Phase 1 Trial of Sorafenib and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
Purpose To determine the maximally tolerated dose of sorafenib delivered before, during, and after stereotactic body radiation therapy (SBRT) in hepatocellular carinoma (HCC). Methods and Materials Eligible patients had locally advanced Child-Pugh class A HCC, showed Eastern Cooperative Oncology Gro...
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| Veröffentlicht in: | International journal of radiation oncology, biology, physics biology, physics, 2016-03, Vol.94 (3), p.580-587 |
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| creator | Brade, Anthony M., MD, CM, PhD Ng, Sylvia, MD, PhD Brierley, James, MD Kim, John, MD Dinniwell, Robert, MD, MSc Ringash, Jolie, MD Wong, Rebecca R., MD Cho, Charles, MD Knox, Jennifer, MD Dawson, Laura A., MD |
| description | Purpose To determine the maximally tolerated dose of sorafenib delivered before, during, and after stereotactic body radiation therapy (SBRT) in hepatocellular carinoma (HCC). Methods and Materials Eligible patients had locally advanced Child-Pugh class A HCC, showed Eastern Cooperative Oncology Group performance status 0-1, and were ineligible for standard local-regional therapies. Sorafenib was dose escalated in 2 strata: ( 1 ) low effective irradiated liver volume (veff) |
| doi_str_mv | 10.1016/j.ijrobp.2015.11.048 |
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| fullrecord | <record><control><sourceid>proquest_osti_</sourceid><recordid>TN_cdi_osti_scitechconnect_22645108</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S036030161526796X</els_id><sourcerecordid>1805498705</sourcerecordid><originalsourceid>FETCH-LOGICAL-c544t-bcdfa575aa5785f4c929248bf275e3fa17cd780ebb6f5078dc186aa9ce39ba0a3</originalsourceid><addsrcrecordid>eNqFksGL1TAQxoMo7nP1PxAJePHSmrRNml4E96GusKD4nrC3ME0nvNS-pCat8P57W7p68OJl5vKbmY_vG0JecpZzxuXbPnd9DO2YF4yLnPOcVeoR2XFVN1kpxP1jsmOlZFm5wFfkWUo9Y4zzunpKrgqpZK2U3BH99QQJKafH6GCgwdJDiGDRu5aC7-hhwohhAjM5Q29Cd6HfoHMwueDp8YQRxgu1IdJbHGEKBodhHiDSPUTjfDjDc_LEwpDwxUO_Jt8_fjjub7O7L58-79_fZUZU1ZS1prMgagFLUcJWpimaolKtLWqBpQVem65WDNtWWsFq1RmuJEBjsGxaYFBek9fb3pAmp5NxE5qTCd6jmXRRyEpwphbqzUaNMfycMU367NIqGjyGOWmumKgaVTOxoNWGmhhSimj1GN0Z4kVzptcAdK-3APQagOZcLwEsY68eLsztGbu_Q38cX4B3G4CLG78cxlUseoOdi6vWLrj_Xfh3gRmcdwaGH3jB1Ic5-sVpzXUqNNOH9QnWH-CikHUj78vfKkOuDA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1805498705</pqid></control><display><type>article</type><title>Phase 1 Trial of Sorafenib and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Brade, Anthony M., MD, CM, PhD ; Ng, Sylvia, MD, PhD ; Brierley, James, MD ; Kim, John, MD ; Dinniwell, Robert, MD, MSc ; Ringash, Jolie, MD ; Wong, Rebecca R., MD ; Cho, Charles, MD ; Knox, Jennifer, MD ; Dawson, Laura A., MD</creator><creatorcontrib>Brade, Anthony M., MD, CM, PhD ; Ng, Sylvia, MD, PhD ; Brierley, James, MD ; Kim, John, MD ; Dinniwell, Robert, MD, MSc ; Ringash, Jolie, MD ; Wong, Rebecca R., MD ; Cho, Charles, MD ; Knox, Jennifer, MD ; Dawson, Laura A., MD</creatorcontrib><description>Purpose To determine the maximally tolerated dose of sorafenib delivered before, during, and after stereotactic body radiation therapy (SBRT) in hepatocellular carinoma (HCC). Methods and Materials Eligible patients had locally advanced Child-Pugh class A HCC, showed Eastern Cooperative Oncology Group performance status 0-1, and were ineligible for standard local-regional therapies. Sorafenib was dose escalated in 2 strata: ( 1 ) low effective irradiated liver volume (veff) < 30% and ( 2 ) high veff 30%to 60%. Sorafenib (400 mg daily = dose level 1) was administered for 12 weeks, with 6 fractions SBRT delivered weeks 2 and 3, and escalation to full dose (400 mg twice daily) after 12 weeks as tolerated. Standard 3 + 3 cohorts with dose escalation of sorafenib were planned. Results Sixteen patients (4 low veff, median dose 51 Gy; 12 high veff, median dose 33 Gy) were treated at 2 sorafenib dose levels. Of those patients 75% were had Barcelona Clinic Liver Cancer stage C, and 63% had main branch portal vein invasion. In the low veff stratum, no dose-limiting toxicities (DLTs) were observed in 4 patients treated with SBRT and sorafenib 400 mg. Inb the high veff stratum: 2 of 3 evaluable patients treated with sorafenib 400 mg experienced DLT (grade 3 large bowel bleed and grade 4 bowel obstruction 51 and 27 days, respectively, after SBRT). One of 6 evaluable patients at dose level −1 (200 mg once daily) experienced a grade 3 tumor rupture at week 5. Median overall survival and in-field local progression have not been reached. Worsening of Child-Pugh liver function class was seen in 6 of 12 patients in the high veff stratum. Conclusions Significant toxicity was observed in the high veff stratum, and concurrent SBRT with sorafenib is not recommended outside a clinical trial.</description><identifier>ISSN: 0360-3016</identifier><identifier>EISSN: 1879-355X</identifier><identifier>DOI: 10.1016/j.ijrobp.2015.11.048</identifier><identifier>PMID: 26867886</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - surgery ; Carinoma ; CLINICAL TRIALS ; Dose Fractionation ; Female ; GY RANGE 10-100 ; Hematology, Oncology and Palliative Medicine ; Humans ; Intestines - drug effects ; Intestines - radiation effects ; LIVER ; Liver - drug effects ; Liver - radiation effects ; Liver Neoplasms - drug therapy ; Liver Neoplasms - surgery ; Male ; Maximum Tolerated Dose ; Middle Aged ; NEOPLASMS ; Niacinamide - administration & dosage ; Niacinamide - adverse effects ; Niacinamide - analogs & derivatives ; PATIENTS ; Phenylurea Compounds - administration & dosage ; Phenylurea Compounds - adverse effects ; RADIATION DOSES ; Radiology ; RADIOLOGY AND NUCLEAR MEDICINE ; Radiosurgery - adverse effects ; Radiosurgery - methods ; RADIOTHERAPY ; Radiotherapy Dosage ; TOXICITY</subject><ispartof>International journal of radiation oncology, biology, physics, 2016-03, Vol.94 (3), p.580-587</ispartof><rights>2016</rights><rights>Copyright © 2016. Published by Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c544t-bcdfa575aa5785f4c929248bf275e3fa17cd780ebb6f5078dc186aa9ce39ba0a3</citedby><cites>FETCH-LOGICAL-c544t-bcdfa575aa5785f4c929248bf275e3fa17cd780ebb6f5078dc186aa9ce39ba0a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S036030161526796X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26867886$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://www.osti.gov/biblio/22645108$$D View this record in Osti.gov$$Hfree_for_read</backlink></links><search><creatorcontrib>Brade, Anthony M., MD, CM, PhD</creatorcontrib><creatorcontrib>Ng, Sylvia, MD, PhD</creatorcontrib><creatorcontrib>Brierley, James, MD</creatorcontrib><creatorcontrib>Kim, John, MD</creatorcontrib><creatorcontrib>Dinniwell, Robert, MD, MSc</creatorcontrib><creatorcontrib>Ringash, Jolie, MD</creatorcontrib><creatorcontrib>Wong, Rebecca R., MD</creatorcontrib><creatorcontrib>Cho, Charles, MD</creatorcontrib><creatorcontrib>Knox, Jennifer, MD</creatorcontrib><creatorcontrib>Dawson, Laura A., MD</creatorcontrib><title>Phase 1 Trial of Sorafenib and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma</title><title>International journal of radiation oncology, biology, physics</title><addtitle>Int J Radiat Oncol Biol Phys</addtitle><description>Purpose To determine the maximally tolerated dose of sorafenib delivered before, during, and after stereotactic body radiation therapy (SBRT) in hepatocellular carinoma (HCC). Methods and Materials Eligible patients had locally advanced Child-Pugh class A HCC, showed Eastern Cooperative Oncology Group performance status 0-1, and were ineligible for standard local-regional therapies. Sorafenib was dose escalated in 2 strata: ( 1 ) low effective irradiated liver volume (veff) < 30% and ( 2 ) high veff 30%to 60%. Sorafenib (400 mg daily = dose level 1) was administered for 12 weeks, with 6 fractions SBRT delivered weeks 2 and 3, and escalation to full dose (400 mg twice daily) after 12 weeks as tolerated. Standard 3 + 3 cohorts with dose escalation of sorafenib were planned. Results Sixteen patients (4 low veff, median dose 51 Gy; 12 high veff, median dose 33 Gy) were treated at 2 sorafenib dose levels. Of those patients 75% were had Barcelona Clinic Liver Cancer stage C, and 63% had main branch portal vein invasion. In the low veff stratum, no dose-limiting toxicities (DLTs) were observed in 4 patients treated with SBRT and sorafenib 400 mg. Inb the high veff stratum: 2 of 3 evaluable patients treated with sorafenib 400 mg experienced DLT (grade 3 large bowel bleed and grade 4 bowel obstruction 51 and 27 days, respectively, after SBRT). One of 6 evaluable patients at dose level −1 (200 mg once daily) experienced a grade 3 tumor rupture at week 5. Median overall survival and in-field local progression have not been reached. Worsening of Child-Pugh liver function class was seen in 6 of 12 patients in the high veff stratum. Conclusions Significant toxicity was observed in the high veff stratum, and concurrent SBRT with sorafenib is not recommended outside a clinical trial.</description><subject>Aged</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Carcinoma, Hepatocellular - drug therapy</subject><subject>Carcinoma, Hepatocellular - surgery</subject><subject>Carinoma</subject><subject>CLINICAL TRIALS</subject><subject>Dose Fractionation</subject><subject>Female</subject><subject>GY RANGE 10-100</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Intestines - drug effects</subject><subject>Intestines - radiation effects</subject><subject>LIVER</subject><subject>Liver - drug effects</subject><subject>Liver - radiation effects</subject><subject>Liver Neoplasms - drug therapy</subject><subject>Liver Neoplasms - surgery</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Middle Aged</subject><subject>NEOPLASMS</subject><subject>Niacinamide - administration & dosage</subject><subject>Niacinamide - adverse effects</subject><subject>Niacinamide - analogs & derivatives</subject><subject>PATIENTS</subject><subject>Phenylurea Compounds - administration & dosage</subject><subject>Phenylurea Compounds - adverse effects</subject><subject>RADIATION DOSES</subject><subject>Radiology</subject><subject>RADIOLOGY AND NUCLEAR MEDICINE</subject><subject>Radiosurgery - adverse effects</subject><subject>Radiosurgery - methods</subject><subject>RADIOTHERAPY</subject><subject>Radiotherapy Dosage</subject><subject>TOXICITY</subject><issn>0360-3016</issn><issn>1879-355X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFksGL1TAQxoMo7nP1PxAJePHSmrRNml4E96GusKD4nrC3ME0nvNS-pCat8P57W7p68OJl5vKbmY_vG0JecpZzxuXbPnd9DO2YF4yLnPOcVeoR2XFVN1kpxP1jsmOlZFm5wFfkWUo9Y4zzunpKrgqpZK2U3BH99QQJKafH6GCgwdJDiGDRu5aC7-hhwohhAjM5Q29Cd6HfoHMwueDp8YQRxgu1IdJbHGEKBodhHiDSPUTjfDjDc_LEwpDwxUO_Jt8_fjjub7O7L58-79_fZUZU1ZS1prMgagFLUcJWpimaolKtLWqBpQVem65WDNtWWsFq1RmuJEBjsGxaYFBek9fb3pAmp5NxE5qTCd6jmXRRyEpwphbqzUaNMfycMU367NIqGjyGOWmumKgaVTOxoNWGmhhSimj1GN0Z4kVzptcAdK-3APQagOZcLwEsY68eLsztGbu_Q38cX4B3G4CLG78cxlUseoOdi6vWLrj_Xfh3gRmcdwaGH3jB1Ic5-sVpzXUqNNOH9QnWH-CikHUj78vfKkOuDA</recordid><startdate>20160301</startdate><enddate>20160301</enddate><creator>Brade, Anthony M., MD, CM, PhD</creator><creator>Ng, Sylvia, MD, PhD</creator><creator>Brierley, James, MD</creator><creator>Kim, John, MD</creator><creator>Dinniwell, Robert, MD, MSc</creator><creator>Ringash, Jolie, MD</creator><creator>Wong, Rebecca R., MD</creator><creator>Cho, Charles, MD</creator><creator>Knox, Jennifer, MD</creator><creator>Dawson, Laura A., MD</creator><general>Elsevier Inc</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>7U7</scope><scope>C1K</scope><scope>OTOTI</scope></search><sort><creationdate>20160301</creationdate><title>Phase 1 Trial of Sorafenib and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma</title><author>Brade, Anthony M., MD, CM, PhD ; Ng, Sylvia, MD, PhD ; Brierley, James, MD ; Kim, John, MD ; Dinniwell, Robert, MD, MSc ; Ringash, Jolie, MD ; Wong, Rebecca R., MD ; Cho, Charles, MD ; Knox, Jennifer, MD ; Dawson, Laura A., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c544t-bcdfa575aa5785f4c929248bf275e3fa17cd780ebb6f5078dc186aa9ce39ba0a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Carcinoma, Hepatocellular - drug therapy</topic><topic>Carcinoma, Hepatocellular - surgery</topic><topic>Carinoma</topic><topic>CLINICAL TRIALS</topic><topic>Dose Fractionation</topic><topic>Female</topic><topic>GY RANGE 10-100</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>Intestines - drug effects</topic><topic>Intestines - radiation effects</topic><topic>LIVER</topic><topic>Liver - drug effects</topic><topic>Liver - radiation effects</topic><topic>Liver Neoplasms - drug therapy</topic><topic>Liver Neoplasms - surgery</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Middle Aged</topic><topic>NEOPLASMS</topic><topic>Niacinamide - administration & dosage</topic><topic>Niacinamide - adverse effects</topic><topic>Niacinamide - analogs & derivatives</topic><topic>PATIENTS</topic><topic>Phenylurea Compounds - administration & dosage</topic><topic>Phenylurea Compounds - adverse effects</topic><topic>RADIATION DOSES</topic><topic>Radiology</topic><topic>RADIOLOGY AND NUCLEAR MEDICINE</topic><topic>Radiosurgery - adverse effects</topic><topic>Radiosurgery - methods</topic><topic>RADIOTHERAPY</topic><topic>Radiotherapy Dosage</topic><topic>TOXICITY</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brade, Anthony M., MD, CM, PhD</creatorcontrib><creatorcontrib>Ng, Sylvia, MD, PhD</creatorcontrib><creatorcontrib>Brierley, James, MD</creatorcontrib><creatorcontrib>Kim, John, MD</creatorcontrib><creatorcontrib>Dinniwell, Robert, MD, MSc</creatorcontrib><creatorcontrib>Ringash, Jolie, MD</creatorcontrib><creatorcontrib>Wong, Rebecca R., MD</creatorcontrib><creatorcontrib>Cho, Charles, MD</creatorcontrib><creatorcontrib>Knox, Jennifer, MD</creatorcontrib><creatorcontrib>Dawson, Laura A., MD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>OSTI.GOV</collection><jtitle>International journal of radiation oncology, biology, physics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brade, Anthony M., MD, CM, PhD</au><au>Ng, Sylvia, MD, PhD</au><au>Brierley, James, MD</au><au>Kim, John, MD</au><au>Dinniwell, Robert, MD, MSc</au><au>Ringash, Jolie, MD</au><au>Wong, Rebecca R., MD</au><au>Cho, Charles, MD</au><au>Knox, Jennifer, MD</au><au>Dawson, Laura A., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase 1 Trial of Sorafenib and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma</atitle><jtitle>International journal of radiation oncology, biology, physics</jtitle><addtitle>Int J Radiat Oncol Biol Phys</addtitle><date>2016-03-01</date><risdate>2016</risdate><volume>94</volume><issue>3</issue><spage>580</spage><epage>587</epage><pages>580-587</pages><issn>0360-3016</issn><eissn>1879-355X</eissn><abstract>Purpose To determine the maximally tolerated dose of sorafenib delivered before, during, and after stereotactic body radiation therapy (SBRT) in hepatocellular carinoma (HCC). Methods and Materials Eligible patients had locally advanced Child-Pugh class A HCC, showed Eastern Cooperative Oncology Group performance status 0-1, and were ineligible for standard local-regional therapies. Sorafenib was dose escalated in 2 strata: ( 1 ) low effective irradiated liver volume (veff) < 30% and ( 2 ) high veff 30%to 60%. Sorafenib (400 mg daily = dose level 1) was administered for 12 weeks, with 6 fractions SBRT delivered weeks 2 and 3, and escalation to full dose (400 mg twice daily) after 12 weeks as tolerated. Standard 3 + 3 cohorts with dose escalation of sorafenib were planned. Results Sixteen patients (4 low veff, median dose 51 Gy; 12 high veff, median dose 33 Gy) were treated at 2 sorafenib dose levels. Of those patients 75% were had Barcelona Clinic Liver Cancer stage C, and 63% had main branch portal vein invasion. In the low veff stratum, no dose-limiting toxicities (DLTs) were observed in 4 patients treated with SBRT and sorafenib 400 mg. Inb the high veff stratum: 2 of 3 evaluable patients treated with sorafenib 400 mg experienced DLT (grade 3 large bowel bleed and grade 4 bowel obstruction 51 and 27 days, respectively, after SBRT). One of 6 evaluable patients at dose level −1 (200 mg once daily) experienced a grade 3 tumor rupture at week 5. Median overall survival and in-field local progression have not been reached. Worsening of Child-Pugh liver function class was seen in 6 of 12 patients in the high veff stratum. Conclusions Significant toxicity was observed in the high veff stratum, and concurrent SBRT with sorafenib is not recommended outside a clinical trial.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26867886</pmid><doi>10.1016/j.ijrobp.2015.11.048</doi><tpages>8</tpages></addata></record> |
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| ispartof | International journal of radiation oncology, biology, physics, 2016-03, Vol.94 (3), p.580-587 |
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| subjects | Aged Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - surgery Carinoma CLINICAL TRIALS Dose Fractionation Female GY RANGE 10-100 Hematology, Oncology and Palliative Medicine Humans Intestines - drug effects Intestines - radiation effects LIVER Liver - drug effects Liver - radiation effects Liver Neoplasms - drug therapy Liver Neoplasms - surgery Male Maximum Tolerated Dose Middle Aged NEOPLASMS Niacinamide - administration & dosage Niacinamide - adverse effects Niacinamide - analogs & derivatives PATIENTS Phenylurea Compounds - administration & dosage Phenylurea Compounds - adverse effects RADIATION DOSES Radiology RADIOLOGY AND NUCLEAR MEDICINE Radiosurgery - adverse effects Radiosurgery - methods RADIOTHERAPY Radiotherapy Dosage TOXICITY |
| title | Phase 1 Trial of Sorafenib and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma |
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