Trial reportCancer2013
Phase 2 study of pre-excision single-dose intraoperative radiation therapy for early-stage breast cancers: six-year update with application of the ASTRO accelerated partial breast irradiation consensus statement criteria.
Trial report in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00182728 (Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Preoperative Partial Breast Irradiation in Patients with Low-Risk Breast Cancer: A Systematic Review of Literature.Annals of surgical oncology · 2023Pooled it
- Feasibility of concervative breast surgery and intraoperative radiation therapy for early breast cancer: a single-center, open, non-randomized, prospective pilot study.Oncology reports · 2014Trial
- Four-year clinical update from a prospective trial of accelerated partial breast intensity-modulated radiotherapy (APBIMRT).Breast cancer research and treatment · 2013Trial
- Article
- Efficacy and safety of accelerated partial breast irradiation: a meta-analysis of published randomized studies.Oncotarget · 2017Article
- Intraoperative radiotherapy in early stage breast cancer: potential indications and evidence to date.The British journal of radiology · 2015Review
- Intraoperative radiation therapy delivered prior to lumpectomy for early-stage breast cancer: a single institution study.American journal of cancer research · 2015Article
- Intraoperative radiotherapy for breast cancer: the lasting effects of a fleeting treatment.International journal of breast cancer · 2014Review
- Clinical and technological transition in breast cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundIntraoperative radiation therapy (IORT) allows delivery of high-dose radiation at the time of lumpectomy, potentially sparing adjuvant daily radiation. A phase 2 study of pre-excision IORT was performed for early-stage breast cancer.
methodsPatients ≥ 48 years of age with invasive ductal carcinoma, ≤ 3 cm, and clinically node-negative were eligible for this study, which was approved by institutional review board. Ultrasound was used to select electron energy and cone size to cover the tumor plus 1.5- to 2.0-cm lateral margins and 1-cm-deep margins (90% isodose). Fifteen Gy was delivered with a Mobetron irradiator, and immediate needle-localized partial mastectomy followed. Local event results were updated using the Kaplan-Meier method.
resultsA total of 53 patients received IORT alone. Median age was 63 years, and median tumor size was 1.2 cm. Of these, 81% were positive for estrogen receptor or progesterone receptor, 11% were positive for human epidermal growth factor receptor 2, and 15% were triple-negative. Also, 42%, 49%, and 9% would have fallen into the Suitable, Cautionary, and Unsuitable groups, respectively, of the American Society of Therapeutic Radiation Oncology consensus statement for accelerated partial breast irradiation. Median follow-up was 69 months. Ipsilateral events occurred in 8 of 53 patients. The 6-year actuarial rate of ipsilateral events was 15% (95% confidence interval = 7%-29%). The crude event rate for Suitable and Cautionary groups was 1 of 22 (5%) and 7 of 26 (27%), respectively. Overall survival was 94.4%, and breast cancer-specific survival was 100%.
conclusionsThe rate of local events in this study is a matter of concern, especially in the Cautionary group. On the basis of these findings, pre-excision IORT, as delivered in this study, may not provide adequate local control for less favorable early-stage breast cancers.
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