Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)
Background Postoperative portal vein infusion (PVI) of 5‐fluorouracil (5‐FU) is a well tolerated and widely applicable treatment for colorectal cancer that might have an enormous public health impact, even if it produced survival benefits of just a few per cent. Very large trials are required to det...
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| Veröffentlicht in: | British journal of surgery 2003-10, Vol.90 (10), p.1200-1212 |
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| creator | James, R D Donaldson, D Gray, R Northover, J M A Stenning, S P Taylor, I |
| description | Background
Postoperative portal vein infusion (PVI) of 5‐fluorouracil (5‐FU) is a well tolerated and widely applicable treatment for colorectal cancer that might have an enormous public health impact, even if it produced survival benefits of just a few per cent. Very large trials are required to detect such differences, and the Adjuvant X‐ray and 5‐FU Infusion Study (AXIS) is the largest such trial yet reported.
Methods
Consenting patients with presumed colorectal cancer were randomized to surgery with or without 7 days of PVI (1 g 5‐FU plus 5000 units heparin in 1 litre 5 per cent dextrose infused over each 24‐h period). In addition, patients with rectal cancer could be randomized to radiotherapy or no radiotherapy to be given either before or after surgery.
Results
Between November 1989 and December 1997, 3583 patients were randomized with respect to PVI. The survival hazard ratios (95 per cent confidence interval (c.i.)) in all patients randomized and in the curatively resected subgroup (71·2 per cent of patients) were 1·00 (0·92 to 1·11) and 0·94 (0·83 to 1·06) respectively. Tests for heterogeneity suggested a greater treatment benefit for patients with colonic cancer than for patients with rectal cancer with respect to disease‐free survival (hazard ratio 0·79 versus 1·03; P = 0·07), and there was a non‐significant trend with respect to overall survival (hazard ratio 0·87 versus 1·03; P = 0·17). No survival benefit was seen in the 761 patients randomized with respect to radiotherapy; although not statistically significant, the impact on local recurrence rates was similar to that reported in the literature.
Conclusion
No overall benefit of PVI was established in AXIS when colonic and rectal cancers were considered together, but the evidence suggesting a differential treatment effect according to site of cancer in AXIS was strongly supported by a meta‐analysis incorporating the previous trials. Combining the data gave hazard ratios of 0·82 and 1·00 for colonic and rectal tumours respectively (test for interaction, P = 0·024), equating to an absolute survival benefit for patients with colonic cancer of 5·8 (95 per cent c.i. 2·8 to 8·5) per cent, a level close to that seen for prolonged systemic therapy. Copyright © 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Potential benefit of 5‐FU infusion in colon cancer |
| doi_str_mv | 10.1002/bjs.4266 |
| format | Article |
| fullrecord | <record><control><sourceid>wiley_pubme</sourceid><recordid>TN_cdi_pubmed_primary_14515287</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>BJS4266</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3866-d94db9db889654770953556cc57d871bd2d67db6402956ed48b983589454654e3</originalsourceid><addsrcrecordid>eNpFkF9LwzAUxYMoOqfgJ5C8CPrQmTTNnz7OqXMyFJxO30KapJjZtSNt1fnpzdh0L_dcuL97uecAcIJRDyMUX2azupfEjO2ADiaMRjFmYhd0EEI8wiQmB-CwrmcIYYJovA8OcEIxjQXvgNmTKk01dz_WQF240mlVwMa7UKscKjNrP1XZQK-Mq5p369ViCcMGpFFetJWvWq-0K6Ar87Z2VRkaqKui8lY34YRWpbYenvffRpOLI7CXq6K2xxvtgpfbm-fBXTR-HI4G_XGkiWAsMmlistRkQqSMJpyjlBJKmdaUG8FxZmLDuMlYguKUMmsSkaWCUJEmNAkLlnTB6fruos3m1siFd3Pll_LPdADONoCqg93chy9dveUoFiiwgYvW3Jcr7HI7R3IVugyhy1Xo8up-stIt7-rGfv_zyn9Ixgmn8vVhKKfT4OueXUtEfgEfAIGj</addsrcrecordid><sourcetype>Index Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>James, R D ; Donaldson, D ; Gray, R ; Northover, J M A ; Stenning, S P ; Taylor, I</creator><creatorcontrib>James, R D ; Donaldson, D ; Gray, R ; Northover, J M A ; Stenning, S P ; Taylor, I ; AXIS collaborators</creatorcontrib><description>Background
Postoperative portal vein infusion (PVI) of 5‐fluorouracil (5‐FU) is a well tolerated and widely applicable treatment for colorectal cancer that might have an enormous public health impact, even if it produced survival benefits of just a few per cent. Very large trials are required to detect such differences, and the Adjuvant X‐ray and 5‐FU Infusion Study (AXIS) is the largest such trial yet reported.
Methods
Consenting patients with presumed colorectal cancer were randomized to surgery with or without 7 days of PVI (1 g 5‐FU plus 5000 units heparin in 1 litre 5 per cent dextrose infused over each 24‐h period). In addition, patients with rectal cancer could be randomized to radiotherapy or no radiotherapy to be given either before or after surgery.
Results
Between November 1989 and December 1997, 3583 patients were randomized with respect to PVI. The survival hazard ratios (95 per cent confidence interval (c.i.)) in all patients randomized and in the curatively resected subgroup (71·2 per cent of patients) were 1·00 (0·92 to 1·11) and 0·94 (0·83 to 1·06) respectively. Tests for heterogeneity suggested a greater treatment benefit for patients with colonic cancer than for patients with rectal cancer with respect to disease‐free survival (hazard ratio 0·79 versus 1·03; P = 0·07), and there was a non‐significant trend with respect to overall survival (hazard ratio 0·87 versus 1·03; P = 0·17). No survival benefit was seen in the 761 patients randomized with respect to radiotherapy; although not statistically significant, the impact on local recurrence rates was similar to that reported in the literature.
Conclusion
No overall benefit of PVI was established in AXIS when colonic and rectal cancers were considered together, but the evidence suggesting a differential treatment effect according to site of cancer in AXIS was strongly supported by a meta‐analysis incorporating the previous trials. Combining the data gave hazard ratios of 0·82 and 1·00 for colonic and rectal tumours respectively (test for interaction, P = 0·024), equating to an absolute survival benefit for patients with colonic cancer of 5·8 (95 per cent c.i. 2·8 to 8·5) per cent, a level close to that seen for prolonged systemic therapy. Copyright © 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Potential benefit of 5‐FU infusion in colon cancer</description><identifier>ISSN: 0007-1323</identifier><identifier>EISSN: 1365-2168</identifier><identifier>DOI: 10.1002/bjs.4266</identifier><identifier>PMID: 14515287</identifier><identifier>CODEN: BJSUAM</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anticoagulants - administration & dosage ; Antimetabolites, Antineoplastic - administration & dosage ; Biological and medical sciences ; Colonic Neoplasms - drug therapy ; Colonic Neoplasms - radiotherapy ; Colonic Neoplasms - surgery ; Diseases of the digestive system ; Drug Therapy, Combination ; Female ; Fluorouracil - administration & dosage ; Follow-Up Studies ; Heparin - administration & dosage ; Humans ; Infusions, Intravenous ; Male ; Medical sciences ; Middle Aged ; Patient Compliance ; Portal Vein ; Postoperative Care - methods ; Preoperative Care - methods ; Radiotherapy, Adjuvant ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Rectal Neoplasms - drug therapy ; Rectal Neoplasms - radiotherapy ; Rectal Neoplasms - surgery ; Survival Analysis ; Treatment Outcome</subject><ispartof>British journal of surgery, 2003-10, Vol.90 (10), p.1200-1212</ispartof><rights>Copyright © 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.</rights><rights>2004 INIST-CNRS</rights><rights>Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3866-d94db9db889654770953556cc57d871bd2d67db6402956ed48b983589454654e3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fbjs.4266$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fbjs.4266$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15180451$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14515287$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>James, R D</creatorcontrib><creatorcontrib>Donaldson, D</creatorcontrib><creatorcontrib>Gray, R</creatorcontrib><creatorcontrib>Northover, J M A</creatorcontrib><creatorcontrib>Stenning, S P</creatorcontrib><creatorcontrib>Taylor, I</creatorcontrib><creatorcontrib>AXIS collaborators</creatorcontrib><title>Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)</title><title>British journal of surgery</title><addtitle>Br J Surg</addtitle><description>Background
Postoperative portal vein infusion (PVI) of 5‐fluorouracil (5‐FU) is a well tolerated and widely applicable treatment for colorectal cancer that might have an enormous public health impact, even if it produced survival benefits of just a few per cent. Very large trials are required to detect such differences, and the Adjuvant X‐ray and 5‐FU Infusion Study (AXIS) is the largest such trial yet reported.
Methods
Consenting patients with presumed colorectal cancer were randomized to surgery with or without 7 days of PVI (1 g 5‐FU plus 5000 units heparin in 1 litre 5 per cent dextrose infused over each 24‐h period). In addition, patients with rectal cancer could be randomized to radiotherapy or no radiotherapy to be given either before or after surgery.
Results
Between November 1989 and December 1997, 3583 patients were randomized with respect to PVI. The survival hazard ratios (95 per cent confidence interval (c.i.)) in all patients randomized and in the curatively resected subgroup (71·2 per cent of patients) were 1·00 (0·92 to 1·11) and 0·94 (0·83 to 1·06) respectively. Tests for heterogeneity suggested a greater treatment benefit for patients with colonic cancer than for patients with rectal cancer with respect to disease‐free survival (hazard ratio 0·79 versus 1·03; P = 0·07), and there was a non‐significant trend with respect to overall survival (hazard ratio 0·87 versus 1·03; P = 0·17). No survival benefit was seen in the 761 patients randomized with respect to radiotherapy; although not statistically significant, the impact on local recurrence rates was similar to that reported in the literature.
Conclusion
No overall benefit of PVI was established in AXIS when colonic and rectal cancers were considered together, but the evidence suggesting a differential treatment effect according to site of cancer in AXIS was strongly supported by a meta‐analysis incorporating the previous trials. Combining the data gave hazard ratios of 0·82 and 1·00 for colonic and rectal tumours respectively (test for interaction, P = 0·024), equating to an absolute survival benefit for patients with colonic cancer of 5·8 (95 per cent c.i. 2·8 to 8·5) per cent, a level close to that seen for prolonged systemic therapy. Copyright © 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Potential benefit of 5‐FU infusion in colon cancer</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Colonic Neoplasms - drug therapy</subject><subject>Colonic Neoplasms - radiotherapy</subject><subject>Colonic Neoplasms - surgery</subject><subject>Diseases of the digestive system</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Follow-Up Studies</subject><subject>Heparin - administration & dosage</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patient Compliance</subject><subject>Portal Vein</subject><subject>Postoperative Care - methods</subject><subject>Preoperative Care - methods</subject><subject>Radiotherapy, Adjuvant</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Rectal Neoplasms - drug therapy</subject><subject>Rectal Neoplasms - radiotherapy</subject><subject>Rectal Neoplasms - surgery</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>0007-1323</issn><issn>1365-2168</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkF9LwzAUxYMoOqfgJ5C8CPrQmTTNnz7OqXMyFJxO30KapJjZtSNt1fnpzdh0L_dcuL97uecAcIJRDyMUX2azupfEjO2ADiaMRjFmYhd0EEI8wiQmB-CwrmcIYYJovA8OcEIxjQXvgNmTKk01dz_WQF240mlVwMa7UKscKjNrP1XZQK-Mq5p369ViCcMGpFFetJWvWq-0K6Ar87Z2VRkaqKui8lY34YRWpbYenvffRpOLI7CXq6K2xxvtgpfbm-fBXTR-HI4G_XGkiWAsMmlistRkQqSMJpyjlBJKmdaUG8FxZmLDuMlYguKUMmsSkaWCUJEmNAkLlnTB6fruos3m1siFd3Pll_LPdADONoCqg93chy9dveUoFiiwgYvW3Jcr7HI7R3IVugyhy1Xo8up-stIt7-rGfv_zyn9Ixgmn8vVhKKfT4OueXUtEfgEfAIGj</recordid><startdate>200310</startdate><enddate>200310</enddate><creator>James, R D</creator><creator>Donaldson, D</creator><creator>Gray, R</creator><creator>Northover, J M A</creator><creator>Stenning, S P</creator><creator>Taylor, I</creator><general>John Wiley & Sons, Ltd</general><general>Wiley</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></search><sort><creationdate>200310</creationdate><title>Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)</title><author>James, R D ; Donaldson, D ; Gray, R ; Northover, J M A ; Stenning, S P ; Taylor, I</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3866-d94db9db889654770953556cc57d871bd2d67db6402956ed48b983589454654e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticoagulants - administration & dosage</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Colonic Neoplasms - drug therapy</topic><topic>Colonic Neoplasms - radiotherapy</topic><topic>Colonic Neoplasms - surgery</topic><topic>Diseases of the digestive system</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Follow-Up Studies</topic><topic>Heparin - administration & dosage</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Patient Compliance</topic><topic>Portal Vein</topic><topic>Postoperative Care - methods</topic><topic>Preoperative Care - methods</topic><topic>Radiotherapy, Adjuvant</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Rectal Neoplasms - drug therapy</topic><topic>Rectal Neoplasms - radiotherapy</topic><topic>Rectal Neoplasms - surgery</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>James, R D</creatorcontrib><creatorcontrib>Donaldson, D</creatorcontrib><creatorcontrib>Gray, R</creatorcontrib><creatorcontrib>Northover, J M A</creatorcontrib><creatorcontrib>Stenning, S P</creatorcontrib><creatorcontrib>Taylor, I</creatorcontrib><creatorcontrib>AXIS collaborators</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><jtitle>British journal of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>James, R D</au><au>Donaldson, D</au><au>Gray, R</au><au>Northover, J M A</au><au>Stenning, S P</au><au>Taylor, I</au><aucorp>AXIS collaborators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)</atitle><jtitle>British journal of surgery</jtitle><addtitle>Br J Surg</addtitle><date>2003-10</date><risdate>2003</risdate><volume>90</volume><issue>10</issue><spage>1200</spage><epage>1212</epage><pages>1200-1212</pages><issn>0007-1323</issn><eissn>1365-2168</eissn><coden>BJSUAM</coden><abstract>Background
Postoperative portal vein infusion (PVI) of 5‐fluorouracil (5‐FU) is a well tolerated and widely applicable treatment for colorectal cancer that might have an enormous public health impact, even if it produced survival benefits of just a few per cent. Very large trials are required to detect such differences, and the Adjuvant X‐ray and 5‐FU Infusion Study (AXIS) is the largest such trial yet reported.
Methods
Consenting patients with presumed colorectal cancer were randomized to surgery with or without 7 days of PVI (1 g 5‐FU plus 5000 units heparin in 1 litre 5 per cent dextrose infused over each 24‐h period). In addition, patients with rectal cancer could be randomized to radiotherapy or no radiotherapy to be given either before or after surgery.
Results
Between November 1989 and December 1997, 3583 patients were randomized with respect to PVI. The survival hazard ratios (95 per cent confidence interval (c.i.)) in all patients randomized and in the curatively resected subgroup (71·2 per cent of patients) were 1·00 (0·92 to 1·11) and 0·94 (0·83 to 1·06) respectively. Tests for heterogeneity suggested a greater treatment benefit for patients with colonic cancer than for patients with rectal cancer with respect to disease‐free survival (hazard ratio 0·79 versus 1·03; P = 0·07), and there was a non‐significant trend with respect to overall survival (hazard ratio 0·87 versus 1·03; P = 0·17). No survival benefit was seen in the 761 patients randomized with respect to radiotherapy; although not statistically significant, the impact on local recurrence rates was similar to that reported in the literature.
Conclusion
No overall benefit of PVI was established in AXIS when colonic and rectal cancers were considered together, but the evidence suggesting a differential treatment effect according to site of cancer in AXIS was strongly supported by a meta‐analysis incorporating the previous trials. Combining the data gave hazard ratios of 0·82 and 1·00 for colonic and rectal tumours respectively (test for interaction, P = 0·024), equating to an absolute survival benefit for patients with colonic cancer of 5·8 (95 per cent c.i. 2·8 to 8·5) per cent, a level close to that seen for prolonged systemic therapy. Copyright © 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Potential benefit of 5‐FU infusion in colon cancer</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>14515287</pmid><doi>10.1002/bjs.4266</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Aged Aged, 80 and over Anticoagulants - administration & dosage Antimetabolites, Antineoplastic - administration & dosage Biological and medical sciences Colonic Neoplasms - drug therapy Colonic Neoplasms - radiotherapy Colonic Neoplasms - surgery Diseases of the digestive system Drug Therapy, Combination Female Fluorouracil - administration & dosage Follow-Up Studies Heparin - administration & dosage Humans Infusions, Intravenous Male Medical sciences Middle Aged Patient Compliance Portal Vein Postoperative Care - methods Preoperative Care - methods Radiotherapy, Adjuvant Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Rectal Neoplasms - drug therapy Rectal Neoplasms - radiotherapy Rectal Neoplasms - surgery Survival Analysis Treatment Outcome |
| title | Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS) |
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