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What is the quality of hydrogel spacer insertions? and which patients will benefit? A literature review

Published online by Cambridge University Press:  15 January 2020

Joseph Drabble Open the ORCID record for Joseph Drabble [Opens in a new window]  and
Heather Drury-Smith
Joseph Drabble*
Affiliation:
GenesisCare, Oxford, UK
Heather Drury-Smith
Affiliation:
Sheffield Hallam University, Sheffield, UK
*
Author for correspondence: Joseph Drabble, GenesisCare, Sandy Ln W, OxfordOX4 6LB, UK. E-mail: joe.drabble@genesiscare.co.uk
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Abstract

Aim:

To evaluate the quality of rectal hydrogel spacer (HS) insertions from literature in patients undergoing radical radiotherapy for prostate cancer. The secondary aim is to assess the benefit of HSs in patients with risk factors more likely to have rectal complications, such as non-conventional radiotherapy dose fractionations and high-risk disease.

Method and materials:

A literature search of peer-reviewed electronic articles was carried out using Boolean connectors and Medical Subject Headings in the databases. Databases searched included ScienceDirect, Medline and Cinahl. The articles were assessed using relevant critical appraisal skills programme tools.

Results:

From the 26 studies used, HS showed a clinically significant relative reduction in rectal planning dose volumes for both high- and low-risk prostate cancer patients in a range of radiotherapy treatment modalities including volumetric modulated arc therapy, intensity-modulated radiotherapy, intensity-modulated proton therapy, stereotactic ablative body radiotherapy and brachytherapy. Spacer placements were successfully inserted in 99% of patients. However, rectal wall infiltration occurrence was 6% and ≥2 cm unsymmetrical placements in 2%.

Findings:

A spacer scoring system based on the HS symmetry has provided evidence of the quality of the position inserted, which was visually aided by T2-wieghted MRIs. Despite optimal HS placements ranging from 62 to 72%, HS had a clinically significant reduction of ≥25% in planned rectal V70 dose in 97% of patients.

Keywords

gastrointestinal toxicityhydrogel spacerprostate cancerrectal wall infiltration
Type
Literature Review
Information
Journal of Radiotherapy in Practice , Volume 19 , Issue 4 , December 2020 , pp. 385 - 392
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Copyright
© The Author(s), 2020. Published by Cambridge University Press.

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References

Cancer Research. Prostate cancer statistics. https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer. Accessed on 9th July 2019.Google Scholar
Naismith, O F, Griffin, C, Syndikus, I et al. Forward- and inverse-planned intensity-modulated radiotherapy in the CHHiP trial: a comparison of dosimetry and normal tissue toxicity. Clin Oncol 2019; 31 (9): 600–610.CrossRefGoogle ScholarPubMed
Augmenix, Inc. De Novo classification request for SpaceOAR system. Decision summary. Regulatory information. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140030.pdf. Accessed on 20th July 2019.Google Scholar
Hamstra, D A, Mariados, N, Sylvester, J et al. Continued benefit to rectal separation for prostate RT: final results of a phase III trial. Int J Radiat Oncol Biol Phys 2017; 97 (5): 976–985.CrossRefGoogle ScholarPubMed
National Institute for Health and Care Excellence. IP overview: biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer. https://www.nice.org.uk/guidance/ipg590. Accessed on 15th July 2019.Google Scholar
Vanneste, B G L, Hoffman, A L, van Lin, E N et al. Who will benefit most from hydrogel rectum spacer implantation in prostate cancer radiotherapy? A model-based approach for patient selection. Radiother Oncol 2016; 121 (1): 118–123.CrossRefGoogle ScholarPubMed
The Royal College of Radiologists. Radiotherapy Dose Fractionation, 3rd edition. London: The Royal College of Radiologists, 2019.Google Scholar
National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology, prostate cancer. https://www.nccn.org/professionals/physician_gls/. Accessed on 21st July 2019.Google Scholar
Weber, D C, Zilli, T, Vallee, J P et al. Intensity modulated proton and photon therapy for early prostate cancer with or without transperineal injection of a polyethylene glycol spacer: a treatment planning comparison study. Int J Radiat Oncol Biol Phys 2012; 84 (3): e311–e318.CrossRefGoogle ScholarPubMed
Gulliford, S L, Ghose, S, Ebert, M A et al. Radiotherapy dose-distribution to the perirectal fat space (PRS) is related to gastrointestinal control-related complications. Clin Transl Oncol 2017; 7: 62–70.Google ScholarPubMed
Velde, B L, Westhuyzen, J, Awad, N et al. Can a peri‐rectal hydrogel spaceOAR programme for prostate cancer intensity‐modulated radiotherapy be successfully implemented in a regional setting? J Med Imaging Radiat Oncol 2017; 61 (4): 528–533.CrossRefGoogle Scholar
Pinkawa, M, Berneking, V, Schlenter, M et al. Quality of life after radiation therapy for prostate cancer with a hydrogel spacer: 5-year results. Int J Radiat Oncol Biol Phys 2017; 99 (2): 374–377.CrossRefGoogle ScholarPubMed
Chao, M, Ho, H, Chan, Y et al. Prospective analysis of hydrogel spacer for patients with prostate cancer undergoing radiotherapy. BJU Int 2018; 122: 427–433.CrossRefGoogle ScholarPubMed
Schorghofer, A, Drerup, M, Kunit, T et al. Rectum-spacer related acute toxicity – endoscopy results of 403 prostate cancer patients after implantation of gel or balloon spacers. Radiat Oncol J 2019; 14 (47): 1–7Google ScholarPubMed
Song, D Y, Herfarth, K K, Uhl, M 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 (1): 81–87.CrossRefGoogle ScholarPubMed
Pryor, D. Sidhom, M, Arumugam, S et al. Phase 2 multicenter study of gantry-based stereotactic radiotherapy boost for intermediate and high risk prostate cancer (prometheus). Front Oncol 2019; 9 (217): 1–9.CrossRefGoogle Scholar
Yeh, J, Lehrich, B, Tran, C et al. Polyethylene glycol hydrogel rectal spacer implantation in patients with prostate cancer undergoing combination high-dose-rate brachytherapy and external beam radiotherapy. Brachytherapy 2016; 15 (3): 283–287.CrossRefGoogle ScholarPubMed
Fiorino, C, Valdagni, R, Rancati, T et al. Dose–volume effects for normal tissues in external radiotherapy: pelvis. Radiother Oncol 2009; 93 (2): 153–167.CrossRefGoogle ScholarPubMed
Dearnaley, D, Syndikus, I, Mossop, H et al. 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): 1047–1060.CrossRefGoogle ScholarPubMed
Susil, R C, McNutt, T R, DeWeese, T L et al. Effects of prostate-rectum separation on rectal dose from external beam radiotherapy. Int J Radiat Oncol Biol Phys 2010; 76 (4): 1251–1258.CrossRefGoogle ScholarPubMed
Mariados, N, Sylvester, J, Shah, 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 (5): 971–977.CrossRefGoogle ScholarPubMed
Fischer-Valuck, W, Chundury, A, Gay, H et al. 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.CrossRefGoogle ScholarPubMed
Hatiboglu, G, Pfitzenmaier, J, Pahernik, S et al. Dissection technique for fast and safe transperineal spacer injection. Urology 2011; 78 (3): S333.CrossRefGoogle Scholar
Strom, T J, Wilder, R B, Fernandez, D C et al. A dosimetric study of polyethylene glycol hydrogel in 200 prostate cancer patients treated with high-dose rate brachytherapy+/-intensity modulated radiation therapy. Radiother Oncol 2014;111 (1): 126–131.CrossRefGoogle ScholarPubMed
Patel, P N, Gobin, A S, West, J L et al. Poly (ethylene gycol) hydrogel system supports preadipocyte viability, adhesion, and proliferation. Tissue Eng 2005; 11 (9/10): 1498–1505.CrossRefGoogle Scholar
Hatiboglu, G, Pinkawa, M, Vallée, J P et al. Application technique: placement of a prostate–rectum spacer in men undergoing prostate radiation therapy. BJUI 2012; 110 (11b): E647–E652.CrossRefGoogle ScholarPubMed
Pinkawa, M, Schubert, C, Escobar-Corral, N, Holy, R et al. Application of a hydrogel spacer for postoperative salvage radiotherapy of prostate cancer. Strahlenther Onkol 2015; 191 (4): 375–379.CrossRefGoogle ScholarPubMed
Goldner, G, Tomicek, B, Becker, G et al. 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.Google ScholarPubMed
Valdagni, R, Kattan, M W, Rancati, T et al. Is it time to tailor the prediction of radio-induced toxicity in prostate cancer patients? Building the first set of nomograms for late rectal syndrome. Int J Radiat Oncol Biol Phys 2012; 82 (5): 1957–1966.CrossRefGoogle ScholarPubMed
Van Wijk, Y, Vanneste, B G L, Walsh, S et al. 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): 107–112.CrossRefGoogle ScholarPubMed
Kothari, G, Loblaw, A, Tree, A C. Stereotactic body radiotherapy for primary prostate cancer. Technol Cancer Res Treat 2018; 17: 1–13.CrossRefGoogle ScholarPubMed