Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: SBRT offered similar PRQOL and less toxicity compared with CFRT in Chinese men with localized PC.
Highlights
External beam radiotherapy (EBRT) is an effective curative treatment option for localized prostate cancer (PC) [1]
Biochemical progressions (Phoenix criteria, prostate-specific antigen (PSA) nadir + 2 ng/mL [21]) occurred in two conventional fractionated radiotherapy (CFRT) patients, resulting in 98.4%, 100% and 97% biochemical failure-free survival at 1 year for all patients, Stereotactic body radiotherapy (SBRT) and CFRT groups, respectively (p = 0.08). In this phase II study of SBRT vs. CFRT in low- and intermediate-risk localized PC, SBRT resulted in a similar patient-reported quality of life (PRQOL) in terms of the proportion of patients with significant reductions in Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary scores at 1 year from baseline, and seemingly favorable physician-scored acute and late toxicities compared with CFRT
Our results suggest that SBRT is a safe, tolerable alternative to CFRT for patients with early-stage localized PC
Summary
External beam radiotherapy (EBRT) is an effective curative treatment option for localized prostate cancer (PC) [1]. Conventional fractionated radiotherapy (CFRT), with daily dose fractionation of 1.8–2 Gy over 8 to 9 weeks, has been commonly administered worldwide [2]. Such a protracted total treatment time, together with the mounting incidence of PC, poses burdens for the healthcare system [3]. Methods: In this prospective phase II study, patients with lowand 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.
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