Fair W R, Betancourt J E
Department of Urology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
Mol Urol. 2000 Fall;4(3):241-8;discussion 249-50.
We report the results of surgery in 520 patients with clinically localized carcinoma of the prostate (CaP) who received preoperative neoadjuvant hormonal therapy (NHT) for 3 to 11(+) months.
The results in the NHT patients were compared with those in 1,413 men having surgery without NHT at our institution during the same time period. In the group without pretreatment, the median and mean follow-up was 36 and 21 months, respectively. In the patients receiving NHT, the median follow-up was 33 months and the mean 41 months.
The overall disease-free survival (DFS) rate (serum prostate specific antigen [PSA] concentration < or = 0.2 ng/mL) was 75% at 5 years and 50% at 10 years. There was no statistically significant difference in overall DFS rate between men who had NHT and those who did not. No DFS advantage could be demonstrated for those patients with a presenting PSA >20 ng/mL who received NHT compared with patients with the same PSA concentration who did not receive NHT. Despite our previous experience indicating improved survival with NHT in men with a presenting PSA of > 10 ng/mL, we could find no advantage to NHT in enhancing DFS. At a median survival of 35 months (mean 41 months) in 201 men with an initial PSA > or = 10 ng/mL, 70% had an undetectable PSA concentration at 5 years compared with 72% at the same time point in men presenting with PSA <10 ng/mL. In the group expected to have the best surgical result; i.e. those men whose preoperative PSA was < or = 7 ng/mL, there was no DFS difference in men given NHT compared with those having no hormonal manipulation. Patients presenting with stage T(1) disease had a significantly better DFS than those with either T(2) or T(3) CaP. However, within each stage, the addition of NHT to surgery did not result in a higher DFS rate. The 5- and 10-year DFS rates for stage T(1) were 80% and 64%, for T2 disease 78% and 50%, and for T3 disease 67% and 50%. There was a statistically significant difference (P < or = 0.003) in survival between stage T(1) and stage T(2) disease, but no significant difference in DFS was noted in patients presenting with stage T(2) compared with T3 cancer (P = 0.431). Gleason score was not a significant predictor of durable DFS, and the addition of NHT did not improve the DFS within groups of patients with similar Gleason scores. Men with only one or two positive biopsy cores did significantly better than those with more than three positive cores (P = 0.06). There was a significant difference in DFS between men who had organ-confined disease and those with disease outside the gland (P = 0.0003). However, NHT did not improve DFS. The presence of positive surgical margins was a negative prognostic factor (P = 0. 001). Men who received NHT had a statistically lower positive margin rate (P = 0.001), but NHT did not increase the likelihood of a durable DFS (P = 0.175). The duration of NHT did not affect the DFS (P = 0.100 for <3 v >3 months).
There appears to be no subset of men undergoing radical prostatectomy in whom the routine administration of NHT is beneficial despite the statistically significant improvement in the pathologic findings.
我们报告了520例临床局限性前列腺癌（CaP）患者接受3至11（+）个月术前新辅助激素治疗（NHT）后的手术结果。
将接受NHT治疗患者的结果与同期在我们机构接受手术但未接受NHT的1413名男性的结果进行比较。在未进行预处理的组中，中位随访时间和平均随访时间分别为36个月和21个月。在接受NHT治疗的患者中，中位随访时间为33个月，平均为41个月。
5年时总体无病生存率（DFS）（血清前列腺特异性抗原[PSA]浓度≤0.2 ng/mL）为75%，10年时为50%。接受NHT治疗的男性与未接受NHT治疗的男性在总体DFS率上无统计学显著差异。与未接受NHT治疗且PSA浓度相同的患者相比，接受NHT治疗且初始PSA>20 ng/mL的患者在DFS方面未显示出优势。尽管我们之前的经验表明，初始PSA>10 ng/mL的男性接受NHT治疗后生存率有所提高，但我们未发现NHT在提高DFS方面有优势。在201例初始PSA≥10 ng/mL的男性中，中位生存期为35个月（平均41个月），5年时70%的患者PSA浓度检测不到，而初始PSA<10 ng/mL的男性在同一时间点这一比例为72%。在预期手术效果最佳的组中，即术前PSA≤7 ng/mL的男性中，接受NHT治疗的男性与未进行激素处理的男性在DFS方面无差异。表现为T（1）期疾病的患者DFS明显优于T（2）期或T（3）期CaP患者。然而，在每个分期内，手术联合NHT治疗并未导致更高的DFS率。T（1）期的5年和10年DFS率分别为80%和64%，T2期疾病分别为78%和50%，T3期疾病分别为67%和50%。T（1）期和T（2）期疾病在生存率上有统计学显著差异（P≤0.003），但T（2）期患者与T3期癌症患者在DFS方面未发现显著差异（P = 0.431）。Gleason评分不是持久DFS的显著预测因素，在Gleason评分相似的患者组中添加NHT并未改善DFS。仅一两个活检核心阳性的男性比三个以上活检核心阳性的男性DFS明显更好（P = 0.06）。有器官局限性疾病的男性与腺体外有疾病的男性在DFS方面有显著差异（P = 0.0003）。然而，NHT并未改善DFS。手术切缘阳性是一个不良预后因素（P = 0.001）。接受NHT治疗的男性手术切缘阳性率在统计学上较低（P = 0.001），但NHT并未增加持久DFS的可能性（P = 0.175）。NHT的持续时间未影响DFS（<3个月与>3个月相比，P = 0.100）。
尽管病理结果有统计学显著改善，但在接受根治性前列腺切除术的男性中，似乎没有一个亚组能从常规给予NHT中获益。
