Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial.
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SUBMITTER: Vicini FA
PROVIDER: S-EPMC7199428 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
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Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial.
Vicini Frank A FA Cecchini Reena S RS White Julia R JR Arthur Douglas W DW Julian Thomas B TB Rabinovitch Rachel A RA Kuske Robert R RR Ganz Patricia A PA Parda David S DS Scheier Michael F MF Winter Kathryn A KA Paik Soonmyung S Kuerer Henry M HM Vallow Laura A LA Pierce Lori J LJ Mamounas Eleftherios P EP McCormick Beryl B Costantino Joseph P JP Bear Harry D HD Germain Isabelle I Gustafson Gregory G Grossheim Linda L Petersen Ivy A IA Hudes Richard S RS Curran Walter J WJ Bryant John L JL Wolmark Norman N
Lancet (London, England) 20191205 10215
<h4>Background</h4>Whole-breast irradiation after breast-conserving surgery for patients with early-stage breast cancer decreases ipsilateral breast-tumour recurrence (IBTR), yielding comparable results to mastectomy. It is unknown whether accelerated partial breast irradiation (APBI) to only the tumour-bearing quadrant, which shortens treatment duration, is equally effective. In our trial, we investigated whether APBI provides equivalent local tumour control after lumpectomy compared with whole ...[more]
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Project description:BackgroundLocal recurrences after breast conserving treatment are mainly close to the original tumor site, and as such shorter fractionation strategies focused on and nearest mammary gland, i.e. accelerated partial breast irradiation (APBI), have been developed. Stereotactic APBI has been attempted, although there is little experience using CyberKnife (CK) for early breast cancer.MethodsThis pilot study was designed to assess the feasibility of CK-APBI on 20 evaluable patients of 29 eligible, followed for 2 years. The primary endpoint was acute/sub-acute toxicity; secondary endpoints were late toxicity and the cosmetic result.ResultsMean pathological tumor size was 10.5 mm (±4.3, range 3-18), 8 of these patients were classified as LumA-like, 11 as LumB-like, and 1 as LumB-HER2-enriched. Using CK-APBI with Iris, the treatment time was approximately 60 min (range~ 35 to ~ 120). All patients received 30 Gy in five fractions delivered to the PTV. The median number of beams was 180 (IQR 107-213; range:56-325) with a median PTV isodose prescription of 86.0% (IQR 85.0-88.5; range:82-94). The median PTV was 88.1 cm3 (IQR 63.8-108.6; range:32.3-238.8). The median breast V100 and V50 was 0.6 (IQR 0.1-1.5; range:0-13) and 18.6 (IQR 13.1-21.7; range:7.5-37), respectively. The median PTV minimum dose was 26.2 Gy (IQR 24.7-27.6; range 22.3-29.3). Mild side effects were recorded during the period of observation. Cosmetic evaluations were performed by three observers from the start of radiotherapy up to 2 years. Patients' evaluation progressively increase from 60% to 85% of excellent rating; this trend was similar to that of external observer.ConclusionsThese preliminary results showed the safe feasibility of CK-APBI in early breast cancer, with mild acute and late toxicity and very good cosmetic results.Trial registrationThe present study is registered at Clinicaltrial.gov ( NCT02896322 ). Retrospectively egistered August 4, 2016.
| S-EPMC5865347 | biostudies-literature
Project description:To evaluate the efficacy and safety of four techniques of partial breast irradiation (PBI) including interstitial brachytherapy (ISBT), balloon-based brachytherapy (BBT), Intraoperative radiotherapy (IORT) and three-dimensional conformal radiotherapy (3DCRT) in the treatment for early-stage breast cancer patients after breast-conserving surgery. A systematic search was performed according to the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) guidelines using the PubMed, Embase, Cochrane Library and Web of Science databases. The inclusion criteria were clinical trials and observational studies that reported on outcome measures of principal PBI techniques. The methodological quality of the included research data was assessed using bias risk assessment tool with the Methodological Index for Non-Randomized Studies (MINORS), and the research information were analyzed using data analysis software. Clinical studies were collected from the earliest available date until September 2023. Fifty-one studies were included, with a total sample size of 7708. The results of network meta-analysis (NMA) showed that ISBT can lower the local recurrence (SUCRA: 73.8%). In terms of reducing distant metastasis, 3DCRT may be the best choice (SUCRA: 52.5%). And IORT has the highest 5-year overall survival (SUCRA: 90%). Furthermore, ISBT also has the advantages of lowest risk with fat necrosis (SUCRA: 72.5%), infection (SUCRA: 78.3%) and breast pain (SUCRA: 86.2%). BBT may be the optimal solution for fibrosis (SUCRA: 76.9%) and hyperpigmentation (SUCRA: 66.7%). 3DCRT has lower incidence of telangiectasia (SUCRA: 56.7%) and better cosmetic result (SUCRA: 85%). Postoperative PBI treatment using ISBT after breast-conserving surgery in patients with early-stage breast cancer may be a more valuable choice based on the treatment efficacy and is associated with fewer late side-effects. Large-scale, prospective, long-term studies are warranted to clarify the role of different PBI techniques in selected patients.
| S-EPMC11436892 | biostudies-literature
Project description:Accelerated partial breast irradiation (APBI) has been under clinical investigation for more than 15 years. There are several technical approaches that are clinically established, e.g. brachytherapy, intraoperative radiotherapy (IORT), or external-beam radiotherapy. The understanding of the underlying biology, optimal technical procedures, patient selection criteria, and imaging changes during follow-up has increased enormously. After completion of several phase III trials using brachytherapy or IORT, APBI is currently increasingly used either in phase IV studies, registries, or in selected patients outside of clinical studies. Consensus statements about suitable patients are available from several international and national societies like ASTRO, ESTRO, and DEGRO. One may expect that 15-25% of patients undergoing breast-conserving surgery may qualify for APBI, i.e. patients with small invasive ductal breast cancer without clinical lymph node involvement.
| S-EPMC4608660 | biostudies-literature
Project description:Accelerated partial breast irradiation (APBI) focuses higher doses of radiation during a shorter interval to the lumpectomy cavity, in the setting of breast conserving therapy for early stage breast cancer. The utilization of APBI has increased in the past decade because of the shorter treatment schedule and a growing body of outcome data showing positive cosmetic outcomes and high local control rates in selected patients undergoing breast conserving therapy. Technological advances in various APBI modalities, including intracavitary and interstitial brachytherapy, intraoperative radiation therapy, and external beam radiation therapy, have made APBI more accessible in the community. Results of early APBI trials served as the basis for the current consensus guidelines, and multiple prospective randomized clinical trials are currently ongoing. The pending long term results of these trials will help us identify optimal candidates that can benefit from ABPI. Here we provide an overview of the clinical and cosmetic outcomes of various APBI techniques and review the current guidelines for selecting suitable breast cancer patients. We also discuss the impact of APBI on the economics of cancer care and patient reported quality of life.
| S-EPMC5056328 | biostudies-literature
Project description:PurposeOur purpose was to evaluate the usage and perceived benefit of surgical clips for breast radiation therapy planning in Canada, focusing on partial breast irradiation (PBI) after breast-conserving surgery.Methods and materialsA retrospective institutional review identified patients eligible for PBI based on clinicopathologic criteria, and tumor bed visualization was determined from computed tomography-planning scans. An online survey was subsequently distributed to Canadian radiation oncologists addressing the usage and added value of surgical clips for breast radiation therapy planning purposes. The survey also evaluated PBI usage and regimens. Responses were collected over a 4-week period. PBI regimen usage at our institution was also reviewed from May 1 to December 18, 2020.ResultsBased on clinicopathologic criteria, 306 patients were identified between 2013 and 2018 who were eligible for PBI. However, only 24% (72/306) of cases were noted to have surgical clips, of which over 50% did not assist in tumor bed localization due to inconsistent clip positioning. Similarly, nearly two-thirds (28/43) of survey respondents indicated that surgical clips are placed in the tumor bed in less than 50% of cases. Almost all respondents (42/43) indicated that surgical clips facilitate breast radiation therapy planning and favor the development of guidelines to increase the consistent placement of surgical clips in the tumor bed after breast-conserving surgery. Approximately two-thirds of respondents (28/43) offer PBI to eligible patients as routine treatment, with moderate hypofractionated regimens most commonly recommended. However, the 1-week daily regimen of 26 Gy in 5 fractions is now offered to the majority (77%) of patients at our institution.ConclusionsThere was strong agreement among Canadian radiation oncologists that surgical clip placement facilitates breast radiation therapy planning, and most favor the development of surgical guidelines for the consistent placement of surgical clips in this setting. With the growing use of PBI, accurate localization of the tumor bed is extremely important.
| S-EPMC8360935 | biostudies-literature
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.
| S-EPMC10837889 | biostudies-literature
Project description:PurposeThe aim of this study is to evaluate the cosmetic outcome among early stage breast cancer patients who underwent accelerated partial breast irradiation with either intraoperative electron radiotherapy (IOERT) or photon external beam radiotherapy (EB-APBI).Materials and methodsThis prospective multicenter cohort study enrolled women aged 60 years and older who underwent breast-conserving therapy. Following breast-conserving surgery, patients were treated with either IOERT or EB-APBI. Cosmetic outcome was evaluated over a 5 year follow-up period using both subjective scoring by patients and physicians, as well as objective scoring using BCCT.core software. Differences between treatments over time were described with mixed model analyses.ResultsA total of 241 patients treated with IOERT and 164 patients treated with EB-APBI were eligible for cosmetic analysis. In both groups, the majority of patients reported a satisfactory cosmetic outcome, with no significant differences between treatments over time (p = 0.538). This was also observed by physicians, with satisfactory outcomes ranging from 94 % (170/181) to 91 % (69/76) over time in the IOERT group and from 93 % (124/133) to 95 % (54/57) in the EB-APBI group (p = 0.579). BCCT.core analysis returned satisfactory cosmetic outcomes in 75 % (54/72) of the IOERT patients at 3 years and in 77 % (20/26) at 5 years. These numbers were 86 % (72/84) and 90 % (36/40) for the EB-APBI patients, with no significant differences between treatment over time (p = 0.834).ConclusionRegarding the cosmetic results, IOERT and EB-APBI yield comparable and satisfactory outcomes over 5 years follow-up in the treatment of early stage breast cancer.
| S-EPMC11416622 | biostudies-literature
Project description:Two randomized trials recently demonstrated that regional nodal irradiation (RNI) could reduce the risk of recurrence in early breast cancer; however, these trials were conducted in the pretrastuzumab era. Whether these results are applicable to human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients treated with anti-HER2-targeted therapy is unknown. This retrospective analysis was performed on patients with node-positive breast cancer who were enrolled in the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization phase III adjuvant trial and subjected to BCS. The primary objective of the present study was to examine the effect of RNI on disease-free survival (DFS). A multivariable cox regression analysis adjusted for number of positive lymph nodes, tumor size, grade, age, hormone receptors status, presence of macrometastatis, treatment arm, and chemotherapy timing was carried out to investigate the relationship between RNI and DFS. One thousand six hundred sixty-four HER2-positive breast cancer patients were included, of whom 878 (52.8%) had received RNI to the axillary, supraclavicular, and/or internal mammary lymph nodes. Patients in the RNI group had higher nodal burden and more frequently had tumors larger than 2 cm. At a median follow-up of 4.5 years, DFS was 84.3% in the RNI group and 88.3% in the non-RNI group. No differences in regional recurrence (0.9 % vs 0.6 %) or in overall survival (93.6% vs 95.3%) were observed between the two groups. After adjustment in multivariable analysis, there was no statistically significant association between RNI and DFS (hazard ratio = 0.96, 95% confidence interval = 0.71 to 1.29). Our analysis did not demonstrate a DFS benefit of RNI in HER2-positive, node-positive patients treated with adjuvant HER2-targeted therapy. The benefit of RNI in HER2-positive breast cancer needs further testing within randomized clinical trials.
| S-EPMC6279283 | biostudies-literature
Project description:Hypofractionated whole breast irradiation (HF-WBI) has been proved effective and safe and even better for late or acute radiation toxicity for early breast cancer. Moreover, it improves patient convenience, quality of life and is expected to be advantageous in the medical care system by reducing overall cost. In this review, we examined key randomized trials of HF-WBI, focusing on adequate patient selection as suggested by the American Society of Therapeutic Radiology and Oncology (ASTRO) guideline and the radiobiologic aspects of HF-WBI in relation to its adoption into clinical settings. Further investigation to identify the current practice pattern or cost effectiveness is warranted under the national health insurance service system in Korea.
| S-EPMC4938347 | biostudies-other
Project description:Purpose Accelerated partial breast irradiation (APBI) after breast-conserving surgery offers a well-tolerated adjuvant radiation therapy option for patients with breast cancer. We sought to describe patient-reported acute toxicity as a function of salient dosimetric parameters during and after an APBI regimen of 40 Gy in 10 once-daily fractions. Methods and Materials From June 2019 to July 2020, patients undergoing APBI were assigned a weekly, response-adapted, patient reported outcomes-common terminology criteria for adverse events-based acute toxicity assessment. Patients reported acute toxicity during treatment and for up to 8 weeks after treatment. Dosimetric treatment parameters were collected. Descriptive statistics and univariable analyses were used to summarize patient-reported outcomes and their correlation to corresponding dosimetric measures, respectively. Results Overall, 55 patients who received APBI completed a total of 351 assessments. Median planning target volume was 210 cc (range, 64-580 cc), and median planning target volume:ipsilateral breast volume ratio was 0.17 (range, 0.05-0.44). Overall, 22% of patients reported moderate breast enlargement and 27% reported maximum skin toxicity as severe or very severe. Furthermore, 35% of patients reported fatigue, and 44% of patients reported pain in the radiated area as moderate to very severe. Median time to first report of any moderate to very severe symptom was 10 days (interquartile range, 6-27 days). By 8 weeks after APBI, most patients reported resolution of symptoms, with 16% reporting residual moderate symptoms. Upon univariable analysis, none of the ascertained salient dosimetric parameters were associated with maximum symptoms or with the presence of moderate to very severe toxicity. Conclusions Weekly assessments during and after APBI showed that patients experienced moderate to very severe toxicities, most commonly skin toxicity, but that these typically resolved by 8 weeks after radiation therapy. More comprehensive evaluations among larger cohorts are warranted to define the precise dosimetric parameters that correspond to outcomes of interest.
| S-EPMC10248091 | biostudies-literature