A systematic review and meta-analysis of randomised trials of neo-adjuvant hormone therapy for localised and locally advanced prostate carcinoma

Background: We performed a systematic review and meta-analysis of randomised trials of neo-adjuvant hormone therapy (NHT) in localised and locally advanced prostate cancer to assess the effectiveness of this therapy. Methods: We searched MEDLINE, The Cochrane Library, Science Citation Index, LILACS and SIGLE for randomised trials comparing NHT plus primary therapy (radiotherapy or prostatectomy) with primary therapy alone. Data included information on study design, participants, interventions, and outcomes. Comparable data were extracted from eligible studies and pooled for meta-analysis with intention to treat principle. Findings: NHT prior to prostatectomy did not improve overall or disease-free survival, but did significantly reduce positive margin rates (RR 0.49, 95% CI 0.42-0.56, p < 0.00001), organ confinement (RR 1.63, 95% CI 1.37-1.95, p < 0.0001) and lymph node invasion (RR 0.49, 95% CI 0.42-0.56, p < 0.02). In one study NHT before radiotherapy significantly improved overall survival for men with Gleason 2-6 (p = 0.015). In addition, there was a significant improvement in both clinical disease-free survival (RR 1.46, 95% CI 1.24-1.71, p < 0.00001) and biochemical disease-free survival (RR 1.59, 95% CI 1.00-2.55, p = 0.05). Toxicities included hot flushes, gastrointestinal, hepatic and miscellaneous adverse events. Conclusions: NHT is associated with significant clinical benefit when given with radiotherapy and improves pathological outcome prior to prostatectomy but is of minimal value prior to radical prostatectomy. The decision to use hormone therapy should be discussed between the patient, the clinician and policy maker based on the benefits, toxicity and cost.