Added by | JPPOUGET |
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Group name | EquipeJPP |
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) |