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• W2043143497 abstract "Dose escalation in prostate radiotherapy (RT) leads to improved tumour control rates [[1]Pollack A. Zagars G.K. Starkschall G. Antolak J.A. Lee J.J. Huang E. et al.Prostate cancer radiation dose response: results of the M.D. Anderson phase III randomized trial.Int J Radiat Oncol Biol Phys. 2002; 53: 1097-1105Abstract Full Text Full Text PDF PubMed Scopus (1211) Google Scholar], but is limited by the vicinity of surrounding normal tissues, particularly the anorectum, as several dose–effect relationships for late anorectal toxicity have been observed. Even with modern treatment techniques such as IMRT and image-guidance, late anorectal toxicity rates varying from 5% to 65% are reported [2De Meerleer G.O. Fonteyne V.H. Vakaet L. Villeirs G.M. Denoyette L. Verbaeys A. et al.Intensity-modulated radiation therapy for prostate cancer: late morbidity and results on biochemical control.Radiother Oncol. 2007; 82: 160-166Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar, 3Zelefsky M.J. Levin E.J. Hunt M. Yamada Y. Shippy A.M. Jackson A. et al.Incidence of late rectal and urinary toxicities after three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for localized prostate cancer.Int J Radiat Oncol Biol Phys. 2008; 70: 1124-1129Abstract Full Text Full Text PDF PubMed Scopus (589) Google Scholar]. To further spare anorectal structures in modern high-dose external beam RT, additional devices have been developed. These can be divided into endorectal balloons (ERBs) and relatively novel spacers to separate the anterior rectal wall from the prostate. The purpose of applying these devices is mainly to reduce anorectal doses by increasing the distance between the prostate and (parts of) the anorectum, and subsequently to lower toxicity rates. Most data with regard to dose reduction are known from the application of ERBs, which are inserted into the rectum before each RT session and subsequently inflated, thereby pushing the lateral and posterior parts of the anorectal wall away from the PTV [[4]Smeenk R.J. Teh B.S. Butler E.B. van Lin E.N. Kaanders J.H. Is there a role for endorectal balloons in prostate radiotherapy? A systematic review.Radiother Oncol. 2010; 95: 277-282Abstract Full Text Full Text PDF PubMed Scopus (79) Google Scholar]. Although the anterior anorectal wall is pushed towards the prostate, the overall effect proved to be beneficial in 3D conformal RT and IMRT. Several studies have confirmed this beneficial dosimetric effect in external beam RT, both as primary treatment and after radical prostatectomy. Obviously, the most important argument to use such devices is to eventually reduce anorectal toxicity, and low toxicity rates have been described in cohorts of patients treated with ERBs [[5]Teh B.S. Dong L. McGary J.E. Mai W.Y. Grant III, W. Butler E.B. Rectal wall sparing by dosimetric effect of rectal balloon used during intensity-modulated radiation therapy (IMRT) for prostate cancer.Med Dosim. 2005; 30: 25-30Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar]. To date, however, only one trial has compared a group of patients treated with ERB to patients treated without ERB with regard to late toxicity showing a reduced incidence of rectal bleeding with application of ERBs [[6]van Lin E.N. Kristinsson J. Philippens M.E. de Jong D.J. Van d V. Kaanders J.H. et al.Reduced late rectal mucosal changes after prostate three-dimensional conformal radiotherapy with endorectal balloon as observed in repeated endoscopy.Int J Radiat Oncol Biol Phys. 2007; 67: 799-811Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar]. So far, randomized trials are lacking. An interesting development in the recent years has been the use of transperinealy inserted spacers (TIS) between the prostate and the anorectum. Injection of hyaluronic acid [[7]Prada P.J. Fernandez J. Martinez A.A. De la R.A. Gonzalez J.M. Fernandez J.M. et al.Transperineal injection of hyaluronic acid in anterior perirectal fat to decrease rectal toxicity from radiation delivered with intensity modulated brachytherapy or EBRT for prostate cancer patients.Int J Radiat Oncol Biol Phys. 2007; 69: 95-102Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar] and hydrogels [[8]Pinkawa M. Piroth M.D. Holy R. Escobar-Corral N. Caffaro M. Djukic V. et al.Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis.Strahlenther Onkol. 2012; 188: 917-925Crossref PubMed Scopus (38) Google Scholar], as well as implantation of biodegradable balloons [[9]Levy Y. Paz A. Yosef R.B. Corn B.W. Vaisman B. Shuhat S. et al.Biodegradable inflatable balloon for reducing radiation adverse effects in prostate cancer.J Biomed Mater Res B Appl Biomater. 2009; 91: 855-867Crossref PubMed Scopus (39) Google Scholar] has been described. By increasing the distance between the CTV and the anorectum, the latter can be spared and dosimetric benefits of these spacers have recently been shown [[10]Pinkawa M. Corral N.E. Caffaro M. Piroth M.D. Holy R. Djukic V. et al.Application of a spacer gel to optimize three-dimensional conformal and intensity modulated radiotherapy for prostate cancer.Radiother Oncol. 2011; 100: 436-441Abstract Full Text Full Text PDF PubMed Scopus (97) Google Scholar]. In this issue of Radiotherapy & Oncology, some aspects of TIS are discussed [11Melchert M. Gez E. Garg M. Bohlen G. Kalnicki S. Scarzello G. et al.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: 210-214Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 12Pinkawa M. Piroth M.D. Holy R. Escobar-Corral N. Caffaro M. Djukic V. et al.Spacer stability and prostate position variability during radiotherapy for prostate cancer applying a hydrogel to protect the rectal wall.Radiother Oncol. 2013; 106: 220-224Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 13Uhl M. van T.B. Eble M.J. Weber D.C. Herfarth K. De Weese T.L. 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: 215-219Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar]. An important difference between TIS and ERBs is the part of the anorectum that is spared: ERBs reduce doses to the lateral and posterior anorectal wall, whereas the benefit of TIS mainly seems to involve the anterior wall. This difference may indicate that the optimal indications for both devices are not equal. Application of TIS may especially be beneficial when mainly the anterior rectal wall is of interest, i.e. when very small posterior margins are applied and/or when a steep dose gradient can be accomplished. This makes it potentially beneficial to prostate brachytherapy [[14]Prada P.J. Gonzalez H. Menendez C. Llaneza A. Fernandez J. Santamarta E. et al.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: 210-217Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar]. In this case, application of ERBs is probably less attractive and may even be counteractive, as the anterior wall is pushed towards the high-dose region and only a small gain of pushing the lateral and posterior parts of the rectum away from the CTV can be expected due to the steep dose fall-off. Also when intrafraction motion is continuously tracked and corrected for, enabling small CTV-PTV margins, TIS may be interesting. However, when conventional margins are applied, both ERBs and TIS may be of benefit, according to the abovementioned studies. With regard to the anal wall, application of ERBs has shown to reduce doses, supposedly by increasing the distance between the CTV and the posterior and lateral anal wall by the balloon itself, as well as the shaft [[15]Smeenk R.J. van Lin E.N. Van K.P. Kunze-Busch M. Kaanders J.H. Anal wall sparing effect of an endorectal balloon in 3D conformal and intensity-modulated prostate radiotherapy.Radiother Oncol. 2009; 93: 131-136Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar]. The anal wall sparing effect of TIS has not yet been specifically addressed. Early results on toxicity in patients treated with TIS are reported in this issue of Radiotherapy & Oncology and suggest low toxicity rates after 12 months [[13]Uhl M. van T.B. Eble M.J. Weber D.C. Herfarth K. De Weese T.L. 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: 215-219Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar]. However, given the progressive nature of late anorectal damage long-term results are needed. Nevertheless, the results presented here are promising. An additional potential benefit of these devices is a prostate immobilizing effect. Comparative studies using real-time tracking have shown that application of an ERB reduces intrafraction prostate motion compared to patients irradiated without ERB, enabling the use of smaller CTV-PTV margins and thereby potentially reducing toxicity rates [16Smeenk R.J. Louwe R.J. Langen K.M. Shah A.P. Kupelian P.A. van Lin E.N. et al.An endorectal balloon reduces intrafraction prostate motion during radiotherapy.Int J Radiat Oncol Biol Phys. 2012; 83: 661-669Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar, 17Wang K.K. Vapiwala N. Deville C. Plastaras J.P. Scheuermann R. Lin H. et al.A study to quantify the effectiveness of daily endorectal balloon for prostate intrafraction motion management.Int J Radiat Oncol Biol Phys. 2012; 83: 1055-1063Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar]. One of the suggested underlying mechanisms is that the ERB pushes the prostate towards the pubic bone. Another potential explanation may be that the ERB prevents gas and stools, which are causes of intrafraction motion, to pass. Whether TIS have the same effect is questionable, as with its application rectal filling may still vary. Clearly, when using an invasive device, patient tolerability and potential side effects are a concern. With regard to ERBs, this topic has been studied fairly well in cohorts of up to several thousands of patients, and it is concluded that ERBs are overall well tolerated, although patients with preexistent anorectal disease are at risk of ERB-related toxicity [[18]Ronson B.B. Yonemoto L.T. Rossi C.J. Slater J.M. Slater J.D. Patient tolerance of rectal balloons in conformal radiation treatment of prostate cancer.Int J Radiat Oncol Biol Phys. 2006; 64: 1367-1370Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar]. Given the relative novelty of TIS, only small patient cohorts have been studied, but in these patients safe injection procedures are described [[7]Prada P.J. Fernandez J. Martinez A.A. De la R.A. Gonzalez J.M. Fernandez J.M. et al.Transperineal injection of hyaluronic acid in anterior perirectal fat to decrease rectal toxicity from radiation delivered with intensity modulated brachytherapy or EBRT for prostate cancer patients.Int J Radiat Oncol Biol Phys. 2007; 69: 95-102Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar]. Theoretically, it could be expected that application of TIS may lead to complications, as it is transperinealy injected, thereby potentially inducing an infection, bleeding or perforation. Its injection, however, is a single action, while ERBs have to be applied during all treatment fractions. When ERBs or TIS are used in combination with small margins their stability is essential, as differences in their volume or diameters may lead to overdosage to the anorectum and/or underdosage of the prostate. Although fiducial based imaging may correct for the latter, the first may lead to unexpected rectal toxicity if not actively checked by means of portal imaging (in case of an air-filled ERB) or cone-beam CT. A study presented in this issue of Radiotherapy & Oncology shows that application of hydrogel TIS remains stable during the time of treatment, after which slowly degrades [[12]Pinkawa M. Piroth M.D. Holy R. Escobar-Corral N. Caffaro M. Djukic V. et al.Spacer stability and prostate position variability during radiotherapy for prostate cancer applying a hydrogel to protect the rectal wall.Radiother Oncol. 2013; 106: 220-224Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar]. It has been suggested that application of hyaluronic acid TIS is more viscous, thereby distributing less evenly than its hydrogel counterpart and that it may be susceptible to radiation-induced degradation [[19]Daar E. King L. Nisbet A. Thorpe R.B. Bradley D.A. Viscosity changes in hyaluronic acid: irradiation and rheological studies.Appl Radiat Isot. 2010; 68: 746-750Crossref PubMed Scopus (48) Google Scholar]. Based on the abovementioned data, future research should be mainly focused on clinical outcome with application of ERBs or TIS, both with regard to tumour control and to late toxicity, preferably in a randomized controlled trial. In addition to comparing patients treated with and without a specific device, comparing patients treated with ERB to patients irradiated with TIS may be interesting to investigate whether both devices have the same beneficial effect in modern external beam RT." @default.
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