根治性前列腺切除术术后辅助放疗与观察等待的比较：ARO 96-02/AUO AP 09/95 试验的 10 年随访结果。

Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96-02/AUO AP 09/95 trial.

机构信息

Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany.

出版信息

Eur Urol. 2014 Aug;66(2):243-50. doi: 10.1016/j.eururo.2014.03.011. Epub 2014 Mar 21.

DOI:10.1016/j.eururo.2014.03.011

PMID:24680359

Abstract

BACKGROUND

Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy (ART) compared with a wait-and-see (WS) policy.

OBJECTIVE

To determine the efficiency of ART after a 10-yr follow-up in the ARO 96-02 study.

DESIGN, SETTING, AND PARTICIPANTS: After RP, 388 patients with pT3 pN0 prostate cancer (PCa) were randomized to WS or three-dimensional conformal ART with 60 Gy. The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP (ITT2 population)--that is, 159 WS plus 148 ART men.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary end point of the study was progression-free survival (PFS) (events: biochemical recurrence, clinical recurrence, or death). Outcomes were compared by log-rank test. Cox regression analysis served to identify variables influencing the course of disease.

RESULTS AND LIMITATIONS

The median follow-up was 111 mo for ART and 113 mo for WS. At 10 yr, PFS was 56% for ART and 35% for WS (p<0.0001). In pT3b and R1 patients, the rates for WS even dropped to 28% and 27%, respectively. Of all 307 ITT2 patients, 15 died from PCa, and 28 died for other or unknown reasons. Neither metastasis-free survival nor overall survival was significantly improved by ART. However, the study was underpowered for these end points. The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity. No grade 4 events occurred.

CONCLUSIONS

Compared with WS, ART reduced the risk of (biochemical) progression with a hazard ratio of 0.51 in pT3 PCa. With only one grade 3 case of late toxicity, ART was safe.

PATIENT SUMMARY

Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors.

摘要

背景

根治性前列腺切除术（RP）后局部复发在肿瘤突破包膜的患者中很常见。三项前瞻性随机试验表明，辅助放疗（ART）与观察等待（WS）策略相比具有优势。

目的

在 ARO 96-02 研究的 10 年随访中确定 ART 的疗效。

设计、地点和参与者：在 RP 后，388 例 pT3 pN0 前列腺癌（PCa）患者被随机分为 WS 或三维适形 ART 组，接受 60 Gy 放疗。本分析重点关注 RP 后前列腺特异性抗原（PSA）检测不到的意向治疗（ITT2 人群）患者，即 159 例 WS 加 148 例 ART 男性。

测量和统计分析的结果

研究的主要终点是无进展生存（PFS）（事件：生化复发、临床复发或死亡）。采用对数秩检验比较结果。Cox 回归分析用于确定影响疾病进程的变量。

结果和局限性

ART 的中位随访时间为 111 个月，WS 为 113 个月。10 年时，ART 的 PFS 为 56%，WS 为 35%（p<0.0001）。在 pT3b 和 R1 患者中，WS 的比率甚至分别降至 28%和 27%。在所有 307 例 ITT2 患者中，有 15 例死于 PCa，28 例死于其他原因或原因不明。ART 并不能显著改善无转移生存或总生存。然而，这些终点的研究效力不足。ART 队列中最严重的晚期后遗症是 1 例 3 级和 3 例 2 级膀胱毒性和 2 例 2 级直肠毒性。没有发生 4 级事件。