A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer
Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were ente...
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Veröffentlicht in: | Annals of oncology 2001-07, Vol.12 (7), p.929-935 |
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description | Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR |
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A. ; Moffitt, D. D. ; Glaholm, J. G. ; Peake, D. ; Wallace, D. M. A. ; James, N. D.</creator><creatorcontrib>Hussain, S. A. ; Moffitt, D. D. ; Glaholm, J. G. ; Peake, D. ; Wallace, D. M. A. ; James, N. D.</creatorcontrib><description>Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR <50 ml/min. Toxicity was mild to moderate with the five-day schedule. More severe toxicity was seen with the seven-day schedule: five of nine patients failed to complete planned therapy. Pathological complete response rate at three months was 74% (5-day regimen) and 50% (7-day regimen). Overall 12-month survival was 65%. Conclusion: Chemoradiotherapy with the five-day schedule is feasible with acceptable toxicity in poor prognosis patients. A randomised trial is being launched.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1023/A:1011133820532</identifier><identifier>PMID: 11521797</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Aged ; Antibiotics, Antineoplastic - administration & dosage ; Antimetabolites, Antineoplastic - administration & dosage ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; bladder cancer ; Carcinoma, Transitional Cell - diagnosis ; Carcinoma, Transitional Cell - drug therapy ; Carcinoma, Transitional Cell - physiopathology ; Carcinoma, Transitional Cell - radiotherapy ; chemoradiation ; Chemotherapy, Adjuvant ; Combined treatments (chemotherapy of immunotherapy associated with an other treatment) ; Female ; Fluorouracil - administration & dosage ; Glomerular Filtration Rate ; Humans ; Male ; Medical sciences ; Middle Aged ; Mitomycin - administration & dosage ; Neoplasm Invasiveness ; organ preservation ; Pharmacology. Drug treatments ; Prognosis ; Radiotherapy, Adjuvant ; Survival Analysis ; Treatment Outcome ; Urinary Bladder Neoplasms - diagnosis ; Urinary Bladder Neoplasms - drug therapy ; Urinary Bladder Neoplasms - physiopathology ; Urinary Bladder Neoplasms - radiotherapy</subject><ispartof>Annals of oncology, 2001-07, Vol.12 (7), p.929-935</ispartof><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c401t-d3b0e6a0d76b07d9e7a3065ad0e2010e52b010fcc3e1af1345b1aa5cf4c8095a3</citedby><cites>FETCH-LOGICAL-c401t-d3b0e6a0d76b07d9e7a3065ad0e2010e52b010fcc3e1af1345b1aa5cf4c8095a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1110462$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11521797$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hussain, S. A.</creatorcontrib><creatorcontrib>Moffitt, D. D.</creatorcontrib><creatorcontrib>Glaholm, J. G.</creatorcontrib><creatorcontrib>Peake, D.</creatorcontrib><creatorcontrib>Wallace, D. M. A.</creatorcontrib><creatorcontrib>James, N. D.</creatorcontrib><title>A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR <50 ml/min. Toxicity was mild to moderate with the five-day schedule. More severe toxicity was seen with the seven-day schedule: five of nine patients failed to complete planned therapy. Pathological complete response rate at three months was 74% (5-day regimen) and 50% (7-day regimen). Overall 12-month survival was 65%. Conclusion: Chemoradiotherapy with the five-day schedule is feasible with acceptable toxicity in poor prognosis patients. A randomised trial is being launched.</description><subject>Aged</subject><subject>Antibiotics, Antineoplastic - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>bladder cancer</subject><subject>Carcinoma, Transitional Cell - diagnosis</subject><subject>Carcinoma, Transitional Cell - drug therapy</subject><subject>Carcinoma, Transitional Cell - physiopathology</subject><subject>Carcinoma, Transitional Cell - radiotherapy</subject><subject>chemoradiation</subject><subject>Chemotherapy, Adjuvant</subject><subject>Combined treatments (chemotherapy of immunotherapy associated with an other treatment)</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Glomerular Filtration Rate</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mitomycin - administration & dosage</subject><subject>Neoplasm Invasiveness</subject><subject>organ preservation</subject><subject>Pharmacology. Drug treatments</subject><subject>Prognosis</subject><subject>Radiotherapy, Adjuvant</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><subject>Urinary Bladder Neoplasms - diagnosis</subject><subject>Urinary Bladder Neoplasms - drug therapy</subject><subject>Urinary Bladder Neoplasms - physiopathology</subject><subject>Urinary Bladder Neoplasms - radiotherapy</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkDFv2zAQhYmgQeI6mbsVHLKquRNF0cpmBE1swHWWBDCyECeSqpTKpkDaRbT1R_QX9pdUho00Xe7hcN874D3GPiF8QUjF9fQGARGFmKQgRXrCRijzIplAhh_YCIpUJEqK7Jx9jPEFAPIiLc7YOaJMURVqxOop72qKjs___Po9n_O43dme-4rHfmPq4Dd-F7mp3doHso3f1i5Q1_PKB975_Qj--8bHJvLWG2rbnpP9SRvjLC9bstYFbvZruGCnFbXRXR51zJ7uvj7ezpLFw_38drpITAa4TawoweUEVuUlKFs4RQJySRZcCghOpuUglTHCIVUoMlkikTRVZiZQSBJjdn34a4KPMbhKd6FZU-g1gt53pqf6v84Gx-eDo9uVa2f_8ceSBuDqCFAcMlZhCNTEdxxClu__JAesiVv3-nam8EPnSiipZ6tnfTf7ppaL5UovxV_Bo4Uf</recordid><startdate>20010701</startdate><enddate>20010701</enddate><creator>Hussain, S. A.</creator><creator>Moffitt, D. D.</creator><creator>Glaholm, J. G.</creator><creator>Peake, D.</creator><creator>Wallace, D. M. A.</creator><creator>James, N. D.</creator><general>Oxford University Press</general><scope>BSCLL</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></search><sort><creationdate>20010701</creationdate><title>A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer</title><author>Hussain, S. A. ; Moffitt, D. D. ; Glaholm, J. G. ; Peake, D. ; Wallace, D. M. A. ; James, N. D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c401t-d3b0e6a0d76b07d9e7a3065ad0e2010e52b010fcc3e1af1345b1aa5cf4c8095a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Aged</topic><topic>Antibiotics, Antineoplastic - administration & dosage</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>bladder cancer</topic><topic>Carcinoma, Transitional Cell - diagnosis</topic><topic>Carcinoma, Transitional Cell - drug therapy</topic><topic>Carcinoma, Transitional Cell - physiopathology</topic><topic>Carcinoma, Transitional Cell - radiotherapy</topic><topic>chemoradiation</topic><topic>Chemotherapy, Adjuvant</topic><topic>Combined treatments (chemotherapy of immunotherapy associated with an other treatment)</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Glomerular Filtration Rate</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mitomycin - administration & dosage</topic><topic>Neoplasm Invasiveness</topic><topic>organ preservation</topic><topic>Pharmacology. Drug treatments</topic><topic>Prognosis</topic><topic>Radiotherapy, Adjuvant</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><topic>Urinary Bladder Neoplasms - diagnosis</topic><topic>Urinary Bladder Neoplasms - drug therapy</topic><topic>Urinary Bladder Neoplasms - physiopathology</topic><topic>Urinary Bladder Neoplasms - radiotherapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hussain, S. A.</creatorcontrib><creatorcontrib>Moffitt, D. D.</creatorcontrib><creatorcontrib>Glaholm, J. G.</creatorcontrib><creatorcontrib>Peake, D.</creatorcontrib><creatorcontrib>Wallace, D. M. A.</creatorcontrib><creatorcontrib>James, N. D.</creatorcontrib><collection>Istex</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><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hussain, S. A.</au><au>Moffitt, D. D.</au><au>Glaholm, J. G.</au><au>Peake, D.</au><au>Wallace, D. M. A.</au><au>James, N. D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2001-07-01</date><risdate>2001</risdate><volume>12</volume><issue>7</issue><spage>929</spage><epage>935</epage><pages>929-935</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR <50 ml/min. Toxicity was mild to moderate with the five-day schedule. More severe toxicity was seen with the seven-day schedule: five of nine patients failed to complete planned therapy. Pathological complete response rate at three months was 74% (5-day regimen) and 50% (7-day regimen). Overall 12-month survival was 65%. Conclusion: Chemoradiotherapy with the five-day schedule is feasible with acceptable toxicity in poor prognosis patients. A randomised trial is being launched.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>11521797</pmid><doi>10.1023/A:1011133820532</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Aged Antibiotics, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - administration & dosage Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences bladder cancer Carcinoma, Transitional Cell - diagnosis Carcinoma, Transitional Cell - drug therapy Carcinoma, Transitional Cell - physiopathology Carcinoma, Transitional Cell - radiotherapy chemoradiation Chemotherapy, Adjuvant Combined treatments (chemotherapy of immunotherapy associated with an other treatment) Female Fluorouracil - administration & dosage Glomerular Filtration Rate Humans Male Medical sciences Middle Aged Mitomycin - administration & dosage Neoplasm Invasiveness organ preservation Pharmacology. Drug treatments Prognosis Radiotherapy, Adjuvant Survival Analysis Treatment Outcome Urinary Bladder Neoplasms - diagnosis Urinary Bladder Neoplasms - drug therapy Urinary Bladder Neoplasms - physiopathology Urinary Bladder Neoplasms - radiotherapy |
title | A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer |
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