Barriers to urogynecological care in a population of gynecological oncology patients.

INTRODUCTION AND HYPOTHESIS: The objective was to identify barriers to urogynecological evaluation in a population of new patients presenting to a gynecological oncology practice with symptoms of pelvic floor dysfunction. METHODS: A pelvic floor dysfunction screening questionnaire was given to new patients presenting to a university-based gynecological oncology practice between 1 August 2010 and 31 August 2012. Patients indicating symptoms related to pelvic floor dysfunction in the survey were offered urogynecological evaluations. Charts of those patients declining further evaluation were reviewed. Results of the pelvic floor dysfunction questionnaires were assessed. Reasons provided for not desiring further evaluation were extracted from the questionnaire and stratified. RESULTS: A total of 549 surveys were reviewed. Two hundred and thirty-six patients (42.0 %) of the patients surveyed reported being bothered by pelvic floor dysfunction symptoms. Only 6.7 % (16 out of 236) wanted a referral for an urogynecological evaluation; 93.2 % declined an evaluation. Of patients reporting moderate to severe bother from pelvic floor symptoms, the most frequently cited barrier to care was feeling overwhelmed with the current medical situation (28 %). Other reasons for declining an urogynecological evaluation included a previous evaluation (14 %), financial concerns (6.9 %), and believing that oncological treatment would cure pelvic floor symptoms (6 %). CONCLUSIONS: Quality of life after cancer treatment is important. The ability to provide treatment for gynecological cancer and pelvic floor disorders concomitantly has the potential to improve the quality of life in this patient population. Understanding barriers to care of gynecological oncology patients seeking evaluation for conditions affecting their quality of life is essential in alleviating fears, preventing misconceptions, and for making informed decisions.

Patterns of recurrence in stage I endometrioid endometrial adenocarcinoma with lymphovascular space invasion.

OBJECTIVE: The objective of this study was to determine the patterns of recurrence of stage IB-IIA endometrioid endometrial adenocarcinoma (EMCA) with lymphovascular invasion (LVSI). METHODS: A multicenter retrospective study of 1988 International Federation of Gynecology and Obstetrics stage IB-IIA EMCA patients with LVSI treated with surgery with or without radiation was conducted. Those with papillary serous or clear cell histologies and women treated with chemotherapy were excluded. Data regarding surgical-pathologic factors, treatment, and outcome were collected. Data were analyzed using χ test, Kaplan-Meier estimates, and Cox multivariate proportional hazards models. RESULTS: From 1997 to 2008, we identified 131 patients with LVSI who met entry criteria among 5 institutions. Median age was 67 years (25%-75%: 60-75 years), and median follow-up was 4.25 years (25%-75%: 3-10 years). Following surgery, 45 patients were observed (Obs), and 86 patients received adjuvant radiation. We observed 30 total relapses 30/131 (23%): 11/45 (24%) in the Obs group and 19/86 (22%) in the adjuvant radiation group. Recurrence rates were similar between staged and unstaged patients: 24% (20/84) and 21% (10/47), respectively. Among Obs patients, 82% of relapses were local, whereas in patients treated with adjuvant radiation, 84% were distant. Relapses were significantly associated with invasion of the lower uterine segment (LUS) (P = 0.035). Both cancer-related survival and overall survival (OS) were not significantly impacted by adjuvant radiation, because of distant failure rates. Adjuvant radiation significantly improved pelvic control (P = 0.007). In a multivariate analysis, OS correlated with LUS invasion (P = 0.008) and was borderline-associated with stage (P = 0.06), whereas age (P = 0.12), grade (P = 0.31), myometrial invasion (P = 0.99), and radiation treatment (P = 0.23) were not. CONCLUSIONS: Overall recurrence rates for stage IB-IIA EMCA patients with LVSI are high (23%). Although adjuvant radiation therapy improved pelvic control, it did not impact recurrence rates, cancer-related survival, and OS, likely secondary to distant failures. The role of systemic therapy with or without radiotherapy for early-stage EMCA with LVSI should be evaluated, particularly in patients with high-grade tumors or involvement of the LUS.

Localized delivery of chemotherapy to the cervix for radiosensitization.

OBJECTIVE: Chemoradiation is the mainstay of therapy for advanced cervical cancer, with the most effective treatment regimens involving combinations of radiosensitizing agents. However, administration of radiosensitizing chemotherapeutics concurrently with pelvic radiation is not without side effects. The aim of this study was to examine the utility of localized drug delivery as a means of improving drug targeting of radiosensitizing chemotherapeutics to the cervix while limiting systemic toxicities. METHODS: An initial proof-of-concept study was performed in 14 healthy women following local administration of diazepam utilizing a novel cervical delivery device (CerviPrep™). Uterine vein and peripheral blood samples were collected and diazepam was measured using a GC-MS method. In the follow-up study, gemcitabine was applied to the cervix in 17 women undergoing hysterectomy for various gynecological malignancies. Cervical tissue, uterine vein blood samples, and peripheral plasma were collected, and gemcitabine and its deaminated metabolite 2',2'-difluorodeoxyuridine (dFdU) were measured using HPLC-UV and LC/MS methods. RESULTS: Targeted delivery of diazepam to the cervix was consistent with parent drug detectable in the uterine vein of 13 of 14 women. In the second study, pharmacologically relevant concentrations of gemcitabine (0.01-6.6 nmol/g tissue) were detected in the cervical tissue of 11 of 16 available specimens with dFdU measureable in 15 samples (0.04-8.8 nmol/g tissue). Neither gemcitabine nor its metabolites were detected in the peripheral plasma of any subject. CONCLUSIONS: Localized drug delivery to the cervix is possible and may be useful in limiting toxicity associated with intravenous administration of chemotherapeutics for radiosensitization.

A phase II study of fulvestrant in the treatment of multiply-recurrent epithelial ovarian cancer.

Objective. The goal of treating recurrent ovarian cancer is disease control while minimizing toxicity. Fulvestrant, a novel estrogen receptor (ER) antagonist, has proven clinically beneficial and well-tolerated in treating recurrent breast cancer. Ovarian cancer often expresses ER and may respond to anti-estrogen therapy. We evaluated fulvestrant in women with recurrent ovarian or primary peritoneal cancer. Methods. Patients with ER-positive, multiply recurrent ovarian or primary peritoneal carcinoma and either measurable disease according to RECIST criteria or an abnormal and rising CA-125 were eligible for enrollment. Treatment consisted of single agent fulvestrant, 500 mg IM on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression. Disease response was assessed by monthly physical exams and CA-125 levels as well as CT scans bimonthly. The primary endpoint was clinical benefit (CB=complete response (CR)+partial response (PR)+stable disease (SD)) at 90 days. Results. Thirty-one women were enrolled and 26 women (median age of 61) met inclusion criteria and received at least one dose. Patients had received a median of 5 prior chemotherapeutic regimens (range: 2-13). We observed one CR (4%), one PR (4%), and 9 patients with SD (35%) using modified-Rustin criteria (CA-125 level). Using modified-RECIST criteria 13 patients (50%) achieved SD. The median time to disease progression was 62 days (mean 86 days). Grade 1 toxicity included headache (1 patient) and bromidrosis (2 patients). Conclusions. Fulvestrant is well-tolerated and efficacious. Objective response rates are low, but disease stabilization was common.

Prevalence of symptomatic pelvic floor disorders among gynecologic oncology patients.

OBJECTIVE: To describe the prevalence of urinary incontinence and pelvic organ prolapse (POP) in patients with gynecologic cancer before cancer treatment. METHODS: A screening questionnaire on pelvic floor dysfunction was administered as part of the baseline health questionnaire to 549 consecutive new patients presenting to a gynecologic oncology practice. Patients were asked whether they felt a bulge from their vagina or experienced loss of urine associated with activity or urge to urinate. The prevalence of urinary incontinence, POP, or both was determined for each malignancy and benign conditions. χ2 analyses and logistic regression were used to assess significance of differences. RESULTS: Among the 347 women with a gynecologic malignancy, 49.9% women had uterine, 21.0% ovarian, and 14.4% cervical cancer. More than half of the patients with cancer reported baseline urinary incontinence (UI) and 10.9% felt a bulge from their vagina. Approximately 19% of these women had moderate-to-severe symptoms. The prevalence of baseline UI (P=.86) and POP (P=.08) did not differ by gynecologic cancer nor did they differ compared with women with benign gynecologic conditions (UI P=.89, POP P=.20). Logistic regression demonstrated an association between incontinence symptoms and increased age and body mass index (BMI). CONCLUSIONS: Women with gynecologic cancer show high prevalence of symptomatic POP and UI. Age and BMI are risk factors for UI. Coordinated surgical intervention to address both the malignancy and pelvic floor dysfunction could be considered in select patients to enhance postoperative quality of life and to reduce the economic and quality-of-life costs of multiple surgeries. LEVEL OF EVIDENCE: II.

Feasibility and morbidity of using saline filled tissue expanders to reduce radiation-induced bowel injury in patients with gynecologic malignancies.

OBJECTIVES: To evaluate the feasibility and morbidity of using saline filled tissue expanders (TE) to displace the small bowel during radiation therapy in patients with gynecologic malignancies. STUDY DESIGN: Ten patients undergoing surgical exploration for a gynecologic malignancy and deemed to be at high risk for the late effects of radiation therapy were consented for the possible placement of a TE. Indication for placement was need for post-operative radiation. Small bowel exclusion was reported in terms of the lowest loop identified on treatment planning film using orally ingested barium. RESULTS: Small bowel loops were excluded from the pelvis to varying degrees in all patients. Lowest identifiable bowel was marked at the L4-L5 interspace in one patient, L5-S1 interspace in three patients, at or near the sacral promontory in three patients, and to the middle of S2 in one patient. In two patients the TE was removed prior to simulation. Early complications included migration of the TE during treatment, development of a vesicovaginal fistula requiring immediate removal of the TE, and enterocutaneous fistula formation in a patient who developed an abscess following treatment completion. Another patient experienced a rectovaginal fistula 18 months after removal of the TE. CONCLUSIONS: TE placement can successfully isolate small bowel from the pelvis. Usage should be individualized to minimize the likelihood of short and long-term complications, particularly in patients at higher risk of morbidity.