Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer.
dc.contributor.author | Cunningham, D | |
dc.contributor.author | Pyrhönen, S | |
dc.contributor.author | James, Roger D | |
dc.contributor.author | Punt, C J | |
dc.contributor.author | Hickish, T F | |
dc.contributor.author | Heikkila, R | |
dc.contributor.author | Johannesen, T B | |
dc.contributor.author | Starkhammar, H | |
dc.contributor.author | Topham, C A | |
dc.contributor.author | Awad, L | |
dc.contributor.author | Jacques, C | |
dc.contributor.author | Herait, P | |
dc.date.accessioned | 2010-02-12T10:51:33Z | |
dc.date.available | 2010-02-12T10:51:33Z | |
dc.date.issued | 1998-10-31 | |
dc.identifier.citation | Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. 1998, 352 (9138):1413-8 Lancet | en |
dc.identifier.issn | 0140-6736 | |
dc.identifier.pmid | 9807987 | |
dc.identifier.doi | 10.1016/S0140-6736(98)02309-5 | |
dc.identifier.uri | http://hdl.handle.net/10541/91916 | |
dc.description.abstract | BACKGROUND: 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.iso | en | en |
dc.subject | Colorectal Cancer | en |
dc.subject | Cancer Metastasis | en |
dc.subject.mesh | Adult | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Antimetabolites, Antineoplastic | |
dc.subject.mesh | Antineoplastic Agents, Phytogenic | |
dc.subject.mesh | Camptothecin | |
dc.subject.mesh | Colorectal Neoplasms | |
dc.subject.mesh | Female | |
dc.subject.mesh | Fluorouracil | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Male | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Neoplasm Metastasis | |
dc.subject.mesh | Palliative Care | |
dc.subject.mesh | Probability | |
dc.subject.mesh | Quality of Life | |
dc.subject.mesh | Survival Analysis | |
dc.subject.mesh | Treatment Failure | |
dc.title | Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. | en |
dc.contributor.department | Royal Marsden Hospital, Sutton, Surrey, UK. | en |
dc.identifier.journal | Lancet | en |
html.description.abstract | BACKGROUND: 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. |