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Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial.

ABSTRACT: PURPOSE:Shorter courses of accelerated partial-breast irradiation delivered as single-fraction intraoperative therapy are now offered as an alternative to 4 to 6 weeks of whole-breast irradiation after lumpectomy. However, this approach has potential shortcomings in patient selection and target volume definition and in dosimetric, radiobiological, and logistical issues. We designed a prospective, phase 2, multi-institution clinical trial to study 2- or 3-day accelerated partial breast irradiation delivered with brachytherapy applicators. METHODS AND MATERIALS:This trial treats select breast cancers after breast-conserving surgery with brachytherapy applicators that deliver 22.5 Gy in 3 fractions of 7.5 Gy. The planning treatment volume was 1 to 1.5 cm beyond the surgical cavity. Eligible women were aged ?45 years with unicentric invasive or in situ tumors ?3.0 cm with positive estrogen or progesterone receptors and no metastasis to axillary nodes that have been excised with negative margins. Strict dosimetric parameters were required to be met before acceptance into the trial. RESULTS:A group of 200 patients was prospectively enrolled and followed for a minimum of 6 months. Two- or 3-day brachytherapy was associated with low acute or subacute toxicity, 97.25% excellent or good cosmetic outcomes, and excellent local control in select breast cancers. CONCLUSIONS:Ultrashort breast brachytherapy is dosimetrically feasible and can be delivered with excellent short-term tolerance and low toxicity.

SUBMITTER: Khan AJ

PROVIDER: S-EPMC7373303 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial.

Khan Atif J AJ Chen Peter Y PY Yashar Catheryn C Poppe Matthew M MM Li Linna L Abou Yehia Zeinab Z Vicini Frank A FA Moore Dirk D Dale Roger R Arthur Doug D Shah Chirag C Haffty Bruce G BG Kuske Robert R

International journal of radiation oncology, biology, physics 20190104 1

<h4>Purpose</h4>Shorter courses of accelerated partial-breast irradiation delivered as single-fraction intraoperative therapy are now offered as an alternative to 4 to 6 weeks of whole-breast irradiation after lumpectomy. However, this approach has potential shortcomings in patient selection and target volume definition and in dosimetric, radiobiological, and logistical issues. We designed a prospective, phase 2, multi-institution clinical trial to study 2- or 3-day accelerated partial breast ir ...[more]

PMID: 30611839

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Project description:BACKGROUND:Accelerated 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. METHODS:In 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. DISCUSSION:In 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 REGISTRATION:Netherlands Trial Register, NTR6549 . Registered on 27 June 2017.

Project description:BackgroundAccelerated partial breast irradiation (APBI) is an alternative breast-conserving therapy approach where radiation is delivered in less time compared to whole breast irradiation (WBI), resulting in improved patient convenience, less toxicity, and cost savings. This prospective randomized study compares the external beam APBI with commonly used moderate hypofractionated WBI in terms of feasibility, safety, tolerance, and cosmetic effects.MethodsEarly breast cancer patients after partial mastectomy were equally randomized into two arms- external APBI and moderate hypofractionated WBI. External beam technique using available technical innovations commonly used in targeted hypofractionated radiotherapy to minimize irradiated volumes was used (cone beam computed tomography navigation to clips in the tumor bed, deep inspiration breath hold technique, volumetric modulated arc therapy dose application, using flattening filter free beams and the six degrees of freedom robotic treatment couch). Cosmetics results and toxicity were evaluated using questionnaires, CTCAE criteria, and photo documentation.ResultsThe analysis of 84 patients with a median age of 64 years showed significantly fewer acute adverse events in the APBI arm regarding skin reactions, local and general symptoms during a median follow-up of 37 months (range 21-45 months). A significant difference in favor of the APBI arm in grade ≥ 2 late skin toxicity was observed (p = 0.026). Late toxicity in the breast area (deformation, edema, fibrosis, and pain), affecting the quality of life and cosmetic effect, occurred in 61% and 17% of patients in WBI and APBI arms, respectively. The cosmetic effect was more favorable in the APBI arm, especially 6 to 12 months after the radiotherapy.ConclusionExternal APBI demonstrated better feasibility and less toxicity than the standard regimen in the adjuvant setting for treating early breast cancer patients. The presented study confirmed the level of evidence for establishing the external APBI in daily clinical practice.Trial registrationNCT06007118.

Project description:BACKGROUND:To analyze the clinical outcome of elderly women with early breast cancer who underwent accelerated partial breast irradiation (APBI) based on a post-operative single fraction of multicatheter interstitial high dose-rate brachytherapy (MIB). METHODS:A single institution retrospective cohort study was performed focusing on elderly patients (? 65 years old) presenting a low-risk breast carcinoma treated by lumpectomy plus axillary evaluation followed by MIB. A single fraction of 16 Gy was prescribed on the 100% isodose. Clinical outcome at 3 years was reported based on local relapse free survival (3-y LRFS), specific survival (SS) and overall survival (OS). Acute (<?180 days after APBI) and late toxicity were evaluated. Cosmetic results were clinically evaluated by the physician. RESULTS:Between January 2012 and August 2015, 48 women (51 lesions) were treated. Median age was 77.7 years (range: 65-92) with a median tumor size of 12 mm (range: 3-32). Five patients (pts) presented an axillary lymph node involvement (4 Nmic, 1 N1). Invasive ductal carcinoma was the most frequent histology type (86.3%). With a median follow-up of 40 months (range: 36-42), no local relapse occurred while 1 pt. developed axillary relapse (2.1%). The 3-y LRFS, SS and OS rates were 100%, 100% and 93.1% respectively. Forty-five acute events were remained. The most frequent acute toxicity was grade (G) 1 hyperpigmentation (26.7%), 3 pts. (6.3%) presented G3 acute toxicity (2 breast hematomas, 1 breast abscess). No ? G3 late toxicity was observed while 15 late toxicities occurred (G1: 13 events - 86.7%) mainly breast fibrosis). The rate of excellent cosmetic outcome was 76.4%. CONCLUSION:We reported promising and encouraging clinical outcome of a post-operative single fraction of MIB ABPI in the elderly. This approach leads to consider a sfAPBI as an attractive alternative to intra-operative radiation therapy while all the patients will be good candidates for APBI in regards to the post-operative pathological report. More mature results (number of patients and follow-up) are needed.

Project description:Historically, treatment of malignant surface lesions has been achieved with linear accelerator based electron beams or superficial x-ray beams. Recent developments in the field of brachytherapy now allow for the treatment of surface lesions with specialized conical applicators placed directly on the lesion. Applicators are available for use with high dose rate (HDR)(192)Ir sources, as well as electronic brachytherapy sources. Part I of this paper will discuss the applicators used with electronic brachytherapy sources; Part II will discuss those used with HDR (192)Ir sources. Although the use of these applicators has gained in popularity, the dosimetric characteristics including depth dose and surface dose distributions have not been independently verified. Additionally, there is no recognized method of output verification for quality assurance procedures with applicators like these. Existing dosimetry protocols available from the AAPM bookend the cross-over characteristics of a traditional brachytherapy source (as described by Task Group 43) being implemented as a low-energy superficial x-ray beam (as described by Task Group 61) as observed with the surface applicators of interest.This work aims to create a cohesive method of output verification that can be used to determine the dose at the treatment surface as part of a quality assurance/commissioning process for surface applicators used with HDR electronic brachytherapy sources (Part I) and(192)Ir sources (Part II). Air-kerma rate measurements for the electronic brachytherapy sources were completed with an Attix Free-Air Chamber, as well as several models of small-volume ionization chambers to obtain an air-kerma rate at the treatment surface for each applicator. Correction factors were calculated using MCNP5 and EGSnrc Monte Carlo codes in order to determine an applicator-specific absorbed dose to water at the treatment surface from the measured air-kerma rate. Additionally, relative dose measurements of the surface dose distributions and characteristic depth dose curves were completed in-phantom.Theoretical dose distributions and depth dose curves were generated for each applicator and agreed well with the measured values. A method of output verification was created that allows users to determine the applicator-specific dose to water at the treatment surface based on a measured air-kerma rate.The novel output verification methods described in this work will reduce uncertainties in dose delivery for treatments with these kinds of surface applicators, ultimately improving patient care.

Project description:PurposeTo evaluate the clinical use of 3D printing technology for the modelling of individual applicators for advanced gynecological tumors in magnetic resonance imaging (MRI)-based brachytherapy (BT).Material and methodsWe tested individually designed 3D-printed applicators in nine patients with advanced gynecological cancer. Before BT was performed, all patients were treated with external beam radiotherapy (EBRT). The most common indication for individualized BT was advanced gynecological tumors where the use of standard BT applicators was not feasible. Other indications were suboptimal dose-volume histogram (DVH) parameters for high-risk clinical target volume (CTV-THR) at the first BT (V100 ≤ 90% of CTV-THR volume and D98 ≤ 80%, D90 ≤ 100%, and D100 ≤ 60% of dose aim). The EQD2 dose aim to the target volume D90 CTV-THR per one BT fraction was 20 Gy for cervical or recurrent endometrial cancer and 16 Gy for vaginal cancer patient. The first BT with the standard applicator in situ was used as the virtual plan for designing a 3D-printed applicator. The next BT was performed with a 3D-printed applicator in situ. The primary endpoint was to improve CTV-THR DVH parameters without exceeding the dose to the organs at risk (OARs).ResultsAll DVH parameters for CTV-THR were significantly higher with the use of an individually designed applicator. Mean D90 CTV-THR improved from 14.1 ±5.4 Gy to 22.0 ±2.5 Gy and from 7.1 Gy to 16.2 Gy for cervical/recurrent endometrial and vaginal cancer, respectively (p < 0.001). The mean D2cm3 bladder, rectum, sigmoid, and bowel dose was within institutional dose constraints, and increased from 13.0 ±1.5 Gy to 13.6 ±1.5 Gy (p = 0.045), 10.8 ±1.2 Gy to 11.7 ±1.3 Gy (p = 0.004), 8.9 ±3.2 Gy to 10.3 ±3.3 Gy (p = 0.008), and 8.7 ±3.8 Gy to 9.2 ±3.1 Gy (p = 0.2).ConclusionsWith the use of individual 3D-printed applicators, all DVH parameters for CTV-THR significantly improved without compromising the dose constraints for the OARs.

Dataset Information

Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial.

Publications

Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial.

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