Witjes W P, Schulman C C, Debruyne F M
Department of Urology, University Hospital Nijmegen, The Netherlands.
Urology. 1997 Mar;49(3A Suppl):65-9. doi: 10.1016/s0090-4295(97)00171-4.
To evaluate the short- and long-term effects of neoadjuvant hormonal treatment in locally confined prostate cancer.
We report the preliminary results of 354 patients (199 with a clinical T2 tumor and 155 with a clinical T3 tumor) of whom 164 randomly received neoadjuvant total androgen deprivation using a luteinizing-hormone-releasing hormone (LHRH) analog (goserelin) plus flutamide for a period of 3 months.
Serum prostate-specific antigen (PSA) levels and prostatic volume decreased from a mean of 19.9 ng/mL and 37.7 cm3 to a mean of 0.8 ng/mL and 26.5 cm3 after 3 months of neoadjuvant therapy. "Clinical down-staging" was seen in 32% in the neoadjuvantly treated group. "Pathological downstaging" percentages were 6% and 16% in the direct radical prostatectomy group and neoadjuvantly-treated group, respectively (P < 0.01). In patients with clinical T2 tumors, a significant difference in number of positive margins was shown in favor of the neoadjuvantly treated group (P < 0.01). In patients with clinical T3 tumors, a significant difference could not be detected (P = 0.14). In 215 patients with a mean follow-up time of 15 months, the calculated 95% confidence intervals of mean time of PSA progression-free survival were 26 to 35 months in the neoadjuvantly-treated group and 28 to 37 months in the direct radical prostatectomy group, indicating no significant differences between treatment groups. However, follow-up time is currently too short to draw definite conclusions.
These early data confirm high understaging percentages in clinical staging. The clinical relevance of the statistically significant smaller numbers of patients with positive margins in the neoadjuvantly treated group with a clinical T2 tumor will have to be confirmed when further follow-up allows an accurate evaluation of time to PSA progression, local recurrence, and distant metastases. Presently, neoadjuvant therapy is not advisable outside clinical research settings.
评估新辅助激素治疗对局限性前列腺癌的短期和长期影响。
我们报告了354例患者（199例临床T2期肿瘤患者和155例临床T3期肿瘤患者）的初步结果，其中164例患者随机接受使用促黄体激素释放激素（LHRH）类似物（戈舍瑞林）加氟他胺进行为期3个月的新辅助全雄激素剥夺治疗。
新辅助治疗3个月后，血清前列腺特异性抗原（PSA）水平和前列腺体积从平均19.9 ng/mL和37.7 cm³分别降至平均0.8 ng/mL和26.5 cm³。新辅助治疗组中32%出现“临床降期”。直接根治性前列腺切除术组和新辅助治疗组的“病理降期”百分比分别为6%和16%（P<0.01）。在临床T2期肿瘤患者中，切缘阳性数量在新辅助治疗组中显示出显著差异（P<0.01）。在临床T3期肿瘤患者中，未检测到显著差异（P = 0.14）。在215例平均随访时间为15个月的患者中，新辅助治疗组PSA无进展生存期的平均时间计算的95%置信区间为26至35个月，直接根治性前列腺切除术组为28至37个月，表明治疗组之间无显著差异。然而，目前随访时间过短，无法得出明确结论。
这些早期数据证实临床分期中分期不足的比例很高。当进一步随访能够准确评估PSA进展时间、局部复发和远处转移时，新辅助治疗组中临床T2期肿瘤且切缘阳性患者数量在统计学上显著较少的临床相关性将必须得到证实。目前，在临床研究环境之外，新辅助治疗并不建议使用。
