Medicine and Health Sciences Commons^™

Impact Of Homologous Recombination Status And Responses With Veliparib Combined With First-Line Chemotherapy In Ovarian Cancer In The Phase 3 Velia/Gog-3005 Study, Elizabeth M Swisher, Carol Aghajanian, David M O'Malley, Gini F Fleming, Scott H Kaufmann, Douglas A Levine, Michael J Birrer, Kathleen N Moore, Nick M Spirtos, Mark S Shahin, Thomas J Reid, Michael Friedlander, Karina Dahl Steffensen, Aikou Okamoto, Vasudha Sehgal, Peter J Ansell, Minh H Dinh, Michael A Bookman, Robert L Coleman

Kimmel Cancer Center Faculty Papers

Objective: In the Phase 3 VELIA trial (NCT02470585), PARP inhibitor (PARPi) veliparib was combined with first-line chemotherapy and continued as maintenance for patients with ovarian carcinoma enrolled regardless of chemotherapy response or biomarker status. Here, we report exploratory analyses of the impact of homologous recombination deficient (HRD) or proficient (HRP) status on progression-free survival (PFS) and objective response rates during chemotherapy.

Methods: Women with Stage III-IV ovarian carcinoma were randomized to veliparib-throughout, veliparib-combination-only, or placebo. Stratification factors included timing of surgery and germline BRCA mutation status. HRD status was dichotomized at genomic instability score 33. During combination therapy, …

Elagolix Treatment For Up To 12 Months In Women With Heavy Menstrual Bleeding And Uterine Leiomyomas, James A Simon, Ayman Al-Hendy, David F Archer, Kurt T Barnhart, Linda D Bradley, Bruce R Carr, Thomas Dayspring, Eve C Feinberg, Veronica Gillispie, Sandra Hurtado, Jinhee Kim, Ran Liu, Charlotte D Owens, Ozgul Muneyyirci-Delale, Alice Wang, Nelson B Watts, William Schlaff

Department of Obstetrics and Gynecology Faculty Papers

Objective: To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.

Methods: Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of …

Elagolix For Heavy Menstrual Bleeding In Women With Uterine Fibroids., William D. Schlaff, Ronald T. Ackerman, Ayman Al-Hendy, David F. Archer, Kurt T. Barnhart, Linda D. Bradley, Bruce R. Carr, Eve C. Feinberg, Sandra M. Hurtado, Jinhee Kim, Ran Liu, R. Garn Mabey, Charlotte D. Owens, Alfred Poindexter, Elizabeth E. Puscheck, Henry Rodriguez-Ginorio, James A. Simon, Ahmed M. Soliman, Elizabeth A. Stewart, Nelson B. Watts, Ozgul Muneyyirci-Delale

Department of Obstetrics and Gynecology Faculty Papers

BACKGROUND: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding.

METHODS: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal "add-back" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone …

High Report Of Miscarriage Among Women Living With Hiv Who Want To Conceive In Uganda., Sarah Finocchario-Kessler, Kathy Goggin, Vincent S. Staggs, Rhoda K. Wanyenze, Jolly Beyeza-Kashesya, Deborah Mindry, Josephine Birungi, Glenn J Wagner

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: Data on early miscarriage incidence is limited due to various social and methodological barriers. We report on 24-month pregnancy outcomes of 299 female Ugandan HIV clients in committed relationships with an intention to conceive. Miscarriage data are reported as auxiliary findings to a larger study (5R01HD072633).

RESULTS: 127 (42%) participants reported a pregnancy during the study; among the remaining 172, 82 indicated they stopped trying to conceive, and 16 dropped out prior to month 24. Of the 127 pregnancies, 55 (43%) resulted in live births, 67 (53%) in spontaneous miscarriage, 1 (< 1%) in stillbirth, 1 (< 1%) in abortion, and 3 (2%) in unknown outcomes. Three-quarters (75%) of miscarriages for which time until miscarriage was available were reported to occur in the first trimester (mean = 11.3 weeks gestation). The 67 participants who reported a miscarriage tended to be older (mean 33 vs. 30 years), but the significance of age did not persist after adjusting for multiple tests. We observed relatively low rates of pregnancy and high rates of miscarriage among this cohort of HIV-positive women wanting to conceive. Rigorously designed studies are needed to better understand the observed high rate of early miscarriage among HIV-infected women.

Treatments For Opioid Use Disorder Among Pregnant And Reproductive-Aged Women., Dennis J. Hand, Vanessa L. Short, Diane J. Abatemarco

Department of Obstetrics and Gynecology Faculty Papers

The increased prevalence of opioid use disorder and access to medical insurance is subsequently increasing the likelihood that medical professionals will encounter individuals with opioid use disorder. Sharp increases in opioid use disorder among women mean that obstetricians, gynecologists, and other reproductive medicine providers may be especially likely to encounter such patients. Medical professionals' understanding of treatment for opioid use disorder and their roles in their patients' treatment may increase referrals to treatment, reduce stigma, and improve the quality of medical care. Treatment for opioid use disorder falls into four overlapping domains: medication management, medical care, behavioral/mental health care, and …

Is Pregnancy-Associated Melanoma Associated With Adverse Outcomes?, Maris S Jones, Jihey Lee, Stacey L Stern, Mark Faries

Articles, Abstracts, and Reports

BACKGROUND: Melanoma is the most common malignancy encountered during pregnancy. Conflicting data have led to ongoing confusion regarding pregnancy-associated melanoma (PAM) in the media and among the public. The objective of this study was to better characterize both the clinical presentation of PAM and its prognostic implications.

STUDY DESIGN: Female patients of reproductive age, with stage 0 to IV cutaneous melanoma, were identified from our prospectively maintained database. Clinical and histopathologic factors were analyzed with appropriate statistical methods. Univariable and then multivariable analysis were used on matched data to compare disease-free survival (DFS), overall survival (OS), and melanoma-specific survival (MSS) …

Tx-004hr Improves Sexual Function As Measured By The Female Sexual Function Index In Postmenopausal Women With Vulvar And Vaginal Atrophy: The Rejoice Trial., Sheryl A Kingsberg, Leonard Derogatis, James A Simon, Ginger D Constantine, Shelli Graham, Brian Bernick, Gina Gasper, Sebastian Mirkin

Obstetrics and Gynecology Faculty Publications

INTRODUCTION: TX-004HR is an investigational, applicator-free, vaginal soft gel capsule containing low-dose solubilized 17β-estradiol. The phase 3, randomized, double-blinded, placebo-controlled, multicenter REJOICE trial has shown TX-004HR to be safe and effective for the treatment of moderate to severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy (VVA).

AIM: To evaluate the effect of TX-004HR on female sexual dysfunction in postmenopausal women with VVA.

METHODS: The REJOICE study compared the effects of 12-week treatment with TX-004HR (4, 10, or 25 μg) with placebo in postmenopausal women (40-75 years old) with VVA and a most bothersome symptom of moderate to severe …

Attitudes Of Women In Their Forties Toward The 2009 Uspstf Mammogram Guidelines: A Randomized Trial On The Effects Of Media Exposure, Autumn Davidson, Xun Liao, B. Magee

B. Dale Magee

OBJECTIVE: The objective of the study was to assess women's attitudes toward 2009 US Preventive Services Task Force mammography screening guideline changes and evaluate the role of media in shaping opinions. STUDY DESIGN: Two hundred forty-nine women, aged 39-49 years, presenting for annual examinations randomized to read 1 of 2 articles, and survey completion comprised the design of the study. RESULTS: Eighty-eight percent overestimated the lifetime breast cancer (BrCa) risk. Eighty-nine percent want yearly mammograms in their 40s. Eighty-six percent felt the changes were unsafe, and even if the changes were doctor recommended, 84% would not delay screening until age …

Serum Inhibin-B In Fertile Men Is Strongly Correlated With Low But Not High Sperm Counts: A Coordinated Study Of 1,797 European And Us Men, N. Jorgensen, F. Liu, A. Andersson, M. Vierula, D. Irvine, J. Auger, C. Brazil, E. Drobnis, T. Jensen, P. Jouannet, J. Overstreet, J. Redmon, Amy Sparks, J. Toppari, C. Wang, N. Skakkebaek, S. Swan

Amy E.T. Sparks

OBJECTIVE: To describe associations between serum inhibin-b and sperm counts, adjusted for effect of time of blood sampling, in larger cohorts than have been previously reported. DESIGN: Cross-sectional studies of spermatogenesis markers. SETTING: Four European and four US centers. PATIENT(S): Fertile men (1,797) were included and examined from October 1996-February 2005. INTERVENTION(S): The study was observational and therefore without any intervention. MAIN OUTCOME MEASURE(S): Associations between inhibin-b and semen variables controlled for time of blood sampling and other covariates. RESULT(S): Inhibin-b decreased about 2.00% per hour from 8 am-12 pm and then about 3.25% per hour from 12 pm-4 pm. …

Psychological Empowerment And Job Satisfaction Between Baby Boomer And Generation X Nurses, Amy Sparks

Amy E.T. Sparks

AIM: This paper is a report of a study of differences in nurses' generational psychological empowerment and job satisfaction. BACKGROUND: Generations differ in work styles such as autonomy, work ethics, involvement, views on leadership, and primary views on what constitutes innovation, quality, and service. METHOD: A secondary analysis was conducted from two data sets resulting in a sample of 451 registered nurses employed at five hospitals in West Virginia. One data set was gathered from a convenience sample and one from a randomly selected sample. Data were collected from 2000 to 2004. RESULTS: Baby Boomer nurses reported higher mean total …

Characterization Of Human Sperm Antigens Reacting With Anti-Sperm Antibodies From An Infertile Female Patient's Serum, H. Feng, Y. Han, Amy Sparks, J. Sandlow

Amy E.T. Sparks

Identification of sperm antigens that elicit immunoglobulin (Ig) production and knowledge of their roles in sperm transport and fertilization may enhance diagnosis and treatment of immunologic infertility. Sperm antigens recognized by a female patient's serum anti-sperm antibodies were characterized using an indirect immunobead-binding test, immunoblot analysis, and immunochemical labeling. The anti-sperm antibodies' effect on sperm function was evaluated by acrosome induction by calcium ionophore. Immunobeads specific for IgG were bound to the head of 79% of motile donor sperm. Immunochemical labeling of antibody-binding sites was restricted to the plasma membrane over the acrosomal crescent. No labeling was observed on the …

Social Cognition, Empathy And Functional Outcome In Schizophrenia, Amy Sparks, S. Mcdonald, B. Lino, M. O'Donnell, M. Green

Amy E.T. Sparks

Social and occupational functioning difficulties are a characteristic feature of schizophrenia, and a growing body of evidence suggests that deficits in social cognition contribute significantly to these functional impairments. The present study sought to investigate whether the association between social cognition and social functioning in schizophrenia would be mediated by self-reported levels of empathy. Thirty outpatients with a diagnosis of schizophrenia or schizoaffective disorder, and twenty-five healthy controls completed a well-validated facial affect processing task (Ekman 60-faces facial task from the Facial Expressions of Emotion - Stimuli and Tests; FEEST), The Awareness of Social Inference Test (TASIT; to assess emotion …

Are Environmental Levels Of Bisphenol A Associated With Reproductive Function In Fertile Men?, J. Mendiola, N. Jorgensen, A. Andersson, A. Calafat, X. Ye, J. Redmon, E. Drobnis, C. Wang, Amy Sparks, S. Thurston, F. Liu, S. Swan

Amy E.T. Sparks

BACKGROUND: Rodent and in vitro studies have demonstrated the estrogenicity of bisphenol A (BPA). However, few studies have examined the relationship between human exposure to BPA and male reproductive function. OBJECTIVES: We investigated the relationships between environmental BPA exposure and reproductive parameters, including semen quality and male reproductive hormones, in prospectively recruited fertile men. METHODS: Participants (n = 375) were partners of pregnant women who participated in the Study for Future Families in four U.S. cities, and all of the men provided blood, semen, and urine samples. BPA was measured in urine. Serum samples were analyzed for reproductive hormones, including …

The Cost Of Infertility Evaluation And Therapy: Findings Of A Self-Insured University Healthcare Plan., D. Stovall, B. Allen, Amy Sparks, Craig Syrop, R. Saunders, Bradley Van Voorhis

Amy E.T. Sparks

OBJECTIVE: To assess the total costs of infertility coverage, determine the proportion of healthcare costs related to infertility, compare infertility costs to those of other diseases, and calculate a per member per month cost of an infertility benefit. DESIGN: Historical prospective analysis. SETTING: A university-based, self-insured, fee-for-service healthcare plan. PATIENT(S): Healthcare policy members from January 1993 through December 1995. INTERVENTION(S): General and infertility-specific healthcare that included diagnostic tests for infertility, induction of ovulation, artificial insemination, donor gametes, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, microsurgical epididymal sperm aspiration, embryo cryopreservation, and frozen embryo transfer. MAIN OUTCOME MEASURE(S): Healthcare …

Impact Of Male Age On The Outcome Of Assisted Reproductive Technology Cycles Using Donor Oocytes, Eyup Duran, D. Dowling-Lacey, S. Bocca, L. Stadtmauer, S. Oehninger

Eyup Hakan Duran

This study assessed the influence of the age of the male partner on the outcome of oocyte donation cycles. A total of 408 couples participating in 519 consecutive anonymous oocyte donation cycles were examined. Main outcome measures were fertilization rate, embryo quality, clinical pregnancy, implantation, miscarriage and live birth rates, as well as the total reproductive potential, which estimates the outcome from fresh and cryopreserved-thawed embryo transfers. A total of 241 cycles resulted in clinical pregnancy (48.5% of transfers). The mean embryo score for transferred embryos (ESTE) was higher in cycles resulting in pregnancy (P=0.003). Semen volume (P<0.001), sperm …

Sperm Dna Quality Predicts Intrauterine Insemination Outcome: A Prospective Cohort Study, Eyup Duran, M. Morshedi, S. Taylor, S. Oehninger

Eyup Hakan Duran

BACKGROUND: We aimed to investigate whether sperm DNA quality may predict intrauterine insemination (IUI) outcome. METHODS: The study was designed in a prospective cohort fashion, at a tertiary centre for reproductive medicine. A total of 119 patients underwent 154 cycles of IUI. Parameters related to demography, cycle management and semen sample used for IUI were evaluated. Conventional semen parameters, morphology (strict criteria), sperm DNA fragmentation and stability [evaluated by terminal deoxynucleotidyl transferase-mediated dUDP nick-end labelling (TUNEL) and acridine orange staining under both acid and acid + heat denaturing conditions respectively] were measured. The main outcome measure was clinical pregnancy, defined …

The Effect Of Age On The Expression Of Apoptosis Biomarkers In Human Spermatozoa, A. Colin, G. Barroso, N. Gomez-Lopez, Eyup Duran, S. Oehninger

Eyup Hakan Duran

OBJECTIVE: To evaluate the impact of age on the expression of apoptotic biomarkers in human spermatozoa. DESIGN: Cross sectional, prospective study. SETTING: Academic centers. PATIENT(S): Healthy volunteers with proven fertility, stratified by age (n = 25, range: 20-68 years). INTERVENTION(S): Examination of serum hormone levels and basic semen parameters, and assessment of early (plasma membrane translocation of phosphatidylserine) and late (DNA fragmentation) sperm apoptotic markers by flow cytometry (using Annexin-V binding and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling). MAIN OUTCOME MEASURE(S): Apoptosis markers. RESULT(S): Advancing male age was significantly and positively correlated with Annexin-V binding results. Although not significant, …

Endometrial Response To Unopposed Estrogens Remains Unaltered In Patients With Chronic Renal Failure Receiving Hemodialysis, M. Ergeneli, Eyup Duran, H. Zeyneloglu, B. Demirhan, M. Erdogan

Eyup Hakan Duran

Most patients with chronic renal failure who are on maintenance hemodialysis are anovulatory and have menstrual abnormalities. This study was designed to determine the prevalence of organic causes of abnormal uterine bleeding in this group of patients exposed to unopposed estrogens. Eighteen patients with chronic renal failure and abnormal uterine bleeding underwent vacuum curettage. The histopathologic findings were compared with a group of 154 premenopausal women who had abnormal uterine bleeding without detectable organic causes. Excluding patients with secretory and atrophic endometrium, only 2 of 8 patients (25%) with chronic renal failure had endometrial lesions while 44 of 131 patients …

The Cost Of Infertility Evaluation And Therapy: Findings Of A Self-Insured University Healthcare Plan., D. Stovall, B. Allen, Amy Sparks, Craig Syrop, R. Saunders, Bradley Van Voorhis

Bradley J Van Voorhis

OBJECTIVE: To assess the total costs of infertility coverage, determine the proportion of healthcare costs related to infertility, compare infertility costs to those of other diseases, and calculate a per member per month cost of an infertility benefit. DESIGN: Historical prospective analysis. SETTING: A university-based, self-insured, fee-for-service healthcare plan. PATIENT(S): Healthcare policy members from January 1993 through December 1995. INTERVENTION(S): General and infertility-specific healthcare that included diagnostic tests for infertility, induction of ovulation, artificial insemination, donor gametes, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, microsurgical epididymal sperm aspiration, embryo cryopreservation, and frozen embryo transfer. MAIN OUTCOME MEASURE(S): Healthcare …

Outcomes From Assisted Reproductive Technology, Bradley Van Voorhis

Bradley J Van Voorhis

The use of assisted reproductive technology (ART) for treating the infertile couple is increasing in the United States. The purpose of this paper is to review the short-term outcomes after ART. Pregnancy rates after ART have shown nearly continuous improvement in the years since its inception. A number of factors affect the pregnancy rate, with the most important being a woman's age. Certain clinical diagnoses are associated with a poorer outcome from ART, including the presence of hydrosalpinges, uterine leiomyomata that distort the endometrial cavity, and decreased ovarian reserve. Multiple gestations are the major complication after ART. New laboratory techniques, …

Immunohistochemical Localization Of Prostaglandin H Synthase In The Female Reproductive Tract And Endometriosis, Bradley Van Voorhis, P. Huettner, M. Clark, J. Hill

Bradley J Van Voorhis

Prostaglandin H synthase, also known as cyclooxygenase, is an essential enzyme in prostaglandin synthesis. Using a monoclonal antibody and immunohistochemical techniques, we studied the localization of this enzyme in the female reproductive tract and in endometriosis. In the uterus, prostaglandin H synthase was primarily localized to endometrial epithelium with surface epithelium containing more immunoreactive prostaglandin H synthase than glandular epithelium. Fallopian tube secretory epithelial cells also contained prostaglandin H synthase while ciliated epithelial cells did not. Cervical epithelium and myometrial cells did not contain prostaglandin H synthase. A higher percentage of glands in endometriosis and adenomyosis, as compared with eutopic …

Pelvic Floor Symptoms And Lifestyle Factors In Older Women, Catherine Bradley, Colleen Kennedy, I. Nygaard

Colleen Kennedy Stockdale

OBJECTIVES: To measure the prevalence of pelvic floor symptoms in noncare-seeking older women and the association between symptoms and lifestyle factors. METHODS: Women enrolled at one site of the Women's Health Initiative Hormone Therapy clinical trial completed a questionnaire, modified from the Pelvic Floor Distress Inventory, on bladder, bowel, and prolapse symptoms. Individual symptoms and symptom groups were examined in a cross-sectional analysis. RESULTS: In the 297 women who participated, mean age was 68.2 years, mean body mass index (BMI) was 30.2 kg/m(2), and median vaginal parity was 3. The median number of symptoms endorsed was 3 (range 0-18). The …

Urinary Incontinence, Depression And Posttraumatic Stress Disorder In Women Veterans, Catherine Bradley, I. Nygaard, M. Mengeling, J. Torner, Colleen Stockdale, B. Booth, A. Sadler

Colleen Kennedy Stockdale

OBJECTIVE: To study associations between urinary incontinence (UI) symptoms, depression, and posttraumatic stress disorder in women veterans. STUDY DESIGN: This cross-sectional study enrolled women 20 to 52 years of age registered at 2 midwestern US Veterans Affairs Medical Centers or outlying clinics within 5 years preceding study interview. Participants completed a computer-assisted telephone interview assessing urogynecologic, medical, and mental health. Multivariable analyses studied independent associations between stress and urgency UI and depression and posttraumatic stress disorder. RESULTS: Nine hundred sixty-eight women mean aged 38.7 +/- 8.7 years were included. Of these, 191 (19.7%) reported urgency/mixed UI and 183 (18.9%) stress …

Bladder And Bowel Symptoms Among Women With Vulvar Disease: Are They Universal?, Colleen Kennedy, I. Nygaard, Catherine Bradley, R. Galask

Colleen Kennedy Stockdale

OBJECTIVE: To compare the prevalence of painful bladder syndrome, recurrent urinary tract infections, urinary leakage and irritable bowel syndrome between women with specific vulvar disorders and controls. STUDY DESIGN: Women with a primary diagnosis of vulvar intraepithelial neoplasia (dysplasia), vulvar vestibulitis (vestibulitis), contact vulvitis, atrophic vulvovaginitis, lichen simplex, lichen sclerosus and lichen planus, were compared to women presenting for annual examinations. RESULTS: As compared to controls, painful bladder syndrome was more prevalent among subjects with dysplasia, vestibulitis and contact vulvitis; a history of recurrent urinary tract infection was more prevalent among subjects with contact vulvitis; and urinary incontinence was less …

Risk Factors For Painful Bladder Syndrome In Women Seeking Gynecologic Care, Colleen Kennedy, Catherine Bradley, R. Galask, I. Nygaard

Colleen Kennedy Stockdale

The aim of this cross-sectional study was to report risk factors for painful bladder syndrome in women. We surveyed 645 women presenting for care to general gynecology clinics and a vulvar specialty clinic using a standardized questionnaire and validated outcome measures. We used two definitions for painful bladder syndrome, based on the O'Leary-Sant interstitial cystitis symptom and problem indices. Of those women surveyed, 29.5% met broader criteria and 8.5% met more restrictive criteria for painful bladder syndrome. After adjusting for confounders, bladder pain was significantly associated with current smoking, irritable bowel syndrome, and a generalized pain disorder. Tobacco use, the …

Examining The Boundaries Of Tailoring: The Utility Of Tailoring Versus Targeting Mammography Interventions For Two Distinct Populations., Ginny Ryan, C. Skinner, D. Farrell, V. Champion

Ginny L. Ryan

Health messages can be generic, targeted to population subsets or tailored for individual recipients. There has been little examination of which populations need tailored interventions or whether tailored and targeted interventions differ in important ways. We used data from a mammography intervention study in two distinct populations to simulate a comparison of individually tailored versus targeted interventions. Tailored intervention content was based on individual recipients' interview responses. Targeted intervention content was based on composite group responses. For more than 60% in each population group, about two-thirds of tailored message content was a good match with content of the targeted intervention …

Vulvar Carcinoma With Hypercalcemia, Jennifer Niebyl, Rene Genadry, E. Friedrich, E. Wilkinson, J. Woodruff

Jennifer R Niebyl

Hypercalcemia associated with nonmetastatic malignancy has been reported most frequently with lung or kidney tumors, while among gynecologic malignancies, the ovary has been the most common primary site. The pertinent clinicopathologic features of 2 cases of nonmetastatic vulvar carcinoma producing hypercalcemia are described in the present report. Including 3 previously reported cases, the vulva is seen to be the second most common site in the female genital tract for production of this paraendocrine syndrome. The clinician should be aware of the association of hypercalcemia and mental confusion with bulky vulvar tumors, so that surgery will not needlessly be delayed in …

Cyclic Changes In Glycemia Assessed By Continuous Glucose Monitoring System During Multiple Complete Menstrual Cycles In Women With Type 1 Diabetes, W. Goldner, V. Kraus, W. Sivitz, Stephen Hunter, J. Dillon

Stephen K. Hunter

Many women with diabetes notice changes in glucose control perimenstrually. To describe the pattern of changes in glucose control throughout the complete menstrual cycle, and the reproducibility of these changes, we performed a pilot study evaluating glycemic profiles continuously for three cycles in four women with type 1 diabetes. All participants had hemoglobin A1c <7.5% and regular menstrual periods off oral contraceptives. They used Medtronic MiniMed (Northridge, CA) Continuous Glucose Monitoring System (CGMS) devices continuously for three complete menstrual cycles, checked capillary glucose measurements six times daily, changed their own sensors every 3 days, and were seen seven times per …

Phase Ii Clinical Trial Of Ixabepilone In Patients With Recurrent Or Persistent Platinum- And Taxane-Resistant Ovarian Or Primary Peritoneal Cancer: A Gynecologic Oncology Group Study, Koen De Geest, John Blessing, Robert Morris, S. Diane Yamada, Bradley Monk, Susan Zweizig, Daniela Matei, Carolyn Muller, William Richards

Koen De Geest

PURPOSE Ixabepilone (BMS-247550) is a microtubule-stabilizing epothilone B analog with activity in taxane-resistant metastatic breast cancer. The Gynecologic Oncology Group conducted a phase II evaluation of the efficacy and safety of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant primary ovarian or peritoneal carcinoma. PATIENTS AND METHODS Patients with measurable platinum- and taxane-resistant ovarian or peritoneal carcinoma, defined as progression during or within 6 months of one prior course of treatment with each agent, received intravenous ixabepilone 20 mg/m(2) administered over 1 hour on days 1, 8, and 15 of a 28-day cycle. RESULTS Of 51 patients entered, …

Preservation Of Immune Function In Cervical Cancer Patients During Chemoradiation Using A Novel Integrative Approach., Susan Lutgendorf, Elizabeth Mullen-Houser, Daniel Russell, Koen De Geest, Geraldine Jacobson, Laura Hart, David Bender, Barrie Anderson, Thomas Buekers, Michael Goodheart, Michael Antoni, Anil Sood, David Lubaroff

Koen De Geest

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side-effects, and immunosuppression. This prospective randomized clinical trial examined effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation. Sixty women with stages IB1 to IVA cervical cancer were randomly assigned to receive UC or 4 ×/weekly individual sessions of either HT or RT immediately following radiation during their 6-week chemoradiation treatment. Patients completed psychosocial …