Abstract：
Stereotactic body radiotherapy (SBRT) has potential radiobiologic and economic advantages over conventional fractionated radiotherapy (CFRT) in localized prostate cancer (PC). This study aimed to compare the effects of these two distinct fractionations on patient-reported quality of life (PRQOL) and tolerability.
In this prospective phase II study, patients with low- and intermediate-risk localized PC were randomly assigned in a 1:1 ratio to the SBRT (36.25 Gy/5 fractions/2 weeks) or CFRT (76 Gy/38 fractions/7.5 weeks) treatment groups. The primary endpoint of variation in PRQOL at 1 year was assessed by changes in the Expanded Prostate Cancer Index Composite (EPIC) questionnaire scores and analysed by z-tests and t-tests.
Sixty-four eligible Chinese men were treated (SBRT, n = 31; CFRT, n = 33) with a median follow-up of 2.3 years. At 1 year, 40.0%/46.9% of SBRT/CFRT patients had a >5-point decrease in bowel score (p = 0.08/0.28), respectively, and 53.3%/46.9% had a >2-point decrease in urinary score (p = 0.21/0.07). There were no significant differences in EPIC score changes between the arms at 3, 6, 9 and 12 months, but SBRT was associated with significantly fewer grade ≥ 1 acute and 1-year late gastrointestinal toxicities (acute: 35% vs. 87%, p < 0.0001; 1-year late: 64% vs. 84%, p = 0.03), and grade ≥ 2 acute genitourinary toxicities (3% vs. 24%, p = 0.04) compared with CFRT.
SBRT offered similar PRQOL and less toxicity compared with CFRT in Chinese men with localized PC.
In this prospective phase II study, patients with low- and intermediate-risk localized PC were randomly assigned in a 1:1 ratio to the SBRT (36.25 Gy/5 fractions/2 weeks) or CFRT (76 Gy/38 fractions/7.5 weeks) treatment groups. The primary endpoint of variation in PRQOL at 1 year was assessed by changes in the Expanded Prostate Cancer Index Composite (EPIC) questionnaire scores and analysed by z-tests and t-tests.
Sixty-four eligible Chinese men were treated (SBRT, n = 31; CFRT, n = 33) with a median follow-up of 2.3 years. At 1 year, 40.0%/46.9% of SBRT/CFRT patients had a >5-point decrease in bowel score (p = 0.08/0.28), respectively, and 53.3%/46.9% had a >2-point decrease in urinary score (p = 0.21/0.07). There were no significant differences in EPIC score changes between the arms at 3, 6, 9 and 12 months, but SBRT was associated with significantly fewer grade ≥ 1 acute and 1-year late gastrointestinal toxicities (acute: 35% vs. 87%, p < 0.0001; 1-year late: 64% vs. 84%, p = 0.03), and grade ≥ 2 acute genitourinary toxicities (3% vs. 24%, p = 0.04) compared with CFRT.
SBRT offered similar PRQOL and less toxicity compared with CFRT in Chinese men with localized PC.
摘要：
在局部前列腺癌（PC）中，立体定向身体放射治疗（SBRT）与常规分割放射治疗（CFRT）相比具有潜在的放射生物学和经济优势。这项研究旨在比较这两种不同的分级对患者报告的生活质量（PRQOL）和耐受性的影响。
在这项前瞻性II期研究中，低危和中危局限性PC患者以1∶1的比例随机分配到SBRT(36.25Gy/5分/2周)或CFRT(76Gy/38分/7.5周)治疗组.通过扩展前列腺癌综合指数（EPIC）问卷评分的变化评估1年PRQOL变化的主要终点，并通过z检验和t检验进行分析。
64名符合条件的中国男子接受了治疗(SBRT，n=31；CFRT，n=33），中位随访时间为2.3年。在1年,40.0%/46.9%的SBRT/CFRT患者肠评分下降>5点(p=0.08/0.28),分别,53.3%/46.9%的尿评分下降>2分(p=0.21/0.07)。3、6、9、12个月两组EPIC评分变化无显著差异,但SBRT与1级以上急性和1年晚期胃肠道毒性显著减少相关(急性：35%vs.87%,p<0.0001；1年后：64%与84%,p=0.03),和≥2级急性泌尿生殖系统毒性(3%与24%,p=0.04）与CFRT相比。
在患有局部PC的中国男性中，与CFRT相比，SBRT提供了相似的PRQOL和更低的毒性。
在这项前瞻性II期研究中，低危和中危局限性PC患者以1∶1的比例随机分配到SBRT(36.25Gy/5分/2周)或CFRT(76Gy/38分/7.5周)治疗组.通过扩展前列腺癌综合指数（EPIC）问卷评分的变化评估1年PRQOL变化的主要终点，并通过z检验和t检验进行分析。
64名符合条件的中国男子接受了治疗(SBRT，n=31；CFRT，n=33），中位随访时间为2.3年。在1年,40.0%/46.9%的SBRT/CFRT患者肠评分下降>5点(p=0.08/0.28),分别,53.3%/46.9%的尿评分下降>2分(p=0.21/0.07)。3、6、9、12个月两组EPIC评分变化无显著差异,但SBRT与1级以上急性和1年晚期胃肠道毒性显著减少相关(急性：35%vs.87%,p<0.0001；1年后：64%与84%,p=0.03),和≥2级急性泌尿生殖系统毒性(3%与24%,p=0.04）与CFRT相比。
在患有局部PC的中国男性中，与CFRT相比，SBRT提供了相似的PRQOL和更低的毒性。
