Comparison of treatment outcome in metastatic colorectal cancer patients included in a clinical trial versus daily practice in The Netherlands
- 21 March 2013
- journal article
- research article
- Published by Taylor & Francis Ltd in Acta Oncologica
- Vol. 52 (5), 950-955
- https://doi.org/10.3109/0284186x.2013.777158
Abstract
The external validity of trial results is a matter of debate, and no strong evidence is available to support whether a trial may have a positive or a negative effect on the outcome of patients. Methods. We compared the results of stage IV colorectal cancer patients treated within a large Dutch phase III trial (CAIRO), in which standard chemotherapy and standard safety eligibility criteria were used, to patients treated outside the trial during the trial accrual period in a representative selection of 29 Dutch hospitals. Non-trial patients were identified by the Netherlands Cancer Registry (NCR), and were checked for the trial eligibility criteria. Results. The NCR registered 1946 stage IV colorectal cancer patients who received chemotherapy, of whom 394 patients were included in the CAIRO trial and 30 patients in other trials. Thus, the CAIRO trial participation rate was 20%. In the 29 hospitals, 162 patients received chemotherapy in the trial and 396 patients received chemotherapy outside the trial. Of the non-trial patients, 224 patients fulfilled the trial eligibility criteria. The overall survival of eligible non-trial patients was comparable to trial patients (HR 1.03, p = 0.70). However, non-eligible non-trial patients had a significantly worse outcome (HR 1.70, pKeywords
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