PMID- 34908240 OWN - NLM STAT- MEDLINE DCOM- 20220920 LR - 20240320 IS - 1743-7563 (Electronic) IS - 1743-7555 (Print) IS - 1743-7555 (Linking) VI - 18 IP - 5 DP - 2022 Oct TI - Efficacy, toxicity, and quality-of-life outcomes of ultrahypofractionated radiotherapy in patients with localized prostate cancer: A single-arm phase 2 trial from Asia. PG - e346-e355 LID - 10.1111/ajco.13742 [doi] AB - AIMS: Ultra-hypofractionated radiotherapy (UHF-RT) is widely utilized in men with localized prostate cancer (PCa). There are limited data in Asian cohorts. We report the outcomes of a single-arm, phase II trial of UHF-RT from an Asian center. METHODS: We recruited men with histologically confirmed, nonmetastatic localized PCa. UHF-RT regimens were 36.25 Gy (Cohort A) and 37.5 Gy (Cohort B) delivered in five fractions every other day over 1.5-2.5 weeks. Primary endpoint was physician-scored late genitourinary (GU) and gastrointestinal (GI) adverse events (AEs). Quality-of-life (QoL) was assessed by Expanded Prostate Cancer Index Composite (EPIC) at baseline, 1- and 2-year post-UHF-RT. RESULTS: Between March 2014 and August 2019, 105 men were recruited; four were subsequently excluded from analysis. Median age was 68.0 (Interquartile range (IQR): 63.8-73.0) years. 26 (24.8%) and 68 (64.8%) men had NCCN-defined low-and intermediate-risk PCa, respectively. No late >/=G3 GU or GI toxicities were reported in both cohorts. Peak incidence of acute >/=G2 GU AEs at 14 days post-UHF-RT was 23.6% (17/72) and 24.0% (6/25) in Cohorts A and B, respectively; >/=G2 GI AEs were observed in 9.7% (7/72) and 36.0% (9/25), respectively. Late >/=G2 GU and GI AEs occurred in 4.7% and 3.1% of Cohort A patients, and 5.0% in Cohort B at 12 months, with no AEs at 24 months. EPIC scores changed minimally across all domains. At a median follow-up of 44.9 months, we recorded one (1.3%) biochemical relapse by the Phoenix criteria (Cohort A). CONCLUSION: UHF-RT is well tolerated in Asian men and can be a recommended fractionation schema for localized PCa. CI - (c) 2021 The Authors. Asia-Pacific Journal of Clinical Oncology published by John Wiley & Sons Australia, Ltd. FAU - Tan, Janice S H AU - Tan JSH AUID- ORCID: 0000-0002-7011-2740 AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. FAU - Teh, Jonathan Y H AU - Teh JYH AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. AD - Asian Alliance Radiation Oncology Centre, Singapore. FAU - Tan, Laura L Y AU - Tan LLY AUID- ORCID: 0000-0003-4735-5522 AD - Ministry of Health Holdings, Singapore. FAU - Tan, Sheena X F AU - Tan SXF AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. FAU - Li, You Quan AU - Li YQ AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. FAU - Tan, Terence W K AU - Tan TWK AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. AD - Duke University and National University of Singapore (Duke-NUS) Medical School, Singapore. FAU - Wang, Michael L C AU - Wang MLC AUID- ORCID: 0000-0001-7882-8957 AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. AD - Duke University and National University of Singapore (Duke-NUS) Medical School, Singapore. FAU - Kanesvaran, Ravindran AU - Kanesvaran R AD - Duke University and National University of Singapore (Duke-NUS) Medical School, Singapore. AD - Division of Medical Oncology, National Cancer Centre Singapore, Singapore. FAU - Ong, Enya H W AU - Ong EHW AUID- ORCID: 0000-0002-2591-7910 AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. AD - Division of Medical Sciences, National Cancer Centre Singapore, Singapore. FAU - Tay, Kae Jack AU - Tay KJ AD - Duke University and National University of Singapore (Duke-NUS) Medical School, Singapore. AD - Department of Urology, Singapore General Hospital, Singapore. FAU - Lee, Lui Shiong AU - Lee LS AUID- ORCID: 0000-0002-8208-0635 AD - Duke University and National University of Singapore (Duke-NUS) Medical School, Singapore. AD - Department of Urology, Seng Kang General Hospital, Singapore. FAU - Tuan, Jeffrey K L AU - Tuan JKL AUID- ORCID: 0000-0002-4353-8439 AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. AD - Duke University and National University of Singapore (Duke-NUS) Medical School, Singapore. FAU - Tan, Daniel Y H AU - Tan DYH AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. AD - Asian Alliance Radiation Oncology Centre, Singapore. FAU - Chua, Melvin L K AU - Chua MLK AUID- ORCID: 0000-0002-1648-1473 AD - Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. AD - Duke University and National University of Singapore (Duke-NUS) Medical School, Singapore. AD - Division of Medical Sciences, National Cancer Centre Singapore, Singapore. LA - eng GR - National Cancer Centre of Singapore/ GR - Duke-NUS Medical School/ GR - Ministry of Education - Singapore/ GR - National Research Foundation/ GR - National Medical Research Council/ PT - Clinical Trial, Phase II PT - Journal Article DEP - 20211214 PL - Australia TA - Asia Pac J Clin Oncol JT - Asia-Pacific journal of clinical oncology JID - 101241430 SB - IM MH - Aged MH - Dose Fractionation, Radiation MH - *Gastrointestinal Diseases/etiology MH - Humans MH - Male MH - Middle Aged MH - *Prostatic Neoplasms/pathology/radiotherapy MH - Quality of Life MH - Radiation Dose Hypofractionation MH - *Radiotherapy, Intensity-Modulated/adverse effects PMC - PMC10946613 OTO - NOTNLM OT - Asian OT - intermediate-risk OT - localized prostate cancer OT - stereotactic body radiotherapy OT - ultrahypofractionated radiotherapy COIS- Melvin L.K. Chua reports personal fees from Astellas, Janssen, Bayer, Pfizer, MSD, personal fees and nonfinancial support from AstraZeneca, personal fees and grants from Ferring, personal fees and nonfinancial support from Varian, nonfinancial support from Decipher Biosciences, nonfinancial support from MedLever, and consults for immunoSCAPE Inc., outside the submitted work. All other authors declare no conflict of interest. EDAT- 2021/12/16 06:00 MHDA- 2022/09/21 06:00 PMCR- 2024/03/18 CRDT- 2021/12/15 09:05 PHST- 2021/09/19 00:00 [received] PHST- 2021/11/07 00:00 [accepted] PHST- 2021/12/16 06:00 [pubmed] PHST- 2022/09/21 06:00 [medline] PHST- 2021/12/15 09:05 [entrez] PHST- 2024/03/18 00:00 [pmc-release] AID - AJCO13742 [pii] AID - 10.1111/ajco.13742 [doi] PST - ppublish SO - Asia Pac J Clin Oncol. 2022 Oct;18(5):e346-e355. doi: 10.1111/ajco.13742. Epub 2021 Dec 14.