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dc.contributor.authorCunningham, D
dc.contributor.authorPyrhönen, S
dc.contributor.authorJames, Roger D
dc.contributor.authorPunt, C J
dc.contributor.authorHickish, T F
dc.contributor.authorHeikkila, R
dc.contributor.authorJohannesen, T B
dc.contributor.authorStarkhammar, H
dc.contributor.authorTopham, C A
dc.contributor.authorAwad, L
dc.contributor.authorJacques, C
dc.contributor.authorHerait, P
dc.date.accessioned2010-02-12T10:51:33Z
dc.date.available2010-02-12T10:51:33Z
dc.date.issued1998-10-31
dc.identifier.citationRandomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. 1998, 352 (9138):1413-8 Lanceten
dc.identifier.issn0140-6736
dc.identifier.pmid9807987
dc.identifier.doi10.1016/S0140-6736(98)02309-5
dc.identifier.urihttp://hdl.handle.net/10541/91916
dc.description.abstractBACKGROUND: In phase II studies, irinotecan is active in metastatic colorectal cancer, but the overall benefit has not been assessed in a randomised clinical trial. METHODS: Patients with proven metastatic colorectal cancer, which had progressed within 6 months of treatment with fluorouracil, were randomly assigned either 300-350 mg/m2 irinotecan every 3 weeks with supportive care or supportive care alone, in a 2:1 ratio. FINDINGS: 189 patients were allocated irinotecan and supportive care and 90 supportive care alone. The mean age of the participants was 58.8 years; 181 (65%) were men and 98 (35%) were women. WHO performance status was 0 in 79 (42%) patients, 1 in 77 (41%) patients, and 2 in 32 (17%) patients. Tumour-related symptoms were present in 134 (71%) patients and weight loss of more than 5% was seen in 15 (8%) patients. With a median follow-up of 13 months, the overall survival was significantly better in the irinotecan group (p=0.0001), with 36.2% 1-year survival in the irinotecan group versus 13.8% in the supportive-care group. The survival benefit, adjusted for prognostic factors in a multivariate analysis, remained significant (p=0.001). Survival without performance-status deterioration (p=0.0001), without weight loss of more than 5% (p=0.018), and pain-free survival (p=0.003) were significantly better in the patients given irinotecan. In a quality-of-life analysis, all significant differences, except on diarrhoea score, were in favour of the irinotecan group. INTERPRETATION: Our study shows that despite the side-effects of treatment, patients who have metastatic colorectal cancer, and for whom fluorouracil has failed, have a longer survival, fewer tumour-related symptoms, and a better quality of life when treated with irinotecan than with supportive care alone.
dc.language.isoenen
dc.subjectColorectal Canceren
dc.subjectCancer Metastasisen
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAntimetabolites, Antineoplastic
dc.subject.meshAntineoplastic Agents, Phytogenic
dc.subject.meshCamptothecin
dc.subject.meshColorectal Neoplasms
dc.subject.meshFemale
dc.subject.meshFluorouracil
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasm Metastasis
dc.subject.meshPalliative Care
dc.subject.meshProbability
dc.subject.meshQuality of Life
dc.subject.meshSurvival Analysis
dc.subject.meshTreatment Failure
dc.titleRandomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer.en
dc.contributor.departmentRoyal Marsden Hospital, Sutton, Surrey, UK.en
dc.identifier.journalLanceten
html.description.abstractBACKGROUND: In phase II studies, irinotecan is active in metastatic colorectal cancer, but the overall benefit has not been assessed in a randomised clinical trial. METHODS: Patients with proven metastatic colorectal cancer, which had progressed within 6 months of treatment with fluorouracil, were randomly assigned either 300-350 mg/m2 irinotecan every 3 weeks with supportive care or supportive care alone, in a 2:1 ratio. FINDINGS: 189 patients were allocated irinotecan and supportive care and 90 supportive care alone. The mean age of the participants was 58.8 years; 181 (65%) were men and 98 (35%) were women. WHO performance status was 0 in 79 (42%) patients, 1 in 77 (41%) patients, and 2 in 32 (17%) patients. Tumour-related symptoms were present in 134 (71%) patients and weight loss of more than 5% was seen in 15 (8%) patients. With a median follow-up of 13 months, the overall survival was significantly better in the irinotecan group (p=0.0001), with 36.2% 1-year survival in the irinotecan group versus 13.8% in the supportive-care group. The survival benefit, adjusted for prognostic factors in a multivariate analysis, remained significant (p=0.001). Survival without performance-status deterioration (p=0.0001), without weight loss of more than 5% (p=0.018), and pain-free survival (p=0.003) were significantly better in the patients given irinotecan. In a quality-of-life analysis, all significant differences, except on diarrhoea score, were in favour of the irinotecan group. INTERPRETATION: Our study shows that despite the side-effects of treatment, patients who have metastatic colorectal cancer, and for whom fluorouracil has failed, have a longer survival, fewer tumour-related symptoms, and a better quality of life when treated with irinotecan than with supportive care alone.


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