Adjuvant portal-vein infusion of fluorouracil and heparin in colorectal cancer: a randomised trial
There is conflicting evidence on the efficacy of regional adjuvant chemotherapy, via portal-vein infusion (PVI), after resection of colorectal cancer. We undertook a randomised controlled multicentre trial to investigate the efficacy of PVI (500 mg/m 2 fluorouracil plus 5000 IU heparin daily for 7 d...
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| Veröffentlicht in: | The Lancet (British edition) 1998-06, Vol.351 (9117), p.1677-1681 |
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| creator | Rougier, Philippe Sahmoud, Tarek Nitti, Donato Curran, Desmond Doci, Roberto De Waele, B Nakajima, Toshifusa Rauschecker, Helmut Labianca, Roberto Pector, Jean-Claude Apolone, Giovanni Lasser, Philippe Couvreur, Marie Laure Wils, Jacques Marsoni, Silvia |
| description | There is conflicting evidence on the efficacy of regional adjuvant chemotherapy, via portal-vein infusion (PVI), after resection of colorectal cancer. We undertook a randomised controlled multicentre trial to investigate the efficacy of PVI (500 mg/m
2 fluorouracil plus 5000 IU heparin daily for 7 days).
1235 of about 1500 potentially eligible patients were randomly assigned surgery plus PVI or surgery alone (control). The patients were followed up for a median of 63 months, with yearly screening for recurrent disease. The primary endpoint was survival; analyses were by intention to treat.
619 patients in the control group and 616 in the PVI group met eligibility criteria. 164 (26%) control-group patients and 173 (28%) PVI-group patients died. 5-year survival did not differ significantly between the groups (73
vs 72%; 95% CI for difference -6 to 4). The control and PVI groups were also similar in terms of disease-free survival at 5 years (67
vs 65%) and the number of patients with liver metastases (79
vs 77%).
PVI of fluorouracil, at a dose of 500 mg/m
2 for 7 days, cannot be recommended as the sole adjuvant treatment for high-risk colorectal cancer after complete surgical excision. However, these results cannot eliminate a small benefit when PVI is used at a higher dosage or in combination with mitomycin. |
| doi_str_mv | 10.1016/S0140-6736(97)08169-5 |
| format | Article |
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2 fluorouracil plus 5000 IU heparin daily for 7 days).
1235 of about 1500 potentially eligible patients were randomly assigned surgery plus PVI or surgery alone (control). The patients were followed up for a median of 63 months, with yearly screening for recurrent disease. The primary endpoint was survival; analyses were by intention to treat.
619 patients in the control group and 616 in the PVI group met eligibility criteria. 164 (26%) control-group patients and 173 (28%) PVI-group patients died. 5-year survival did not differ significantly between the groups (73
vs 72%; 95% CI for difference -6 to 4). The control and PVI groups were also similar in terms of disease-free survival at 5 years (67
vs 65%) and the number of patients with liver metastases (79
vs 77%).
PVI of fluorouracil, at a dose of 500 mg/m
2 for 7 days, cannot be recommended as the sole adjuvant treatment for high-risk colorectal cancer after complete surgical excision. However, these results cannot eliminate a small benefit when PVI is used at a higher dosage or in combination with mitomycin.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(97)08169-5</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Antineoplastic agents ; Biological and medical sciences ; Cancer ; Chemotherapy ; Colorectal cancer ; Colorectal carcinoma ; Medical sciences ; Pharmacology. Drug treatments ; Surgery</subject><ispartof>The Lancet (British edition), 1998-06, Vol.351 (9117), p.1677-1681</ispartof><rights>1998 Elsevier Ltd</rights><rights>1998 INIST-CNRS</rights><rights>Copyright Lancet Ltd. Jun 6, 1998</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c458t-ec4d38cbddb142563ec9921c78baa7bc545a327cd2522682b38252241e26a6343</citedby><cites>FETCH-LOGICAL-c458t-ec4d38cbddb142563ec9921c78baa7bc545a327cd2522682b38252241e26a6343</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673697081695$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65309</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2249751$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Rougier, Philippe</creatorcontrib><creatorcontrib>Sahmoud, Tarek</creatorcontrib><creatorcontrib>Nitti, Donato</creatorcontrib><creatorcontrib>Curran, Desmond</creatorcontrib><creatorcontrib>Doci, Roberto</creatorcontrib><creatorcontrib>De Waele, B</creatorcontrib><creatorcontrib>Nakajima, Toshifusa</creatorcontrib><creatorcontrib>Rauschecker, Helmut</creatorcontrib><creatorcontrib>Labianca, Roberto</creatorcontrib><creatorcontrib>Pector, Jean-Claude</creatorcontrib><creatorcontrib>Apolone, Giovanni</creatorcontrib><creatorcontrib>Lasser, Philippe</creatorcontrib><creatorcontrib>Couvreur, Marie Laure</creatorcontrib><creatorcontrib>Wils, Jacques</creatorcontrib><creatorcontrib>Marsoni, Silvia</creatorcontrib><creatorcontrib>the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group, the Gruppo Interdisciplinare Valutazione Interventi in Oncologia, and the Japanese Foundation for Cancer Research</creatorcontrib><title>Adjuvant portal-vein infusion of fluorouracil and heparin in colorectal cancer: a randomised trial</title><title>The Lancet (British edition)</title><description>There is conflicting evidence on the efficacy of regional adjuvant chemotherapy, via portal-vein infusion (PVI), after resection of colorectal cancer. We undertook a randomised controlled multicentre trial to investigate the efficacy of PVI (500 mg/m
2 fluorouracil plus 5000 IU heparin daily for 7 days).
1235 of about 1500 potentially eligible patients were randomly assigned surgery plus PVI or surgery alone (control). The patients were followed up for a median of 63 months, with yearly screening for recurrent disease. The primary endpoint was survival; analyses were by intention to treat.
619 patients in the control group and 616 in the PVI group met eligibility criteria. 164 (26%) control-group patients and 173 (28%) PVI-group patients died. 5-year survival did not differ significantly between the groups (73
vs 72%; 95% CI for difference -6 to 4). The control and PVI groups were also similar in terms of disease-free survival at 5 years (67
vs 65%) and the number of patients with liver metastases (79
vs 77%).
PVI of fluorouracil, at a dose of 500 mg/m
2 for 7 days, cannot be recommended as the sole adjuvant treatment for high-risk colorectal cancer after complete surgical excision. However, these results cannot eliminate a small benefit when PVI is used at a higher dosage or in combination with mitomycin.</description><subject>Antineoplastic agents</subject><subject>Biological and medical sciences</subject><subject>Cancer</subject><subject>Chemotherapy</subject><subject>Colorectal cancer</subject><subject>Colorectal carcinoma</subject><subject>Medical sciences</subject><subject>Pharmacology. 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Central Basic</collection><collection>SIRS Editorial</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rougier, Philippe</au><au>Sahmoud, Tarek</au><au>Nitti, Donato</au><au>Curran, Desmond</au><au>Doci, Roberto</au><au>De Waele, B</au><au>Nakajima, Toshifusa</au><au>Rauschecker, Helmut</au><au>Labianca, Roberto</au><au>Pector, Jean-Claude</au><au>Apolone, Giovanni</au><au>Lasser, Philippe</au><au>Couvreur, Marie Laure</au><au>Wils, Jacques</au><au>Marsoni, Silvia</au><aucorp>the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group, the Gruppo Interdisciplinare Valutazione Interventi in Oncologia, and the Japanese Foundation for Cancer Research</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adjuvant portal-vein infusion of fluorouracil and heparin in colorectal cancer: a randomised trial</atitle><jtitle>The Lancet (British edition)</jtitle><date>1998-06-06</date><risdate>1998</risdate><volume>351</volume><issue>9117</issue><spage>1677</spage><epage>1681</epage><pages>1677-1681</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>There is conflicting evidence on the efficacy of regional adjuvant chemotherapy, via portal-vein infusion (PVI), after resection of colorectal cancer. We undertook a randomised controlled multicentre trial to investigate the efficacy of PVI (500 mg/m
2 fluorouracil plus 5000 IU heparin daily for 7 days).
1235 of about 1500 potentially eligible patients were randomly assigned surgery plus PVI or surgery alone (control). The patients were followed up for a median of 63 months, with yearly screening for recurrent disease. The primary endpoint was survival; analyses were by intention to treat.
619 patients in the control group and 616 in the PVI group met eligibility criteria. 164 (26%) control-group patients and 173 (28%) PVI-group patients died. 5-year survival did not differ significantly between the groups (73
vs 72%; 95% CI for difference -6 to 4). The control and PVI groups were also similar in terms of disease-free survival at 5 years (67
vs 65%) and the number of patients with liver metastases (79
vs 77%).
PVI of fluorouracil, at a dose of 500 mg/m
2 for 7 days, cannot be recommended as the sole adjuvant treatment for high-risk colorectal cancer after complete surgical excision. However, these results cannot eliminate a small benefit when PVI is used at a higher dosage or in combination with mitomycin.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><doi>10.1016/S0140-6736(97)08169-5</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 1998-06, Vol.351 (9117), p.1677-1681 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_journals_199028605 |
| source | Elsevier ScienceDirect Journals; Business Source Complete |
| subjects | Antineoplastic agents Biological and medical sciences Cancer Chemotherapy Colorectal cancer Colorectal carcinoma Medical sciences Pharmacology. Drug treatments Surgery |
| title | Adjuvant portal-vein infusion of fluorouracil and heparin in colorectal cancer: a randomised trial |
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