Blumenthal Cancer Center

Charlotte, NC, United States

Blumenthal Cancer Center

Charlotte, NC, United States
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Weber J.S.,H. Lee Moffitt Cancer Center and Research Institute | Amin A.,Blumenthal Cancer Center | Minor D.,California Pacific Medical Center | Siegel J.,Bristol Myers Squibb | Berman D.,Bristol Myers Squibb
Melanoma Research | Year: 2011

Melanoma has a high propensity to metastasize to the brain, and this is often responsible for treatment failure in patients with advanced disease. Melanoma patients with brain metastases are usually excluded from clinical trials because of their expected survival of approximately 5 months. A growing body of evidence suggests that ipilimumab, a human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4, has activity against melanoma brain metastases. We conducted a retrospective analysis of data from a phase II study of ipilimumab in advanced melanoma patients. Twelve of 115 patients randomized in the parent trial had stable brain metastases at baseline, as identified by an Independent Review Committee, and were evaluated for efficacy. Two of the 12 patients achieved a partial response and three had stable disease. Both patients with a partial response and one with stable disease were alive at the last follow-up, with survival time of more than 4 years. The median overall survival of the 12 patients was 14 months (range: 2.7-56.4+). An additional four patients with stable brain metastases at baseline were identified by a secondary Independent Review Committee reviewer, and were evaluated for safety. Central nervous system-related adverse events of grade 3-4, specifically cerebral edema and convulsion/seizure, occurred in two of 16 patients. Although the present study is limited by the fact that it is a retrospective analysis of a small number of patients, the results provide further evidence for the safety and efficacy of ipilimumab in melanoma patients with stable brain metastases. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Rashid M.U.,Shaukat Khanum Memorial Cancer Hospital and Research Center SKMCH and RC | 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.

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.

Finkler N.J.,Florida Hospital Cancer Institute | Hall J.B.,Blumenthal Cancer Center | Melnyk O.,Bay Area Cancer Research Group LLC | Edwards R.P.,University of Pittsburgh | And 9 more authors.
International Journal of Gynecological Cancer | Year: 2010

Objective: To evaluate the safety and efficacy of canfosfamide in combination with pegylated liposomal doxorubicin (PLD) in platinum-resistant ovarian cancer (OC). Methods: Patients with platinum-refractory or -resistant (primary or secondary) OC were randomized to receive canfosfamide at 1000 mg/m2 and PLD at 50 mg/m2 intravenously or PLD alone at 50 mg/m2 intravenously on day 1 every 28 days until tumor progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Other end points were objective response rate and safety. The study was originally planned for 244 patients. The trial was temporarily placed on hold after 125 patients were randomized while the results of another trial were being reviewed and the sponsor decided not to resume enrollment. The interim analysis became the final analysis. Results: The median PFS was 5.6 months for canfosfamide + PLD (n = 65) versus 3.7 months for PLD (n = 60) (hazards ratio, 0.92; P = 0.7243). A preplanned subgroup analysis showed that 75 patients with platinum-refractory or primary platinum-resistant OC had a median PFS of 5.6 months for canfosfamide + PLD versus 2.9 months for PLD (hazards ratio, 0.55; P = 0.0425). Hematologic adverse events were 66% on the canfosfamide + PLD arm versus 44% on the PLD arm, manageable with dose reductions. Nonhematologic adverse events were similar for both arms. The incidence of palmar-plantar erythrodysesthesia and stomatitiswas lower on canfosfamide + PLD(23%, 31%, respectively) versus (39%, 49%, respectively) on PLD. Conclusions: Overall median PFS showed a positive trend but was not statistically significant. The median PFS in the platinum-refractory and primary platinum-resistant OC patients was significantly longer for canfosfamide + PLD versus PLD. Canfosfamide may ameliorate the palmar-plantar erythrodysesthesia and stomatitis known to be associated with PLD. Further study of this active well-tolerated regimen in platinum-refractory and primary platinum-resistant OC is planned. Copyright © 2010 by IGCS and ESGO.

Rashid M.U.,Shaukat Khanum Memorial Cancer Hospital | Rashid M.U.,German Cancer Research Center | Rashid M.U.,University of Health Sciences, Lahore | Gull S.,Shaukat Khanum Memorial Cancer Hospital | And 6 more authors.
Familial Cancer | Year: 2011

Pathogenic germ line mutations in the BRCA1 and BRCA2 genes confer elevated risk of breast and ovarian cancer in females and have a link with variety of cancers other than breast cancer in males. Here we report the first case of a 45-year-old Pakistani male with renal cell carcinoma who was identified to harbor a disease-associated BRCA1 germ line mutation, 2080insA. Detailed description of the family history, clinical presentation and histopathological features of the renal cell carcinoma are presented. © 2011 Springer Science+Business Media B.V.

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.

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.

Foureau D.M.,Carolinas Medical Center | Foureau D.M.,Blumenthal Cancer Center | McKillop I.H.,Carolinas Medical Center | Jones C.P.,Carolinas Medical Center | And 6 more authors.
Cancer Immunology, Immunotherapy | Year: 2011

Recombinant human interleukin-2 (rhIL-2) therapy is approved for treating patients with advanced melanoma yet significant responses are observed in only 10-15% of patients. Interleukin-2 induces Foxp3 expression in activated human CD8 T cells in vitro and expands circulating CD8 Foxp3+ T cells in melanoma patients. Employing IL-2 responsive (B16-F1, B16-BL6, JB/MS, MCA-205) and nonresponsive (JB/RH, B16-F10) subcutaneous tumor mouse models, we evaluated CD8 Foxp3+ T cell distribution and changes in response to rhIL-2 (50, 000 U, i.p. or s.q., twice daily for 5 days). In tumorfree mice and subcutaneous tumor-bearing mouse models, CD8 Foxp3+ T cells were a rare but naturally occurring cell subset. Primarily located in skin-draining lymph nodes, CD8 Foxp3+ T cells expressed both activated T cell (CD28 +, CD44 +) and Treg (CTLA4 +, PD1 lo/var, NKG2A +/var) markers. Following treatment with rhIL-2, a dramatic increase in CD8 Foxp3+ T cell prevalence was observed in the circulation and tumor-draining lymph nodes (TD.LNs) of animals bearing IL-2 nonresponsive tumors, while no significant changes were observed in the circulation and TD.LNs of animals bearing IL-2 responsive tumors. These findings suggest expansion of CD8 Foxp3+ T cell population in response to rhIL-2 treatment may serve as an early marker for tumor responsiveness to immunotherapy in an immune competent model. Additionally, these data may provide insight to predict response in patients with melanoma undergoing rhIL-2 treatment.

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.

PubMed | Blumenthal Cancer Center
Type: Journal Article | Journal: Oncology nursing forum | Year: 2010

To analyze the incidence of chemotherapy-induced neuropathy in a set of patients with gynecologic cancer who were treated with known neurotoxic agents, to identify correlative factors related to patients experience of neuropathy, and to analyze providers assessment and treatment of neuropathy.Observational descriptive study of patient-reported neuropathy using a retrospective chart analysis.A hospital-based outpatient infusion center in the southeastern United States.A convenience sample of 171 patients with gynecologic cancer for a total of 302 chemotherapy treatments.A mixed model and compound symmetry covariance matrix was used to adjust for correlations between neuropathy treatment scores and patients who completed more than one chemotherapy cycle. Backward elimination method was used to determine the final model.Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neuropathy Treatment scores, patients demographic information, past medical history, and chemotherapy history.Patients who were physically shorter and heavier than the average population had the highest rating of neuropathy. Patients who were treated with nontaxane and platinum therapies had less neuropathy than patients who were treated with first-line taxanes and platinums. Neuropathy was noted by providers early in the course of treatment, and providers grading was consistent with the patients scoring.First-line treatments for gynecologic malignancies resulted in the highest neuropathy scores; however, patients who had received previous treatment with taxane and platinum therapies had lower neuropathy scores than patients currently receiving taxanes and platinums, suggesting that neuropathy improved after completion of first-line therapy and that second-line therapies were not necessarily correlative with worsening scores.Nurses must educate patients about symptoms of neuropathy and the need to report symptoms. Nurses must recognize patients at highest risk for neuropathy and advocate use of validated assessment tools.

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