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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
5-6
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pubmed:dateCreated |
1999-6-23
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pubmed:abstractText |
This study compared the efficacy and safety of 5-fluorouracil (5-FU) monotherapy to that of 5-FU combined with natural human interferon-beta (IFN-beta) in patients with unresectable, advanced colorectal carcinoma. Forty-nine chemotherapy-naive patients were randomized to 5-FU alone or to the combination. All patients received 750 mg m(-2) day(-1) 5-FU for 5 days by continuous intravenous (i.v.) infusion, followed after day 15 by a weekly i.v. bolus of 750 mg m(-2). IFN-beta was injected intramuscularly three times weekly at 9 M IU. Treatment continued for 52 weeks, or until disease progression or intolerable toxicity. Clinical endpoints were tumor response, time to progression, survival and toxicity. The addition of IFN-3 to 5-FU significantly improved response rate (33.3% vs 4.5% for evaluable patients; P = 0.021), time to progression (median 7.2 vs 4.2 months; P = 0.0435), and survival time (median 15.9 vs 7.2 months; P = 0.038) without significantly increasing toxicity compared to 5-FU alone. Cumulative 5-FU dose was higher with combined therapy (P < 0.001): more patients receiving monotherapy discontinued treatment because of disease progression. Fever was more frequent with combined therapy (P = 0.008); there were no other differences in toxicity. The only grade IV toxicity observed was neutropenia (two patients per group). A randomized phase III trial has been initiated to confirm the synergy between 5-FU and IFN-beta.
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pubmed:commentsCorrections |
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-1255749,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-13418758,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-168961,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-2230894,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-2249187,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-2476530,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-2494120,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-2585018,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-3280741,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-6157095,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-7139598,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-7606310,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-7642571,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-7669711,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-7751874,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-7751875,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-8027027,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-8708717,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-8874326,
http://linkedlifedata.com/resource/pubmed/commentcorrection/10360656-8879370
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
May
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pubmed:issn |
0007-0920
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pubmed:author |
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pubmed:issnType |
Print
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pubmed:volume |
80
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
786-91
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pubmed:dateRevised |
2009-11-18
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pubmed:meshHeading |
pubmed-meshheading:10360656-Aged,
pubmed-meshheading:10360656-Antimetabolites, Antineoplastic,
pubmed-meshheading:10360656-Antineoplastic Agents,
pubmed-meshheading:10360656-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:10360656-Colorectal Neoplasms,
pubmed-meshheading:10360656-Combined Modality Therapy,
pubmed-meshheading:10360656-Disease Progression,
pubmed-meshheading:10360656-Drug Administration Schedule,
pubmed-meshheading:10360656-Drug Synergism,
pubmed-meshheading:10360656-Female,
pubmed-meshheading:10360656-Fluorouracil,
pubmed-meshheading:10360656-Humans,
pubmed-meshheading:10360656-Infusions, Intravenous,
pubmed-meshheading:10360656-Interferon-beta,
pubmed-meshheading:10360656-Male,
pubmed-meshheading:10360656-Middle Aged,
pubmed-meshheading:10360656-Survival Analysis
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pubmed:year |
1999
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pubmed:articleTitle |
A randomized phase II trial of 5-fluorouracil, with or without human interferon-beta, for advanced colorectal cancer.
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pubmed:affiliation |
H. Arnau de Vilanova, Valencia, Spain.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Randomized Controlled Trial,
Multicenter Study,
Clinical Trial, Phase II
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