Chemotherapy for patients with hormone-refractory prostate cancer

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Abstract
Recognition that chemotherapy can provide useful palliation for patients with hormone-refractory prostate cancer (HRPC) is relatively recent. Most early clinical trials either evaluated response to chemotherapy in (the relatively rare) patients with measurable disease or used criteria developed by the National Prostate Cancer Project (NPCP), where response included ‘stable disease’ on bone scans [1]. These criteria could not separate patients who were experiencing meaningful effects of chemotherapy from those with slow progression of disease that was not influenced by treatment. Patients with HRPC are often elderly, and have co-morbid conditions, so that chemotherapy is relatively toxic. In the mid-1980s, two reviews of this prior experience suggested that there was no routine role for chemotherapy in the management of HRPC and that it should only be used in the context of a well-designed clinical trial [2, 3]. More recently, the role of chemotherapy has been revisited with the use of less toxic regimens and the development of more relevant outcomes. A decline of at least 50% of the serum level of prostate-specific antigen (PSA) has been adopted as a surrogate marker for tumour response in the absence of clinical or radiographic evidence of disease progression. This end point is useful in phase II trials that seek to demonstrate the activity of new agents or combinations [4]. Palliative end points that are more relevant to pragmatic phase III trials have been developed based on control of symptoms, using validated self-report scales for pain and quality-of-life questionnaires [5].

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