Debruyne F M, Witjes W P
Department of Urology, University Medical Center, Nijmegen, The Netherlands. F.debruyne@
Mol Urol. 2000 Fall;4(3):251-6;discussion 257.
Neoadjuvant hormonal therapy (NHT) has been used for more than a decade for prostate cancer, but the results of clinical trials are only now becoming available, and the value of the treatment is not yet clear. The authors reviewed the results of the European randomized trials to increase our understanding of the role of this treatment.
We report the results of 402 patients with prostate cancer (220 clinical stage T(2) and 182 clinical T(3) tumor), of whom 192 were randomly assigned to NHT using an LHRH analog (goserelin) plus flutamide for a period of 3 months (NHT) and 210 underwent radical prostatectomy only (RP).
"Pathologic downstaging" occurred in 15% and 7% of the NHT and the RP group, respectively (P < 0.01). Fifty of the 189 patients in the NHT group (26%) and 68 of the 209 patients in the RP group (33%) developed disease progression, as determined by rising serum prostate specific antigen (PSA) concentration. Regarding local disease progression, the advantage for the use of NHT approached but did not reach statistical significance:18 of 189 patients (10%) in the NHT group and 33 of 209 patients (16%) in the RP group (P = 0. 07).
Although there was a trend in favor of the NHT group with respect to the number of patients with PSA progression and the number with local disease progression, it did not reach statistical significance. These results may be attributable to a true lack of benefit of adjuvant hormonal ablation or to a lack of statistical power to demonstrate a difference in a subset of patients who might benefit from this therapy.
新辅助激素治疗（NHT）用于前列腺癌已有十多年，但临床试验结果目前才可得，且该治疗的价值尚不清楚。作者回顾了欧洲随机试验的结果，以增进我们对这种治疗作用的理解。
我们报告了402例前列腺癌患者的结果（220例临床分期为T(2)期，182例临床T(3)期肿瘤），其中192例被随机分配接受使用促性腺激素释放激素类似物（戈舍瑞林）加氟他胺进行为期3个月的NHT（NHT组），210例仅接受根治性前列腺切除术（RP组）。
NHT组和RP组分别有15%和7%出现“病理降期”（P<0.01）。根据血清前列腺特异性抗原（PSA）浓度升高判断，NHT组189例患者中有50例（26%）、RP组209例患者中有68例（33%）出现疾病进展。关于局部疾病进展，使用NHT的优势接近但未达到统计学意义：NHT组189例患者中有18例（10%），RP组209例患者中有33例（16%）（P = 0.07）。
尽管在PSA进展患者数量和局部疾病进展患者数量方面，NHT组有一定趋势，但未达到统计学意义。这些结果可能归因于辅助激素消融治疗确实缺乏益处，或缺乏统计学效力来证明在可能从该治疗中获益的部分患者中存在差异。
