm A and 16 in arm B), and there were no significant differences in baseline characteristics between the two groups. During the observation period of this study, grade 2 or 3 HFSR on the soles of the feet was found in 29% of patients in arm A and was significantly less than the 69% in arm B (P = 0.03). The incidence of HFSR on the hands, however, was similar in both arms. The median time to grade 2 or 3 HFSR on the soles of the feet was also significantly longer in arm A than in arm B (P = 0.03).
These results indicate that a hydrocolloid dressing containing ceramide prevented the worsening of HFSR caused by sorafenib in metastatic RCC patients.
UMIN000002016.</description><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Bandages, Hydrocolloid</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Renal Cell - drug therapy</subject><subject>Carcinoma, Renal Cell - secondary</subject><subject>ceramide</subject><subject>Ceramides - administration & dosage</subject><subject>Female</subject><subject>hand-foot skin reaction</subject><subject>Hand-Foot Syndrome - therapy</subject><subject>Humans</subject><subject>hydrocolloid dressing</subject><subject>Kaplan-Meier Estimate</subject><subject>Kidney Neoplasms - drug therapy</subject><subject>Kidney Neoplasms - pathology</subject><subject>Kidneys</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Niacinamide - adverse effects</subject><subject>Niacinamide - analogs & derivatives</subject><subject>Niacinamide - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>Phenylurea Compounds - adverse effects</subject><subject>Phenylurea Compounds - therapeutic use</subject><subject>renal cell carcinoma</subject><subject>Sorafenib</subject><subject>Surface Properties</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Tumors of the urinary system</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc2OFCEUhYnROD2tS7eGjYmbcqCA-llOJqN2MokbXVeoy8VGq6AFypn2bX0TaavVlRsguR_nnpxDyAvO3nDWiyvtffBwNZusJH9ENlw1fdUxyR-TDetrUbVKyAtymdIXxljT1_1TclFLobhk9Yb8vKZRexNm9wMNnZcpO0CfMdLDXiekux3N0emJBk_zHila60DDkQZLNd0fTQwQpik4Q03ElJz_TCH4rJ3__cSoZ2eQ3ru8Lx-mcF_Z6CC7oocPZY8v2mmJVgNSGyLdFzeVDSHT9NV5GlGvMOglFYfjkaYQtUXvRlrmB51d8ZvWBRFPcoBTOXQE58Osn5EnVk8Jn5_vLfn09vbjzfvq7sO73c31XQWSs1wJZi3TStSNqVvGa6wR2g56LgAaxVnT1p1ApdBKbkRXYpasN_3YjoqJGqXYkter7iGGbwumPMwunaxoj2FJA5e9aHspi-KWVCsKMaQU0Q6H6GYdjwNnw6nVYW11WFst_Muz9DLOaP7Sf2oswKszoBPoyZZKwaV_XMebTnFVuHblsATx3WEcEpT4AI2LCHkwwf3Hwi_TnMVD</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Shinohara, N.</creator><creator>Nonomura, N.</creator><creator>Eto, M.</creator><creator>Kimura, G.</creator><creator>Minami, H.</creator><creator>Tokunaga, S.</creator><creator>Naito, S.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><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></search><sort><creationdate>20140201</creationdate><title>A randomized multicenter phase II trial on the efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma</title><author>Shinohara, N. ; Nonomura, N. ; Eto, M. ; Kimura, G. ; Minami, H. ; Tokunaga, S. ; Naito, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-30ff0a5326d27012e2ec78c913cc651067283e55ef41d38156409d9b7b5032e43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Bandages, Hydrocolloid</topic><topic>Biological and medical sciences</topic><topic>Carcinoma, Renal Cell - drug therapy</topic><topic>Carcinoma, Renal Cell - secondary</topic><topic>ceramide</topic><topic>Ceramides - administration & dosage</topic><topic>Female</topic><topic>hand-foot skin reaction</topic><topic>Hand-Foot Syndrome - therapy</topic><topic>Humans</topic><topic>hydrocolloid dressing</topic><topic>Kaplan-Meier Estimate</topic><topic>Kidney Neoplasms - drug therapy</topic><topic>Kidney Neoplasms - pathology</topic><topic>Kidneys</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Niacinamide - adverse effects</topic><topic>Niacinamide - analogs & derivatives</topic><topic>Niacinamide - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>Phenylurea Compounds - adverse effects</topic><topic>Phenylurea Compounds - therapeutic use</topic><topic>renal cell carcinoma</topic><topic>Sorafenib</topic><topic>Surface Properties</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Tumors of the urinary system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shinohara, N.</creatorcontrib><creatorcontrib>Nonomura, N.</creatorcontrib><creatorcontrib>Eto, M.</creatorcontrib><creatorcontrib>Kimura, G.</creatorcontrib><creatorcontrib>Minami, H.</creatorcontrib><creatorcontrib>Tokunaga, S.</creatorcontrib><creatorcontrib>Naito, S.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><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><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shinohara, N.</au><au>Nonomura, N.</au><au>Eto, M.</au><au>Kimura, G.</au><au>Minami, H.</au><au>Tokunaga, S.</au><au>Naito, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized multicenter phase II trial on the efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2014-02-01</date><risdate>2014</risdate><volume>25</volume><issue>2</issue><spage>472</spage><epage>476</epage><pages>472-476</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>The purpose of this study was to investigate the usefulness of a hydrocolloid dressing containing ceramide for hand-foot skin reaction (HFSR) on the soles of the feet in metastatic renal cell carcinoma (RCC) patients treated with sorafenib.
Patients with grade 1 HFSR on the soles of the feet were randomly assigned in to two groups. One group received a hydrocolloid dressing containing ceramide (arm A) and the other received 10% urea cream (arm B). Patients in both groups applied treatment to the affected sites on the soles of the feet, but not to the hands. The primary end point was the incidence of grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks.
Thirty-three patients were assessed (17 in arm A and 16 in arm B), and there were no significant differences in baseline characteristics between the two groups. During the observation period of this study, grade 2 or 3 HFSR on the soles of the feet was found in 29% of patients in arm A and was significantly less than the 69% in arm B (P = 0.03). The incidence of HFSR on the hands, however, was similar in both arms. The median time to grade 2 or 3 HFSR on the soles of the feet was also significantly longer in arm A than in arm B (P = 0.03).
These results indicate that a hydrocolloid dressing containing ceramide prevented the worsening of HFSR caused by sorafenib in metastatic RCC patients.
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| ispartof | Annals of oncology, 2014-02, Vol.25 (2), p.472-476 |
| issn | 0923-7534 1569-8041 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Aged Antineoplastic agents Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Bandages, Hydrocolloid Biological and medical sciences Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - secondary ceramide Ceramides - administration & dosage Female hand-foot skin reaction Hand-Foot Syndrome - therapy Humans hydrocolloid dressing Kaplan-Meier Estimate Kidney Neoplasms - drug therapy Kidney Neoplasms - pathology Kidneys Male Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Nephrology. Urinary tract diseases Niacinamide - adverse effects Niacinamide - analogs & derivatives Niacinamide - therapeutic use Pharmacology. Drug treatments Phenylurea Compounds - adverse effects Phenylurea Compounds - therapeutic use renal cell carcinoma Sorafenib Surface Properties Treatment Outcome Tumors Tumors of the urinary system |
| title | A randomized multicenter phase II trial on the efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma |
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