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Rabinovitch R.,Aurora University | Winter K.,Radiation Therapy Oncology Group | Kuske R.,AZ Oncology Services | Bolton J.,Ochsner Clinic | And 5 more authors.
Brachytherapy | Year: 2014

Purpose: Radiation Therapy Oncology Group (RTOG) 95-17, a Phase II trial to evaluate multicatheter brachytherapy (mCathBrachy) as the sole method of radiation therapy for Stage I-II breast cancer (BrCa), was the first cooperative group trial in North America to evaluate accelerated partial breast irradiation (APBI) and include patient-reported outcomes (PROs). This report presents the year-5 toxicity and cosmesis data. Methods and Materials: After lumpectomy and axillary dissection for invasive BrCa (tumor size <3. cm with zero to three positive lymph nodes), 100 patients (pts), 98 evaluable, were treated (txed) with mCathBrachy from 1997 to 2000 with 34. Gy administered twice daily in 10 high-dose-rate fractions or 45. Gy in 3.5-6 days as a low-dose-rate implant to 1-2. cm beyond the lumpectomy bed. The PROs and physician-reported outcomes of toxicity, cosmesis, and tx satisfaction at year-5 are reported here, defined as data submitted 54-78 months after tx. Results: Grade (G) 1-2 skin toxicity developed in 78% of the pts and G3 in 13% (no G4). The tx effects included skin dimpling/indentation (37%), fibrosis (45%), telangiectasias (45%), skin catheter marks (54%), and symptomatic fat necrosis (15%). Breast asymmetry was reported in 73%. Rates of excellent-to-good cosmesis were similar between PROs (66%) and radiation oncologists (68%). The PROs of tx satisfaction at year-5 was 75%. Conclusions: RTOG 95-17 documents the year-5 skin toxicity and tx effects of mCathBrachy APBI, which are associated with PROs of good-to-excellent cosmesis and high tx satisfaction. This emphasizes the importance of PROs when assessing BrCa tx. National Surgical Adjuvant Breast and Bowel Project B39/RTOG 0413 will allow for definitive comparisons between APBI and whole breast radiation therapy. © 2014.


Polepally A.R.,University of Minnesota | Remmel R.P.,University of Minnesota | Brundage R.C.,University of Minnesota | Leppik I.E.,University of Minnesota | And 4 more authors.
Journal of Clinical Pharmacology | Year: 2015

A classic 2-period crossover bioavailability study was conducted to evaluate the relative and absolute bioavailability of immediate-release (IR) and extended-release (XR) lamotrigine formulations under steady-state conditions in elderly patients with epilepsy. On treatment days, each subject's morning dose (IR or XR lamotrigine) was replaced with an intravenous 50-mg dose of stable-labeled lamotrigine. Lamotrigine concentrations were measured at 13 points between 0 and 96 hours. XR and IR lamotrigine formulations were similar with respect to steady-state area under the concentration-time curve from 0 to 24 hours (AUC0-24h ss), average concentration (Cavg, ss), and trough concentration (Cτ, ss). A 33% lower fluctuation in concentrations with XR was observed relative to IR lamotrigine. The time to peak concentration (Tmax, ss) was delayed for XR lamotrigine (3.0 vs 1.3 hours) with lower peak concentration (15% lower). The absolute bioavailability for IR and XR formulations was 73% and 92%, respectively. The formulations were bioequivalent with respect to AUC0-24h ss, Cτ, ss, and Cavg, ss indicating that it may be possible to switch directly from IR to XR lamotrigine without changes in the total daily dose. © 2015, The American College of Clinical Pharmacology.


Royster E.I.,Ochsner Baptist Medical Center | Crumbley K.,Ochsner Baptist Medical Center
Ochsner Journal | Year: 2011

Objective: To report 4 cases of improved pain control and function in patients with chronic cephalgia secondary to chronic headaches and/or trigeminal neuralgia. Methods: Four patients with refractory cephalgia came to our clinic for interventional therapy after medications failure. Each patient underwent a trial with a temporary array of peripheral nerve stimulation depending on the distribution of their pain. Trials varied in duration from 1 to 3 days. Patients who received greater than 50% pain relief during trials were candidates for full implantation. All 4 patients went to full implantation of a permanent peripheral nerve stimulator lead array and generator battery. Results: After implantation of the permanent lead array and generator, average pain relief among the 4 patients was 60%. Their function improved, and medication usage decreased along with side effects. Overall, all 4 patients reported that they would undergo implantation if given the choice again. Tolerance for medication decreases has varied widely, although all patients were on regimens that were stable and without side effects. Conclusions: Initial experience suggests that refractory pain secondary to chronic migraines and trigeminal neuralgia may respond to peripheral nerve stimulation. Further studies are indicated to evaluate efficacy over the long term and to elucidate the optimal array and implantation technique. © Academic Division of Ochsner Clinic Foundation.

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