Department of Radiotherapy and Oncology, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.
Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):101-8. doi: 10.1016/j.ijrobp.2012.03.001. Epub 2012 Jun 1.
To assess the survival benefit of early vs late salvage hormonal therapy (HT), we performed a secondary analysis on patients who developed recurrence from Irish Clinical Oncology Research Group 97-01, a randomized trial comparing 4 vs 8 months neoadjuvant HT plus radiation therapy (RT) in intermediate- and high-risk prostate adenocarcinoma.
A total of 102 patients from the trial who recurred were analyzed at a median follow-up of 8.5 years. The patients were divided into 3 groups based on the timing of salvage HT: 57 patients had prostate-specific antigen (PSA)≤10 ng/mL and absent distant metastases (group 1, early), 21 patients had PSA>10 ng/mL and absent distant metastases (group 2, late), and 24 patients had distant metastases (group 3, late). The endpoint analyzed was overall survival (OS) calculated from 2 different time points: date of enrolment in the trial (OS1) and date of initiation of salvage HT (OS2). Survival was estimated using Kaplan-Meier curves and a Cox regression model.
The OS1 differed significantly between groups (P<.0005): OS1 at 10 years was 78% in group 1, 42% in group 2, and 29% in group 3. The OS2 also differed significantly between groups (P<.0005): OS2 at 6 years was 70% in group 1, 47% in group 2, and 22% in group 3. Group 1 had the longest median time from end of RT to biochemical failure compared with groups 2 and 3 (3.3, 0.9, and 1.7 years, respectively; P<.0005). Group 1 also had the longest median PSA doubling time compared with groups 2 and 3 (9.9, 3.6, and 2.4 months, respectively; P<.0005). On multivariate analysis, timing of salvage HT, time from end of RT to biochemical failure, and PSA nadir on salvage HT were significant predictors of survival.
Early salvage HT based on PSA≤10 ng/mL and absent distant metastases improved survival in patients with prostate cancer after failure of initial treatment with neoadjuvant HT plus RT.
为了评估早期与晚期挽救性激素治疗（HT）的生存获益，我们对爱尔兰临床肿瘤研究组 97-01 试验中出现复发的患者进行了二次分析，该试验比较了 4 个月与 8 个月新辅助 HT 加放疗（RT）在中高危前列腺腺癌中的疗效。
对该试验中 102 例复发患者进行了中位随访 8.5 年的分析。根据挽救性 HT 的时间将患者分为 3 组：57 例前列腺特异性抗原（PSA）≤10ng/mL 且无远处转移（组 1，早期），21 例 PSA>10ng/mL 且无远处转移（组 2，晚期），24 例有远处转移（组 3，晚期）。分析的终点是从 2 个不同时间点计算的总生存（OS）：试验入组日期（OS1）和挽救性 HT 开始日期（OS2）。使用 Kaplan-Meier 曲线和 Cox 回归模型估计生存情况。
组间 OS1 差异有统计学意义（P<.0005）：组 1 的 10 年 OS 为 78%，组 2 为 42%，组 3 为 29%。组间 OS2 差异也有统计学意义（P<.0005）：组 1 的 6 年 OS 为 70%，组 2 为 47%，组 3 为 22%。与组 2 和组 3 相比，组 1 从 RT 结束到生化失败的中位时间最长（分别为 3.3、0.9 和 1.7 年；P<.0005）。与组 2 和组 3 相比，组 1 的 PSA 倍增时间最长（分别为 9.9、3.6 和 2.4 个月；P<.0005）。多因素分析显示，挽救性 HT 的时机、RT 结束到生化失败的时间以及挽救性 HT 时的 PSA 最低点是生存的显著预测因素。
基于 PSA≤10ng/mL 和无远处转移的早期挽救性 HT 可改善新辅助 HT 加 RT 初始治疗失败后前列腺癌患者的生存。
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