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Background: Electron intraoperative radiotherapy (IORT) can be used during breast conserving surgery to treat early-stage invasive breast cancer. Using data from current clinical and observational studies, this study aimed to assess the impact of single-fraction electron IORT on local recurrence rates. Methods: Studies on single-fraction electron IORT during breast conserving surgery were identified through a search of PubMed and Google Scholar, as well as through secondary referencing. Local recurrence rate was the main outcome of interest. A meta-analysis of proportions using a binomial distribution to model the within-study variability and a random effects model was conducted to estimate a pooled local recurrence rate. To estimate a 5-year recurrence rate, a single-sample Poisson-normal model was applied to model the probability of events occurring during a fixed period (60 months). Results: The study identified 13 publications. The analysis demonstrated a pooled monthly local recurrence rate of 0.02% per person-month (95% confidence interval CI 0.00-0.06%) for the studies with a follow-up period shorter than 5 years, 0.03% per person-month (95% CI 0.02-0.06%) for studies with a follow-up period of 5 years or longer, and 0.02% per person-month (95% CI 0.01-0.04%) overall. Based on this model, the predicted 5-year local recurrence rate was 2.7% (range 1.9-3.7%). Conclusions: According to the published literature, the rate of breast cancer local recurrence after electron IORT was 0.02% per person-month, with an adjusted 5-year recurrence rate of 2.7%. These findings support the recent guidelines from the American Society for Radiation Oncology (ASTRO) supporting the use of electron IORT for low-risk patients. [ABSTRACT FROM AUTHOR]

Purpose: The U.S. NCI's PRO-CTCAE is a library of self-report items for assessing symptomatic adverse events in cancer clinical trials from the patient perspective. The aim of this study was to translate and linguistically validate a Spanish version.Methods: PRO-CTCAE's 124 items were translated from English into Spanish using multiple forward and back translations. Native Spanish speakers undergoing cancer treatment were enrolled at six cancer treatment sites. Participants each completed approximately 50 items and were then interviewed using cognitive probes. The interviews were analyzed at the item level by linguistic themes, and responses were examined for evidence of equivalence to English. Items for which ≥20 % of participants experienced difficulties were reviewed, and phrasing was revised and then retested in subsequent interviews. Items where <20 % of respondents experienced difficulties were also reviewed and were considered for rephrasing and retesting.Results: One hundred nine participants from diverse Spanish-speaking countries were enrolled (77 in Round 1 and 32 in Round 2). A majority of items were well comprehended in Round 1. Two items presented difficulties in ≥20 % of participants and were revised/retested without further difficulties. Two items presented difficulties in <20 %, and when retested exhibited no further difficulties. Two items presented difficulties in <20 %, but were not revised due to lack of alternatives. Sixteen items presented difficulties in ≤12 % and were not revised because difficulties were minor.Conclusions: The Spanish PRO-CTCAE has been developed and refined for use in Spanish-speaking populations, with high levels of comprehension and equivalence to the English PRO-CTCAE.Trial Registration: ClinicalTrials.gov:NCT01436240. [ABSTRACT FROM AUTHOR]

Since the emergence of breast conserving surgery (BCS) as an alternative to mastectomy in the 1980's, there has been little consensus on what constitutes acceptable margins for cases of invasive breast cancer, how best to evaluate margins in the operating room, or an understanding of the challenging process of margin assessment by pathologists. The program committee for the 15th Annual Meeting of The American Society of Breast Surgeons organized a plenary session to discuss the latest thinking and guidelines for these important issues. The SSO/ASTRO Consensus Guideline on Margins for BCS was an important focus of discussion. The SSO/ASTRO consensus panelists concluded that "no ink on tumor" is an adequate surgical margin for BCS in patients with invasive breast cancers. Intraoperative strategies to decrease the incidence of positive margins include intraoperative localization techniques (wire-localization, ultrasound, radioactive seed) and intraoperative margin assessments with specimen radiography, imprint cytology, and frozen section. Studies also demonstrate the positive effect of shave margins with or without intraoperative margin assessment. The College of American Pathologists protocols for breast specimen margin evaluation consider multiple variables that can impact the proper assessment of margins. These variables include: tissue fixation time, specimen orientation, cold ischemia time, leaking ink, specimen pancaking and others that surgeons need to be aware of. Determining when "enough is enough" should not only be the application of guidelines and national standards, but also a multidisciplinary discussion between breast cancer specialists for what is right for the individual patient's unique circumstances. [ABSTRACT FROM AUTHOR]