Department of Radiation Oncology, Dana Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.
Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1046-52. doi: 10.1016/j.ijrobp.2009.06.038. Epub 2009 Oct 26.
Six months of androgen suppression therapy (AST) plus radiation (RT) prolongs survival vs. RT alone in men with unfavorable risk localized prostate cancer (PCa), but it is unknown if this benefit applies to all risk subgroups and, in particular, the intermediate-risk group.
Among 206 men with stages T1b to T2b PCa and either a prostate-specific antigen level of >10 or a Gleason score of > or =7 or MRI evidence of T3 disease randomized to receive 70 Gy of RT with or without 6 months of AST, Cox multivariable analysis was used to assess the impact of AST on overall survival in intermediate- and high-risk localized PCa, adjusting for age, Adult Comorbidity Evaluation 27 comorbidity score, interaction between comorbidity and treatment, and known prognostic factors. Survival estimates were compared using a two-sided log-rank test.
After an 8.2-year median follow-up, 74 men died. Compared to treatment with AST plus RT, treatment with RT alone was associated with an increased risk of death in intermediate-risk (adjusted hazard ratio, 3.0 [95% confidence interval, 1.3-7.2]; p = 0.01) and high-risk PCa (adjusted hazard ratio, 3.3 [95% confidence interval, 0.94-11.3]; p = 0.06). The survival benefit of adding AST was restricted to men with no or mild comorbidity in both the intermediate-risk (90.9% vs. 85.8% survival, respectively, at 7 years for AST plus RT vs. RT alone; p = 0.009) and high-risk (88.9% vs. 51.2% survival, respectively, at 7 years for AST plus RT vs. RT alone; p = 0.007) subgroups.
In men with localized PCa who have no or mild comorbidity, adding 6 months of AST to RT was associated with improved survival for those with both intermediate-risk and high-risk disease, but in men with moderate to severe comorbidity, no benefit was observed in either risk group.
与单独接受放疗（RT）相比，雄激素抑制治疗（AST）加放疗（RT）可延长局部前列腺癌（PCa）伴不利风险男性的生存期，但尚不清楚该获益是否适用于所有风险亚组，尤其是中危组。
206 例 T1b 至 T2b 期 PCa 患者，前列腺特异性抗原（PSA）水平＞10ng/ml 或 Gleason 评分≥7 分或 MRI 显示 T3 期疾病，随机分为接受 70Gy RT 联合或不联合 6 个月 AST 治疗，采用 Cox 多变量分析评估 AST 对中高危局限性 PCa 患者总生存期的影响，调整年龄、成人合并症评估 27 项合并症评分、合并症与治疗的相互作用以及已知预后因素的影响。采用双侧对数秩检验比较生存估计。
中位随访 8.2 年后，74 例患者死亡。与单独接受 RT 治疗相比，中危（调整风险比，3.0[95%置信区间，1.3-7.2]；p=0.01）和高危（调整风险比，3.3[95%置信区间，0.94-11.3]；p=0.06）PCa 患者单独接受 RT 治疗死亡风险增加。AST 治疗可显著改善无或轻度合并症中危（AST+RT 组与 RT 组分别为 7 年时 90.9%和 85.8%的生存率；p=0.009）和高危（AST+RT 组与 RT 组分别为 7 年时 88.9%和 51.2%的生存率；p=0.007）亚组患者的生存获益。
在无或轻度合并症的局限性 PCa 患者中，将 6 个月 AST 联合 RT 治疗与改善中危和高危疾病患者的生存相关，但在中重度合并症患者中，在两个风险组中均未观察到获益。
