Yang David D, Muralidhar Vinayak, Nguyen Paul L, Buzurovic Ivan, Martin Neil E, Mouw Kent W, Devlin Phillip M, Trinh Quoc-Dien, Orio Peter F, King Martin T
Harvard Medical School, Boston, Massachusetts; Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts.
Harvard Medical School, Boston, Massachusetts; Harvard Radiation Oncology Program, Boston, Massachusetts.
Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):904-911. doi: 10.1016/j.ijrobp.2017.07.034. Epub 2017 Jul 31.
A recent randomized controlled trial demonstrated that the addition of external beam radiation therapy (EBRT) to brachytherapy did not improve progression-free survival in select patients with intermediate-risk prostate cancer. We evaluated whether the addition of EBRT to brachytherapy improves prostate cancer-specific mortality (PCSM) for intermediate- and high-risk disease using a large national database.
We identified 5836 patients in the Surveillance, Epidemiology, and End Results-Medicare linked database with a diagnosis of National Comprehensive Cancer Network intermediate-risk (Gleason score 7, prostate-specific antigen 10-20 ng/mL, or stage cT2b-T2c) or high-risk (Gleason score 8-10 or prostate-specific antigen >20 ng/mL and stage ≤cT3a) prostate cancer who had undergone brachytherapy, with or without EBRT and androgen deprivation therapy (ADT). Patients were diagnosed from 2004 through 2009. Intermediate-risk patients with Gleason score ≤3+4 and 1 intermediate-risk factor were considered favorable and all others unfavorable. We used multivariable Fine-Gray competing risks regression to study PCSM while adjusting for sociodemographic and clinical factors and ADT use.
Overall, 50.3% of intermediate- and high-risk patients who received brachytherapy and EBRT did not have significantly improved PCSM compared with that of the patients who received brachytherapy alone (adjusted hazard ratio [AHR] 1.46, 95% confidence interval [CI] 0.69-3.11; P=.322; 5-year PCSM 2.4% vs 1.0%). This lack of benefit was seen among favorable intermediate-risk (AHR 2.66, 95% CI 0.93-7.62, P=.069; 5-year PCSM 1.3% vs 0.6%), unfavorable intermediate-risk (AHR 0.68, 95% CI 0.16-2.96, P=.612; 5-year PCSM 1.0% vs 1.2%), and high-risk (AHR 1.82, 95% CI 0.67-4.98, P=.242; 5-year PCSM 5.3% vs 2.1%) subgroups.
These results suggest that certain patients with intermediate- or high-risk prostate cancer treated with brachytherapy might not benefit from the addition of EBRT. A randomized controlled trial of brachytherapy plus ADT with or without EBRT for unfavorable intermediate- and favorable high-risk organ-confined prostate cancer should be undertaken.
最近一项随机对照试验表明,对于部分中危前列腺癌患者,在近距离放射治疗基础上加用外照射放疗(EBRT)并不能改善无进展生存期。我们使用一个大型国家数据库评估在近距离放射治疗基础上加用EBRT对中危和高危前列腺癌患者的前列腺癌特异性死亡率(PCSM)的影响。
我们在监测、流行病学和最终结果-医疗保险链接数据库中识别出5836例诊断为美国国立综合癌症网络中危( Gleason评分7分、前列腺特异性抗原10 - 20 ng/mL或cT2b - T2c期)或高危(Gleason评分8 - 10分或前列腺特异性抗原>20 ng/mL且分期≤cT3a)前列腺癌的患者,这些患者接受了近距离放射治疗,无论是否接受EBRT和雄激素剥夺治疗(ADT)。患者诊断时间为2004年至2009年。Gleason评分≤3 + 4且有1个中危因素的中危患者被视为预后良好,其他患者则为预后不良。我们使用多变量Fine - Gray竞争风险回归分析来研究PCSM,同时对社会人口统计学和临床因素以及ADT的使用进行校正。
总体而言,与单纯接受近距离放射治疗的患者相比,接受近距离放射治疗和EBRT的中危和高危患者中,50.3%的患者PCSM没有显著改善(校正风险比[AHR] 1.46,95%置信区间[CI] 0.69 - 3.11;P = 0.322;5年PCSM分别为2.4%和1.0%)。在预后良好的中危(AHR 2.66,95% CI 0.93 - 7.62,P = 0.069;5年PCSM分别为1.3%和0.6%)、预后不良的中危(AHR 0.68,95% CI 0.16 - 2.96,P = 0.612;5年PCSM分别为1.0%和1.2%)和高危(AHR 1.82,95% CI 0.67 - 4.98,P = 0.242;5年PCSM分别为5.3%和2.1%)亚组中均未观察到这种获益。
这些结果表明,某些接受近距离放射治疗的中危或高危前列腺癌患者可能无法从加用EBRT中获益。对于预后不良的中危和预后良好的高危器官局限性前列腺癌患者,应进行一项关于近距离放射治疗联合ADT加或不加EBRT的随机对照试验。