Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia.
Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania; Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.
Int J Radiat Oncol Biol Phys. 2015 Mar 15;91(4):752-9. doi: 10.1016/j.ijrobp.2014.11.038.
Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events.
The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate.
A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes).
Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However, the timing of radiation therapy did not influence the risk of radiation therapy-associated adverse events in this cohort, which contradicts the commonly held clinical tenet that delaying radiation therapy reduces the risk of adverse events.
尽管与放射性相关的不良事件发生的可能性会影响有资格接受前列腺切除术的患者接受放射治疗的决策，但目前可用于辅助决策的数据有限。本研究旨在评估前列腺切除术后放射治疗相关的泌尿生殖、胃肠道和性功能不良事件，并评估放射治疗时机对不良事件风险的影响。
通过检索意大利艾米利亚-罗马涅地区的纵向卫生保健利用数据库，确定了一组 2003 年至 2009 年期间因前列腺癌接受前列腺根治性切除术的男性患者，包括接受前列腺切除术后放射治疗的患者。排除既往接受过放射治疗的患者。术后不良事件的评估指标为泌尿生殖、胃肠道和性功能不良事件。比较了接受和未接受术后放射治疗的两组患者的不良事件发生率。针对每种不良事件类别，包括将放射治疗作为时变协变量的模型，均建立了多变量 Cox 比例风险模型。
共纳入 9876 名患者进行分析：2176 名（22%）接受放射治疗，7700 名（78%）仅接受前列腺切除术治疗。在多变量 Cox 比例风险模型中，前列腺切除术后接受放射治疗的额外暴露与胃肠道（发生率比 [RR] 1.81；95%置信区间 [CI] 1.44-2.27；P<.001）和非尿失禁性泌尿生殖不良事件（RR 1.83；95% CI 1.83-2.80；P<.001）的发生率增加相关，但与尿失禁或勃起功能障碍无关。对于任何不良事件结局，添加前列腺切除术与放射治疗时间间隔的交互项并不显著（所有结局 P>.1）。
前列腺切除术后的放射治疗与胃肠道和泌尿生殖系统不良事件的增加相关。然而，在本队列中，放射治疗时机并未影响与放射治疗相关的不良事件的风险，这与普遍存在的临床观点相悖，即延迟放射治疗可降低不良事件的风险。
