Fredman Elisha, Tschernichovsky Roi, Shemesh Danielle, Weinstock-Sabbah Miriam, Azuz Ruth Dadush, Radus Roman, Moore Assaf, Limon Dror
Department of Radiation Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikvah 494149, Israel.
Department of Molecular Cell Biology, Weizmann Institute of Science, Rehovot 763270, Israel.
Cancers (Basel). 2025 Jun 13;17(12):1970. doi: 10.3390/cancers17121970.
: Stereotactic radiotherapy (SABR) is a recognized standard treatment modality for localized prostate cancer, though data is limited regarding the risk of increased toxicity when including the elective nodes (ENI) for high-risk disease. Placement of a peri-rectal spacer can decrease the risk of toxicity to the rectum when administering high-dose prostate radiotherapy. Herein we present toxicity findings for patients who underwent five-fraction prostate SABR with ENI in a setting with peri-rectal spacing. : Genitourinary (GU) and gastrointestinal (GI) toxicity data was analyzed for patients with ≥12 months of follow-up who were treated with curative-intent five-fraction SABR with ENI. A radiopaque hydrogel spacer was placed for all eligible patients. The primary endpoints were the three-month toxicity, which was measured using CTCAEv5, and quality of life (QoL), which was measured using EPIC 26. Secondary endpoints included intermediate-term GU and GI toxicity between 6 and 12 months. Univariable logistic regression was used to assess associations between baseline patient characteristics and the presence of a peri-rectal hydrogel spacer and GU and GI toxicity. : Among the 100 patients treated, 69 had grade group 4/5 disease and 40 had evidence of T3a/3b extension. The ENI dose was 25 Gy/5, and 78.9% of the patients received 40 Gy to the prostate, while the remainder were given 36.25-37.5 Gy. A total of 70% underwent placement of a radiopaque hydrogel spacer. GU toxicities of grades 1, 2, and 3 were reported in 28/22/1% of the patients, respectively, at three months; in 18/11/0% at six months; in 11/9/0% at nine months; and in 5/3/0% at twelve months. GI toxicities of grades 1 and 2 were reported in 14/0% of the patients at three months and 8/1% at six months, with all cases resolving by nine months. MCICs in the urinary incontinence, urinary obstructive, and bowel domains were reported in 5%, 18%, and 4% at three months; by twelve months, these values decreased to 2%, 2%, and 0%, respectively. The presence of a hydrogel spacer resulted in reductions in high and intermediate doses to the rectum and had a significant inverse association with short-term GI toxicity (HR: 0.09, CI: 0.27-0.35, 0.0004). : In this prospective series, five-fraction SABR including ENI was well tolerated, and the presence of a hydrogel spacer was associated with a lower risk of rectal toxicity.
立体定向放射治疗（SABR）是局限性前列腺癌公认的标准治疗方式，不过对于高危疾病纳入选择性淋巴结（ENI）时毒性增加风险的数据有限。在进行高剂量前列腺放疗时，放置直肠周围间隔物可降低直肠毒性风险。在此，我们呈现了在直肠周围有间隔的情况下接受五分割前列腺SABR并伴有ENI的患者的毒性研究结果。对接受根治性意图的五分割SABR并伴有ENI且随访时间≥12个月的患者的泌尿生殖系统（GU）和胃肠道（GI）毒性数据进行了分析。为所有符合条件的患者放置了不透射线的水凝胶间隔物。主要终点是三个月时的毒性（使用CTCAEv5进行测量）和生活质量（QoL，使用EPIC 26进行测量）。次要终点包括6至12个月时的中期GU和GI毒性。采用单变量逻辑回归评估基线患者特征与直肠周围水凝胶间隔物的存在以及GU和GI毒性之间的关联。在接受治疗的100例患者中，69例为4/5级组疾病，40例有T3a/3b期扩展的证据。ENI剂量为25 Gy/5次，78.9%的患者前列腺接受40 Gy照射，其余患者接受36.25 - 37.5 Gy照射。总共70%的患者接受了不透射线的水凝胶间隔物放置。三个月时，分别有28%/22%/1%的患者报告了1/2/3级GU毒性；六个月时为18%/11%/0%；九个月时为11%/9%/0%；十二个月时为5%/3%/0%。三个月时，14%/0%的患者报告了1/2级GI毒性，六个月时为8%/1%，所有病例在九个月时均缓解。三个月时，尿失禁、尿路梗阻和肠道领域的MCICs分别报告为5%、18%和4%；到十二个月时，这些值分别降至2%、2%和0%。水凝胶间隔物的存在导致直肠接受的高剂量和中等剂量减少，并且与短期GI毒性存在显著负相关（HR：0.09，CI：0.27 - 0.35，P = 0.0004）。在这个前瞻性系列研究中，包括ENI的五分割SABR耐受性良好，并且水凝胶间隔物的存在与较低的直肠毒性风险相关。
