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Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer.

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Title: Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer.
Authors: Rougier, Philippe, Van Cutsem, Eric, Bajetta, Emilio, Niederle, Norbert, Possinger, Kurt, Labianca, Roberto, Navarro, Matilde, Morant, Rudolf, Bleiberg, Harry, Wils, Jacques, Awad, Lucile, Herait, Patrice, Jacques, Christian, Rougier, P (AUTHOR), Van Cutsem, E (AUTHOR), Bajetta, E (AUTHOR), Niederle, N (AUTHOR), Possinger, K (AUTHOR), Labianca, R (AUTHOR), Navarro, M (AUTHOR)
Source: Lancet. 10/31/1998, Vol. 352 Issue 9138, p1407-1412. 6p. 1 Diagram, 5 Charts, 3 Graphs.
Subjects: Camptothecin, Fluorouracil, Colon cancer, Metastasis, Cancer chemotherapy, Drug therapy, Therapeutics
Abstract: Background: In phase II trials, irinotecan is active in patients with advanced colorectal cancer, but the survival and clinical benefit of irinotecan compared with second-line fluorouracil by continuous infusion is not known.Methods: 267 patients who had failed to respond to first-line fluorouracil, or whose disease had progressed after treatment with first-line fluorouracil were randomly allocated irinotecan 300-350 mg/m2 infused once every 3 weeks or fluorouracil by continuous infusion. Treatment was given until disease progression, unacceptable toxic effects, or the patient refused to continue treatment. The primary endpoint was survival, while progression-free survival, response rate, symptom-free survival, adverse events, and quality of life (QoL) were secondary endpoints.Findings: 133 patients were randomly allocated irinotecan and 134 were allocated fluorouracil by continuous infusion. Patients treated with irinotecan lived for significantly longer than patients on fluorouracil (p=0.035). Survival at 1 year was increased from 32% in the fluorouracil group to 45% in the irinotecan group. Median survival was 10.8 months in the irinotecan group and 8.5 months in the fluorouracil group. Median progression-free survival was longer with irinotecan (4.2 vs 2.9 months for irinotecan vs fluorouracil, respectively; p=0.030). The median pain-free survival was 10.3 months and 8.5 months (p=0.06) for irinotecan and fluorouracil, respectively. Both treatments were equally well tolerated. QoL was similar in both groups.Interpretation: Compared with fluorouracil by continuous infusion second-line irinotecan significantly improved survival in patients with advanced colorectal cancer. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer.
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  Data: <searchLink fieldCode="AR" term="%22Rougier%2C+Philippe%22">Rougier, Philippe</searchLink><br /><searchLink fieldCode="AR" term="%22Van+Cutsem%2C+Eric%22">Van Cutsem, Eric</searchLink><br /><searchLink fieldCode="AR" term="%22Bajetta%2C+Emilio%22">Bajetta, Emilio</searchLink><br /><searchLink fieldCode="AR" term="%22Niederle%2C+Norbert%22">Niederle, Norbert</searchLink><br /><searchLink fieldCode="AR" term="%22Possinger%2C+Kurt%22">Possinger, Kurt</searchLink><br /><searchLink fieldCode="AR" term="%22Labianca%2C+Roberto%22">Labianca, Roberto</searchLink><br /><searchLink fieldCode="AR" term="%22Navarro%2C+Matilde%22">Navarro, Matilde</searchLink><br /><searchLink fieldCode="AR" term="%22Morant%2C+Rudolf%22">Morant, Rudolf</searchLink><br /><searchLink fieldCode="AR" term="%22Bleiberg%2C+Harry%22">Bleiberg, Harry</searchLink><br /><searchLink fieldCode="AR" term="%22Wils%2C+Jacques%22">Wils, Jacques</searchLink><br /><searchLink fieldCode="AR" term="%22Awad%2C+Lucile%22">Awad, Lucile</searchLink><br /><searchLink fieldCode="AR" term="%22Herait%2C+Patrice%22">Herait, Patrice</searchLink><br /><searchLink fieldCode="AR" term="%22Jacques%2C+Christian%22">Jacques, Christian</searchLink><br /><searchLink fieldCode="AR" term="%22Rougier%2C+P%22">Rougier, P</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Van+Cutsem%2C+E%22">Van Cutsem, E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bajetta%2C+E%22">Bajetta, E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Niederle%2C+N%22">Niederle, N</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Possinger%2C+K%22">Possinger, K</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Labianca%2C+R%22">Labianca, R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Navarro%2C+M%22">Navarro, M</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 10/31/1998, Vol. 352 Issue 9138, p1407-1412. 6p. 1 Diagram, 5 Charts, 3 Graphs.
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  Data: <searchLink fieldCode="DE" term="%22Camptothecin%22">Camptothecin</searchLink><br /><searchLink fieldCode="DE" term="%22Fluorouracil%22">Fluorouracil</searchLink><br /><searchLink fieldCode="DE" term="%22Colon+cancer%22">Colon cancer</searchLink><br /><searchLink fieldCode="DE" term="%22Metastasis%22">Metastasis</searchLink><br /><searchLink fieldCode="DE" term="%22Cancer+chemotherapy%22">Cancer chemotherapy</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+therapy%22">Drug therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: <bold>Background: </bold>In phase II trials, irinotecan is active in patients with advanced colorectal cancer, but the survival and clinical benefit of irinotecan compared with second-line fluorouracil by continuous infusion is not known.<bold>Methods: </bold>267 patients who had failed to respond to first-line fluorouracil, or whose disease had progressed after treatment with first-line fluorouracil were randomly allocated irinotecan 300-350 mg/m2 infused once every 3 weeks or fluorouracil by continuous infusion. Treatment was given until disease progression, unacceptable toxic effects, or the patient refused to continue treatment. The primary endpoint was survival, while progression-free survival, response rate, symptom-free survival, adverse events, and quality of life (QoL) were secondary endpoints.<bold>Findings: </bold>133 patients were randomly allocated irinotecan and 134 were allocated fluorouracil by continuous infusion. Patients treated with irinotecan lived for significantly longer than patients on fluorouracil (p=0.035). Survival at 1 year was increased from 32% in the fluorouracil group to 45% in the irinotecan group. Median survival was 10.8 months in the irinotecan group and 8.5 months in the fluorouracil group. Median progression-free survival was longer with irinotecan (4.2 vs 2.9 months for irinotecan vs fluorouracil, respectively; p=0.030). The median pain-free survival was 10.3 months and 8.5 months (p=0.06) for irinotecan and fluorouracil, respectively. Both treatments were equally well tolerated. QoL was similar in both groups.<bold>Interpretation: </bold>Compared with fluorouracil by continuous infusion second-line irinotecan significantly improved survival in patients with advanced colorectal cancer. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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