An integrated nonprofit health care system with 13 North Carolina medical centers conducted a time-pressured quality improvement simulation of its plan to implement the "North Carolina Protocol for Allocating Scarce Inpatient Critical Care Resources in a Pandemic" attendant to pandemic scenario planning. Simulation objectives included assessing the plan in terms of a) efficiency and effectiveness; b) comorbidity scoring validity; c) impact by race/ethnicity, gender, age, and payer status; and d) simulation participant impressions of potential impact on clinicians. The simulation scenario involved scoring 14 patients with the constraint that only 10 could be afforded critical care resources.
View Article and Find Full Text PDFBackground: Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.
Objective: To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.
Methods: This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy.
Objective: OCEANS is a randomized, placebo (PL)-controlled, phase 3 trial evaluating the efficacy and safety of bevacizumab combined with gemcitabine+carboplatin (GC) for patients with platinum-sensitive recurrent ovarian cancer (ROC). The study met its primary endpoint, demonstrating improved progression-free survival with GC+bevacizumab compared with GC+PL. Herein, we describe results of final overall survival (OS) and updated safety.
View Article and Find Full Text PDFObjective: OCEANS, a randomized, placebo-controlled, phase III trial, found that adding bevacizumab to gemcitabine-carboplatin (GC) significantly improved investigator-determined progression-free survival (PFS) and objective response rate (ORR) in platinum-sensitive, recurrent ovarian cancer. To evaluate the reliability of assessment of progression and objective response per RECIST, radiologic and clinical data were assessed by an independent review committee (IRC).
Methods: Radiologic images and clinical data were provided prospectively to the IRC for all randomized patients (N=484).
J Clin Oncol
June 2012
Purpose: This randomized, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevacizumab (BV) with gemcitabine and carboplatin (GC) compared with GC in platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC).
Patients And Methods: Patients with platinum-sensitive ROC (recurrence ≥ 6 months after front-line platinum-based therapy) and measurable disease were randomly assigned to GC plus either BV or placebo (PL) for six to 10 cycles. BV or PL, respectively, was then continued until disease progression.
Background: The aim of this randomized clinical trial was to evaluate the efficacy and safety of combination (cDC) and sequential (sDC) weekly docetaxel and carboplatin in women with recurrent platinum-sensitive epithelial ovarian cancer (EOC).
Methods: Participants were randomized to either weekly docetaxel 30 mg/m(2) on days 1 and 8 and carboplatin area under the curve (AUC) = 6 on day 1, every 3 weeks or docetaxel 30 mg/m(2) on days 1 and 8, every 3 weeks for 6 cycles followed by carboplatin AUC = 6 on day 1, every 3 weeks for 6 cycles or until disease progression. The primary endpoint was measurable progression-free survival (PFS).
Gynecol Oncol
December 2011
Objectives: A phase II clinical trial compared docetaxel in combination with carboplatin to sequential single agent docetaxel followed by carboplatin for treatment of recurrent platinum-sensitive ovarian, peritoneal, or tubal cancer. This manuscript reports prospectively collected health-related quality of life (HRQL).
Methods: Participants were randomized to either weekly docetaxel 30 mg/m(2)/days 1 and 8 and carboplatin AUC 6/day 1 every 3 weeks (cDC) or docetaxel 30 mg/m(2)/days 1 and 8, repeated every 3 weeks for 6 cycles followed by carboplatin AUC 6/day 1 every 3 weeks for 6 cycles or until disease progression (sDC).
Background: In a randomized controlled trial (RCT) of patients with recurrent, platinum-sensitive ovarian cancer, the combination weekly docetaxel and carboplatin was associated a with progression-free survival (PFS) of 13.7 months compared with 8.4 months for sequential, single-agent docetaxel followed by carboplatin.
View Article and Find Full Text PDFObjective: The Department of Defense health care system provides access to care without respect to age, race, or socioeconomic status. We sought to determine the effect of race as a predictor of survival in patients with endometrial cancer treated in the Department of Defense medical system.
Methods: Information on patients with endometrial carcinoma was extracted from the Department of Defense centralized tumor registry for the period 1988 to 1995.
Background: While pelvic infection is known to be an infrequent complication of intrauterine device (IUD) use, infections are usually related to microorganisms introduced at the time of insertion or by sexual contact.
Case: We diagnosed a 35-year-old woman with an IUD for 6 years with pelvic inflammatory disease (PID) and implemented antibiotic therapy. Her clinical course worsened, and exploratory surgery revealed a right tuboovarian abscess with multiple loculated pelvic abscesses.