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Item Type Journal Article
Title Prostate hypofractionated radiotherapy (62Gy at 3.1Gy per fraction) with injection of hyaluronic acid: final results of the RPAH1 study
Creator Chapet et al.
Author Olivier Chapet
Author Corina Udrescu
Author Sylvie Bin
Author Evelyne Decullier
Author Pascal Fenoglietto
Author Amandine Beneux
Author Bruno Segui
Author Ciprian Enachescu
Author Sonya Gaudioz
Author Alain Ruffion
Author David Azria
Abstract OBJECTIVES: The present multicenter Phase II study evaluated the rate of late grade ?2 gastrointestinal (GI) toxicities at 3 years, after hypofractionated radiotherapy (HFR) of prostate cancer with injection of hyaluronic acid (HA) between the prostate and the rectum. METHODS: Between 2010 and 2013, 36 patients with low- or intermediate-risk prostate cancer were treated by HFR/IMRT-IGRT. 20 fractions of 3.1?Gy were delivered, 5 days per week for a total dose of 62?Gy. A transperineal injection of 10cc of HA was performed between the rectum and the prostate. Late toxicities were evaluated between 3 and 36 months after the end of treatment (CTCAE v4). RESULTS: Median pretreatment prostate-specific antigen was 8?ng?ml-1. Among the 36 included patients, 2 were not evaluated because they withdrew the study in the first 3 months of follow-up, and 4 withdrew between 3 and 36 months, the per protocol population was therefore composed.Late grade ?2?GI toxicities occurred in 4 (12%) patients with 3 (9%) Grade 2 rectal bleedings and one diarrhoea. Therefore, the inefficacy hypothesis following Fleming one-stage design cannot be rejected. None of the patients experienced late Grade 3-4 toxicities. Among the 30 patients completing the 36 months' visit, none still had a grade ?2?GI toxicity. Late grade ?2 genitourinary (GU) toxicities occurred in 14 (41%) patients. The most frequent toxicities were dysuria and pollakiuria. Four patients still experienced a grade ?2?GU toxicity at 36 months.The biochemical relapse rate (nadir +2?ng?ml-1) was 6% (2 patients). Overall, HA was very well tolerated with no pain or discomfort. CONCLUSION: Despite the inefficacy of HA injection was not rejected, we observed the absence of Grade 3 or 4 rectal toxicity as well as a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up. Late urinary toxicities are the most frequent but the rate decreases largely at 3 years. ADVANCES IN KNOWLEDGE: With an injection of HA, hypofractionated irradiation in 4 weeks is well tolerated with no Grade 3 or 4?GI toxicity and a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up.
Publication The British Journal of Radiology
Volume 94
Issue 1124
Pages 20210242
Date 2021-08-01
Journal Abbr Br J Radiol
Language eng
DOI 10.1259/bjr.20210242
ISSN 1748-880X
Short Title Prostate hypofractionated radiotherapy (62Gy at 3.1Gy per fraction) with injection of hyaluronic acid
Library Catalog PubMed
Extra Number: 1124 PMID: 34282946 PMCID: PMC8764931
Tags Aged, clinic, first-last-coresponding, Gastrointestinal Diseases, Humans, Hyaluronic Acid, Injections, last, Male, Middle Aged, Prostatic Neoplasms, Radiation Dose Hypofractionation, Radiation Injuries, Radiotherapy Dosage, Time Factors
Date Added 2023/11/23 - 12:48:31
Date Modified 2024/12/15 - 11:25:57
Notes and Attachments PubMed entry (Attachment)
Texte intégral (Attachment)


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