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    Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer.

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    Authors
    Cunningham, D
    Pyrhönen, S
    James, Roger D
    Punt, C J
    Hickish, T F
    Heikkila, R
    Johannesen, T B
    Starkhammar, H
    Topham, C A
    Awad, L
    Jacques, C
    Herait, P
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    Affiliation
    Royal Marsden Hospital, Sutton, Surrey, UK.
    Issue Date
    1998-10-31
    
    Metadata
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    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.
    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
    Journal
    Lancet
    URI
    http://hdl.handle.net/10541/91916
    DOI
    10.1016/S0140-6736(98)02309-5
    PubMed ID
    9807987
    Language
    en
    ISSN
    0140-6736
    ae974a485f413a2113503eed53cd6c53
    10.1016/S0140-6736(98)02309-5
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