Objectives: Improvements in quality of life (QoL) and disease-related symptoms are key goals in the treatment of hormone refractory prostate cancer (HRPC). Our aim was to evaluate the impact of gefitinib on QoL of patients with HRPC. Methods: Patients with HRPC received gefitinib 250 mg daily in addition to antiandrogen plus luteinizing hormone-releasing hormone (LHRH) analogue for at least 2 months or until disease progression. QoL was evaluated monthly by the European Organisation for Research on the Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Pain was assessed daily by patients and scored by visual analogue scale and analgesic consumption in a diary. Monthly pain intensity was estimated using the McGill-Melzack questionnaire. Results: Analysis of global health status according to EORTC QLQ-C30 showed an improvement of the status in only 6 patients (26%). The greatest benefit in the patients was in the subscale representing prostate-specific concerns (including appetite, pain, physical comfort, and genitourinary function). Improvement of symptoms was correlated with antiandrogen withdrawal. Global health status and QoL decreased during treatment according to tumor progression. Conclusions: Among HRPC patients treated with gefitinib, improvement of symptoms preceded evidence of biochemical response of prostate-specific antigen following antiandrogen withdrawal. These findings suggest no beneficial effect of gefitinib in QoL improvement.

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