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Open Access 01-12-2019 | Endoscopy | Research

Rectum-spacer related acute toxicity – endoscopy results of 403 prostate cancer patients after implantation of gel or balloon spacers

Authors: Andreas Schörghofer, Martin Drerup, Thomas Kunit, Lukas Lusuardi, Josef Holzinger, Josef Karner, Michael Groher, Christoph Zoubek, Rosemarie Forstner, Felix Sedlmayer, Frank Wolf

Published in: Radiation Oncology | Issue 1/2019

Abstract

Background

Rectal spacers are used to limit dose to the anterior rectal wall in high dose external beam radiation therapy of the prostate and have been shown to reduce radiation induced toxicity. Here we report the complication rate and toxicity of the implantation procedure in a large cohort of patients who have either received a gel- or balloon-type spacer.

Methods

In total, 403 patients received rectal spacing, 264 with balloon, 139 with gel. Allocation was non-randomized. Two hundred seventy-six patients were treated with normofractionated regimen, the remaining 125 patients in moderate hypofractionation. Spacer related acute and late rectal toxicity was prospectively assessed by endoscopy using a mucosa scoring system (Vienna Rectoscopy Score) as well as CTCAE V.4. For the balloon subgroup, position and rotation of balloon spacers were additionally correlated to incidence and grade of rectal reactions in a post-hoc analysis of post-implant planning MRIs.

Results

Overall rectal toxicity was very low with average VRS scores of 0.06 at the day after implantation, 0.10 at the end of RT, 0.31 at 6 months and 0.42 at 12 months follow up. Acute Grade 3 toxicity (rectum perforation and urethral damage) directly related to the implantation procedure occurred in 1.49% (n = 6) and was seen exclusively in patients who had received the spacer balloon. Analysis of post implant MR imaging did not identify abnormal or mal-rotated positions of this spacer to be a predictive factors for the occurrence of spacer related G3 toxicities.

Conclusions

Spacer technology is an effective means to minimize dose to the anterior rectal wall. However, the benefits in terms of dose sparing need to be weighed against the low, but possible risks of complications such as rectum perforation.

Viani GA, Stefano EJ, Afonso SL. Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trials. Int J Radiat Oncol Biol Phys. 2009;74(5):1405–18.CrossRef

Susil RC, McNutt TR, DeWeese TL, Song D. Effects of prostate-rectum separation on rectal dose from external beam radiotherapy. Int J Radiat Oncol Biol Phys. 2010;76(4):1251–8.CrossRef

Pinkawa M, Corral NE, Caffaro M, Piroth MD, Holy R, Djukic V, Otto G, Schoth F, Eble MJ. Application of a spacer gel to optimize three-dimensional conformal and intensity modulated radiotherapy for prostate cancer. Radiother Oncol. 2011;100(3):436–41.CrossRef

Prada PJ, Gonzalez H, Menendez C, Llaneza A, Fernandez J, Santamarta E, Ricarte PP. Transperineal injection of hyaluronic acid in the anterior perirectal fat to decrease rectal toxicity from radiation delivered with low-dose-rate brachytherapy for prostate cancer patients. Brachytherapy. 2009;8(2):210–7.CrossRef

Mok G, Benz E, Vallee JP, Miralbell R, Zilli T. Optimization of radiation therapy techniques for prostate cancer with prostate-rectum spacers: a systematic review. Int J Radiat Oncol Biol Phys. 2014;90(2):278–88. https://doi.org/10.1016/j.ijrobp.2014.06.044.CrossRefPubMed

Pasquier D, Bogart E, Bonodeau F, Lacornerie T, Lartigau E, Latorzeff I. BioPro-RCMI-1505 trial: multicenter study evaluating the use of a biodegradable balloon for the treatment of intermediate risk prostate cancer by intensity modulated radiotherapy; study protocol. BMC Cancer. 2018;18(1):566. https://doi.org/10.1186/s12885-018-4492-5.CrossRefPubMedPubMedCentral

Melchert C, Gez E, Bohlen G, Scarzello G, Koziol I, Anscher M, Cytron S, Paz A, Torre T, Bassignani M, Dal MF, Jocham D, Yosef RB, Corn BW, Kovacs G. Interstitial biodegradable balloon for reduced rectal dose during prostate radiotherapy: results of a virtual planning investigation based on the pre- and post-implant imaging data of an international multicenter study. Radiother Oncol. 2013;106(2):210–4.CrossRef

Wolf F, Gaisberger C, Ziegler I, Krenn E, Scherer P, Hruby S, Schatz T, Forstner R, Holzinger J, Vaszi A, Kametriser G, Steininger P, Deutschmann H, Sedlmayer F. Comparison of two different rectal spacers in prostate cancer external beam radiotherapy in terms of rectal sparing and volume consistency. Radiother Oncol. 2015. https://doi.org/10.1016/j.radonc.2015.07.027.

Hamstra DA, Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, Beyer D, Kurtzman S, Bogart J, Hsi RA, Kos M, Ellis R, Logsdon M, Zimberg S, Forsythe K, Zhang H, Soffen E, Francke P, Mantz C, Rossi P, DeWeese T, Daignault-Newton S, Fischer-Valuck BW, Chundury A, Gay H, Bosch W, Michalski J. Continued benefit to rectal separation for prostate radiation therapy: final results of a phase III trial. Int J Radiat Oncol Biol Phys. 2017;97(5):976–85. https://doi.org/10.1016/j.ijrobp.2016.12.024.CrossRefPubMed

10.

Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, Beyer D, Kurtzman S, Bogart J, Hsi RA, Kos M, Ellis R, Logsdon M, Zimberg S, Forsythe K, Zhang H, Soffen E, Francke P, Mantz C, Rossi P, DeWeese T, Hamstra DA, Bosch W, Gay H, Michalski J. 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(5):971–7. https://doi.org/10.1016/j.ijrobp.2015.04.030.CrossRefPubMed

11.

Vanneste BGL, van De Beek K, Lutgens L, Lambin P. Implantation of a biodegradable rectum balloon implant: tips, tricks and pitfalls. Int Braz J Urol. 2017;43(6):1033–42. https://doi.org/10.1590/s1677-5538.ibju.2016.0494.CrossRefPubMedPubMedCentral

12.

Montoya J, Gross E, Karsh L. How I do it: hydrogel spacer placement in men scheduled to undergo prostate radiotherapy. Can J Urol. 2018;25(2):9288–93.PubMed

13.

Goldner G, Tomicek B, Becker G, Geinitz H, Wachter S, Zimmermann F, Wachter-Gerstner N, Reibenwein J, Glocker S, Bamberg M, Feldmann H, Potzi R, Molls M, Potter R. Proctitis after external-beam radiotherapy for prostate cancer classified by Vienna Rectoscopy score and correlated with EORTC/RTOG score for late rectal toxicity: results of a prospective multicenter study of 166 patients. Int J Radiat Oncol Biol Phys. 2007;67(1):78–83. https://doi.org/10.1016/j.ijrobp.2006.08.055.CrossRefPubMed

14.

Marks LB, Yorke ED, Jackson A, Ten Haken RK, Constine LS, Eisbruch A, Bentzen SM, Nam J, Deasy JO. Use of normal tissue complication probability models in the clinic. Int J Radiat Oncol Biol Phys. 2010;76(3 Suppl):S10–9.CrossRef

15.

Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized phase III noninferiority study comparing two radiotherapy fractionation schedules in patients with low-risk prostate cancer. J Clin Oncol. 2016;34(20):2325–U2339. https://doi.org/10.1200/Jco.2016.67.0448.CrossRefPubMedPubMedCentral

16.

Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008;70(1):67–74.CrossRef

17.

Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E, Investigators CH. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016;17(8):1047–60. https://doi.org/10.1016/S1470-2045(16)30102-4.CrossRefPubMedPubMedCentral

18.

Cahlon O, Zelefsky MJ, Shippy A, Chan H, Fuks Z, Yamada Y, Hunt M, Greenstein S, Amols H. Ultra-high dose (86.4 Gy) IMRT for localized prostate cancer: toxicity and biochemical outcomes. Int J Radiat Oncol Biol Phys. 2008;71(2):330–7. https://doi.org/10.1016/j.ijrobp.2007.10.004.CrossRefPubMed

19.

Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006;24(13):1990–6.CrossRef

20.

van Wijk Y, Vanneste BGL, Walsh S, van der Meer S, Ramaekers B, van Elmpt W, Pinkawa M, Lambin P. Development of a virtual spacer to support the decision for the placement of an implantable rectum spacer for prostate cancer radiotherapy: comparison of dose, toxicity and cost-effectiveness. Radiother Oncol. 2017;125(1):107–12. https://doi.org/10.1016/j.radonc.2017.07.026.CrossRefPubMed

21.

Klotz T, Mathers MJ, Lazar Y, Gagel B. Use of hydrogel as spacer in Denovier’s space: optimization of IMRT radiotherapy of localized prostate cancer. Urologe A. 2013;52(12):1690–7. https://doi.org/10.1007/s00120-013-3290-6.CrossRefPubMed

22.

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(3):195–202. https://doi.org/10.1016/j.prro.2016.10.004.CrossRefPubMed

Title: Rectum-spacer related acute toxicity – endoscopy results of 403 prostate cancer patients after implantation of gel or balloon spacers
Authors: Andreas Schörghofer
Martin Drerup
Thomas Kunit
Lukas Lusuardi
Josef Holzinger
Josef Karner
Michael Groher
Christoph Zoubek
Rosemarie Forstner
Felix Sedlmayer
Frank Wolf
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Endoscopy
Rectoscopy
Published in: Radiation Oncology / Issue 1/2019
Electronic ISSN: 1748-717X
DOI: https://doi.org/10.1186/s13014-019-1248-6

At a glance: The STEP trials

Springer Medicine

Rectum-spacer related acute toxicity – endoscopy results of 403 prostate cancer patients after implantation of gel or balloon spacers

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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