Phase II randomised trial of raltitrexed–oxaliplatin vs raltitrexed–irinotecan as first-line treatment in advanced colorectal cancer
The purpose of this phase II randomised trial was to determine which of two schemes, raltitrexed-irinotecan or raltitrexed-oxaliplatin, offered better activity and less toxicity in patients with advanced colorectal cancer (CRC). A total of 94 patients with previously untreated metastatic CRC were in...
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| Veröffentlicht in: | British journal of cancer 2005-11, Vol.93 (11), p.1230-1235 |
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| creator | Feliu, J Castañón, C Salud, A Mel, J R Escudero, P Pelegrín, A López-Gómez, L Ruiz, M González, E Juárez, F Lizón, J Castro, J González-Barón, M |
| description | The purpose of this phase II randomised trial was to determine which of two schemes, raltitrexed-irinotecan or raltitrexed-oxaliplatin, offered better activity and less toxicity in patients with advanced colorectal cancer (CRC). A total of 94 patients with previously untreated metastatic CRC were included and randomised to receive raltitrexed 3 mg m
−2
followed by oxaliplatin 130 mg m
−2
on day 1 (arm A), or CPT-11 350 mg m
−2
followed by raltitrexed 3 mg m
−2
(arm B). In both arms treatment was repeated every 3 weeks. Intent-to-treat (ITT) analysis showed an overall response rate of 46% (95% CI, 29.5–57.7%) for arm A, and 34% (95% CI, 19.8–48.4%) for arm B. Median time to progression was 8.2 months for arm A and 8.8 months for arm B. After a median follow-up of 14 months, 69% of patients included in arm A were still alive, compared to 59% of those included in arm B. Overall, 31 patients (65%) experienced some episode of toxicity in arm A and 32 patients (70%) in arm B, usually grade 1–2. The most common toxicity was hepatic, with 29 patients (60%) in arm A and 24 patients (62%) in arm B, and was grade 3–4 in four (8%) and four (9%) patients, respectively. In all, 14 patients (29%) from arm A and 24 patients (52%) from arm B had some grade of diarrhoea (
P |
| doi_str_mv | 10.1038/sj.bjc.6602860 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2361515</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>958877191</sourcerecordid><originalsourceid>FETCH-LOGICAL-c485t-ba946e9000eb268264a773c7969bd7eeb623eae46399a9dc919b2b04724197773</originalsourceid><addsrcrecordid>eNp1kU9v1DAQxS0EosvClSOKkHrM1nGydnxBQhV_VqoEBzhbE2fSOsrai-1dtTeOvfMN-SRMtRELSJwse34z740fYy8rvqp43V6kcdWNdiUlF63kj9iiWteirFqhHrMF51yVXAt-xp6lNNJV81Y9ZWeVFHJdN82C3X--gYTFZlNE8H3YuoR9kaODqQgDvU3Z5Yi32P_8_iPcwuR2E2Tni0P6p-ii8yGjBV9AKgYXUy4n55GGIeQt-lxQG_QH8JYkbJhCRJtJxz68xOfsyQBTwhfzuWRf37_7cvmxvPr0YXP59qq0TbvOZQe6kahpFeyEbIVsQKnaKi111yvETooaARtZaw26t7rSneh4o0RTaUXokr05zt3tuy32lozRImYX3RbinQngzN8V727MdTgYUctqTb-7ZK_nATF822PKZgz76MmzEUJrqdqGE7Q6QjaGlCIOvwUqbh6CM2k0FJyZg6OGV3_aOuFzUgSczwAkC9NAcVmXTpwSmma1xF0cuUQlf43xZO8_0r8AKi63KQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>229967840</pqid></control><display><type>article</type><title>Phase II randomised trial of raltitrexed–oxaliplatin vs raltitrexed–irinotecan as first-line treatment in advanced colorectal cancer</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Springer Nature - Complete Springer Journals</source><source>Nature Journals Online</source><source>PubMed Central</source><creator>Feliu, J ; Castañón, C ; Salud, A ; Mel, J R ; Escudero, P ; Pelegrín, A ; López-Gómez, L ; Ruiz, M ; González, E ; Juárez, F ; Lizón, J ; Castro, J ; González-Barón, M</creator><creatorcontrib>Feliu, J ; Castañón, C ; Salud, A ; Mel, J R ; Escudero, P ; Pelegrín, A ; López-Gómez, L ; Ruiz, M ; González, E ; Juárez, F ; Lizón, J ; Castro, J ; González-Barón, M ; Oncopaz Cooperative Group, Spain ; for the Oncopaz Cooperative Group, Spain</creatorcontrib><description>The purpose of this phase II randomised trial was to determine which of two schemes, raltitrexed-irinotecan or raltitrexed-oxaliplatin, offered better activity and less toxicity in patients with advanced colorectal cancer (CRC). A total of 94 patients with previously untreated metastatic CRC were included and randomised to receive raltitrexed 3 mg m
−2
followed by oxaliplatin 130 mg m
−2
on day 1 (arm A), or CPT-11 350 mg m
−2
followed by raltitrexed 3 mg m
−2
(arm B). In both arms treatment was repeated every 3 weeks. Intent-to-treat (ITT) analysis showed an overall response rate of 46% (95% CI, 29.5–57.7%) for arm A, and 34% (95% CI, 19.8–48.4%) for arm B. Median time to progression was 8.2 months for arm A and 8.8 months for arm B. After a median follow-up of 14 months, 69% of patients included in arm A were still alive, compared to 59% of those included in arm B. Overall, 31 patients (65%) experienced some episode of toxicity in arm A and 32 patients (70%) in arm B, usually grade 1–2. The most common toxicity was hepatic, with 29 patients (60%) in arm A and 24 patients (62%) in arm B, and was grade 3–4 in four (8%) and four (9%) patients, respectively. In all, 14 patients (29%) from arm A and 24 patients (52%) from arm B had some grade of diarrhoea (
P
<0.03). Neurologic toxicity was observed in 31 patients (64%) in arm A, and was grade 3–4 in five patients (10%), while a cholinergic syndrome was detected in nine patients (19%) in arm B. There were no differences in haematologic toxicity. One toxic death (2%) occurred in arm A and three (6.5%) in arm B. In conclusion, both schemes have high efficacy as first-line treatment in metastatic CRC and their total toxicity levels are similar. Regimens with raltitrexed seem a reasonable alternative to fluoropyrimidines.</description><identifier>ISSN: 0007-0920</identifier><identifier>EISSN: 1532-1827</identifier><identifier>DOI: 10.1038/sj.bjc.6602860</identifier><identifier>PMID: 16265344</identifier><identifier>CODEN: BJCAAI</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Biomedical and Life Sciences ; Biomedicine ; Camptothecin - administration & dosage ; Camptothecin - analogs & derivatives ; Cancer Research ; Clinical Study ; Colorectal Neoplasms - drug therapy ; Colorectal Neoplasms - pathology ; Drug Resistance ; Epidemiology ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Infusions, Intravenous ; Irinotecan ; Male ; Medical sciences ; Middle Aged ; Molecular Medicine ; Oncology ; Organoplatinum Compounds - administration & dosage ; Oxaliplatin ; Quinazolines - administration & dosage ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Survival Analysis ; Thiophenes - administration & dosage ; Treatment Outcome ; Tumors</subject><ispartof>British journal of cancer, 2005-11, Vol.93 (11), p.1230-1235</ispartof><rights>The Author(s) 2005</rights><rights>2006 INIST-CNRS</rights><rights>Copyright Nature Publishing Group Nov 28, 2005</rights><rights>Copyright © 2005 Cancer Research UK 2005 Cancer Research UK</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c485t-ba946e9000eb268264a773c7969bd7eeb623eae46399a9dc919b2b04724197773</citedby><cites>FETCH-LOGICAL-c485t-ba946e9000eb268264a773c7969bd7eeb623eae46399a9dc919b2b04724197773</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361515/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361515/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,882,27905,27906,41469,42538,51300,53772,53774</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17296608$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16265344$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Feliu, J</creatorcontrib><creatorcontrib>Castañón, C</creatorcontrib><creatorcontrib>Salud, A</creatorcontrib><creatorcontrib>Mel, J R</creatorcontrib><creatorcontrib>Escudero, P</creatorcontrib><creatorcontrib>Pelegrín, A</creatorcontrib><creatorcontrib>López-Gómez, L</creatorcontrib><creatorcontrib>Ruiz, M</creatorcontrib><creatorcontrib>González, E</creatorcontrib><creatorcontrib>Juárez, F</creatorcontrib><creatorcontrib>Lizón, J</creatorcontrib><creatorcontrib>Castro, J</creatorcontrib><creatorcontrib>González-Barón, M</creatorcontrib><creatorcontrib>Oncopaz Cooperative Group, Spain</creatorcontrib><creatorcontrib>for the Oncopaz Cooperative Group, Spain</creatorcontrib><title>Phase II randomised trial of raltitrexed–oxaliplatin vs raltitrexed–irinotecan as first-line treatment in advanced colorectal cancer</title><title>British journal of cancer</title><addtitle>Br J Cancer</addtitle><addtitle>Br J Cancer</addtitle><description>The purpose of this phase II randomised trial was to determine which of two schemes, raltitrexed-irinotecan or raltitrexed-oxaliplatin, offered better activity and less toxicity in patients with advanced colorectal cancer (CRC). A total of 94 patients with previously untreated metastatic CRC were included and randomised to receive raltitrexed 3 mg m
−2
followed by oxaliplatin 130 mg m
−2
on day 1 (arm A), or CPT-11 350 mg m
−2
followed by raltitrexed 3 mg m
−2
(arm B). In both arms treatment was repeated every 3 weeks. Intent-to-treat (ITT) analysis showed an overall response rate of 46% (95% CI, 29.5–57.7%) for arm A, and 34% (95% CI, 19.8–48.4%) for arm B. Median time to progression was 8.2 months for arm A and 8.8 months for arm B. After a median follow-up of 14 months, 69% of patients included in arm A were still alive, compared to 59% of those included in arm B. Overall, 31 patients (65%) experienced some episode of toxicity in arm A and 32 patients (70%) in arm B, usually grade 1–2. The most common toxicity was hepatic, with 29 patients (60%) in arm A and 24 patients (62%) in arm B, and was grade 3–4 in four (8%) and four (9%) patients, respectively. In all, 14 patients (29%) from arm A and 24 patients (52%) from arm B had some grade of diarrhoea (
P
<0.03). Neurologic toxicity was observed in 31 patients (64%) in arm A, and was grade 3–4 in five patients (10%), while a cholinergic syndrome was detected in nine patients (19%) in arm B. There were no differences in haematologic toxicity. One toxic death (2%) occurred in arm A and three (6.5%) in arm B. In conclusion, both schemes have high efficacy as first-line treatment in metastatic CRC and their total toxicity levels are similar. Regimens with raltitrexed seem a reasonable alternative to fluoropyrimidines.</description><subject>Adult</subject><subject>Aged</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>Camptothecin - administration & dosage</subject><subject>Camptothecin - analogs & derivatives</subject><subject>Cancer Research</subject><subject>Clinical Study</subject><subject>Colorectal Neoplasms - drug therapy</subject><subject>Colorectal Neoplasms - pathology</subject><subject>Drug Resistance</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Irinotecan</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Molecular Medicine</subject><subject>Oncology</subject><subject>Organoplatinum Compounds - administration & dosage</subject><subject>Oxaliplatin</subject><subject>Quinazolines - administration & dosage</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Survival Analysis</subject><subject>Thiophenes - administration & dosage</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0007-0920</issn><issn>1532-1827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</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>eNp1kU9v1DAQxS0EosvClSOKkHrM1nGydnxBQhV_VqoEBzhbE2fSOsrai-1dtTeOvfMN-SRMtRELSJwse34z740fYy8rvqp43V6kcdWNdiUlF63kj9iiWteirFqhHrMF51yVXAt-xp6lNNJV81Y9ZWeVFHJdN82C3X--gYTFZlNE8H3YuoR9kaODqQgDvU3Z5Yi32P_8_iPcwuR2E2Tni0P6p-ii8yGjBV9AKgYXUy4n55GGIeQt-lxQG_QH8JYkbJhCRJtJxz68xOfsyQBTwhfzuWRf37_7cvmxvPr0YXP59qq0TbvOZQe6kahpFeyEbIVsQKnaKi111yvETooaARtZaw26t7rSneh4o0RTaUXokr05zt3tuy32lozRImYX3RbinQngzN8V727MdTgYUctqTb-7ZK_nATF822PKZgz76MmzEUJrqdqGE7Q6QjaGlCIOvwUqbh6CM2k0FJyZg6OGV3_aOuFzUgSczwAkC9NAcVmXTpwSmma1xF0cuUQlf43xZO8_0r8AKi63KQ</recordid><startdate>20051128</startdate><enddate>20051128</enddate><creator>Feliu, J</creator><creator>Castañón, C</creator><creator>Salud, A</creator><creator>Mel, J R</creator><creator>Escudero, P</creator><creator>Pelegrín, A</creator><creator>López-Gómez, L</creator><creator>Ruiz, M</creator><creator>González, E</creator><creator>Juárez, F</creator><creator>Lizón, J</creator><creator>Castro, J</creator><creator>González-Barón, M</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</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>5PM</scope></search><sort><creationdate>20051128</creationdate><title>Phase II randomised trial of raltitrexed–oxaliplatin vs raltitrexed–irinotecan as first-line treatment in advanced colorectal cancer</title><author>Feliu, J ; Castañón, C ; Salud, A ; Mel, J R ; Escudero, P ; Pelegrín, A ; López-Gómez, L ; Ruiz, M ; González, E ; Juárez, F ; Lizón, J ; Castro, J ; González-Barón, M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c485t-ba946e9000eb268264a773c7969bd7eeb623eae46399a9dc919b2b04724197773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Aged</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>Camptothecin - administration & dosage</topic><topic>Camptothecin - analogs & derivatives</topic><topic>Cancer Research</topic><topic>Clinical Study</topic><topic>Colorectal Neoplasms - drug therapy</topic><topic>Colorectal Neoplasms - pathology</topic><topic>Drug Resistance</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Irinotecan</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Molecular Medicine</topic><topic>Oncology</topic><topic>Organoplatinum Compounds - administration & dosage</topic><topic>Oxaliplatin</topic><topic>Quinazolines - administration & dosage</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. 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A total of 94 patients with previously untreated metastatic CRC were included and randomised to receive raltitrexed 3 mg m
−2
followed by oxaliplatin 130 mg m
−2
on day 1 (arm A), or CPT-11 350 mg m
−2
followed by raltitrexed 3 mg m
−2
(arm B). In both arms treatment was repeated every 3 weeks. Intent-to-treat (ITT) analysis showed an overall response rate of 46% (95% CI, 29.5–57.7%) for arm A, and 34% (95% CI, 19.8–48.4%) for arm B. Median time to progression was 8.2 months for arm A and 8.8 months for arm B. After a median follow-up of 14 months, 69% of patients included in arm A were still alive, compared to 59% of those included in arm B. Overall, 31 patients (65%) experienced some episode of toxicity in arm A and 32 patients (70%) in arm B, usually grade 1–2. The most common toxicity was hepatic, with 29 patients (60%) in arm A and 24 patients (62%) in arm B, and was grade 3–4 in four (8%) and four (9%) patients, respectively. In all, 14 patients (29%) from arm A and 24 patients (52%) from arm B had some grade of diarrhoea (
P
<0.03). Neurologic toxicity was observed in 31 patients (64%) in arm A, and was grade 3–4 in five patients (10%), while a cholinergic syndrome was detected in nine patients (19%) in arm B. There were no differences in haematologic toxicity. One toxic death (2%) occurred in arm A and three (6.5%) in arm B. In conclusion, both schemes have high efficacy as first-line treatment in metastatic CRC and their total toxicity levels are similar. Regimens with raltitrexed seem a reasonable alternative to fluoropyrimidines.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>16265344</pmid><doi>10.1038/sj.bjc.6602860</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0007-0920 |
| ispartof | British journal of cancer, 2005-11, Vol.93 (11), p.1230-1235 |
| issn | 0007-0920 1532-1827 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2361515 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Springer Nature - Complete Springer Journals; Nature Journals Online; PubMed Central |
| subjects | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Biomedical and Life Sciences Biomedicine Camptothecin - administration & dosage Camptothecin - analogs & derivatives Cancer Research Clinical Study Colorectal Neoplasms - drug therapy Colorectal Neoplasms - pathology Drug Resistance Epidemiology Female Gastroenterology. Liver. Pancreas. Abdomen Humans Infusions, Intravenous Irinotecan Male Medical sciences Middle Aged Molecular Medicine Oncology Organoplatinum Compounds - administration & dosage Oxaliplatin Quinazolines - administration & dosage Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Analysis Thiophenes - administration & dosage Treatment Outcome Tumors |
| title | Phase II randomised trial of raltitrexed–oxaliplatin vs raltitrexed–irinotecan as first-line treatment in advanced colorectal cancer |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-21T09%3A09%3A18IST&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%20raltitrexed%E2%80%93oxaliplatin%20vs%20raltitrexed%E2%80%93irinotecan%20as%20first-line%20treatment%20in%20advanced%20colorectal%20cancer&rft.jtitle=British%20journal%20of%20cancer&rft.au=Feliu,%20J&rft.aucorp=Oncopaz%20Cooperative%20Group,%20Spain&rft.date=2005-11-28&rft.volume=93&rft.issue=11&rft.spage=1230&rft.epage=1235&rft.pages=1230-1235&rft.issn=0007-0920&rft.eissn=1532-1827&rft.coden=BJCAAI&rft_id=info:doi/10.1038/sj.bjc.6602860&rft_dat=%3Cproquest_pubme%3E958877191%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=229967840&rft_id=info:pmid/16265344&rfr_iscdi=true |