Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ.

OBJECTIVE: The aim of this study was to determine the impact of the results of the 12-gene DCIS Score assay on (i) radiotherapy recommendations for patients with pure ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS), and (ii) patient decisional conflict and state anxiety. METHODS: Thirteen sites across the US enrolled patients (March 2014-August 2015) with pure DCIS undergoing BCS. Prospectively collected data included clinicopathologic factors, physician estimates of local recurrence risk, DCIS Score results, and pre-/post-assay radiotherapy recommendations for each patient made by a surgeon and a radiation oncologist. Patients completed pre-/post-assay decisional conflict scale and state-trait anxiety inventory instruments. RESULTS: The analysis cohort included 127 patients: median age 60 years, 80 % postmenopausal, median size 8 mm (39 % ≤5 mm), 70 % grade 1/2, 88 % estrogen receptor-positive, 75 % progesterone receptor-positive, 54 % with comedo necrosis, and 18 % multifocal. Sixty-six percent of patients had low DCIS Score results, 20 % had intermediate DCIS Score results, and 14 % had high DCIS Score results; the median result was 21 (range 0-84). Pre-assay, surgeons and radiation oncologists recommended radiotherapy for 70.9 and 72.4 % of patients, respectively. Post-assay, 26.4 % of overall recommendations changed, including 30.7 and 22.0 % of recommendations by surgeons and radiation oncologists, respectively. Among patients with confirmed completed questionnaires (n = 32), decision conflict (p = 0.004) and state anxiety (p = 0.042) decreased significantly from pre- to post-assay. CONCLUSIONS: Individualized risk estimates from the DCIS Score assay provide valuable information to physicians and patients. Post-assay, in response to DCIS Score results, surgeons changed treatment recommendations more often than radiation oncologists. Further investigation is needed to better understand how such treatment changes may affect clinical outcomes.

Cephalic vein cut-down verses percutaneous access: a retrospective study of complications of implantable venous access devices.

BACKGROUND: Central venous access devices play an integral role in providing long-term venous access. Percutaneous and cut-down techniques have been used with varying complications. METHODS: Between January 1998 and July of 2001, 358 venous access devices were placed at Albert Einstein Medical Center in Philadelphia, Pennsylvania. A retrospective study was performed to compare complications and operative times for 2 methods of catheter insertion. RESULTS: Overall complication rate was 14%. In lines successfully placed percutaneously, the complication rate was 15% (25 of 163) compared with 11% (16 of 148) in the successful cephalic cut-down group, P = .11. Complications including -- pneumothorax, late catheter transection, and bradycardia -- only occurred in percutaneously placed lines. Mean operative times were similar for both groups. COMMENTS: Use of the cut-down approach for long-term venous access may result in improved patient safety. The cut-down technique should be considered a safe initial approach for placement of venous access devices.