Prostate hypofractionated radiotherapy (62Gy at 3.1Gy per fraction) with injection of hyaluronic acid: final results of the RPAH1 study
| Autor: | O. Chapet, Pascal Fenoglietto, Alain Ruffion, Amandine Beneux, Evelyne Decullier, Corina Udrescu, Sonya Gaudioz, David Azria, Sylvie Bin, Bruno Segui, Ciprian Enachescu |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Male
Hypofractionated Radiotherapy medicine.medical_specialty Time Factors Gastrointestinal Diseases Urology Phases of clinical research Injections 030218 nuclear medicine & medical imaging 03 medical and health sciences chemistry.chemical_compound Prostate cancer 0302 clinical medicine Prostate Hyaluronic acid Humans Medicine Radiology Nuclear Medicine and imaging Hyaluronic Acid Radiation Injuries Aged Full Paper business.industry Prostatic Neoplasms Radiotherapy Dosage General Medicine Middle Aged medicine.disease Clinical trial medicine.anatomical_structure Multicenter study chemistry 030220 oncology & carcinogenesis Radiation Dose Hypofractionation business |
| Zdroj: | Br J Radiol |
| ISSN: | 1748-880X 0007-1285 |
| DOI: | 10.1259/bjr.20210242 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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