Summary
Very strict entry criteria are employed by the EORTC Genito-Urinary Group in phase II chemotherapy studies in metastatic prostate cancer. In order to objectively define response, only bi-dimensionally measurable soft tissue and visceral lesions are accepted. There is a paucity of such lesions. The primary lesion, measured by rectal ultrasound, was used as an indicator lesion in patients with bone metastases in two consecutive single-agent studies in an attempt to increase recruitment. This patient population was shown to have different characteristics than the patients with measurable metastatic indicator lesions in both studies. Besides differences in the proportions in the response categories, other differences between the two groups were evident. Consequently the primary lesion will no longer be used to assess response in future studies.
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Other members of the EORTC Genito-Urinary Group contributing to this study were: F. Calais da Silva, Lisbon, Portugal; L. Denis and F. Keuppens, Brussels, Belgium; M. Pavone-Macaluso, Palermo, Italy; G. Stoter, Amsterdam, The Netherlands
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Jones, W.G., Bono, A.V., Verbaeys, A. et al. Can the primary tumour be used as the sole parameter for response in phase II chemotherapy studies in metastatic prostate cancer? An EORTC Genito-Urinary Group Report. World J Urol 4, 176–181 (1986). https://doi.org/10.1007/BF00327016
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DOI: https://doi.org/10.1007/BF00327016