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Charlotte, NC, United States

Objective: This study examines the design of previous and future trials of lymph node dissection in endometrial cancer. Methods: Data from previous trials were used to construct a decision analysis modeling the risk of lymphatic spread and the effects of treatment on patients with endometrial cancer. This model was then applied to previous trials as well as other future trial designs that might be used to address this subject. Results: Comparing the predicted and actual results in the ASTEC trial, the model closely mimics the survival results with and without lymph node dissection for the low and high risk groups. The model suggests a survival difference of less than 2% between the experimental and control arms of the ASTEC trial under all circumstances. Sensitivity analyses reveal that these conclusions are robust. Future trial designs were also modeled with hysterectomy only, hysterectomy with radiation in intermediate risk patients, and staging with radiation only with node positive patients. Predicted outcomes for these approaches yield survival rates of 88%, 90%, and 93% in clinical stage I patients who have a risk of pelvic node involvement of approximately 7%. These estimates were 78%, 82%, and 89% in intermediate risk patients who have a risk of nodal spread of approximately 15%. Conclusions: This model accurately predicts the outcome of previous trials and demonstrates that even if lymph node dissection was therapeutic, these trials would have been negative due to study design. Furthermore, future trial designs that are being considered would need to be conducted in high-intermediate risk patients to detect any difference. © 2012 Elsevier Inc. All rights reserved.

Brunner Huber L.R.,Health Science University | Ersek J.L.,Blumenthal Cancer Center
Annals of Epidemiology | Year: 2011

Purpose: An important, although understudied, area related to contraceptive use is perceptions of contraceptive responsibility. The purpose of this exploratory study was to investigate these perceptions among female college students. Methods: Web-based or mailed questionnaires were completed by 326 students from 2006-2007. Logistic regression was used to obtain odds ratios and 95% confidence intervals (CI) to model the associations between select demographic and lifestyle characteristics and contraceptive responsibility (shared vs. individual responsibility). Results: Although 89.1% of women felt that contraceptive responsibility should be shared, only 51.8% indicated that responsibility is actually shared in their relationships. After adjustment for age, race/ethnicity, marital status, and year of study, women using " other" methods of contraception (i.e. withdrawal, rhythm, sterilization, etc.) had 3.25 times the odds of stating that contraceptive responsibility is actually shared as compared to hormonal users (95% CI: 1.20, 8.80). Conclusions: For college women, there is a disconnect between who they feel should be responsible for contraception and who actually is responsible. Insight into perceptions of contraceptive responsibility in the university setting may help guide health educators and clinicians in designing pregnancy and sexually transmitted infection prevention programming. © 2011 Elsevier Inc.

Rashid M.U.,Shaukat Khanum Memorial Cancer Hospital and Research Center and | Rashid M.U.,German Cancer Research Center | Rashid M.U.,University of Health Sciences, Lahore | Shah M.A.,SKMCH and RC | And 4 more authors.
Pathology Research and Practice | Year: 2011

Metaplastic breast carcinoma (MBC) is a relatively rare subtype of breast cancer that encompasses a pathologically heterogeneous group of tumors. Pathogenic germ line mutations in the major breast cancer susceptibility genes BRCA1 and BRCA2 genes have been rarely found or described in MBC. We report the identification of the BRCA1 185delAG mutation in a 22-year-old Pakistani woman with triple-negative MBC that showed biphasic morphological features, including sarcomatous and malignant epithelial components. A comprehensive description of the clinical, histopathological, morphological, and immunohistochemical features of the tumor and the patient's treatment course is presented. © 2011 Elsevier GmbH.

Kneisl J.S.,Blumenthal Cancer Center | Jackson J.B.,Carolinas Medical Center
Surgical Oncology Clinics of North America | Year: 2011

Developing a successful cancer center within the community is achievable. This article provides an understanding of the standards and guidelines of the Commission on Cancer (CoC), the different community cancer center program categories, and the accreditation process. The pivotal roles of institutional support and physician leadership in the development of a successful cancer center have been elucidated. © 2011 Elsevier Inc.

Thompson J.A.,Fred Hutchinson Cancer Research Center | Hamid O.,Angeles Clinic and Research Institute | Minor D.,California Pacific Medical Center | Amin A.,Blumenthal Cancer Center | And 6 more authors.
Journal of Immunotherapy | Year: 2012

Ipilimumab is a fully human, monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 to potentiate antitumor T-cell responses. In a phase III trial, ipilimumab monotherapy at 3 mg/kg demonstrated an improvement in overall survival (OS) in patients with previously treated, metastatic melanoma. Here, we conducted a retrospective analysis of efficacy and safety data from a phase II clinical trial in which treatment-naive and previously treated patients with metastatic melanoma received ipilimumab at an investigational dose of 10 mg/kg. Patients were randomized 1:1 to receive oral budesonide or placebo, and ipilimumab at 10 mg/kg every 3 weeks for 4 doses, to determine whether prophylactic budesonide affected the rate of grade ≥2 diarrhea. One hundred fifteen patients were randomized and treated: 62 had received prior systemic therapy for metastatic disease and 53 had not. No efficacy endpoint was affected by budesonide therapy, and the efficacy data were therefore pooled for budesonide and placebo subgroups. Median OS was 30.5 months for treatment-naive patients who received ipilimumab, with survival rates of 69.4%, 62.9%, and 56.9% at 12, 18, and 24 months. In previously treated patients who received ipilimumab, median OS was 13.6 months, with survival rates of 50.0%, 37.7%, and 28.5% at 12, 18, and 24 months. There were no meaningful differences in the number of objective responses or rate of grade ≥2 diarrhea between groups. These retrospective analyses are the first to provide survival data for ipilimumab in treatment-naive and previously treated patients within the same clinical trial. Copyright © 2011 by Lippincott Williams &Wilkins.

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