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    Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial.

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    Authors
    Rustin, G
    Van der Burg, M
    Griffin, C
    Guthrie, D
    Lamont, A
    Jayson, Gordon C
    Kristensen, G
    Mediola, C
    Coens, C
    Qian, W
    Parmar, M
    Swart, A
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    Affiliation
    Mount Vernon Cancer Centre, Northwood, UK.
    Issue Date
    2010-10-02
    
    Metadata
    Show full item record
    Abstract
    BACKGROUND: Serum CA125 concentration often rises several months before clinical or symptomatic relapse in women with ovarian cancer. In the MRC OV05/EORTC 55955 collaborative trial, we aimed to establish the benefits of early treatment on the basis of increased CA125 concentrations compared with delayed treatment on the basis of clinical recurrence. METHODS: Women with ovarian cancer in complete remission after first-line platinum-based chemotherapy and a normal CA125 concentration were registered for this randomised controlled trial. Clinical examination and CA125 measurement were done every 3 months. Patients and investigators were masked to CA125 results, which were monitored by coordinating centres. If CA125 concentration exceeded twice the upper limit of normal, patients were randomly assigned (1:1) by minimisation to early or delayed chemotherapy. Patients and clinical sites were informed of allocation to early treatment, and treatment was started as soon as possible within 28 days of the increased CA125 measurement. Patients assigned to delayed treatment continued masked CA125 measurements, with treatment commencing at clinical or symptomatic relapse. All patients were treated according to standard local practice. The primary outcome was overall survival. Analysis was by intention to treat. This study is registered, ISRCTN87786644. FINDINGS: 1442 patients were registered for the trial, of whom 529 were randomly assigned to treatment groups and were included in our analysis (265 early, 264 delayed). With a median follow-up of 56·9 months (IQR 37·4-81·8) from randomisation and 370 deaths (186 early, 184 delayed), there was no evidence of a difference in overall survival between early and delayed treatment (HR 0·98, 95% CI 0·80-1·20, p=0·85). Median survival from randomisation was 25·7 months (95% CI 23·0-27·9) for patients on early treatment and 27·1 months (22·8-30·9) for those on delayed treatment. INTERPRETATION: Our findings showed no evidence of a survival benefit with early treatment of relapse on the basis of a raised CA125 concentration alone, and therefore the value of routine measurement of CA125 in the follow-up of patients with ovarian cancer who attain a complete response after first-line treatment is not proven. FUNDING: UK Medical Research Council and the European Organisation for Research and Treatment of Cancer.
    Citation
    Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. 2010, 376 (9747):1155-63 Lancet
    Journal
    Lancet
    URI
    http://hdl.handle.net/10541/115828
    DOI
    10.1016/S0140-6736(10)61268-8
    PubMed ID
    20888993
    Type
    Article
    Language
    en
    Description
    Tumor Markers, Biological
    ISSN
    1474-547X
    ae974a485f413a2113503eed53cd6c53
    10.1016/S0140-6736(10)61268-8
    Scopus Count
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    All Christie Publications
    Medical Oncology

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