Nichols R Charles, Hu Chen, Bahary Jean-Paul, Zeitzer Kenneth L, Souhami Luis, Leibenhaut Mark H, Rotman Marvin, Gore Elizabeth M, Balogh Alexander G, McGowan David, Michalski Jeff, Raben Adam, Rudoler Shari, Jones Christopher U, Sandler Howard
University of Florida Health Science Center, Jacksonville, Florida.
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Adv Radiat Oncol. 2017 Aug 3;2(4):608-614. doi: 10.1016/j.adro.2017.07.004. eCollection 2017 Oct-Dec.
We reviewed testosterone changes for patients who were treated with radiation therapy (RT) alone on NRG oncology RTOG 9408.
Patients (T1b-T2b, prostate-specific antigen <20 ng/mL) were randomized between RT alone and RT plus 4 months of androgen ablation. Serum testosterone (ST) levels were investigated at enrollment, RT completion, and the first follow-up 3 months after RT. The Wilcoxon signed rank test was used to compare pre- and post-treatment ST levels in patients who were randomized to the RT-alone arm.
Of 2028 patients enrolled, 992 patients were randomized to receive RT alone and 917 (92.4%) had baseline ST values available and completed RT. Of these 917 patients, immediate and 3-month post-RT testosterone levels were available for 447 and 373 patients, respectively. Excluding 2 patients who received hormonal therapy off protocol after RT, 447 and 371 patients, respectively, were analyzed. For all patients, the median change in ST values at completion of RT and at 3-month follow-up were -30.0 ng/dL (p5-p95; -270.0 to 162.0; < .001) and -34.0 ng/dL (p5-p95, -228.0 to 160.0; < .01), respectively.
RT for prostate cancer was associated with a median 9.2% decline in ST at completion of RT and a median 9.3% decline 3 months after RT. These changes were statistically significant.
我们回顾了在NRG肿瘤学RTOG 9408研究中仅接受放射治疗(RT)的患者的睾酮变化情况。
患者(T1b - T2b,前列腺特异性抗原<20 ng/mL)被随机分为单纯放疗组和放疗加4个月雄激素剥夺组。在入组时、放疗结束时以及放疗后3个月的首次随访时检测血清睾酮(ST)水平。采用Wilcoxon符号秩检验比较随机分配至单纯放疗组患者治疗前后的ST水平。
在2028名入组患者中,992名患者被随机分配接受单纯放疗,其中917名(92.4%)有可用的基线ST值并完成了放疗。在这917名患者中,分别有447名和373名患者可获得放疗后即刻和3个月时的睾酮水平。排除2名放疗后接受非方案规定激素治疗的患者后,分别对447名和371名患者进行了分析。对于所有患者,放疗结束时和3个月随访时ST值的中位数变化分别为-30.0 ng/dL(p5 - p95;-270.0至162.0;<.001)和-34.0 ng/dL(p5 - p95,-228.0至160.0;<.01)。
前列腺癌放疗结束时ST中位数下降9.2%,放疗后3个月中位数下降9.3%。这些变化具有统计学意义。