ASSESSMENT OF HORMONE-REFRACTORY PROSTATE-CANCER

Objectives. To define guidelines for the assessment of treatment in pa tients with hormone-refractory prostate cancer (HRPC). Methods. In the light of modern research, and taking new treatment options into accou nt, the Committee essays to specify different categories of patients e ntering clinical trials, and to define response criteria and those end points that are relevant in phase III studies and in short-term follow -up. Results. HRPC comprises a range of disease states with varying re sponsiveness to therapy and length of survival. Patients with progress ion as evaluated by increasing prostate-specific antigen (PSA) values alone have a more favorable prognosis than those presenting with incre asing tumor spread. In the assessment of these patients, the modes of previous therapy and the kind of tumor progression must be taken into account. The benefit of treatment of HRPC is often modest. While durat ion of survival remains the main and ultimate endpoint, the means of m easuring short-term responsiveness to therapy are limited, A minority of patients have measurable tumor lesions. Decrease of PSA or other bi ochemical turner markers may indicate depression of the tumor activity , but is not always associated with prolongation of survival. A variet y of new treatments in HRPC are being investigated. They affect measur able tumor parameters in different ways. Conclusions. When a new agent is to be tested, it is important to measure all possible parameters b efore deciding which particular ones are appropriate for future invest igations of this agent, In symptomatic patients, evaluation of subject ive parameters, for example, relief of pain or improvement of performa nce status, is often the most reliable measure of treatment effect. Ho wever, these parameters should be clearly defined. (C) 1997 by Elsevie r Science Inc.