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Journal of Radiation Oncology Sep 2015The aim of this study is to define the maximal safe radiation dose to guide further study of the GliaSite balloon brachytherapy (GSBT) system in untreated newly...
Outcome of Adult Brain Tumor Consortium (ABTC) prospective dose-finding trials of I-125 balloon brachytherapy in high-grade gliomas: challenges in clinical trial design and technology development when MRI treatment effect and recurrence appear similar.
OBJECTIVES
The aim of this study is to define the maximal safe radiation dose to guide further study of the GliaSite balloon brachytherapy (GSBT) system in untreated newly diagnosed glioblastoma (NEW-GBM) and recurrent high-grade glioma (REC-HGG). GBST is a balloon placed in the resection cavity and later filled through a subcutaneous port with liquid I-125 Iotrex, providing radiation doses that diminish uniformly with distance from the balloon surface.
METHODS
The Adult Brain Tumor Consortium initiated prospective dose-finding studies to determine maximum tolerated dose in NEW-GBM treated before standard RT or after surgery for REC-HGG. Patients were inevaluable if there was progression before the 90-day posttreatment toxicity evaluation point.
RESULTS
Ten NEW-GBM patients had the balloon placed, and 2/10 reached the 90 day timepoint. Five REC-HGG enrolled and two were assessable at the 90-day evaluation endpoint. Imaging progression occurred before 90-day evaluation in 7/12 treated patients. The trials were closed as too few patients were assessable to allow dose escalation, although no dose-limiting toxicities (DLTs) were observed. Median survival from treatment was 15.3 months (95 % CI 7.1-23.6) for NEW-GBM and 12.8 months (95 % CI 4.2-20.9) for REC-HGG.
CONCLUSION
These trials failed to determine a maximum tolerated dose (MTD) for further testing as early imaging changes, presumed to be progression, were common and interfered with the assessment of treatment-related toxicity. The survival outcomes in these and other related studies, although based on small populations, suggest that GSBT may be worthy of further study using clinical and survival endpoints, rather than standard imaging results. The implications for local therapy development are discussed.
PubMed: 27695605
DOI: 10.1007/s13566-015-0210-y -
Journal of Contemporary Brachytherapy Aug 2016In this study, we present the clinical implementation of a novel transoral balloon centering esophageal applicator (BCEA) and the initial clinical experience in...
PURPOSE
In this study, we present the clinical implementation of a novel transoral balloon centering esophageal applicator (BCEA) and the initial clinical experience in high-dose-rate (HDR) brachytherapy treatment of esophageal cancer, using this applicator.
MATERIAL AND METHODS
Acceptance testing and commissioning of the BCEA were performed prior to clinical use. Full performance testing was conducted including measurements of the dimensions and the catheter diameter, evaluation of the inflatable balloon consistency, visibility of the radio-opaque markers, congruence of the markers, absolute and relative accuracy of the HDR source in the applicator using the radiochromic film and source position simulator, visibility and digitization of the applicator on the computed tomography (CT) images under the clinical conditions, and reproducibility of the offset. Clinical placement of the applicator, treatment planning, treatment delivery, and patient's response to the treatment were elaborated as well.
RESULTS
The experiments showed sub-millimeter accuracy in the source positioning with distal position at 1270 mm. The digitization (catheter reconstruction) was uncomplicated due to the good visibility of markers. The treatment planning resulted in a favorable dose distribution. This finding was pronounced for the treatment of the curvy anatomy of the lesion due to the improved repeatability and consistency of the delivered fractional dose to the patient, since the radioactive source was placed centrally within the lumen with respect to the clinical target due to the five inflatable balloons.
CONCLUSIONS
The consistency of the BCEA positioning resulted in the possibility to deliver optimized non-uniform dose along the catheter, which resulted in an increase of the dose to the cancerous tissue and lower doses to healthy tissue. A larger number of patients and long-term follow-up will be required to investigate if the delivered optimized treatment can lead to improved clinical outcomes.
PubMed: 27648086
DOI: 10.5114/jcb.2016.61933 -
JACC. Cardiovascular Interventions Jun 2016
Topics: Angioplasty, Balloon, Coronary; Brachytherapy; Coronary Restenosis; Humans; Stents
PubMed: 27339843
DOI: 10.1016/j.jcin.2016.04.033 -
JACC. Cardiovascular Interventions Jun 2016The study sought to report safety and long-term clinical efficacy of intravascular brachytherapy (VBT) for recurrent drug-eluting stent in-stent restenosis (DES-ISR).
OBJECTIVES
The study sought to report safety and long-term clinical efficacy of intravascular brachytherapy (VBT) for recurrent drug-eluting stent in-stent restenosis (DES-ISR).
BACKGROUND
Recurrent DES-ISR remains a therapeutic challenge, and VBT has been used selectively in recurrent DES failure.
METHODS
Patients undergoing VBT for recurrent DES-ISR were enrolled from a percutaneous coronary intervention registry. Clinical, procedural, VBT, and outcome data were collected for DES-ISR treated with radiation. Follow-up was obtained by phone call and clinic visits.
RESULTS
A total of 186 patients (283 lesions) were included. Mean age was 65 ± 11 years, and 115 (61.8%) were men. Mean time to failure from last failed DES implantation was 450.65 ± 50 days. Majority (95%) had >2 episodes of target lesion revascularization (TLR). Commonest presentation of DES-ISR was unstable angina (68, 30%). All lesions were treated with balloon angioplasty followed by VBT using Beta-Cath system (Best Vascular Inc., Springfield, Virginia) with a dose of 23 to 25 Gy at 2 mm from source center. Radiation was delivered to site of ISR, without procedural adverse events, in 99% cases. Incidence of TLR was 3.3% at 6 months, 12.1% at 1 year, 19.1% at 2 years, and 20.7% at 3 years. No subacute thrombosis event was noted. One patient had late thrombosis during a 3-year follow-up.
CONCLUSIONS
VBT for recurrent DES-ISR is safe, with low recurrence rates at 12 months post-procedure, and can be safely used as an effective short-term strategy. Overtime, there is a gradual attrition in patency requiring repeat intervention.
Topics: Aged; Brachytherapy; Coronary Restenosis; Coronary Vessels; District of Columbia; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Failure; Recurrence; Registries; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 27339842
DOI: 10.1016/j.jcin.2016.03.018 -
Radiologia Brasileira 2016To perform a comparative dosimetric analysis, based on computer simulations, of temporary balloon implants with (99m)Tc and balloon brachytherapy with high-dose-rate...
OBJECTIVE
To perform a comparative dosimetric analysis, based on computer simulations, of temporary balloon implants with (99m)Tc and balloon brachytherapy with high-dose-rate (HDR) (192)Ir, as boosts to radiotherapy. We hypothesized that the two techniques would produce equivalent doses under pre-established conditions of activity and exposure time.
MATERIALS AND METHODS
Simulations of implants with (99m)Tc-filled and HDR (192)Ir-filled balloons were performed with the Siscodes/MCNP5, modeling in voxels a magnetic resonance imaging set related to a young female. Spatial dose rate distributions were determined. In the dosimetric analysis of the protocols, the exposure time and the level of activity required were specified.
RESULTS
The (99m)Tc balloon presented a weighted dose rate in the tumor bed of 0.428 cGy.h(-1).mCi(-1) and 0.190 cGyh(-1).mCi(-1) at the balloon surface and at 8-10 mm from the surface, respectively, compared with 0.499 and 0.150 cGyh(-1).mCi(-1), respectively, for the HDR (192)Ir balloon. An exposure time of 24 hours was required for the (99m)Tc balloon to produce a boost of 10.14 Gy with 1.0 Ci, whereas only 24 minutes with 10.0 Ci segments were required for the HDR (192)Ir balloon to produce a boost of 5.14 Gy at the same reference point, or 10.28 Gy in two 24-minutes fractions.
CONCLUSION
Temporary (99m)Tc balloon implantation is an attractive option for adjuvant radiotherapy in breast cancer, because of its availability, economic viability, and similar dosimetry in comparison with the use of HDR (192)Ir balloon implantation, which is the current standard in clinical practice.
PubMed: 27141131
DOI: 10.1590/0100-3984.2015.0010 -
Oncology (Williston Park, N.Y.) Apr 2016
PubMed: 27083604
DOI: No ID Found -
Journal of Vascular Surgery Jun 2016The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA)... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA) stenting in comparison with a control group treated with SFA stenting only.
METHODS
In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0 Gy or 14 Gy of EBR to the stent site 24 hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2 years after stenting. Categorical and continuous end points were respectively analyzed using logistic regression models and Wilcoxon tests. End points expressed as time to event were analyzed using a log-rank test.
RESULTS
The study included 155 patients, 46 women and 109 men (mean age, 66 years; range, 45-85 years). In the 0 and 14 Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P = .003) 2 years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0 Gy group and in 33% (25/77) of the 14 Gy group (P = .003). Target lesion revascularization at 2 years was 26% (25/78) in the 0 Gy group and 30% (23/77) in the 14 Gy group (P = .56). There were no significant differences in total walking distances change from baseline to 2 years (46 ± 100 and 26 ± 79 m, respectively, in the 0 Gy and 14 Gy group; P = .25). There were no procedure-related deaths and no major amputations.
CONCLUSIONS
A single 14 Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis.
Topics: Aged; Aged, 80 and over; Angiography, Digital Subtraction; Angioplasty, Balloon; Brachytherapy; Constriction, Pathologic; Disease-Free Survival; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Quebec; Radiotherapy Dosage; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome
PubMed: 27021377
DOI: 10.1016/j.jvs.2016.02.023 -
Journal of Contemporary Brachytherapy Feb 2016To determine differences in patient's reported quality of life and self-reported breast cosmesis between whole breast radiation therapy (WBRT) and accelerated partial...
PURPOSE
To determine differences in patient's reported quality of life and self-reported breast cosmesis between whole breast radiation therapy (WBRT) and accelerated partial breast irradiation (APBI) via single and multi-lumen high-dose-rate (HDR) brachytherapy for women with early stage breast cancer.
MATERIAL AND METHODS
Patient information was retrospectively reviewed and survey data were prospectively collected for women treated between 2004 to 2014 (APBI) and 2012 to 2014 (WBRT). Criteria for APBI treatments were ER+ (after 2010), N0 (after 2010), T < 3 cm, and post-menopausal. All patients were given a survey with modified FACIT (Functional Assessment of Chronic Illness Therapy) breast quality of life questions to rate their amount of pain, self-consciousness, low energy, presence of lymphedema, and breast cosmesis.
RESULTS
242 APBI patients and 59 WBRT patients were identified. In the WBRT cohort, 34 women met departmental criteria for APBI treatment (WBRT who were APBI eligible). The FACIT survey was completed by 80 women treated with APBI (33%; mean follow-up time of 14 months), and 26 women treated with WBRT who were APBI eligible (76%; mean follow-up time of 26 months). During the first year post-treatment, low energy (p = 0.009), self-consciousness (p = 0.0004), and lymphedema (p = 0.0002) scores were significantly lower in the APBI cohort when compared to women treated with WBRT who were APBI eligible. During the second year post-treatment, women treated with APBI reported significantly better breast cosmesis (p = 0.04). The single-lumen balloon (score = 6.3/10) was found to be associated with worse cosmesis compared to the multi-lumen balloons (Mammosite ML and Contura; score = 8.2/10; p = 0.002). There were no significant differences in rates of recurrence between balloons or treatments (p > 0.05).
CONCLUSIONS
APBI treated patients reported higher cosmetic satisfaction than patients in the matched WBRT cohort. Quality of life scores tended to improve over time. Multi-lumen catheters provided superior cosmetic results compared to single-lumen catheters.
PubMed: 26985193
DOI: 10.5114/jcb.2016.57816 -
Technology in Cancer Research &... Jun 2017The efficacy of image-guided high-dose rate brachytherapy for cervical cancer is limited by the ineffective rectal sparing devices available commercially and the...
PURPOSE
The efficacy of image-guided high-dose rate brachytherapy for cervical cancer is limited by the ineffective rectal sparing devices available commercially and the potential applicator movement. We developed a novel device using a balloon catheter and a belt immobilization system, serving for rectal dose reduction and applicator immobilization purposes, respectively.
METHODS
The balloon catheter is constructed by gluing a short inflatable tube to a long regular open-end catheter. Contrast agent (10) cm is injected into the inflatable end, which is affixed to the tandem and ring applicator, to displace the posterior vaginal wall. The belt immobilization system consists of a specially designed bracket that can hold and fix itself to the applicator, a diaper-like Velcro fastener package used for connecting the patient's pelvis to the bracket, and a buckle that holds the fasteners to stabilize the whole system. The treatment data for 21 patients with cervical cancer using both balloon catheter and belt immobilization system were retrospectively analyzed. Computed tomography and magnetic resonance images, acquired about 30 minutes apart, were registered to evaluate the effectiveness of the immobilization system.
RESULTS
In comparison with a virtual rectal blade, the balloon decreased the rectal point dose by 34% ± 4.2% (from 276 ± 57 to 182 ± 38 cGy), corresponding to an extra sparing distance of 7.9 ± 1.1 mm. The maximum sparing distance variation per patient is 1.4 ± 0.6 mm, indicating the high interfractional reproducibility for rectum sparing. With the immobilization system, the mean translational and rotational displacements of the applicator set are <3 mm and <1.5°, respectively, in all directions.
CONCLUSIONS
The rectal balloon provides significant dose reduction to the rectum and it may potentially minimize patient discomfort. The immobilization system permits almost no movement of the applicator during treatment. This work has the potential to be promoted as a standardized solution for high-dose rate treatment of cervical cancer.
Topics: Brachytherapy; Catheters; Cervix Uteri; Contrast Media; Female; Humans; Magnetic Resonance Imaging; Radiotherapy Dosage; Rectum; Tomography, X-Ray Computed; Uterine Cervical Neoplasms
PubMed: 26868850
DOI: 10.1177/1533034616631122 -
Journal of Radiation Oncology Dec 2015The purpose of this study was to report the treatment-induced adverse events and cosmetic and treatment outcomes of accelerated partial breast irradiation (APBI)...
OBJECTIVE
The purpose of this study was to report the treatment-induced adverse events and cosmetic and treatment outcomes of accelerated partial breast irradiation (APBI) delivered with the MammoSite radiation therapy system (RTS) in breast cancer patients undergoing breast-conserving therapy (BCT).
METHODS
This is a prospective clinical trial that was approved by the institutional review board. The study included female breast cancer patients undergoing breast-conserving therapy in the form of surgery and APBI delivered with the MammoSite RTS. Patients and tumor characteristics, treatment-induced acute adverse events based on the Common Toxicity Criteria for Adverse Events (CTCAE) version 2.0, chronic AEs according to Radiation Therapy Oncology Group (RTOG) scale, treatment outcomes (including local control, disease-free survival, and overall survival), and cosmetic outcomes are reported.
RESULTS
The study included 36 eligible patients treated consecutively in our institution between November 2003 and August 2009. The age range was 45-83 years. A total of 29 patients had invasive disease (median size 1.1 cm), while 7 patients had in situ disease only (median size 0.8 cm). The skin distance in most of the patients (91.7 %) was ≥1 cm; only three patients (8.3 %) had skin distance <1 cm. The median balloon diameter was 5 cm (range 4-6 cm). At a median follow-up of 42 months (range 4-65 months), local control, disease-free survival, and overall survival were 100 %. None of the patients experienced any grade 3 or 4 toxicities; 16.7 and 5.6 % of the patients had late grade 2 fibrosis and telangiectasia, respectively. At last follow-up, cosmetic outcome was rated as good or excellent in 94 % of the patients.
CONCLUSION
APBI delivered with the MammoSite RTS is a feasible, tolerable, and effective treatment modality. Multicenter, randomized, controlled clinical trials with a larger number of patients are required for verification.
PubMed: 26779307
DOI: 10.1007/s13566-015-0228-1