Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer.

Background: Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinum-resistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoid receptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy.

Phase I and Randomized Phase II Study of Ruxolitinib With Frontline Neoadjuvant Therapy in Advanced Ovarian Cancer: An NRG Oncology Group Study.

Purpose: The interleukin-6/Janus kinase (JAK)/signal transducers and activators of transcription 3 axis is a reported driver of chemotherapy resistance. We hypothesized that adding the JAK1/2 inhibitor ruxolitinib to standard chemotherapy would be tolerable and improve progression-free survival (PFS) in patients with ovarian cancer in the upfront setting.

Materials And Methods: Patients with ovarian/fallopian tube/primary peritoneal carcinoma recommended for neoadjuvant chemotherapy were eligible.

Genomic characterization of vulvar squamous cell carcinoma reveals differential gene expression based on clinical outcome.

Objective: The greatest challenge in the management of vulvar squamous cell carcinoma (VSCC) is treatment of recurrent disease where options for surgery and radiation have been exhausted, or treatment of disease where distant metastasis is present. Identification of mutations differentially expressed between tumor from patients who died of aggressive disease and tumor from patients with an indolent course could reveal novel prognostic indicators and guide development of therapeutic drugs.

Methods: From 202 consecutive patients with VSCC, patients who recurred and died of disease (group A) were identified and matched by age, tumor size, depth of invasion and nodal status with those whose disease did not recur (group B).

Impact of Screening for Sexual Trauma in a Gynecologic Oncology Setting.

Objectives: Sexual trauma poses a significant concern and is associated with heightened stress, negative health repercussions, and adverse economic effects. A history of abuse may increase a woman's risk of developing cancer, in particular cervical cancer. We analyzed the impact of screening for sexual abuse in a gynecologic oncology population.

A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted, membrane-disrupting peptide, versus paclitaxel alone for refractory or recurrent ovarian cancer.

Objective: This randomized open-label phase II study evaluated the safety and clinical activity of EP-100 plus weekly paclitaxel in patients with recurrent ovarian cancer expressing positive LHRH receptor.

Methods: In a limited "run-in" dose escalation phase for EP-100, six patients were treated with ascending dose levels (13 mg/m, 20 mg/m, 30 mg/m). In the randomized phase, patients received weekly paclitaxel (80 mg/m intravenously) plus twice weekly EP-100 (30 mg/m intravenously; combination arm) or weekly paclitaxel alone (80 mg/m intravenously; paclitaxel arm).

Gender and the Balance of Parenting and Professional Life among Gynecology Subspecialists.

Study Objective: To compare the parenting and career patterns of female and male gynecology subspecialists.

Design: Cross-sectional survey study (Canadian Task Force classification II-3).

Setting: Survey administered electronically in February 2015 to physician members of the Society of Gynecologic Oncology, the American Society for Reproductive Medicine, and the American Urogynecologic Society.

Pembrolizumab in Recurrent Squamous Cell Carcinoma of the Vulva: Case Report and Review of the Literature.

Advanced vulvar cancer is associated with a very poor prognosis. Surgical resection is the mainstay of treatment, with radiation indicated for areas at high risk for recurrence. When surgical and radiation options have been exhausted, the effectiveness of systemic chemotherapy is poor.

Laparoscopic surgery for endometrial cancer: increasing body mass index does not impact postoperative complications.

Objective: To determine the effect of body mass index on postoperative complications and the performance of lymph node dissection in women undergoing laparoscopy or laparotomy for endometrial cancer.

Methods: Retrospective chart review of all patients undergoing surgery for endometrial cancer between 8/2004 and 12/2008. Complications graded and analyzed using Common Toxicity Criteria for Adverse Events ver.

Embryonal rhabdomyosarcoma of the uterine cervix in a 41-year-old woman treated with radical hysterectomy and adjuvant chemotherapy.

Background: Cervical embryonal rhabdomyosarcoma (ERMS) mostly affects young girls. The current treatment protocols are based on trials done on patients under 21 years old. ERMS in women over 40 is rare, and studies on treatment and outcome are limited.

Oral thalidomide as palliative chemotherapy in women with advanced ovarian cancer.

Objective: We prospectively evaluated thalidomide, an oral agent with antiangiogenic and immunomodulatory properties, in patients with recurrent ovarian cancer, comparing the drug to standard intravenous chemotherapy and treatment holiday in terms of both progression-free interval and quality of life.

Methods: Eligible patients had recurrent ovarian or primary peritoneal cancer and had received a minimum of two prior therapeutic regimens. Patients were offered one of three arms: (Arm A) any standard intravenous single-agent chemotherapy; (Arm B) oral thalidomide 200 mg daily; (Arm C) treatment holiday.

Hyperthermic intraperitoneal chemotherapy in conjunction with surgery for the treatment of recurrent ovarian carcinoma.

Objectives: To review experience of secondary surgical cytoreduction (SSC) with hyperthermic intraperitoneal chemotherapy (IPHC).

Methods: Eligible patients with ovarian cancer in whom pre-operative evaluation indicated that there was a good possibility that disease could be resected to < or = 5 mm underwent surgery followed by intraperitoneal perfusion of cisplatin (100 mg/m2) or mitomycin C (30-40 mg total dose) heated to 41-43 degrees C (105.8-109.

The effect of total parenteral nutrition on the survival of terminally ill ovarian cancer patients.

Objectives: Total parenteral nutrition (TPN) for terminal ovarian cancer patients remains controversial. In this study, we compared survival from time of terminal intestinal obstruction (TIO) diagnosis in patients who received TPN versus those who did not.

Methods: A historical cohort of 55 patients with stage IIIC/IV epithelial ovarian cancer hospitalized for TIO between 1994 and 2002 was studied.

Elevated body mass index does not increase the risk of palmar-plantar erythrodysesthesia in patients receiving pegylated liposomal doxorubicin.

Objectives: The dose-limiting toxicity of pegylated liposomal doxorubicin (PLD) is palmar-plantar erythrodysesthesia (PPE). Some physicians are reluctant to use this drug in overweight patients, postulating that larger size increases the likelihood of PPE. We sought to determine whether a correlation exists between body mass index (BMI) and the frequency or severity of skin reactions during PLD chemotherapy.

Two for good measure: six versus eight cycles of carboplatin and paclitaxel as adjuvant treatment for epithelial ovarian cancer.

Introduction: Although the standard of care for advanced epithelial ovarian cancer (EOC) is six cycles (6C) of platinum-taxane (PT), there have been no studies on the optimal duration of treatment in the era of adjuvant taxanes. At our center, some women receive eight cycles (8C) of PT, based on physician judgment. We were interested in evaluating the outcomes of women treated with 8C of PT for EOC as compared to a cohort who received 6C.

Cross-sensitivity between paclitaxel and docetaxel in a women's cancers program.

Purpose: With the use of steroid premedication, the incidence of severe hypersensitivity reactions (S-HSR) to paclitaxel is estimated to be 2%. For those who develop a S-HSR to paclitaxel, docetaxel has been employed as an alternative agent though the presence of cross-sensitivity has not been established. We sought to define the incidence of S-HSR to docetaxel following a paclitaxel S-HSR in an academic women's cancer program.

Adnexal masses in pregnancy: surgery compared with observation.

Objective: To estimate whether the delay of surgery impacts the risk of adverse maternal and fetal outcomes in patients diagnosed with an adnexal mass during pregnancy.

Methods: A review was performed of pregnant patients diagnosed with an adnexal mass 5 cm or greater in diameter. Data collected included age, gravity/parity, gestational age at diagnosis, and presenting symptoms.

Dyspnea during thalidomide treatment for advanced ovarian cancer.

Objective: To detail the dyspnea encountered in women receiving thalidomide as therapy for advanced ovarian cancer.

Case Summaries: Eight of 18 (44%) patients with recurrent ovarian cancer developed dyspnea while receiving thalidomide 200 mg daily as part of a prospective Phase II study. Dyspnea was evaluated with pulse oximetry, chest X-ray and, if indicated, spiral computed tomography scan.

Pathologic evaluation of inguinal sentinel lymph nodes in vulvar cancer patients: a comparison of immunohistochemical staining versus ultrastaging with hematoxylin and eosin staining.

Objectives: To evaluate the value of immunohistochemical (IHC) staining of inguinal sentinel lymph nodes (SLN) found to be negative for metastatic disease by ultrastaging with hematoxylin and eosin (H&E) staining.

Methods: An IRB approved study identified 29 patients who had undergone an inguinal sentinel lymph node dissection for squamous cell carcinoma of the vulva. All sentinel lymph nodes found to be negative for metastatic disease based on ultrastaging with H&E staining were reevaluated with pancytokeratin antibody (AE1/AE3) immunohistochemical (IHC) staining to detect micrometastasis.

Groin recurrence in patients with vulvar cancer with negative nodes on superficial inguinal lymphadenectomy.

Objective: The objective of this study was to investigate the cause of groin recurrence in patients with vulvar cancer who had negative nodes in their superficial inguinal lymphadenectomy (SIL) specimens.

Methods: The records of patients with vulvar cancer treated at M. D.

Mentorship and productivity among gynecologic oncology fellows.

Background: To identify factors that enable gynecologic oncology fellows to achieve goals set by the American Board of Obstetrics and Gynecology (ABOG).

Method: Survey questions identified demographics, mentorship status, productivity, career plans, and opinions in a fourth fellowship year.

Results: Reasons cited for choosing specific programs were academic reputation, faculty, geographic location, and research opportunities.