Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer
Background: Concurrent chemoradiotherapy is a valuable treatment option for localised oesophageal cancer (EC), but improvement is still needed. A randomised phase II trial was initiated to assess the feasibility and efficacy in terms of the endoscopic complete response rate (ECRR) of radiotherapy wi...
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creator | Conroy, T Yataghène, Y Etienne, P L Michel, P Senellart, H Raoul, J L Mineur, L Rives, M Mirabel, X Lamezec, B Rio, E Le Prisé, E Peiffert, D Adenis, A |
description | Background:
Concurrent chemoradiotherapy is a valuable treatment option for localised oesophageal cancer (EC), but improvement is still needed. A randomised phase II trial was initiated to assess the feasibility and efficacy in terms of the endoscopic complete response rate (ECRR) of radiotherapy with oxaliplatin, leucovorin and fluorouracil (FOLFOX4) or cisplatin/fluorouracil.
Methods:
Patients with unresectable EC (any T, any N, M0 or M1a), or medically unfit for surgery, were randomly assigned to receive either six cycles (three concomitant and three post-radiotherapy) of FOLFOX4 (arm A) or four cycles (two concomitant and two post-radiotherapy) of cisplatin/fluorouracil (arm B) along with radiotherapy 50 Gy in both arms. Responses were reviewed by independent experts.
Results:
A total of 97 patients were randomised (arm A/B, 53/44) and 95 were assessable. The majority had squamous cell carcinoma (82%; arm A/B, 42/38). Chemoradiotherapy was completed in 74 and 66%. The ECRR was 45 and 29% in arms A and B, respectively. Median times to progression were 15.2 and 9.2 months and the median overall survival was 22.7 and 15.1 months in arms A and B, respectively.
Conclusion:
Chemoradiotherapy with FOLFOX4, a well-tolerated and convenient combination with promising efficacy, is now being tested in a phase III trial. |
doi_str_mv | 10.1038/sj.bjc.6605943 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2990616</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2173287511</sourcerecordid><originalsourceid>FETCH-LOGICAL-c542t-2473f6b5b8efa538dcf7633ff87d7be53580df2fe508d78384ff569e8c085ff33</originalsourceid><addsrcrecordid>eNp1kc9v0zAUxy0EYt3gyg1kIe3AId1zHMfOZdI0UVapUjmAxM1yHLtxlcbBTob23-MpXQdInCy_93nf9-OL0DsCSwJUXMX9st7rZVkCqwr6Ai0Io3lGRM5fogUA8AyqHM7QeYz79K1A8NfoLIeqAE7EAg1fWxUNXq9xUH3jDy6aBo_BqQ57i3VrDj6oxvmxNUEND_iXG1u82m5W2x8F9gFrF4dOja7HQzdFbLvJBz8FpV2HU9Cb6IdW7UzS06rXJrxBr6zqonl7fC_Q99Xnb7d32Wb7ZX17s8k0K_IxywtObVmzWhirGBWNtryk1FrBG14bRpmAxubWMBANF1QU1rKyMkKDYNZSeoGuZ91hqg-m0aYfg-rkENxBhQfplZN_Z3rXyp2_l3lVQUnKJPBpFmj_Kbu72cjHWDpuQaqK3JPEfjw2C_7nZOIo9-kIfdpP8hKAQJEXCVrOkA4-xmDsSZWAfDRTxr1MZsqjmangw58rnPAn9xJweQRU1KqzycLkxzNHWXJcsMRdzVxMqX5nwvN4_239fq7o1TgFc5J8yv8GNSTDSQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>760010424</pqid></control><display><type>article</type><title>Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer</title><source>MEDLINE</source><source>Nature</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Conroy, T ; Yataghène, Y ; Etienne, P L ; Michel, P ; Senellart, H ; Raoul, J L ; Mineur, L ; Rives, M ; Mirabel, X ; Lamezec, B ; Rio, E ; Le Prisé, E ; Peiffert, D ; Adenis, A</creator><creatorcontrib>Conroy, T ; Yataghène, Y ; Etienne, P L ; Michel, P ; Senellart, H ; Raoul, J L ; Mineur, L ; Rives, M ; Mirabel, X ; Lamezec, B ; Rio, E ; Le Prisé, E ; Peiffert, D ; Adenis, A</creatorcontrib><description>Background:
Concurrent chemoradiotherapy is a valuable treatment option for localised oesophageal cancer (EC), but improvement is still needed. A randomised phase II trial was initiated to assess the feasibility and efficacy in terms of the endoscopic complete response rate (ECRR) of radiotherapy with oxaliplatin, leucovorin and fluorouracil (FOLFOX4) or cisplatin/fluorouracil.
Methods:
Patients with unresectable EC (any T, any N, M0 or M1a), or medically unfit for surgery, were randomly assigned to receive either six cycles (three concomitant and three post-radiotherapy) of FOLFOX4 (arm A) or four cycles (two concomitant and two post-radiotherapy) of cisplatin/fluorouracil (arm B) along with radiotherapy 50 Gy in both arms. Responses were reviewed by independent experts.
Results:
A total of 97 patients were randomised (arm A/B, 53/44) and 95 were assessable. The majority had squamous cell carcinoma (82%; arm A/B, 42/38). Chemoradiotherapy was completed in 74 and 66%. The ECRR was 45 and 29% in arms A and B, respectively. Median times to progression were 15.2 and 9.2 months and the median overall survival was 22.7 and 15.1 months in arms A and B, respectively.
Conclusion:
Chemoradiotherapy with FOLFOX4, a well-tolerated and convenient combination with promising efficacy, is now being tested in a phase III trial.</description><identifier>ISSN: 0007-0920</identifier><identifier>EISSN: 1532-1827</identifier><identifier>DOI: 10.1038/sj.bjc.6605943</identifier><identifier>PMID: 20940718</identifier><identifier>CODEN: BJCAAI</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/92/436/1729 ; 692/699/67/1059 ; 692/699/67/1504/1477 ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Biomedical and Life Sciences ; Biomedicine ; Cancer ; Cancer Research ; Cisplatin - administration & dosage ; Clinical Study ; Combined Modality Therapy ; Drug Resistance ; Epidemiology ; Esophageal Neoplasms - drug therapy ; Esophageal Neoplasms - mortality ; Esophageal Neoplasms - radiotherapy ; Esophagus ; Female ; Fluorouracil - adverse effects ; Fluorouracil - therapeutic use ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Leucovorin - adverse effects ; Leucovorin - therapeutic use ; Life Sciences ; Male ; Medical sciences ; Middle Aged ; Molecular Medicine ; Oncology ; Organoplatinum Compounds - adverse effects ; Organoplatinum Compounds - therapeutic use ; Tumors</subject><ispartof>British journal of cancer, 2010-10, Vol.103 (9), p.1349-1355</ispartof><rights>The Author(s) 2010</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Nature Publishing Group Oct 26, 2010</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>Copyright © 2010 Cancer Research UK 2010 Cancer Research UK</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c542t-2473f6b5b8efa538dcf7633ff87d7be53580df2fe508d78384ff569e8c085ff33</citedby><cites>FETCH-LOGICAL-c542t-2473f6b5b8efa538dcf7633ff87d7be53580df2fe508d78384ff569e8c085ff33</cites><orcidid>0000-0001-7548-284X ; 0000-0001-6305-8953 ; 0000-0002-6546-7627 ; 0000-0003-4000-4981</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2990616/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2990616/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,2727,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23500985$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20940718$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-00741991$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Conroy, T</creatorcontrib><creatorcontrib>Yataghène, Y</creatorcontrib><creatorcontrib>Etienne, P L</creatorcontrib><creatorcontrib>Michel, P</creatorcontrib><creatorcontrib>Senellart, H</creatorcontrib><creatorcontrib>Raoul, J L</creatorcontrib><creatorcontrib>Mineur, L</creatorcontrib><creatorcontrib>Rives, M</creatorcontrib><creatorcontrib>Mirabel, X</creatorcontrib><creatorcontrib>Lamezec, B</creatorcontrib><creatorcontrib>Rio, E</creatorcontrib><creatorcontrib>Le Prisé, E</creatorcontrib><creatorcontrib>Peiffert, D</creatorcontrib><creatorcontrib>Adenis, A</creatorcontrib><title>Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer</title><title>British journal of cancer</title><addtitle>Br J Cancer</addtitle><addtitle>Br J Cancer</addtitle><description>Background:
Concurrent chemoradiotherapy is a valuable treatment option for localised oesophageal cancer (EC), but improvement is still needed. A randomised phase II trial was initiated to assess the feasibility and efficacy in terms of the endoscopic complete response rate (ECRR) of radiotherapy with oxaliplatin, leucovorin and fluorouracil (FOLFOX4) or cisplatin/fluorouracil.
Methods:
Patients with unresectable EC (any T, any N, M0 or M1a), or medically unfit for surgery, were randomly assigned to receive either six cycles (three concomitant and three post-radiotherapy) of FOLFOX4 (arm A) or four cycles (two concomitant and two post-radiotherapy) of cisplatin/fluorouracil (arm B) along with radiotherapy 50 Gy in both arms. Responses were reviewed by independent experts.
Results:
A total of 97 patients were randomised (arm A/B, 53/44) and 95 were assessable. The majority had squamous cell carcinoma (82%; arm A/B, 42/38). Chemoradiotherapy was completed in 74 and 66%. The ECRR was 45 and 29% in arms A and B, respectively. Median times to progression were 15.2 and 9.2 months and the median overall survival was 22.7 and 15.1 months in arms A and B, respectively.
Conclusion:
Chemoradiotherapy with FOLFOX4, a well-tolerated and convenient combination with promising efficacy, is now being tested in a phase III trial.</description><subject>631/92/436/1729</subject><subject>692/699/67/1059</subject><subject>692/699/67/1504/1477</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Cisplatin - administration & dosage</subject><subject>Clinical Study</subject><subject>Combined Modality Therapy</subject><subject>Drug Resistance</subject><subject>Epidemiology</subject><subject>Esophageal Neoplasms - drug therapy</subject><subject>Esophageal Neoplasms - mortality</subject><subject>Esophageal Neoplasms - radiotherapy</subject><subject>Esophagus</subject><subject>Female</subject><subject>Fluorouracil - adverse effects</subject><subject>Fluorouracil - therapeutic use</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Leucovorin - adverse effects</subject><subject>Leucovorin - therapeutic use</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Molecular Medicine</subject><subject>Oncology</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Organoplatinum Compounds - therapeutic use</subject><subject>Tumors</subject><issn>0007-0920</issn><issn>1532-1827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp1kc9v0zAUxy0EYt3gyg1kIe3AId1zHMfOZdI0UVapUjmAxM1yHLtxlcbBTob23-MpXQdInCy_93nf9-OL0DsCSwJUXMX9st7rZVkCqwr6Ai0Io3lGRM5fogUA8AyqHM7QeYz79K1A8NfoLIeqAE7EAg1fWxUNXq9xUH3jDy6aBo_BqQ57i3VrDj6oxvmxNUEND_iXG1u82m5W2x8F9gFrF4dOja7HQzdFbLvJBz8FpV2HU9Cb6IdW7UzS06rXJrxBr6zqonl7fC_Q99Xnb7d32Wb7ZX17s8k0K_IxywtObVmzWhirGBWNtryk1FrBG14bRpmAxubWMBANF1QU1rKyMkKDYNZSeoGuZ91hqg-m0aYfg-rkENxBhQfplZN_Z3rXyp2_l3lVQUnKJPBpFmj_Kbu72cjHWDpuQaqK3JPEfjw2C_7nZOIo9-kIfdpP8hKAQJEXCVrOkA4-xmDsSZWAfDRTxr1MZsqjmangw58rnPAn9xJweQRU1KqzycLkxzNHWXJcsMRdzVxMqX5nwvN4_239fq7o1TgFc5J8yv8GNSTDSQ</recordid><startdate>20101026</startdate><enddate>20101026</enddate><creator>Conroy, T</creator><creator>Yataghène, Y</creator><creator>Etienne, P L</creator><creator>Michel, P</creator><creator>Senellart, H</creator><creator>Raoul, J L</creator><creator>Mineur, L</creator><creator>Rives, M</creator><creator>Mirabel, X</creator><creator>Lamezec, B</creator><creator>Rio, E</creator><creator>Le Prisé, E</creator><creator>Peiffert, D</creator><creator>Adenis, A</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><general>Cancer Research UK</general><scope>C6C</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>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>1XC</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7548-284X</orcidid><orcidid>https://orcid.org/0000-0001-6305-8953</orcidid><orcidid>https://orcid.org/0000-0002-6546-7627</orcidid><orcidid>https://orcid.org/0000-0003-4000-4981</orcidid></search><sort><creationdate>20101026</creationdate><title>Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer</title><author>Conroy, T ; Yataghène, Y ; Etienne, P L ; Michel, P ; Senellart, H ; Raoul, J L ; Mineur, L ; Rives, M ; Mirabel, X ; Lamezec, B ; Rio, E ; Le Prisé, E ; Peiffert, D ; Adenis, A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c542t-2473f6b5b8efa538dcf7633ff87d7be53580df2fe508d78384ff569e8c085ff33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>631/92/436/1729</topic><topic>692/699/67/1059</topic><topic>692/699/67/1504/1477</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer</topic><topic>Cancer Research</topic><topic>Cisplatin - administration & dosage</topic><topic>Clinical Study</topic><topic>Combined Modality Therapy</topic><topic>Drug Resistance</topic><topic>Epidemiology</topic><topic>Esophageal Neoplasms - drug therapy</topic><topic>Esophageal Neoplasms - mortality</topic><topic>Esophageal Neoplasms - radiotherapy</topic><topic>Esophagus</topic><topic>Female</topic><topic>Fluorouracil - adverse effects</topic><topic>Fluorouracil - therapeutic use</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Leucovorin - adverse effects</topic><topic>Leucovorin - therapeutic use</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Molecular Medicine</topic><topic>Oncology</topic><topic>Organoplatinum Compounds - adverse effects</topic><topic>Organoplatinum Compounds - therapeutic use</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Conroy, T</creatorcontrib><creatorcontrib>Yataghène, Y</creatorcontrib><creatorcontrib>Etienne, P L</creatorcontrib><creatorcontrib>Michel, P</creatorcontrib><creatorcontrib>Senellart, H</creatorcontrib><creatorcontrib>Raoul, J L</creatorcontrib><creatorcontrib>Mineur, L</creatorcontrib><creatorcontrib>Rives, M</creatorcontrib><creatorcontrib>Mirabel, X</creatorcontrib><creatorcontrib>Lamezec, B</creatorcontrib><creatorcontrib>Rio, E</creatorcontrib><creatorcontrib>Le Prisé, E</creatorcontrib><creatorcontrib>Peiffert, D</creatorcontrib><creatorcontrib>Adenis, A</creatorcontrib><collection>Springer Nature OA Free Journals</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>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Conroy, T</au><au>Yataghène, Y</au><au>Etienne, P L</au><au>Michel, P</au><au>Senellart, H</au><au>Raoul, J L</au><au>Mineur, L</au><au>Rives, M</au><au>Mirabel, X</au><au>Lamezec, B</au><au>Rio, E</au><au>Le Prisé, E</au><au>Peiffert, D</au><au>Adenis, A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer</atitle><jtitle>British journal of cancer</jtitle><stitle>Br J Cancer</stitle><addtitle>Br J Cancer</addtitle><date>2010-10-26</date><risdate>2010</risdate><volume>103</volume><issue>9</issue><spage>1349</spage><epage>1355</epage><pages>1349-1355</pages><issn>0007-0920</issn><eissn>1532-1827</eissn><coden>BJCAAI</coden><abstract>Background:
Concurrent chemoradiotherapy is a valuable treatment option for localised oesophageal cancer (EC), but improvement is still needed. A randomised phase II trial was initiated to assess the feasibility and efficacy in terms of the endoscopic complete response rate (ECRR) of radiotherapy with oxaliplatin, leucovorin and fluorouracil (FOLFOX4) or cisplatin/fluorouracil.
Methods:
Patients with unresectable EC (any T, any N, M0 or M1a), or medically unfit for surgery, were randomly assigned to receive either six cycles (three concomitant and three post-radiotherapy) of FOLFOX4 (arm A) or four cycles (two concomitant and two post-radiotherapy) of cisplatin/fluorouracil (arm B) along with radiotherapy 50 Gy in both arms. Responses were reviewed by independent experts.
Results:
A total of 97 patients were randomised (arm A/B, 53/44) and 95 were assessable. The majority had squamous cell carcinoma (82%; arm A/B, 42/38). Chemoradiotherapy was completed in 74 and 66%. The ECRR was 45 and 29% in arms A and B, respectively. Median times to progression were 15.2 and 9.2 months and the median overall survival was 22.7 and 15.1 months in arms A and B, respectively.
Conclusion:
Chemoradiotherapy with FOLFOX4, a well-tolerated and convenient combination with promising efficacy, is now being tested in a phase III trial.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>20940718</pmid><doi>10.1038/sj.bjc.6605943</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-7548-284X</orcidid><orcidid>https://orcid.org/0000-0001-6305-8953</orcidid><orcidid>https://orcid.org/0000-0002-6546-7627</orcidid><orcidid>https://orcid.org/0000-0003-4000-4981</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | 631/92/436/1729 692/699/67/1059 692/699/67/1504/1477 Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Biomedical and Life Sciences Biomedicine Cancer Cancer Research Cisplatin - administration & dosage Clinical Study Combined Modality Therapy Drug Resistance Epidemiology Esophageal Neoplasms - drug therapy Esophageal Neoplasms - mortality Esophageal Neoplasms - radiotherapy Esophagus Female Fluorouracil - adverse effects Fluorouracil - therapeutic use Gastroenterology. Liver. Pancreas. Abdomen Humans Leucovorin - adverse effects Leucovorin - therapeutic use Life Sciences Male Medical sciences Middle Aged Molecular Medicine Oncology Organoplatinum Compounds - adverse effects Organoplatinum Compounds - therapeutic use Tumors |
title | Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-29T06%3A16%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Phase%20II%20randomised%20trial%20of%20chemoradiotherapy%20with%20FOLFOX4%20or%20cisplatin%20plus%20fluorouracil%20in%20oesophageal%20cancer&rft.jtitle=British%20journal%20of%20cancer&rft.au=Conroy,%20T&rft.date=2010-10-26&rft.volume=103&rft.issue=9&rft.spage=1349&rft.epage=1355&rft.pages=1349-1355&rft.issn=0007-0920&rft.eissn=1532-1827&rft.coden=BJCAAI&rft_id=info:doi/10.1038/sj.bjc.6605943&rft_dat=%3Cproquest_pubme%3E2173287511%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=760010424&rft_id=info:pmid/20940718&rfr_iscdi=true |