Subcutaneous spacer injection to reduce skin toxicity in breast brachytherapy: A pilot study on mastectomy specimens

Struik, Gerson M.; Pignol, Jean-Philippe; Kolkman-Deurloo, Inger Karine; Godart, J.; Verduijn, Gerda M.; Koppert, Linetta B.; Birnie, Erwin; Ghandi, Ali; Klem, T.M.A.L.

doi:10.1016/j.brachy.2018.11.003

Cited by 4 publications

(6 citation statements)

References 32 publications

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“…However, with the seeds already in place, we expect that any change in PTV geometry will be similar in the treated volume containing the seeds. This hypothesis was supported by the excellent and comparable PTV coverage (V 100% ) before and after injection in the pre-clinical study [44]. However, this finding should be confirmed in a clinical setting.…”

Section: Discussionmentioning

confidence: 66%

“…Based on our pre-clinical study we do not expect the spacer to influence the oncological effectivity of PBSI. [44]. This work in mastectomy specimens showed excellent feasibility of creating an extra 5-mm space directly below the skin using a biodegradable spacer.…”

Section: Discussionmentioning

confidence: 93%

“…This clinical trial was designed because it is unknown whether the dosimetric benefit of the spacer, which was found in our pre-clinical study [44], translates in a real patient benefit. An example of a clinical trial that could not demonstrate that a dosimetric benefit translates into better patient outcomes, is the breast intensity modulated radiation therapy (IMRT) trial.…”

Section: Discussionmentioning

confidence: 99%

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A randomized controlled trial testing a hyaluronic acid spacer injection for skin toxicity reduction of brachytherapy accelerated partial breast irradiation (APBI): a study protocol

Struik

Godart

Verduijn

et al. 2018

Trials

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BackgroundAccelerated partial breast irradiation (APBI) is a treatment option for selected early stage breast cancer patients. Some APBI techniques lead to skin toxicity with the skin dose as main risk factor. We hypothesize that a spacer injected between the skin and target volume reduces the skin dose and subsequent toxicity in permanent breast seed implant (PBSI) patients.MethodsIn this parallel-group, single-center, randomized controlled trial, the effect of a subcutaneous spacer injection on skin toxicity among patients treated with PBSI is tested. Eligibility for participation is derived from international guidelines for suitable patients for partial breast radiotherapy, e.g. women aged ≥ 50 years with a histologically proven non-lobular breast carcinoma and/or ductal carcinoma in situ (DCIS), tumor size ≤ 3 cm, node-negative, and PBSI technically feasible. Among exclusion criteria are neoadjuvant chemotherapy, lymphovascular invasion, and allergy for hyaluronic acid. For the patients allocated to receive spacer, after the PBSI procedure, 4–10 cc of biodegradable hyaluronic acid (Barrigel™, Palette Life Sciences, Santa Barbara, CA, USA or Restylane SubQ®, Galderma Benelux, Breda, the Netherlands) is injected directly under the skin using ultrasound guidance to create an extra 0.5–1 cm space between the treatment volume and the skin. The primary outcome is the rate of telangiectasia at two years, blindly assessed using Bentzen’s 4-point scale. Secondary outcomes include: local recurrence; disease-free and overall survival rates; adverse events (pain, redness, skin/subcutaneous induration, radiation dermatitis, pigmentation, surgical site infection); skin dose; cosmetic and functional results; and health-related quality of life.A Fisher’s exact test will be used to test differences between groups on the primary outcome.Previous studies found 22.4% telangiectasia at two years. We expect the use of a spacer could reduce the occurrence of telangiectasia to 7.7%. A sample size of 230 patients will allow for a 10% lost to follow-up rate.DiscussionIn this study, the effect of a subcutaneous spacer injection on the skin dose, late skin toxicity, and cosmetic outcome is tested in patients treated with PBSI in the setting of breast-conserving therapy. Our results will be relevant for most forms of breast brachytherapy as well as robotic radiosurgery, as skin spacers could protect the skin with these other techniques.Trial registrationNetherlands Trial Register, NTR6549. Registered on 27 June 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3035-3) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 66%

Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

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A randomized controlled trial testing a hyaluronic acid spacer injection for skin toxicity reduction of brachytherapy accelerated partial breast irradiation (APBI): a study protocol

Struik

Godart

Verduijn

et al. 2018

Trials

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“…A hydrogel spacer is used in radiation therapy (RT) for a variety of cancers to decrease the irradiated dose to the organs at risk (OARs) [1][2][3][4][5]. Furthermore, in pelvic radiation therapy, a hydrogel spacer is used to decrease the rectal dose [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

The use of hyperbaric oxygen to treat actinic rectal fistula after SpaceOAR use and radiotherapy for prostate cancer: a case report

Kashihara

Inaba

Komiyama³

et al. 2020

BMC Urol

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Background In definitive radiation therapy for prostate cancer, the SpaceOAR® System, a hydrogel spacer, is widely used to decrease the irradiated dose and toxicity of rectum. On the other hand, periprostatic abscesses formation and rectal perforation are known as rare adverse effects of SpaceOAR. Nevertheless, there is a lack of reports clarifying the association between aggravation of abscesses and radiation therapy, and hyperbaric oxygen therapy (HBOT) is effective for a peri-SpaceOAR abscess and rectal perforation. Case presentation We report a case of a 78-year-old high-risk prostate cancer patient. After SpaceOAR insertion into the correct space, he started to receive external beam radiation therapy (EBRT). He developed a fever, perineal pain and frequent urination after the completion of EBRT, and the magnetic resonance imaging (MRI) revealed a peri-SpaceOAR abscess. Scheduled brachytherapy was postponed, administration of antibiotics and opioid via intravenous drip was commenced, and transperineal drainage was performed. After the alleviation of the abscess, additional EBRT instead of brachytherapy was performed with MRI-guided radiation therapy (MRgRT). On the last day of the MRgRT, perineal pain reoccurred, and MRI and colonoscopy detected the rectal perforation. He received an intravenous antibiotics drip and HBOT, and fully recovered from the rectal perforation. Conclusions Our report indicates that EBRT can lead to a severe rectum complication by causing inflammation for patients with a peri-SpaceOAR abscess. Furthermore, HBOT was effective for the peri-SpaceOAR abscess and rectal perforation associated with EBRT.

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“…A hydrogel spacer is used in radiation therapy (RT) for a variety of cancers to decrease the irradiated dose of organs at risk (OARs) [1][2][3][4][5]. Furthermore, in pelvic radiation therapy, a hydrogel spacer is used to decrease the rectum dose [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Rectal Perforation Associated with Magnetic Resonance-Guided Radiation Therapy (MRgRT) after Peri-SpaceOAR Abscess Formation: A Case Report.

Kashihara¹,

Inaba²,

Komiyama³

et al. 2020

Preprint

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Background In definitive radiation therapy for prostate cancer, SpaceOAR, a hydrogel spacer, is widely used to decrease irradiated dose and toxicity of rectum. On the other hand, periprostatic abscess formation is known as a rare adverse effect of SpaceOAR. There is a lack of reports clarifying the association between aggravation of abscesses and radiation therapy, and whether SpaceOAR insertion succeeded or not. Case presentation We report a case of a 78-year-old high-risk prostate cancer patient. After SpaceOAR insertion into the correct space, he started to receive external beam radiation therapy (EBRT). He developed a fever, perineal pain and frequent urination after the completion of EBRT, and the magnetic resonance imaging (MRI) revealed a peri-SpaceOAR abscess. Scheduled brachytherapy was postponed, administration of antibiotics and opioid via intravenous drip was commenced, and transperineal drainage was performed. After the alleviation of the abscess, additional EBRT instead of brachytherapy was performed with MRI-guided radiation therapy (MRgRT). On the last day of the MRgRT, perineal pain reoccurred, and MRI and colonoscopy detected the rectal perforation. He received an intravenous antibiotics drip and hyperbaric oxygen therapy (HBOT), and fully recovered from the rectal perforation. Conclusions Our report indicates that EBRT can lead to severe rectum complication by causing inflammation for patients with a peri-SpaceOAR abscess. Furthermore, HBOT was effective for the peri-SpaceOAR abscess and rectal perforation associated with EBRT.

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Subcutaneous spacer injection to reduce skin toxicity in breast brachytherapy: A pilot study on mastectomy specimens

Cited by 4 publications

References 32 publications

A randomized controlled trial testing a hyaluronic acid spacer injection for skin toxicity reduction of brachytherapy accelerated partial breast irradiation (APBI): a study protocol

A randomized controlled trial testing a hyaluronic acid spacer injection for skin toxicity reduction of brachytherapy accelerated partial breast irradiation (APBI): a study protocol

The use of hyperbaric oxygen to treat actinic rectal fistula after SpaceOAR use and radiotherapy for prostate cancer: a case report

Rectal Perforation Associated with Magnetic Resonance-Guided Radiation Therapy (MRgRT) after Peri-SpaceOAR Abscess Formation: A Case Report.

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