Rectal Hydrogel Spacer Improves Late Gastrointestinal Toxicity Compared to Rectal Balloon Immobilization After Proton Beam Radiotherapy for Localized Prostate Cancer: A Retrospective Observational Study
By: Dinh TT, Lee HJ, Macomber MW, et al.
- Study was retrospective in nature.
- The SpaceOAR™ Hydrogel pivotal study did not use PBT so the results may not be comparable.
- This study was not designed or powered to make definitive claims about the benefits of a spacer.
- These results may not be achieved with other PBT protocols.
- A limitation of these data is the high drop-out rate in reporting with followup, though the rates are roughly similar between cohorts. A patient-level analysis of EPIC scores was not possible due to the limited number of patients with scores at all time points.
- Incidences of RB were retrospectively graded, and thus subject to availability and heterogeneity of records.
- High-risk patients comprised a higher proportion in the rectal balloon immobilization group, in large part because patients with ECE, SVI, or local invasion were precluded from receiving hydrogel spacer.
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- Dinh TKT, Lee Jr HJ, Macomber MW, et al. Rectal hydrogel spacer improves late gastrointestinal toxicity compared to rectal balloon immobilization after proton beam radiation therapy for localized prostate cancer: a retrospective observational study. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):635-43.
PBT was not the method used in the SpaceOAR™ Hydrogel single-blind Phase III trial performed to evaluate dosimetric and clinical effects of SpaceOAR Hydrogel. IG-IMRT delivered at 79.2 Gy in 1.8-Gy fractions was the method used.
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
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