Ong Wee Loon, Davidson Melanie, Cheung Patrick, Chung Hans, Chu William, Detsky Jay, Liu Stanley, Morton Gerard, Szumacher Ewa, Tseng Chia-Lin, Vesprini Danny, Ravi Ananth, McGuffin Merrylee, Zhang Liying, Mamedov Alexandre, Deabreu Andrea, Kulasingham-Poon Meghan, Loblaw Andrew
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada; Alfred Health Radiation Oncology, Monash University, Melbourne, Australia.
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.
Radiother Oncol. 2023 Nov;188:109864. doi: 10.1016/j.radonc.2023.109864. Epub 2023 Aug 22.
There is no evidence-based data to guide dose constraints in two-fraction prostate stereotactic ablative radiotherapy (SABR). Using individual patient-data from two prospective trials, we aimed to correlate dosimetric parameters with toxicities and quality of life (QoL) outcomes.
We included 60 patients who had two-fraction prostate SABR in the 2STAR (NCT02031328) and 2SMART (NCT03588819) trials. The prescribed dose was 26 Gy to the prostate+/-32 Gy boost to the dominant intraprostatic lesions. Toxicities and QoL data were prospectively collected using CTCAEv4 and EPIC-26 questionnaire. The outcomes evaluated were acute and late grade ≥ 2 toxicities, and late minimal clinical important changes (MCIC) in QoL domains. Dosimetric parameters for bladder, urethra, rectum, and penile bulb were evaluated.
The median follow-up was 56 months (range: 39-78 months). The cumulative incidence of grade ≥ 2 genitourinary (GU), gastrointestinal (GI), and sexual toxicities were 62%, 3%, and 17% respectively in the acute setting (<3 months), and 57%, 15%, and 52% respectively in late setting (>6 months). There were 36%, 28%, and 29% patients who had late MCIC in urinary, bowel and sexual QoL outcomes respectively. Bladder 0.5 cc was significant predictor for late grade ≥ 2 GU toxicities, with optimal cut-off of 25.5 Gy. Penile bulb D5cc was associated of late grade ≥ 2 sexual toxicities (no optimal cut-off was identified). No dosimetric parameters were identified to be associated with other outcomes.
Using real-life patient data from prospective trials with medium-term follow-up, we identified additional dose constraints that may mitigate the risk of late treatment-related toxicities for two-fraction prostate SABR.
目前尚无循证数据可指导两分割前列腺立体定向消融放疗(SABR)的剂量限制。利用两项前瞻性试验的个体患者数据,我们旨在将剂量学参数与毒性和生活质量(QoL)结果相关联。
我们纳入了2STAR(NCT02031328)和2SMART(NCT03588819)试验中接受两分割前列腺SABR的60例患者。前列腺的处方剂量为26 Gy,对主要前列腺内病变追加剂量32 Gy(±)。使用CTCAEv4和EPIC-26问卷前瞻性收集毒性和QoL数据。评估的结果为急性和晚期≥2级毒性,以及QoL领域的晚期最小临床重要变化(MCIC)。评估膀胱、尿道、直肠和阴茎球部的剂量学参数。
中位随访时间为56个月(范围:39 - 78个月)。在急性情况下(<3个月),≥2级泌尿生殖系统(GU)、胃肠道(GI)和性毒性的累积发生率分别为62%、3%和17%,在晚期情况下(>6个月)分别为57%、15%和52%。分别有36%、28%和29%的患者在泌尿、肠道和性QoL结果方面出现晚期MCIC。膀胱0.5 cc是晚期≥2级GU毒性的显著预测因子,最佳截断值为25.5 Gy。阴茎球部D5cc与晚期≥2级性毒性相关(未确定最佳截断值)。未发现剂量学参数与其他结果相关。
通过对中期随访的前瞻性试验使用真实患者数据,我们确定了额外的剂量限制,这可能会降低两分割前列腺SABR晚期治疗相关毒性的风险。