Phase I Trial of Preoperative Chemoradiation plus Sorafenib for High-Risk Extremity Soft Tissue Sarcomas with Dynamic Contrast-Enhanced MRI Correlates
We conducted a phase I trial of the addition of sorafenib to a chemoradiotherapy regimen in patients with high-risk (intermediate/high grade, >5 cm) extremity soft tissue sarcoma undergoing limb salvage surgery. We conducted a correlative study of quantitative dynamic contrast-enhanced MRI (DCE-M...
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| Veröffentlicht in: | Clinical cancer research 2013-12, Vol.19 (24), p.6902-6911 |
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| creator | MEYER, Janelle M PERLEWITZ, Kelly S MORI, Motomi HOLTORF, Megan L AFZAL, Aneela WOODWARD, William J RODLER, Eve T JONES, Robin L WEI HUANG RYAN, Christopher W HAYDEN, James B DOUNG, Yee-Cheen HUNG, Arthur Y VETTO, John T POMMIER, Rodney F MANSOOR, Atiya BECKETT, Brooke R TUDORICA, Alina |
| description | We conducted a phase I trial of the addition of sorafenib to a chemoradiotherapy regimen in patients with high-risk (intermediate/high grade, >5 cm) extremity soft tissue sarcoma undergoing limb salvage surgery. We conducted a correlative study of quantitative dynamic contrast-enhanced MRI (DCE-MRI) to assess response to treatment.
Patients were treated at increasing dose levels of sorafenib (200 mg daily, 400 mg daily, 400 mg twice daily) initiated 14 days before three preoperative and three postoperative cycles of epirubicin/ifosfamide. Radiation (28 Gy) was administered during cycle 2 with epirubicin omitted. The primary objective was to determine the maximum tolerated dose (MTD) of sorafenib. DCE-MRI was conducted at baseline, after 2 weeks of sorafenib, and before surgery. The imaging data were subjected to quantitative pharmacokinetic analyses.
Eighteen subjects were enrolled, of which 16 were evaluable. The MTD of sorafenib was 400 mg daily. Common grade 3-4 adverse events included neutropenia (94%), hypophosphatemia (75%), anemia (69%), thrombocytopenia (50%), and neutropenic fever/infection (50%). Of note, 38% developed wound complications requiring surgical intervention. The rate of ≥95% histopathologic tumor necrosis was 44%. Changes in DCE-MRI biomarker ΔK(trans) after 2 weeks of sorafenib correlated with histologic response (R(2) = 0.67, P = 0.012) at surgery.
The addition of sorafenib to preoperative chemoradiotherapy is feasible and warrants further investigation in a larger trial. DCE-MRI detected changes in tumor perfusion after 2 weeks of sorafenib and may be a minimally invasive tool for rapid assessment of drug effect in soft tissue sarcoma. |
| doi_str_mv | 10.1158/1078-0432.CCR-13-1594 |
| format | Article |
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Patients were treated at increasing dose levels of sorafenib (200 mg daily, 400 mg daily, 400 mg twice daily) initiated 14 days before three preoperative and three postoperative cycles of epirubicin/ifosfamide. Radiation (28 Gy) was administered during cycle 2 with epirubicin omitted. The primary objective was to determine the maximum tolerated dose (MTD) of sorafenib. DCE-MRI was conducted at baseline, after 2 weeks of sorafenib, and before surgery. The imaging data were subjected to quantitative pharmacokinetic analyses.
Eighteen subjects were enrolled, of which 16 were evaluable. The MTD of sorafenib was 400 mg daily. Common grade 3-4 adverse events included neutropenia (94%), hypophosphatemia (75%), anemia (69%), thrombocytopenia (50%), and neutropenic fever/infection (50%). Of note, 38% developed wound complications requiring surgical intervention. The rate of ≥95% histopathologic tumor necrosis was 44%. Changes in DCE-MRI biomarker ΔK(trans) after 2 weeks of sorafenib correlated with histologic response (R(2) = 0.67, P = 0.012) at surgery.
The addition of sorafenib to preoperative chemoradiotherapy is feasible and warrants further investigation in a larger trial. DCE-MRI detected changes in tumor perfusion after 2 weeks of sorafenib and may be a minimally invasive tool for rapid assessment of drug effect in soft tissue sarcoma.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-13-1594</identifier><identifier>PMID: 24132922</identifier><identifier>CODEN: CCREF4</identifier><language>eng</language><publisher>Philadelphia, PA: American Association for Cancer Research</publisher><subject>Adult ; Antineoplastic agents ; Biological and medical sciences ; Chemoradiotherapy ; Combined Modality Therapy ; Dermatology ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Maximum Tolerated Dose ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoplasm Staging ; Niacinamide - administration & dosage ; Niacinamide - analogs & derivatives ; Pharmacology. Drug treatments ; Phenylurea Compounds - administration & dosage ; Preoperative Period ; Radiography ; Sarcoma - diagnostic imaging ; Sarcoma - drug therapy ; Sarcoma - pathology ; Sarcoma - radiotherapy ; Tumors ; Tumors of the skin and soft tissue. Premalignant lesions ; Young Adult</subject><ispartof>Clinical cancer research, 2013-12, Vol.19 (24), p.6902-6911</ispartof><rights>2015 INIST-CNRS</rights><rights>2013 AACR.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c441t-d556fbf1feff118c09ab2924832b5ade5b196c20dfcf8b4d331014ef32af16143</citedby><cites>FETCH-LOGICAL-c441t-d556fbf1feff118c09ab2924832b5ade5b196c20dfcf8b4d331014ef32af16143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,3356,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28044873$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24132922$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>MEYER, Janelle M</creatorcontrib><creatorcontrib>PERLEWITZ, Kelly S</creatorcontrib><creatorcontrib>MORI, Motomi</creatorcontrib><creatorcontrib>HOLTORF, Megan L</creatorcontrib><creatorcontrib>AFZAL, Aneela</creatorcontrib><creatorcontrib>WOODWARD, William J</creatorcontrib><creatorcontrib>RODLER, Eve T</creatorcontrib><creatorcontrib>JONES, Robin L</creatorcontrib><creatorcontrib>WEI HUANG</creatorcontrib><creatorcontrib>RYAN, Christopher W</creatorcontrib><creatorcontrib>HAYDEN, James B</creatorcontrib><creatorcontrib>DOUNG, Yee-Cheen</creatorcontrib><creatorcontrib>HUNG, Arthur Y</creatorcontrib><creatorcontrib>VETTO, John T</creatorcontrib><creatorcontrib>POMMIER, Rodney F</creatorcontrib><creatorcontrib>MANSOOR, Atiya</creatorcontrib><creatorcontrib>BECKETT, Brooke R</creatorcontrib><creatorcontrib>TUDORICA, Alina</creatorcontrib><title>Phase I Trial of Preoperative Chemoradiation plus Sorafenib for High-Risk Extremity Soft Tissue Sarcomas with Dynamic Contrast-Enhanced MRI Correlates</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>We conducted a phase I trial of the addition of sorafenib to a chemoradiotherapy regimen in patients with high-risk (intermediate/high grade, >5 cm) extremity soft tissue sarcoma undergoing limb salvage surgery. We conducted a correlative study of quantitative dynamic contrast-enhanced MRI (DCE-MRI) to assess response to treatment.
Patients were treated at increasing dose levels of sorafenib (200 mg daily, 400 mg daily, 400 mg twice daily) initiated 14 days before three preoperative and three postoperative cycles of epirubicin/ifosfamide. Radiation (28 Gy) was administered during cycle 2 with epirubicin omitted. The primary objective was to determine the maximum tolerated dose (MTD) of sorafenib. DCE-MRI was conducted at baseline, after 2 weeks of sorafenib, and before surgery. The imaging data were subjected to quantitative pharmacokinetic analyses.
Eighteen subjects were enrolled, of which 16 were evaluable. The MTD of sorafenib was 400 mg daily. Common grade 3-4 adverse events included neutropenia (94%), hypophosphatemia (75%), anemia (69%), thrombocytopenia (50%), and neutropenic fever/infection (50%). Of note, 38% developed wound complications requiring surgical intervention. The rate of ≥95% histopathologic tumor necrosis was 44%. Changes in DCE-MRI biomarker ΔK(trans) after 2 weeks of sorafenib correlated with histologic response (R(2) = 0.67, P = 0.012) at surgery.
The addition of sorafenib to preoperative chemoradiotherapy is feasible and warrants further investigation in a larger trial. DCE-MRI detected changes in tumor perfusion after 2 weeks of sorafenib and may be a minimally invasive tool for rapid assessment of drug effect in soft tissue sarcoma.</description><subject>Adult</subject><subject>Antineoplastic agents</subject><subject>Biological and medical sciences</subject><subject>Chemoradiotherapy</subject><subject>Combined Modality Therapy</subject><subject>Dermatology</subject><subject>Female</subject><subject>Humans</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoplasm Staging</subject><subject>Niacinamide - administration & dosage</subject><subject>Niacinamide - analogs & derivatives</subject><subject>Pharmacology. Drug treatments</subject><subject>Phenylurea Compounds - administration & dosage</subject><subject>Preoperative Period</subject><subject>Radiography</subject><subject>Sarcoma - diagnostic imaging</subject><subject>Sarcoma - drug therapy</subject><subject>Sarcoma - pathology</subject><subject>Sarcoma - radiotherapy</subject><subject>Tumors</subject><subject>Tumors of the skin and soft tissue. Premalignant lesions</subject><subject>Young Adult</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkc1u1DAUhS0EoqXwCCBvWLr4-ieTbJBQGOhIRVTTYW05jt0YknhkewrzIjwvjvoDrGxfn3OufT-EXgM9B5D1O6CrmlDB2XnbbglwArIRT9ApSLkinFXyadk_aE7Qi5S-UwoCqHiOTpgAzhrGTtHvq0Enizd4F70ecXD4Ktqwt1Fnf2txO9gpRN37cgwz3o-HhK9LwdnZd9iFiC_8zUC2Pv3A61852snnY1G4jHc-pYPF1zqaMOmEf_o84I_HWU_e4DbMOeqUyXoe9Gxsj79sN6Uaox11tukleub0mOyr-_UMffu03rUX5PLr50374ZIYISCTXsrKdQ6cdQ6gNrTRXfmXqDnrpO6t7KCpDKO9M67uRM85lBlYx5l2UIHgZ-j9Xe7-0E22N3Z51qj20U86HlXQXv1_M_tB3YRbxeuqkZUsAfIuwMSQUrTu0QtULaDUAkEtEFQBpYCrBVTxvfm38aPrgUwRvL0X6GT06GIZk09_dTUVol5x_gfa56AE</recordid><startdate>20131215</startdate><enddate>20131215</enddate><creator>MEYER, Janelle M</creator><creator>PERLEWITZ, Kelly S</creator><creator>MORI, Motomi</creator><creator>HOLTORF, Megan L</creator><creator>AFZAL, Aneela</creator><creator>WOODWARD, William J</creator><creator>RODLER, Eve T</creator><creator>JONES, Robin L</creator><creator>WEI HUANG</creator><creator>RYAN, Christopher W</creator><creator>HAYDEN, James B</creator><creator>DOUNG, Yee-Cheen</creator><creator>HUNG, Arthur Y</creator><creator>VETTO, John T</creator><creator>POMMIER, Rodney F</creator><creator>MANSOOR, Atiya</creator><creator>BECKETT, Brooke R</creator><creator>TUDORICA, Alina</creator><general>American Association for Cancer Research</general><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>5PM</scope></search><sort><creationdate>20131215</creationdate><title>Phase I Trial of Preoperative Chemoradiation plus Sorafenib for High-Risk Extremity Soft Tissue Sarcomas with Dynamic Contrast-Enhanced MRI Correlates</title><author>MEYER, Janelle M ; PERLEWITZ, Kelly S ; MORI, Motomi ; HOLTORF, Megan L ; AFZAL, Aneela ; WOODWARD, William J ; RODLER, Eve T ; JONES, Robin L ; WEI HUANG ; RYAN, Christopher W ; HAYDEN, James B ; DOUNG, Yee-Cheen ; HUNG, Arthur Y ; VETTO, John T ; POMMIER, Rodney F ; MANSOOR, Atiya ; BECKETT, Brooke R ; TUDORICA, Alina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c441t-d556fbf1feff118c09ab2924832b5ade5b196c20dfcf8b4d331014ef32af16143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Antineoplastic agents</topic><topic>Biological and medical sciences</topic><topic>Chemoradiotherapy</topic><topic>Combined Modality Therapy</topic><topic>Dermatology</topic><topic>Female</topic><topic>Humans</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoplasm Staging</topic><topic>Niacinamide - administration & dosage</topic><topic>Niacinamide - analogs & derivatives</topic><topic>Pharmacology. Drug treatments</topic><topic>Phenylurea Compounds - administration & dosage</topic><topic>Preoperative Period</topic><topic>Radiography</topic><topic>Sarcoma - diagnostic imaging</topic><topic>Sarcoma - drug therapy</topic><topic>Sarcoma - pathology</topic><topic>Sarcoma - radiotherapy</topic><topic>Tumors</topic><topic>Tumors of the skin and soft tissue. Premalignant lesions</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>MEYER, Janelle M</creatorcontrib><creatorcontrib>PERLEWITZ, Kelly S</creatorcontrib><creatorcontrib>MORI, Motomi</creatorcontrib><creatorcontrib>HOLTORF, Megan L</creatorcontrib><creatorcontrib>AFZAL, Aneela</creatorcontrib><creatorcontrib>WOODWARD, William J</creatorcontrib><creatorcontrib>RODLER, Eve T</creatorcontrib><creatorcontrib>JONES, Robin L</creatorcontrib><creatorcontrib>WEI HUANG</creatorcontrib><creatorcontrib>RYAN, Christopher W</creatorcontrib><creatorcontrib>HAYDEN, James B</creatorcontrib><creatorcontrib>DOUNG, Yee-Cheen</creatorcontrib><creatorcontrib>HUNG, Arthur Y</creatorcontrib><creatorcontrib>VETTO, John T</creatorcontrib><creatorcontrib>POMMIER, Rodney F</creatorcontrib><creatorcontrib>MANSOOR, Atiya</creatorcontrib><creatorcontrib>BECKETT, Brooke R</creatorcontrib><creatorcontrib>TUDORICA, Alina</creatorcontrib><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>PubMed Central (Full Participant titles)</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>MEYER, Janelle M</au><au>PERLEWITZ, Kelly S</au><au>MORI, Motomi</au><au>HOLTORF, Megan L</au><au>AFZAL, Aneela</au><au>WOODWARD, William J</au><au>RODLER, Eve T</au><au>JONES, Robin L</au><au>WEI HUANG</au><au>RYAN, Christopher W</au><au>HAYDEN, James B</au><au>DOUNG, Yee-Cheen</au><au>HUNG, Arthur Y</au><au>VETTO, John T</au><au>POMMIER, Rodney F</au><au>MANSOOR, Atiya</au><au>BECKETT, Brooke R</au><au>TUDORICA, Alina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I Trial of Preoperative Chemoradiation plus Sorafenib for High-Risk Extremity Soft Tissue Sarcomas with Dynamic Contrast-Enhanced MRI Correlates</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2013-12-15</date><risdate>2013</risdate><volume>19</volume><issue>24</issue><spage>6902</spage><epage>6911</epage><pages>6902-6911</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><coden>CCREF4</coden><abstract>We conducted a phase I trial of the addition of sorafenib to a chemoradiotherapy regimen in patients with high-risk (intermediate/high grade, >5 cm) extremity soft tissue sarcoma undergoing limb salvage surgery. We conducted a correlative study of quantitative dynamic contrast-enhanced MRI (DCE-MRI) to assess response to treatment.
Patients were treated at increasing dose levels of sorafenib (200 mg daily, 400 mg daily, 400 mg twice daily) initiated 14 days before three preoperative and three postoperative cycles of epirubicin/ifosfamide. Radiation (28 Gy) was administered during cycle 2 with epirubicin omitted. The primary objective was to determine the maximum tolerated dose (MTD) of sorafenib. DCE-MRI was conducted at baseline, after 2 weeks of sorafenib, and before surgery. The imaging data were subjected to quantitative pharmacokinetic analyses.
Eighteen subjects were enrolled, of which 16 were evaluable. The MTD of sorafenib was 400 mg daily. Common grade 3-4 adverse events included neutropenia (94%), hypophosphatemia (75%), anemia (69%), thrombocytopenia (50%), and neutropenic fever/infection (50%). Of note, 38% developed wound complications requiring surgical intervention. The rate of ≥95% histopathologic tumor necrosis was 44%. Changes in DCE-MRI biomarker ΔK(trans) after 2 weeks of sorafenib correlated with histologic response (R(2) = 0.67, P = 0.012) at surgery.
The addition of sorafenib to preoperative chemoradiotherapy is feasible and warrants further investigation in a larger trial. DCE-MRI detected changes in tumor perfusion after 2 weeks of sorafenib and may be a minimally invasive tool for rapid assessment of drug effect in soft tissue sarcoma.</abstract><cop>Philadelphia, PA</cop><pub>American Association for Cancer Research</pub><pmid>24132922</pmid><doi>10.1158/1078-0432.CCR-13-1594</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Antineoplastic agents Biological and medical sciences Chemoradiotherapy Combined Modality Therapy Dermatology Female Humans Magnetic Resonance Imaging Male Maximum Tolerated Dose Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Neoplasm Staging Niacinamide - administration & dosage Niacinamide - analogs & derivatives Pharmacology. Drug treatments Phenylurea Compounds - administration & dosage Preoperative Period Radiography Sarcoma - diagnostic imaging Sarcoma - drug therapy Sarcoma - pathology Sarcoma - radiotherapy Tumors Tumors of the skin and soft tissue. Premalignant lesions Young Adult |
| title | Phase I Trial of Preoperative Chemoradiation plus Sorafenib for High-Risk Extremity Soft Tissue Sarcomas with Dynamic Contrast-Enhanced MRI Correlates |
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