Endorectal Balloon during Image Guided Radiation Therapy for Prostate Carcinoma Reduces Radiation Proctitis at 2 Years

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1 Endorectal Balloon during Image Guided Radiation Therapy for Prostate Carcinoma Reduces Radiation Proctitis at 2 Years Poster No.: R-0041 Congress: Type: 2015 ASM Scientific Exhibit Authors: R. Botten, A. DiMatteo, K. Sharma, P. Dinning, B. Higgs, R. Fraser, E. Yeoh; Adelaide/AU Keywords: DOI: Motility, Image guided radiotherapy, Manometry, Treatment effects, Radiation therapy / Oncology, CT, Radioprotection / Radiation dose, Gastrointestinal tract, Pelvis, Toxicity /ranzcr2015/R-0041 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply RANZCR's endorsement, sponsorship or recommendation of the third party, information, product or service. RANZCR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold RANZCR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies,.ppt slideshows,.doc documents and any other multimedia files are not available in the pdf version of presentations. Page 1 of 11

2 Purpose Despite technological advances in radiation therapy for prostate cancer (CaP), radiation proctitis characterised by gastrointestinal (GI) symptoms such as increased frequency and urgency of defaecation, faecal incontinence and rectal bleeding, often persist and adversely affect activities of daily living of ~50% of patients at 5 years [1, 2]. Image guided radiation therapy (IGRT) with an in-situ endorectal balloon (ERB) (QLRAD TM ) daily (Figure 1) has been reported to (a) reduce radiation exposure of the rectum and anal canal (Figures 2 and 3) and (b) decrease the severity of rectal mucosal changes but not symptoms, compared to treatment without ERB [3]. We have been conducting a randomised trial comparing the effects of IGRT +/- ERB on GI symptoms of radiation proctitis, anorectal function and anal sphincteric morphology and have reported that the prevalence of radiation proctitis is reduced at 1 month and 1 year by IGRT+ERB versus IGRT-ERB [4]. As the prevalence of radiation proctitis and anorectal dysfunction increases with time after radiation therapy [1], the preliminary 2 year data after IGRT +/- ERB are presented here. The aims of the study are to (i) prospectively evaluate the effects of IGRT for CaP +/- ERB on GI symptoms of radiaiton proctitis, anorectal function and anal sphincteric morphology on the whole patient population and (ii) compare the effects between the two patient groups. Images for this section: Page 2 of 11

3 Fig. 1: QLRAD Rectal Pro Endorectal Balloon consisting of a flexible polyvinyl chloride shaft 20cm in length and a silicon balloon (shown inflated) 3cm in length Page 3 of 11

4 Fig. 2: IGRT planning with and without ERB. Transverse (top) and sagittal (bottom) % radiation dose distributions without (left) & with (right) ERB for rectal (green) and anal (purple) walls. Balloon inflation pushes the prostate gland against the pubis stretching anorectal wall increasing the surface area to reduce radiation dose to the anorectal wall Page 4 of 11

5 Fig. 3: Mean anal wall dose V20-V70Gy for 3 and 4 field comformal RT versus 4 field IMRT +/- ERB. Page 5 of 11

6 Methods and materials Subjects: 32 patients [73(51-84) years] with localised CaP were randomised to IGRT +ERB (n=17) or IGRT-ERB (n=15). Experimental Protocol: GI symptoms of radiation proctitis, anorectal function and anal sphincteric morphology were evaluated in each patient before IGRT and at 1 month, 1 year and 2 years after completion (Figure 4). Methods: GI symptoms of radiation proctitis including the frequency of bowel actions, diarrhoea, rectal pain, rectal mucous discharge, urgency of defaecation and rectal bleeding were scored using a modified LENT-SOMA questionnaire (Table 1). Anorectal motor and sensory function as well as rectal compliance were evaluated with perfused sleeve and multiport anorectal manometry and graded rectal balloon distension. Anal sphincter morphology was evaluated with endoanal ultrasound. Data Analysis: Individual and total GI LENT-SOMA scores were determined for each patient [1]. Basal pressures and response to squeeze and increased intra-abdominal pressure as well as rectal volumes associated with sensory threshold perception and rectal compliance were calculated for each patient [1]. The thicknesses of the internal and external anal sphincter for each patient were calculated [1]. Statistical Analysis: One way ANOVA examined changes in LENT-SOMA individual and total GI symptom scores and parameters of anorectal function and anal sphincteric morphology over time for the whole patient group. Two way repeated measures ANOVA was used to compare GI symptom scores and parameters of anorectal function and anal morphology. #2 test was used to compare the prevalence of changes in GI symptom scores between the patient groups. A p-value#0.05 was considered significant in all analyses. Images for this section: Page 6 of 11

7 Fig. 4: Schema of measurements Table 1: LENTSOMA Symptom Questionnaire Page 7 of 11

8 Results In the whole patient group, increases in individual LENT-SOMA GI symptom scores of frequency of defaecation, rectal mucous discharge and rectal bleeding after IGRT resulted in increased LENT-SOMA total GI symptom scores at 2 years (Figure 5). In the whole patient group, there were significant reductions in the following parameters of anorectal function and anal sphincteric morphology at 2 years: (i) anal pressures in response to increased intra-abdominal pressure, (ii) threshold volumes for rectal sensory perception, (iii) rectal compliance, (iv) internal and (v) external anal sphincter thicknesses (Table 2). In the comparisons of LENT-SOMA individual and total GI symptom scores between the patient groups, only rectal bleeding scores were significantly higher in patients in the IGRT-ERB group compared to those in the IGRT+ERB group (Figure 6). The prevalences of increased moderate to severe (individual LENT-SOMA GI scores >2) bowel frequency, diarrhoea, rectal pain, rectal mucous discharge and rectal bleeding were significantly higher in the IGRT-ERB versus the IGRT+ERB patient group at 2 years (Table 3). In comparisons between the patient groups for anorectal function and anal sphincteric morphology, only the threshold volume for sensory perception was significantly reduced over time in the IGRT-ERB group (Pre: 25±4ml # 2 years: 15±3ml) compared to the IGRT +ERB group (Pre: 15±2ml # 2 years: 13±2ml) (p<0.05). This reflects an increased rectal sensitivity in the patients in the IGRT-ERB group. Images for this section: Page 8 of 11

9 Fig. 5: LENT-SOMA symptoms over 2 years for (a) frequency of defaecation, (b) rectal mucous discharge, (c) rectal bleeding and (d) total GI symptom score for the whole group of patients. Page 9 of 11

10 Table 2: Anorectal functional and morphological data over 2 years for the whole patient group. Fig. 6: LENT-SOMA rectal bleeding scores over 2 years comparing IGRT+ERB to IGRT- ERB. Table 3: Percentage of patients who experienced moderate to severe GI symptoms 2 years after IGRT. Page 10 of 11

11 Conclusion IGRT + ERB for CaP reduces GI symptoms of radiation proctitis, particularly rectal bleeding and decreases rectal hypersensitivity at 2 years compared with the current standard of care of IGRT - ERB. Follow up studies are required to determine if the beneficial effects are sustained beyond 2 years. Personal information Professor Eric Yeoh MD (Adel), MRCS (Eng), MRCP (UK), FRCR (Lond), FRCP (Edin), FRANZCR Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia. Eric.Yeoh@sa.gov.au References [1] Yeoh et al. Int J Radiat Oncol Biol Phys 2012;84(5):e593-e599 [2] Smeenk et al. Radiother Oncol 2010;95: [3] van Lin et al. Int J Radiat Oncol Biol Phys 2007;67: [4] Botten et al. Gastroenterology 2014;146(5):S Page 11 of 11

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