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Phase 1 Study of Concurrent Sunitinib and Image-Guided Radiotherapy Followed by Maintenance Sunitinib for Patients With Oligometastases: Acute Toxicity and Preliminary Response
To determine the safety and maximum-tolerated dose of concurrent sunitinib and image-guided radiotherapy (IGRT) followed by maintenance sunitinib in oligometastastic patients. Eligible patients had 1 to 5 sites of metastatic cancer measuring
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| Published in: | Cancer 2009-08, Vol.115 (15), p.3571-3580 |
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| Main Authors: | , , , , , , , , , |
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| container_end_page | 3580 |
| container_issue | 15 |
| container_start_page | 3571 |
| container_title | Cancer |
| container_volume | 115 |
| creator | KAO, Johnny PACKER, Stuart HA LINH VU SCHWARTZ, Myron E SUNG, Max W STOCK, Richard G LO, Yeh-Chi HUANG, Delphine CHEN, Shu-Hsia CESARETTI, Jamie A |
| description | To determine the safety and maximum-tolerated dose of concurrent sunitinib and image-guided radiotherapy (IGRT) followed by maintenance sunitinib in oligometastastic patients.
Eligible patients had 1 to 5 sites of metastatic cancer measuring |
| doi_str_mv | 10.1002/cncr.24412 |
| format | article |
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Eligible patients had 1 to 5 sites of metastatic cancer measuring<or=6 cm. The most common treatment sites were bone, liver, and lung. Patients were treated with concurrent sunitinib (Day 1 through Day 28) and IGRT (40-50 Gy in 10 fractions starting on Day 8) followed by maintenance sunitinib (50 mg daily, 4 weeks on/2 weeks off starting on Day 43). The starting dose was sunitinib 25 mg and IGRT 40 Gy. Doses were escalated in a ping-pong design with incremental increases in either sunitinib or IGRT.
Twenty-one patients with 36 metastatic lesions were enrolled, with a median follow-up of 10 months. No dose limiting toxicities (DLT) were noted at dose levels 1 or 2 (SU 37.5 mg/RT 40 Gy). One of 10 patients at dose level 3 (SU 37.5 mg/RT 50 Gy) and 2 of 5 patients at dose level 4 (SU 50 mg/RT 50 Gy) experienced DLTs comprising grade 4 myelosuppression and grade 3 nausea. At last follow-up, 8 patients are alive without evidence of progression. The 1-year local, progression-free, and overall survival were 85%, 44%, and 75%, respectively.
Addition of SU (25 to 37.5 mg) to IGRT is tolerable in patients with oligometastases, without potentiation of RT toxicity. On the basis of promising antitumor responses observed with this novel combination, a multi-institutional phase 2 trial using SU 37.5 mg/RT 50 Gy is ongoing.</description><identifier>ISSN: 0008-543X</identifier><identifier>EISSN: 1097-0142</identifier><identifier>DOI: 10.1002/cncr.24412</identifier><identifier>PMID: 19536893</identifier><identifier>CODEN: CANCAR</identifier><language>eng</language><publisher>Hoboken, NJ: Wiley-Blackwell</publisher><subject>Aged ; Aged, 80 and over ; Biological and medical sciences ; Combined Modality Therapy - adverse effects ; Disease-Free Survival ; Female ; Humans ; Indoles - administration & dosage ; Indoles - adverse effects ; Male ; Maximum Tolerated Dose ; Medical sciences ; Middle Aged ; Neoplasm Metastasis - drug therapy ; Neoplasm Metastasis - radiotherapy ; Neoplasms - drug therapy ; Neoplasms - pathology ; Neoplasms - radiotherapy ; Patient Compliance ; Pyrroles - administration & dosage ; Pyrroles - adverse effects ; Radiation Dosage ; Tumors</subject><ispartof>Cancer, 2009-08, Vol.115 (15), p.3571-3580</ispartof><rights>2009 INIST-CNRS</rights><rights>Copyright (c) 2009 American Cancer Society.</rights><rights>2009 American Cancer Society 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c329t-a3e22615cc6373340c9c731d7483a7cd994740f023504ec996c3bd3c059a8c973</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21736793$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19536893$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KAO, Johnny</creatorcontrib><creatorcontrib>PACKER, Stuart</creatorcontrib><creatorcontrib>HA LINH VU</creatorcontrib><creatorcontrib>SCHWARTZ, Myron E</creatorcontrib><creatorcontrib>SUNG, Max W</creatorcontrib><creatorcontrib>STOCK, Richard G</creatorcontrib><creatorcontrib>LO, Yeh-Chi</creatorcontrib><creatorcontrib>HUANG, Delphine</creatorcontrib><creatorcontrib>CHEN, Shu-Hsia</creatorcontrib><creatorcontrib>CESARETTI, Jamie A</creatorcontrib><title>Phase 1 Study of Concurrent Sunitinib and Image-Guided Radiotherapy Followed by Maintenance Sunitinib for Patients With Oligometastases: Acute Toxicity and Preliminary Response</title><title>Cancer</title><addtitle>Cancer</addtitle><description>To determine the safety and maximum-tolerated dose of concurrent sunitinib and image-guided radiotherapy (IGRT) followed by maintenance sunitinib in oligometastastic patients.
Eligible patients had 1 to 5 sites of metastatic cancer measuring<or=6 cm. The most common treatment sites were bone, liver, and lung. Patients were treated with concurrent sunitinib (Day 1 through Day 28) and IGRT (40-50 Gy in 10 fractions starting on Day 8) followed by maintenance sunitinib (50 mg daily, 4 weeks on/2 weeks off starting on Day 43). The starting dose was sunitinib 25 mg and IGRT 40 Gy. Doses were escalated in a ping-pong design with incremental increases in either sunitinib or IGRT.
Twenty-one patients with 36 metastatic lesions were enrolled, with a median follow-up of 10 months. No dose limiting toxicities (DLT) were noted at dose levels 1 or 2 (SU 37.5 mg/RT 40 Gy). One of 10 patients at dose level 3 (SU 37.5 mg/RT 50 Gy) and 2 of 5 patients at dose level 4 (SU 50 mg/RT 50 Gy) experienced DLTs comprising grade 4 myelosuppression and grade 3 nausea. At last follow-up, 8 patients are alive without evidence of progression. The 1-year local, progression-free, and overall survival were 85%, 44%, and 75%, respectively.
Addition of SU (25 to 37.5 mg) to IGRT is tolerable in patients with oligometastases, without potentiation of RT toxicity. On the basis of promising antitumor responses observed with this novel combination, a multi-institutional phase 2 trial using SU 37.5 mg/RT 50 Gy is ongoing.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Combined Modality Therapy - adverse effects</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Humans</subject><subject>Indoles - administration & dosage</subject><subject>Indoles - adverse effects</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis - drug therapy</subject><subject>Neoplasm Metastasis - radiotherapy</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - pathology</subject><subject>Neoplasms - radiotherapy</subject><subject>Patient Compliance</subject><subject>Pyrroles - administration & dosage</subject><subject>Pyrroles - adverse effects</subject><subject>Radiation Dosage</subject><subject>Tumors</subject><issn>0008-543X</issn><issn>1097-0142</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><recordid>eNpVkd9KHDEUxkOp1NX2pg9QctObwtj8m8mmFwVZ1AqKi1rauyF7ktlNmUmWJFOdt-ojNupiLQRCTn7n-w7nQ-g9JUeUEPYZPMQjJgRlr9CMEiUrQgV7jWaEkHlVC_5zHx2k9Ks8Jav5G7RPVc2bueIz9Ge50cliim_yaCYcOrwIHsYYrc_4ZvQuO-9WWHuDzwe9ttXZ6Iw1-FobF_LGRr2d8Gno-3BXqqsJX2rns_Xag33R34WIlzq7oprwD5c3-Kp36zDYrFM5Nn3BxzBmi2_DvQOXp0fHZbS9G5zXccLXNm2DT_Yt2ut0n-y73X2Ivp-e3C6-VRdXZ-eL44sKOFO50twy1tAaoOGSc0FAgeTUSDHnWoJRSkhBOsJ4TYQFpRrgK8OB1ErPQUl-iL4-6W7H1WANlMmj7tttdEMZpw3atf__eLdp1-F3K7gkrGmKwKcnAYghpWi7515K2ofc2ofc2sfcCvzhpds_dBdUAT7uAJ1A910sC3bpmWNU8kYW7i8oz6VN</recordid><startdate>20090801</startdate><enddate>20090801</enddate><creator>KAO, Johnny</creator><creator>PACKER, Stuart</creator><creator>HA LINH VU</creator><creator>SCHWARTZ, Myron E</creator><creator>SUNG, Max W</creator><creator>STOCK, Richard G</creator><creator>LO, Yeh-Chi</creator><creator>HUANG, Delphine</creator><creator>CHEN, Shu-Hsia</creator><creator>CESARETTI, Jamie A</creator><general>Wiley-Blackwell</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>20090801</creationdate><title>Phase 1 Study of Concurrent Sunitinib and Image-Guided Radiotherapy Followed by Maintenance Sunitinib for Patients With Oligometastases: Acute Toxicity and Preliminary Response</title><author>KAO, Johnny ; PACKER, Stuart ; HA LINH VU ; SCHWARTZ, Myron E ; SUNG, Max W ; STOCK, Richard G ; LO, Yeh-Chi ; HUANG, Delphine ; CHEN, Shu-Hsia ; CESARETTI, Jamie A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c329t-a3e22615cc6373340c9c731d7483a7cd994740f023504ec996c3bd3c059a8c973</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>Combined Modality Therapy - adverse effects</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Humans</topic><topic>Indoles - administration & dosage</topic><topic>Indoles - adverse effects</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis - drug therapy</topic><topic>Neoplasm Metastasis - radiotherapy</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - pathology</topic><topic>Neoplasms - radiotherapy</topic><topic>Patient Compliance</topic><topic>Pyrroles - administration & dosage</topic><topic>Pyrroles - adverse effects</topic><topic>Radiation Dosage</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>KAO, Johnny</creatorcontrib><creatorcontrib>PACKER, Stuart</creatorcontrib><creatorcontrib>HA LINH VU</creatorcontrib><creatorcontrib>SCHWARTZ, Myron E</creatorcontrib><creatorcontrib>SUNG, Max W</creatorcontrib><creatorcontrib>STOCK, Richard G</creatorcontrib><creatorcontrib>LO, Yeh-Chi</creatorcontrib><creatorcontrib>HUANG, Delphine</creatorcontrib><creatorcontrib>CHEN, Shu-Hsia</creatorcontrib><creatorcontrib>CESARETTI, Jamie A</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>Cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>KAO, Johnny</au><au>PACKER, Stuart</au><au>HA LINH VU</au><au>SCHWARTZ, Myron E</au><au>SUNG, Max W</au><au>STOCK, Richard G</au><au>LO, Yeh-Chi</au><au>HUANG, Delphine</au><au>CHEN, Shu-Hsia</au><au>CESARETTI, Jamie A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase 1 Study of Concurrent Sunitinib and Image-Guided Radiotherapy Followed by Maintenance Sunitinib for Patients With Oligometastases: Acute Toxicity and Preliminary Response</atitle><jtitle>Cancer</jtitle><addtitle>Cancer</addtitle><date>2009-08-01</date><risdate>2009</risdate><volume>115</volume><issue>15</issue><spage>3571</spage><epage>3580</epage><pages>3571-3580</pages><issn>0008-543X</issn><eissn>1097-0142</eissn><coden>CANCAR</coden><abstract>To determine the safety and maximum-tolerated dose of concurrent sunitinib and image-guided radiotherapy (IGRT) followed by maintenance sunitinib in oligometastastic patients.
Eligible patients had 1 to 5 sites of metastatic cancer measuring<or=6 cm. The most common treatment sites were bone, liver, and lung. Patients were treated with concurrent sunitinib (Day 1 through Day 28) and IGRT (40-50 Gy in 10 fractions starting on Day 8) followed by maintenance sunitinib (50 mg daily, 4 weeks on/2 weeks off starting on Day 43). The starting dose was sunitinib 25 mg and IGRT 40 Gy. Doses were escalated in a ping-pong design with incremental increases in either sunitinib or IGRT.
Twenty-one patients with 36 metastatic lesions were enrolled, with a median follow-up of 10 months. No dose limiting toxicities (DLT) were noted at dose levels 1 or 2 (SU 37.5 mg/RT 40 Gy). One of 10 patients at dose level 3 (SU 37.5 mg/RT 50 Gy) and 2 of 5 patients at dose level 4 (SU 50 mg/RT 50 Gy) experienced DLTs comprising grade 4 myelosuppression and grade 3 nausea. At last follow-up, 8 patients are alive without evidence of progression. The 1-year local, progression-free, and overall survival were 85%, 44%, and 75%, respectively.
Addition of SU (25 to 37.5 mg) to IGRT is tolerable in patients with oligometastases, without potentiation of RT toxicity. On the basis of promising antitumor responses observed with this novel combination, a multi-institutional phase 2 trial using SU 37.5 mg/RT 50 Gy is ongoing.</abstract><cop>Hoboken, NJ</cop><pub>Wiley-Blackwell</pub><pmid>19536893</pmid><doi>10.1002/cncr.24412</doi><tpages>10</tpages></addata></record> |
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| ispartof | Cancer, 2009-08, Vol.115 (15), p.3571-3580 |
| issn | 0008-543X 1097-0142 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4370266 |
| source | Wiley; EZB Electronic Journals Library |
| subjects | Aged Aged, 80 and over Biological and medical sciences Combined Modality Therapy - adverse effects Disease-Free Survival Female Humans Indoles - administration & dosage Indoles - adverse effects Male Maximum Tolerated Dose Medical sciences Middle Aged Neoplasm Metastasis - drug therapy Neoplasm Metastasis - radiotherapy Neoplasms - drug therapy Neoplasms - pathology Neoplasms - radiotherapy Patient Compliance Pyrroles - administration & dosage Pyrroles - adverse effects Radiation Dosage Tumors |
| title | Phase 1 Study of Concurrent Sunitinib and Image-Guided Radiotherapy Followed by Maintenance Sunitinib for Patients With Oligometastases: Acute Toxicity and Preliminary Response |
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