The calculation of exposures to contaminated soil at Superfund sites has traditionally involved a steady state approach (the time-weighted average intake) which is uncalibrated and unvalidated, based on exposure factors which may be derived from risk management decisions, and which fails to take pharmacokinetics into account. Although the approach has some attractiveness from the standpoint of amenability to standardization and simplicity of operation, it has been criticized as being overly conservative, i.e. it yields chronic intake values which far exceed those actually measured through biological monitoring. Recently, USEPA has developed and published an alternative approach, known as the Integrated Uptake/Biokinetic (UBK) model for the determination of exposure to environmental lead. This model has two principal components -- one involving the uptake of lead into the body from different sources, the second involving the calculation of a blood lead level from the uptake. The blood lead level is subsequently used in conjunction with dose-response functions to predict the probability of adverse health effects. Unlike the average intake approach, it has undergone calibration and validation, is relatively free from risk management, and incorporates pharmacokinetics. The purpose of this paper is to present the results of a critical evaluation of the different approaches used to calculate exposure to lead.

The Oncotype DX DCIS Score was developed to assist in determining a low risk for recurrence subgroup of patients who can avoid radiation therapy following breast conserving surgery. We sought to evaluate our experience using the Oncotype DX DCIS Score and to see if a greater number of patients who did not receive radiation therapy were experiencing a local recurrence than the score predicted. Between February 23, 2011 and November 29, 2017, 145 women were diagnosed with ductal carcinoma in situ (DCIS) without an invasive component. 126 (87%) underwent breast conserving surgery. Thirty-five underwent Oncotype DX DCIS Score, of whom 26 (74%) were low risk, four were intermediate risk (11%), and five were high risk (14%). The scores ranged from 0 (7 patients) to 100 (1 patient). Of the 26 patients with low risk scores, one chose to undergo mastectomy, three received radiation therapy, 20 chose observation without radiation therapy, and two patients were unknown because they had no further treatment or follow-up at our facility. Two of the four intermediate risk patients underwent radiation therapy and two did not. Four of the five high risk patients underwent radiation therapy, but one did not. Twenty-two of the 35 patients who underwent Oncotype DX Score met the criteria for size (based on grade) and margins (at least 3 mm). Ten patients had margins that were less than 3 mm but met the size criteria. Two patients did not meet the size criteria but had at least 3 mm margins. One patient did not meet either the size or margin criteria. None of our 20 patients with low risk Oncotype DX DCIS Score and who met both the size and margin criteria recurred. With the median follow-up of approximately 2-1/2 years, three of the 21 patients (14%) with low or intermediate risk scores who underwent Oncotype DX DCIS Score and did not receive radiation therapy suffered a local recurrence. The predicted average recurrence risk for these patients based on their Oncotype DX DCIS Score was 12%. Two of these patients who recurred had margins less than 3 mm, and one patient met the size and margin criteria, but had an intermediate risk score. By comparison, five of 61 (8%) of patients who underwent breast conserving surgery and adjuvant radiation therapy had a local recurrence. Twenty of the 23 (87%) low risk Oncotype DX DCIS Score patients did not receive radiation therapy and overall 20/35 (57%) of the patients undergoing Oncotype DX DCIS Score did not receive radiation therapy. Although the follow-up is still relatively short, Oncotype DX DCIS Score allows a considerable number of women to avoid adjuvant radiation therapy. Citation Format: Wheeler JA, Vaghefi H, Liu F, Owens V, Morris L, Denham F, Coody L. Effectiveness of Oncotype DX DCIS scoring in a community setting [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-18-12.