Safety of hydrogel spacers for rectal wall protection in patients with prostate cancer: A retrospective analysis of 200 consecutive cases.
hydrogel spacer
prostate cancer
rectal wall protection
retrospective analysis
safety
Journal
International journal of urology : official journal of the Japanese Urological Association
ISSN: 1442-2042
Titre abrégé: Int J Urol
Pays: Australia
ID NLM: 9440237
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
received:
28
07
2022
accepted:
22
12
2022
medline:
4
4
2023
pubmed:
19
1
2023
entrez:
18
1
2023
Statut:
ppublish
Résumé
To evaluate the safety and complications of hydrogel spacer implantation. This single-center historical cohort study retrospectively analyzed cases of hydrogel spacer implantation between October 2018 and March 2022. The survey items were the rates of possible hydrogel injection implementation, the success rate of hydrogel implantation including asymmetry, higher position, rectal wall infiltration, subcapsular injection, and other adverse events, and width created by the spacer. To investigate the learning curve, 1, 2, and 3 points were assigned to adverse event grades G1, G2, and G3, respectively. Spacer effectiveness obstruction, such as asymmetry was assigned 3 points. A Mann-Whitney U test was performed to assess statistically significant differences. The study included a total of 200 patients with a median (range) age of 70 (44-85) years. In 10 (5%) patients, hydrogel injection implementation was not possible. Of 190 patients who underwent hydrogel spacer placement, 168 (88%) received a satisfactory placement. The median (range) width of hydrogel spacers was 13.1 (4.4-18.7) mm. Spacer asymmetry, higher position, rectal wall infiltration, and prostate subcapsular infiltration occurred in 7 (3.7%), 5 (2.6%), 12 (6.3%), and 1 (0.5%) patients, respectively. G1 and G3 adverse events occurred in 13 (7%) and 4 (2%) patients, respectively. Practitioner #1 who performed the highest number of procedures had significantly (p = 0.04) lower total scores in group B. Spacer implantation yielded favorable outcomes with a high percentage of appropriate spacer implantation, and few major complications.
Substances chimiques
Hydrogels
0
Hydrogel, Polyethylene Glycol Dimethacrylate
25852-47-5
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
401-407Informations de copyright
© 2023 The Japanese Urological Association.
Références
Vogelius IR, Bentzen SM. Meta-analysis of the alpha/beta ratio for prostate cancer in the presence of an overall time factor: bad news, good news, or no news? Int J Radiat Oncol Biol Phys. 2013;85:89-94.
Fowler JF, Ritter MA, Fenwick JD, Chappell RJ. How low is the alpha/beta ratio for prostate cancer? In regard to Wang et al., IJROBP 2003;55:194-203. Int J Radiat Oncol Biol Phys. 2003;57:593-5.
Miralbell R, Roberts SA, Zubizarreta E, Hendry JH. Dose-fractionation sensitivity of prostate cancer deduced from radiotherapy outcomes of 5969 patients in seven international institutional datasets: α/β=1.4 (0.9-2.2) Gy. Int J Radiat Oncol Biol Phys. 2012;82:e17-24.
Proust-Lima C, Taylor JMG, Sécher S, Sandler H, Kestin L, Pickles T, et al. Confirmation of a low α/β ratio for prostate cancer treated by external beam radiation therapy alone using a post-treatment repeated-measures model for PSA dynamics. Int J Radiat Oncol Biol Phys. 2011;79:195-201.
Williams SG, Taylor JMG, Liu N, Tra Y, Duchesne GM, Kestin LL, et al. Use of individual fraction size data from 3756 patients to directly determine the alpha/beta ratio of prostate cancer. Int J Radiat Oncol Biol Phys. 2007;68:24-33.
Roberts SA, Miralbell R, Zubizarreta EH, Fowler JF, Hendry JH. A modelled comparison of prostate cancer control rates after high-dose-rate brachytherapy (3145 multicentre patients) combined with, or in contrast to, external-beam radiotherapy. Radiother Oncol. 2014;111:114-9.
Budäus L, Bolla M, Bossi A, Cozzarini C, Crook J, Widmark A, et al. Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature. Eur Urol. 2012;61:112-27.
Tree AC, Alexander EJ, van As NJ, Dearnaley DP, Khoo V. Biological dose escalation and hypofractionation: what is there to be gained and how will it best be done? Clin Oncol. 2013;25:483-98.
Mahal BA, Ziehr DR, Hyatt AS, Neubauer-Sugar EH, O'Farrell DA, O'Leary MP, et al. Use of a rectal spacer with low-dose-rate brachytherapy for treatment of prostate cancer in previously irradiated patients: initial experience and short-term results. Brachytherapy. 2014;13:442-9.
Uhl M, Herfarth K, Eble MJ, Pinkawa M, van Triest B, Kalisvaart R, et al. Absorbable hydrogel spacer use in men undergoing prostate cancer radiotherapy: 12 month toxicity and proctoscopy results of a prospective multicenter phase II trial. Radiat Oncol. 2014;9:96.
Sato H, Kato T, Motoyanagi T, Takemasa K, Narita Y, Kato M, et al. Preliminary analysis of prostate positional displacement using hydrogel spacer during the course of proton therapy for prostate cancer. J Radiat Res. 2021;62:294-9.
Song DY, Herfarth KK, Uhl M, Eble MJ, Pinkawa M, van Triest B, et al. A multi-institutional clinical trial of rectal dose reduction via injected polyethylene-glycol hydrogel during intensity modulated radiation therapy for prostate cancer: analysis of dosimetric outcomes. Int J Radiat Oncol Biol Phys. 2013;87:81-7.
Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, Beyer D, et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2015;92:971-7.
Hamstra DA, Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, et al. Continued benefit to rectal separation for prostate radiation therapy: final results of a phase III trial. Int J Radiat Oncol Biol Phys. 2017;97:976-85.
Fischer-Valuck BW, Chundury A, Gay H, Bosch W, Michalski J. Hydrogel spacer distribution within the perirectal space in patients undergoing radiotherapy for prostate cancer: impact of spacer symmetry on rectal dose reduction and the clinical consequences of hydrogel infiltration into the rectal wall. Pract Radiat Oncol. 2017;7:195-202.
Rohr A, Werth K, Shen X, Collins Z, Fishback S, Jones J, et al. MRI findings of absorbable hydrogel spacer for prostate cancer therapy: a pictorial review. Abdom Radiol. 2019;44:247-51.
Kanda Y. Investigation of the freely available easy-to-use software “EZR” for medical statistics. Bone Marrow Transplant. 2013;48:452-8.
Miller LE, Efstathiou JA, Bhattacharyya SK, Payne HA, Woodward E, Pinkawa M. Association of the Placement of a perirectal hydrogel spacer with the clinical outcomes of men receiving radiotherapy for prostate cancer: a systematic review and meta-analysis. JAMA Netw Open. 2020;3:e208221.
Hatiboglu G, Pinkawa M, Vallée JP, Hadaschik B, Hohenfellner M. Application technique: placement of a prostate-rectum spacer in men undergoing prostate radiation therapy. BJU Int. 2012;110:E647-52.
Uhl M, van Triest B, Eble MJ, Weber DC, Herfarth K, de Weese TL. Low rectal toxicity after dose escalated IMRT treatment of prostate cancer using an absorbable hydrogel for increasing and maintaining space between the rectum and prostate: results of a multi-institutional phase II trial. Radiother Oncol. 2013;106:215-9.
Müller AC, Mischinger J, Klotz T, Gagel B, Habl G, Hatiboglu G, et al. Interdisciplinary consensus statement on indication and application of a hydrogel spacer for prostate radiotherapy based on experience in more than 250 patients. Radiol Oncol. 2016;50(3):329-36.
Pinkawa M, Klotz J, Djukic V, Schubert C, Escobar-Corral N, Caffaro M, et al. Learning curve in the application of a hydrogel spacer to protect the rectal wall during radiotherapy of localized prostate cancer. Urology. 2013;82:963-8.