Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial
Abstract Background Dose-escalation to above 80 Gy during external beam radiotherapy for localised prostate cancer leads to improved oncological outcomes but also substantially increased rectal toxicity. The aim of this study was to demonstrate the safety and efficacy of escalating the dose to 82 Gy...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-07-01
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| Series: | Radiation Oncology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13014-022-02103-5 |
| _version_ | 1818163034553581568 |
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| author | Andrew W. See Patrick Bowden Geoffrey Wells Sree Appu Nathan Lawrentschuk Peter Liodakis Chloe Pandeli Yolanda Aarons Lloyd M. L. Smyth Dean P. McKenzie |
| author_facet | Andrew W. See Patrick Bowden Geoffrey Wells Sree Appu Nathan Lawrentschuk Peter Liodakis Chloe Pandeli Yolanda Aarons Lloyd M. L. Smyth Dean P. McKenzie |
| author_sort | Andrew W. See |
| collection | DOAJ |
| description | Abstract Background Dose-escalation to above 80 Gy during external beam radiotherapy for localised prostate cancer leads to improved oncological outcomes but also substantially increased rectal toxicity. The aim of this study was to demonstrate the safety and efficacy of escalating the dose to 82 Gy following insertion of a peri-rectal hydrogel spacer (HS) prior to radiotherapy. Methods This was a single arm, open-label, prospective study of men with localised prostate cancer who were prescribed a course of intensity modulated radiotherapy escalated to 82 Gy in 2 Gy fractions following insertion of the SpaceOAR™ HS (Boston Scientific, Marlborough, MA). Patients were prescribed a standard course of 78 Gy in 2 Gy fractions where rectal dose constraints could not be met for the 82 Gy plan. The co-primary endpoints were the rate of grade 3 gastrointestinal (GI) and genitourinary (GU) adverse events (CTCAE, v4), and patient-reported quality of life (QoL) (EORTC QLQ-C30 and PR25 modules), up to 37.5 months post-treatment. Results Seventy patients received treatment on the study, with 64 (91.4%) receiving an 82 Gy treatment course. The median follow-up time post-treatment was 37.4 months. The rate of radiotherapy-related grade 3 GI and GU adverse events was 0% and 2.9%, respectively. There were 2 (2.9%) grade 3 adverse events related to insertion of the HS. Only small and transient declines in QoL were observed; there was no clinically or statistically significant decline in QoL beyond 13.5 months and up to 37.5 months post-treatment, compared to baseline. No late RTOG-defined grade ≥ 2 GI toxicity was observed, with no GI toxicity observed in any patient at 37.5 months post-treatment. Nine (12.9%) patients met criteria for biochemical failure within the follow-up period. Conclusions Dose-escalation to 82 Gy, facilitated by use of a hydrogel spacer, is safe and feasible, with minimal toxicity up to 37.5 months post-treatment when compared to rates of rectal toxicity in previous dose-escalation trials up to 80 Gy. Trials with longer follow-up of oncological and functional outcomes are required to robustly demonstrate a sustained widening of the therapeutic window. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12621000056897 , 22/01/2021. Retrospectively registered. |
| first_indexed | 2024-12-11T16:43:09Z |
| format | Article |
| id | doaj.art-e673c3a3b4f2460bae153c915b2c8584 |
| institution | Directory Open Access Journal |
| issn | 1748-717X |
| language | English |
| last_indexed | 2024-12-11T16:43:09Z |
| publishDate | 2022-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Radiation Oncology |
| spelling | doaj.art-e673c3a3b4f2460bae153c915b2c85842022-12-22T00:58:16ZengBMCRadiation Oncology1748-717X2022-07-0117111010.1186/s13014-022-02103-5Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trialAndrew W. See0Patrick Bowden1Geoffrey Wells2Sree Appu3Nathan Lawrentschuk4Peter Liodakis5Chloe Pandeli6Yolanda Aarons7Lloyd M. L. Smyth8Dean P. McKenzie9Icon Cancer CentreIcon Cancer CentreUrology Department, Eastern Health, Box Hill HospitalDepartment of Surgery, Monash UniversityDivision of Cancer Surgery, Peter MacCallum Cancer CentreDepartment of Urology, Austin HealthIcon Cancer CentreIcon Cancer CentreIcon Institute of Innovation and ResearchResearch Development and Governance Unit, Epworth HealthCareAbstract Background Dose-escalation to above 80 Gy during external beam radiotherapy for localised prostate cancer leads to improved oncological outcomes but also substantially increased rectal toxicity. The aim of this study was to demonstrate the safety and efficacy of escalating the dose to 82 Gy following insertion of a peri-rectal hydrogel spacer (HS) prior to radiotherapy. Methods This was a single arm, open-label, prospective study of men with localised prostate cancer who were prescribed a course of intensity modulated radiotherapy escalated to 82 Gy in 2 Gy fractions following insertion of the SpaceOAR™ HS (Boston Scientific, Marlborough, MA). Patients were prescribed a standard course of 78 Gy in 2 Gy fractions where rectal dose constraints could not be met for the 82 Gy plan. The co-primary endpoints were the rate of grade 3 gastrointestinal (GI) and genitourinary (GU) adverse events (CTCAE, v4), and patient-reported quality of life (QoL) (EORTC QLQ-C30 and PR25 modules), up to 37.5 months post-treatment. Results Seventy patients received treatment on the study, with 64 (91.4%) receiving an 82 Gy treatment course. The median follow-up time post-treatment was 37.4 months. The rate of radiotherapy-related grade 3 GI and GU adverse events was 0% and 2.9%, respectively. There were 2 (2.9%) grade 3 adverse events related to insertion of the HS. Only small and transient declines in QoL were observed; there was no clinically or statistically significant decline in QoL beyond 13.5 months and up to 37.5 months post-treatment, compared to baseline. No late RTOG-defined grade ≥ 2 GI toxicity was observed, with no GI toxicity observed in any patient at 37.5 months post-treatment. Nine (12.9%) patients met criteria for biochemical failure within the follow-up period. Conclusions Dose-escalation to 82 Gy, facilitated by use of a hydrogel spacer, is safe and feasible, with minimal toxicity up to 37.5 months post-treatment when compared to rates of rectal toxicity in previous dose-escalation trials up to 80 Gy. Trials with longer follow-up of oncological and functional outcomes are required to robustly demonstrate a sustained widening of the therapeutic window. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12621000056897 , 22/01/2021. Retrospectively registered.https://doi.org/10.1186/s13014-022-02103-5Dose-escalationHydrogelProstate cancerRadiotherapyRectumToxicity |
| spellingShingle | Andrew W. See Patrick Bowden Geoffrey Wells Sree Appu Nathan Lawrentschuk Peter Liodakis Chloe Pandeli Yolanda Aarons Lloyd M. L. Smyth Dean P. McKenzie Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial Radiation Oncology Dose-escalation Hydrogel Prostate cancer Radiotherapy Rectum Toxicity |
| title | Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial |
| title_full | Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial |
| title_fullStr | Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial |
| title_full_unstemmed | Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial |
| title_short | Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial |
| title_sort | dose escalated radiotherapy to 82 gy for prostate cancer following insertion of a peri rectal hydrogel spacer 3 year outcomes from a phase ii trial |
| topic | Dose-escalation Hydrogel Prostate cancer Radiotherapy Rectum Toxicity |
| url | https://doi.org/10.1186/s13014-022-02103-5 |
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