Nigel Armstrong1, Amit Bahl2, Michael Pinkawa3, Steve Ryder4, Charlotte Ahmadu4, Janine Ross4, Samir Bhattacharyya5, Emily Woodward5, Suzanne Battaglia5, Jean Binns5, Heather Payne6. 1. Kleijnen Systematic Reviews Ltd, Escrick, YO, United Kingdom. Electronic address: nigel@systematic-reviews.com. 2. University Hospitals Bristol, Bristol, United Kingdom. 3. Department of Radiation Oncology, MediClin Robert Janker Klinik, Bonn, Germany. 4. Kleijnen Systematic Reviews Ltd, Escrick, YO, United Kingdom. 5. Boston Scientific Corporation, United States. 6. University College Hospital, London, United Kingdom.
Abstract
OBJECTIVE: To evaluate the association between SpaceOAR and radiation dosing, toxicity and quality-of-life vs no spacer across all radiotherapy modalities for prostate cancer. METHODS: A systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase was performed from database inception through May 2020. Two reviewers independently screened titles/abstracts and full papers. Data extraction was performed, and quality assessed by 1 reviewer and checked by a second, using a third reviewer as required. The synthesis was narrative. RESULTS: 19 studies (3,622 patients) were included (only 1 randomized controlled trial, in image-guided intensity-modulated radiotherapy (IG-IMRT), 18 comparatives non-randomized controlled trials in external-beam radiotherapy (EBRT), brachytherapy, and combinations thereof). No hypofractionation studies were found. Regardless of radiotherapy type, SpaceOAR significantly reduced rectal radiation dose (eg, V40 average difference -6.1% in high dose-rate brachytherapy plus IG-IMRT to -9.1% in IG-IMRT) and reduced gastrointestinal and genitourinary toxicities (eg, late gastrointestinal toxicity 1% vs 6% (P = .01), late genitourinary toxicity of 15% vs 32% (P < .001) in stereotactic body radiotherapy). Improvements were observed in most Expanded Prostate Cancer Index Composite quality-of-life domains (eg, bowel function score decrease at 3 and 6 months: Average change of zero vs -6.25 and -3.57 respectively in low dose-rate brachytherapy plus EBRT). CONCLUSION: The randomized controlled trial in IG-IMRT demonstrated that SpaceOAR reduces rectal radiation dose and late gastrointestinal and genitourinary toxicities, with urinary, bowel, and sexual quality-of-life improvement. These advantages were verified in observational studies in various radiotherapy types. Further research is required in hypofractionation.
OBJECTIVE: To evaluate the association between SpaceOAR and radiation dosing, toxicity and quality-of-life vs no spacer across all radiotherapy modalities for prostate cancer. METHODS: A systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase was performed from database inception through May 2020. Two reviewers independently screened titles/abstracts and full papers. Data extraction was performed, and quality assessed by 1 reviewer and checked by a second, using a third reviewer as required. The synthesis was narrative. RESULTS: 19 studies (3,622 patients) were included (only 1 randomized controlled trial, in image-guided intensity-modulated radiotherapy (IG-IMRT), 18 comparatives non-randomized controlled trials in external-beam radiotherapy (EBRT), brachytherapy, and combinations thereof). No hypofractionation studies were found. Regardless of radiotherapy type, SpaceOAR significantly reduced rectal radiation dose (eg, V40 average difference -6.1% in high dose-rate brachytherapy plus IG-IMRT to -9.1% in IG-IMRT) and reduced gastrointestinal and genitourinary toxicities (eg, late gastrointestinal toxicity 1% vs 6% (P = .01), late genitourinary toxicity of 15% vs 32% (P < .001) in stereotactic body radiotherapy). Improvements were observed in most Expanded Prostate Cancer Index Composite quality-of-life domains (eg, bowel function score decrease at 3 and 6 months: Average change of zero vs -6.25 and -3.57 respectively in low dose-rate brachytherapy plus EBRT). CONCLUSION: The randomized controlled trial in IG-IMRT demonstrated that SpaceOAR reduces rectal radiation dose and late gastrointestinal and genitourinary toxicities, with urinary, bowel, and sexual quality-of-life improvement. These advantages were verified in observational studies in various radiotherapy types. Further research is required in hypofractionation.
Authors: Meera B Ganesh; Briana S Kaplunov; Matthew S Lee; Mark A Assmus; Ashley E Ross; Joy Coleman; Amy E Krambeck Journal: Ther Adv Urol Date: 2022-01-19