Randomized phase II trial of sorafenib alone or in combination with carboplatin/paclitaxel in women with recurrent platinum sensitive epithelial ovarian, peritoneal, or fallopian tube cancer.

BACKGROUND/PURPOSE: This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinum-sensitive, recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (EOC). METHODS: Patients with recurrent platinum-sensitive EOC with no more than 2 prior courses of chemotherapy were randomized to single-agent sorafenib 400 mg twice daily or combination sorafenib 400 mg bid (days 2-19) with IV carboplatin (AUC 6) and IV paclitaxel 175 mg/m(2) (S+C/T) every 3 weeks. Single agent sorafenib could cross over to combination upon progression. RESULTS: Patients were initially randomized to either arm, however, due to poor accrual, sorafenib arm was prematurely closed. A total of 13 patients were evaluable for response to sorafenib and 23 patients were evaluable for response to S+C/T. Objective response rate (RR) was 15 % for patients on sorafenib vs. 61 % for patients on S+C/T (p = 0.014); stable disease was seen in 62 % and 35 %, respectively. Clinical benefit rate (CBR) at 4 months (mos.) was 69 % for S and 65 % for S+C/T. The median progression free survival was 5.6 months on sorafenib vs. 16.8 months on S+C/T (p = 0.012) and there was no significant difference of overall survival between two arms (p = 0.974) with median overall survival 25.6 months under sorafenib vs. 25.9 months on S+C/T. Patients remained on trial for a median of 7.8 cycles on sorafenib and 5.4 cycles on S+C/T. CONCLUSION: Sorafenib, alone or in combination with carboplatin and paclitaxel, has activity in patients with platinum-sensitive EOC. Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS; however, there were increased grade and frequencies of toxicities.

Acute gastrointestinal toxicity after robotic stereotactic ablative radiotherapy for treatment of metastatic gynecological malignancies.

AIMS: The aim of this study was to assess acute and subacacute gastrointestinal toxicity after fractionated stereotactic ablative radiotherapy (SABR) in women having recurrent gynecological cancers in the upper abdomen. MATERIALS & METHODS: In total, 34 women underwent upper abdominal SABR (24 Gy/three divided 8 Gy consecutive daily doses) using a robotic Cyberknife® (Accuray, CA, USA) platform. Volumes of the duodenum receiving 10% increments of the prescription dose were associated to post-therapy gastrointestinal toxicities using binary logistic regression analyses. RESULTS: Median clinical follow-up was 10 months. In total, 14 (41%) of the 34 women manifested grade 2 or higher post-therapy gastrointestinal adverse events. The duodenal volume, receiving 80% of a 24-Gy dose, was significantly associated with gastrointestinal toxicity (p = 0.03). However, in a multivariate analysis, only patient age at SABR adjusted the odds of experiencing gastrointestinal toxicity (p = 0.02). CONCLUSION: The duodenal volume receiving 80% of 24 Gy dose may be associated with gastrointestinal toxicity from upper abdominal SABR.

Does adjuvant chemotherapy improve survival for women with early-stage uterine leiomyosarcoma?

OBJECTIVES: To examine whether adjuvant therapy after primary surgery for treatment of early-stage uterine leiomyosarcoma (LMS) improves recurrence and survival rates. METHODS: A multisite, retrospective study of women diagnosed with stage I-II high grade LMS from 1990-2010 was performed. All patients (pts) underwent primary surgery followed by observation (OBS), radiotherapy (RT), or chemotherapy (CT) postoperatively. RESULTS: One hundred eight patients were identified with long-term follow-up; 94 pts (87.0%) had stage I and 14 (13.0%) had stage II disease. The mean patient age was 55.4 years and mean BMI was 28.0. Thirty-four (31.5%) patients underwent OBS, 35 (32.4%) received RT, and 39 (36.1%) received chemotherapy. After a median follow-up of 41.8 months, a recurrence was diagnosed in 70.8%. Recurrence was evident in 25/34 (73.5%) OBS, 23/35 (65.7%) RT, and 28/39 (71.8%) of CT cohorts and was not different based on treatment (p=0.413). However, extra-pelvic recurrences were significantly higher in the RT (95.2%) than in the OBS (60%) or CT (64.3%) cohorts (p=0.012). Additionally, recurrences were more likely to be successfully treated or palliated in those who initially received CT (p=0.031). On multivariate analysis, stage (p<0.001) and chemotherapy (p=0.045) were associated with overall survival. CONCLUSIONS: Women with early-stage, high grade uterine LMS experience high recurrence rates and poor survival outcomes, irrespective of adjuvant therapy. These rates are higher than previously reported in the literature. Although women treated with CT had similar recurrence rates as those treated with OBS or RT, treatment with adjuvant chemotherapy may decrease the risk of extra-pelvic recurrence and improve survival.

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.

The prevalence of urinary catheterization in women and men with multiple sclerosis.

CONTEXT/OBJECTIVE: To determine the prevalence of urinary catheterization in patients with multiple sclerosis (MS). DESIGN/INTERVENTION: After obtaining Institutional Review Board exemption, results from the Fall 2005 North American Research Committee on Multiple Sclerosis (NARCOMS) survey were reviewed. PARTICIPANTS: Respondents to the fall 2005 NARCOMS survey. OUTCOME MEASURES: Responses to the Urogenital Distress Inventory (UDI-6), the Short Form-12 (SF-12), the Patient Determined Disease Steps measure of physical disability, and urologic history were analyzed using descriptive statistics, the χ(2) and Student's t-tests, and multivariable logistic and linear regression. RESULTS: Of 9702 (58%) responses were returned, excluding respondents with prior bladder surgery, 9676 participants were reviewed: primarily white (92.9%), women (75.3%), with average age of diagnosis of 30.2 (SD 10.0) years. Urinary catheterization was reported by 2514 (26%) respondents, with 1091 (11%) reporting current and 1423 (15%) past catheter use. Among all catheter types (possibly ≥ 1), intermittent self-catheterization was most common (81%), followed by transurethral Foley catheterization (43%) and suprapubic catheterization (8%). Males were more likely to catheterize than females (32 versus 24%, P < 0.001) and use indwelling methods (P < 0.001). Catheterizing patients reported longer disease duration, greater physical disability, increased overactive bladder symptoms, and reduced quality of life (QoL) scores (all P < 0.001). CONCLUSIONS: This is the first study to demonstrate significant rates (1 in 4) of urinary catheterization in patients with MS. Although thought to be common, the true rates of catheter use among MS patient were previously unknown. Urinary catheterization appears to be associated with reduced QoL, increased physical disability and longer disease duration as well.

Robotic-assisted hysterectomy for the management of severe endometriosis: a retrospective review of short-term surgical outcomes.

OBJECTIVES: The primary objective was to examine the safety and feasibility of robotic-assisted laparoscopy in a cohort of women treated surgically for stage III and IV endometriosis. The secondary objective was to explore whether the stage of endometriosis affected surgical outcome. METHODS: In this cohort study, 43 women with severe endometriosis were treated with robot-assisted laparoscopic hysterectomy with unilateral or bilateral salpingooophorectomy for stage III (n = 19) or stage IV (n = 24) disease. RESULTS: Histopathologic evaluation confirmed endometriosis in all patients, and fibroids were also shown in 12 patients. The median actual operative time was 145 min (range, 67-325 min), and the median blood loss was 100 mL (range, 20 - 400 mL). All but one of the procedures were completed successfully robotically. The length of hospital stay was 1 d for 95% of patients (41 of 43), and 2 patients had prolonged stays of 4 d and 5 d, respectively. One patient was readmitted for a vaginal cuff abscess; this represented the only complication identified in this series. CONCLUSIONS: Robot-assisted laparoscopic surgery appears to be a reasonably safe and feasible method for the definitive surgical management of women with severe endometriosis.

Reduction in neural activation to high-calorie food cues in obese endometrial cancer survivors after a behavioral lifestyle intervention: a pilot study.

BACKGROUND: Obesity increases the risk of endometrial cancer (EC) and obese EC patients have the highest risk of death among all obesity-associated cancers. However, only two lifestyle interventions targeting this high-risk population have been conducted. In one trial, food disinhibition, as determined by the Three-Factor Eating Questionnaire, decreased post-intervention compared to baseline, suggesting an increase in emotional eating and, potentially, an increase in food related reward. Therefore, we evaluated appetitive behavior using functional magnetic resonance imaging (fMRI) and a visual food task in 8 obese, Stage I/II EC patients before and after a lifestyle intervention (Survivors in Uterine Cancer Empowered by Exercise and a Healthy Diet, SUCCEED), which aimed to improve nutritional and exercise behaviors over 16 group sessions in 6 months using social cognitive theory. RESULTS: Congruent to findings in the general obese population, we found that obese EC patients, at baseline, had increased activation in response to high- vs. low-calorie food cues after eating a meal in brain regions associated with food reward (insula, cingulate gyrus; precentral gyrus; whole brain cluster corrected, p < 0.05). At 6 months post-intervention compared to baseline, we observed decreased activation for the high-calorie vs. non-food contrast, post-meal, in regions involved in food reward and motivation (posterior cingulate, cingulate gyrus, lateral globus pallidus, thalamus; claustrum; whole brain cluster corrected, p < 0.05). CONCLUSIONS: Our preliminary results suggest behavioral lifestyle interventions may help to reduce high-calorie food reward in obese EC survivors who are at a high-risk of death. To our knowledge, this is the first study to demonstrate such changes.

Comparison of single-port laparoscopy, standard laparoscopy, and robotic surgery in patients with endometrial cancer.

BACKGROUND: The aim of this study was to evaluate single-port laparoscopy (SPL) for the surgical treatment of presumed early-stage endometrial cancer and to compare surgical outcomes to laparoscopy and robotics. METHODS: A multi-institutional, matched retrospective cohort study was performed. All patients with clinical stage I or occult stage II endometrial cancer who underwent SPL hysterectomy, bilateral salpingo-oophorectomy +/- lymphadenectomy from April 2009 to September 2010 were identified. Outcomes were compared with patients matched by age, body mass index (BMI), tumor histology, and grade, who underwent laparoscopy or robotic surgery. Data was analyzed using Kruskal-Wallis 1-way analysis of variance and chi-square test for frequency data. A P value of <.05 was considered significant. RESULTS: A total of 90 matched patients (30 SPL, 30 LSC, and 30 robotic) were included in the study. There were no significant differences in median operating time or estimated blood loss between the 3 groups. The median number of pelvic lymph nodes obtained was significantly higher in the robotic (17.0 [8-36] and SPL group (16.0 [11-21]) compared with the laparoscopy group (13.0 [3-18]) P = .04. However, there was no significant difference in the median number of para-aortic nodes obtained between the 3 groups. There was no significant difference between the groups in length of hospital stay, comorbid conditions, complication rates, or operative times. CONCLUSIONS: Our findings suggest SPL surgery for endometrial carcinoma is feasible with similar operating times, hospital length of stay, complication rates, and estimated blood loss when compared with laparoscopy and robotics.

The association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study.

PURPOSE: To explore the association between baseline quality of life (QOL) scores and overall survival (OS) in ovarian cancer patients receiving adjuvant chemotherapy. METHODS: Patients with stage III ovarian cancer on Gynecologic Oncology Group protocol #172 completed the Functional Assessment of Cancer Therapy-General (FACT-G) and were then randomly assigned to either intravenous (IV) or intraperitoneal (IP) chemotherapy. The FACT scale includes physical, functional, social, and emotional well-being domains (PWB, FWB, SWB, EWB). The PWB item, lack of energy, was used to assess the presence of fatigue. RESULTS: After adjusting for patient age, treatment assignment, and the presence of gross disease, PWB was associated with OS. Patients who reported baseline PWB scores in the lowest 25% (PWB score<15 points) relative to those who scored in the highest 25% (PWB score>24 points) had decreased OS (HR: 1.81; 95% CI: 1.2-2.72; p=0.005). Patients experienced death rates 20% lower for every mean item point increase in PWB (Hazard Ratio [HR]: 0.80; 95% CI: 0.68-0.93; p=0.005). Patients complaining of fatigue did not have an increased risk of death compared with those not feeling fatigued (HR: 1.21; 95% CI: 0.91-1.61; p=0.19). CONCLUSIONS: Poor physical well-being reported at baseline is associated with risk of death in patients undergoing adjuvant chemotherapy for advanced ovarian cancer. Identifying modifiable characteristics that are associated with survival offers the potential for providing support that may improve outcomes.

Survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED): a randomized controlled trial.

OBJECTIVE: The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to evaluate an intervention for ECS to promote weight loss and a healthy lifestyle. METHODS: Early stage overweight and obese (body mass index ≥ 25) ECS (N=75) were randomized to a 6-month lifestyle intervention (LI) or usual care (UC). The LI group received education and counseling for six months (10 weekly followed by 6 bi-weekly sessions). Weight change at 12 months was the primary endpoint. Secondary outcomes included fruit/vegetable servings/day and physical activity (PA). Multiple imputations were used for missing data and mixed models were used to analyze changes from baseline. RESULTS: Adherence was 84% and follow-up data were available from 92% of participants at 6 months and 79% at 12 months. Mean [95% CI] difference in weight change between LI and UC groups at 6 months was -4.4 kg [-5.3, -3.5], p<0.001 and at 12 months was -4.6 kg [-5.8, -3.5], p<0.001. Mean [95% CI] difference in PA minutes between groups at 6 months was 100 [6, 194], p=0.038 and at 12 months was 89 [14, 163], p=0.020. Mean difference in kilocalories consumed was -217.8 (p<0.001) at 6 months and -187.2 (p<0.001) at 12 months. Mean [95% CI] difference in fruit and vegetable servings was 0.91 servings/day at 6 months and 0.92 at 12 months (p<0.001). CONCLUSIONS: Behavior change and weight loss are achievable in overweight and obese ECS, however, the clinical implications of these changes are unknown and require a larger trial with longer follow-up.

Minimally invasive surgery versus laparotomy in women with high grade endometrial cancer: a multi-site study performed at high volume cancer centers.

OBJECTIVE: The study aim was to compare outcomes in women with high-grade endometrial cancer (EC) who underwent surgical staging via minimally invasive surgery (MIS) versus laparotomy. METHODS: This is a retrospective, multi-institutional cohort study of patients with high-grade EC who were comprehensively surgically staged by either MIS or laparotomy. Demographic, surgical variables, complications, and survival were analyzed. RESULTS: Three hundred and eighty-three patients met criteria: 191 underwent laparotomy and 192 MIS (65% robotic, 35% laparoscopy). Subgroups were well matched by age (mean 66 years), stage, body mass index, histology and adjuvant therapies. Median operative time was longer in the MIS group (191 vs. 135 min; p<.001). However, the MIS cohort had a higher mean lymph node count (39.0 vs. 34.0; p=.03), shorter hospital stay (1 vs. 4 days) and significantly fewer complications (8.4% vs. 31.3%; p<.001). There was no significant difference in lymph node count with laparoscopic versus robotic staging. With a median follow-up time of 44 months, progression-free (PFS) and overall survival were not significantly different between the surgical cohorts. On multivariable analysis, stage, treatment were associated with PFS. CONCLUSIONS: Women with high grade endometrial cancers staged by minimally invasive techniques experienced fewer complications and similar survival outcomes compared to those staged by laparotomy. As this population is elderly and most will receive adjuvant therapies, minimization of surgical morbidity is of interest. When managed by expert laparoscopists or robotic surgeons, a high-risk histologic subtype is not a contraindication to minimally invasive surgery in women with apparent early-stage disease.

Toxicity of weekly oral topotecan in relation to dosage for gynecologic malignancies: a phase I study.

The aim of this study was to determine the dose of weekly oral topotecan that allows safe administration and to evaluate the pharmacokinetics of this dose in patients with recurrent gynecologic malignancies. The first cohort of patients received oral topotecan 6 mg/week administered orally on days 1, 8, and 15 of a 28-day regimen. A standard 3+3 dose-escalating phase design was used for dose levels II-V (8, 10, 12 and 14 mg/week). Toxicity was scored according to the Common Terminology Criteria for Adverse Events. Cumulative toxicity was summarized in the 6-12 mg/week combined cohort and 14 mg/week cohort separately. Pharmacokinetic samples were obtained for day 1, cycle 1 only in the expansion cohort (dose level V). Twenty-five patients received a total of 88 cycles of therapy. Hematologic toxicities of grade 3 (6-12 mg dose) were neutropenia (25%) and anemia (8.3%). Gastrointestinal toxicities of grade 3 were diarrhea (16.7%) and obstruction (8.3%, disease-related). Grade 3 or 4 (14 mg/week) hematologic toxicities consisted of neutropenia (38.5%), platelets (15.4%), anemia (15.4%), infection with neutropenia (7.7%), and thrombosis (7.7%). Gastrointestinal toxicities of grade 3 were diarrhea (7.7%), obstruction (7.7%), and vomiting (7.7%). One patient died secondary to neutropenic sepsis. One patient (4%; 95% confidence interval: 2.1, 22.3) showed a partial response and five patients (20%; 95% confidence interval: 7.6, 41.3) had stable disease. An oral topotecan dose of 14 mg/week for 3 consecutive weeks out of 4 is mostly associated with acceptable toxicities and may be considered for use in future single-agent phase II trials.

Feasibility of a lifestyle intervention for ovarian cancer patients receiving adjuvant chemotherapy.

OBJECTIVES: This study aimed to assess the feasibility of a lifestyle intervention for promoting physical activity (PA) and diet quality during adjuvant chemotherapy for ovarian cancer. METHODS: Patients were enrolled post-operatively and received PA and nutrition counseling, at every chemotherapy visit for six cycles. Quality of life (QoL) was measured with the Functional Assessment of Cancer Therapy (FACT-G), PA with the Leisure Score Index (LSI), dietary intake with 3-day food records, and symptom severity/distress by the Memorial Symptom Assessment Scale (MSAS). Pedometer step count was collected during chemotherapy cycles. RESULTS: Recruitment was 73% with 27 patients enrolled. Mean [95% confidence interval] change in minutes of PA from cycle #3 to following cycle #6 was 61 min [-3, 120] p=0.063, and from baseline to after cycle #6 was 73 min [-10, 15]; p=0.082. Mean change in total fruit and vegetable consumption between baseline and during chemotherapy was 0.56 [-0.09, 0.64]; p=0.090. FACT-G increased from 75.4 at baseline to 77.6 during chemotherapy and 83.9 following chemotherapy (p=0.001 for change from baseline to post-chemotherapy). Mean total MSAS score was 20.6 at baseline, 26.6 at cycle #3 and decreased to 17.0 following chemotherapy (p=0.01 comparison of cycle #3 and following chemotherapy). Increased moderate to strenuous PA was correlated with higher physical well-being during chemotherapy (r=0.48, p=0.037). CONCLUSIONS: Lifestyle counseling during adjuvant chemotherapy for ovarian cancer is feasible and may improve PA and diet quality. Randomized controlled trials examining the effects of lifestyle counseling on quality of life and treatment outcomes in ovarian cancer patients are warranted.

The effect of sleep disturbance on quality of life in women with ovarian cancer.

OBJECTIVE: To estimate the prevalence of sleep disturbances, and to determine if there is an association between sleep disturbances with quality of life (QOL), depression or clinical demographic variables. METHODS: Patients diagnosed with ovarian, fallopian tube or primary peritoneal cancer during the last 5years completed questionnaires regarding sleep patterns and disturbances [Pittsburgh Sleep Quality Index (PSQI)], depression [Beck Depression inventory (BDI)], and QOL [The Functional Assessment of Cancer Therapy-Ovarian (FACT-O), fatigue module (-F)]. Data were analyzed by Student's t-test or Pearson correlation coefficient to determine if there were differences between PSQI score with QOL, depression or clinical demographic variables. RESULTS: 86/275 (31% response) of patients returned the surveys. Mean age was 58.1 (SD=14.6) years and 70% had advanced disease at diagnosis. Thirty-six percent had current disease of which 81% were receiving chemotherapy. Sixty-seven percent of patients had a PSQI score≥5 corresponding to overall poor sleep quality and 46% of patients reported using sleep medication at least once during the prior month. PSQI score was significantly inversely correlated with all QOL domains (physical: r=-.599, p<.001, functional: r=-.692, p<.001, social: r=-.212, p<.001, emotional: r=-.379, p<.001, fatigue; r=-.655 p<.001) and with depression (r=.539, p<.001). PSQI was not correlated with age, time since diagnosis, number of previous chemotherapy regimens. PSQI score did not differ by current disease or chemotherapy status. CONCLUSIONS: Sleep disturbances reduce QOL, a prognostic indicator for survival, in ovarian cancer patients. These patients should undergo routine screening and would benefit from interventions that aim to promote restful sleep.

Abnormal cervical cytology in the diagnosis of uterine papillary serous carcinoma: earlier detection of a poor prognostic cancer subtype?

OBJECTIVE: Early detection of uterine papillary serous (UPSC), clear cell (CCC), and grade 3 endometrioid carcinomas (G3EC) - all poor prognostic variants of endometrial carcinoma (EC) - is of particular clinical relevance. The study objective was to assess the utility of liquid-based cytology (Pap) in the detection of high-grade EC. STUDY DESIGN: A retrospective, two-institution analysis of patients diagnosed with UPSC, CCC, or G3EC with a preoperative Pap from 1999 to 2010 was conducted. RESULTS: One hundred and one patients were evaluated; 51.5% had UPSC, 27.7% had CCC, and 20.8% had G3EC. Stage I/II disease was found in 69.3% of patients, and 46/101 patients (45.5%) had abnormal Paps. Significantly more patients with UPSC had abnormal Paps (65.7%) than those with CCC (25%) or G3EC (23.8%; p < 0.001). An abnormal Pap was the only presenting clinical finding in a significant number of asymptomatic UPSC patients (26.9%) compared with 4% of patients with CCC and G3EC (p = 0.005). On multivariate analysis, UPSC histology was the only variable associated with an abnormal Pap. CONCLUSIONS: A high incidence of abnormal cervical cytology was observed in women with high-grade EC, particularly in UPSC patients. Although hypothesis generating, a proportion of asymptomatic UPSC patients had abnormal cytology, signifying that Pap smear screening may help detect the disease before the patient develops symptoms.

A review of issues surrounding quality of life among women with ovarian cancer.

OBJECTIVES: Progress has been made towards prolonging survival of ovarian cancer patients. This trend has placed increasing attention upon the quality of life (QoL). The aim of this study was to review the existing literature on QoL, including measurement tools, and to explore opportunities to optimize well-being. METHODS: A comprehensive computer literature search of English language studies was performed in MEDLINE databases up to February 2010. RESULTS: Validated tools have been used in multiple studies to provide a mechanism to asses information about QoL in ovarian cancer. Ovarian cancer and its treatment have significant effects on QoL including fatigue and the physical and functional domains. Studies indicate that ovarian cancer patients needs and QoL change during the trajectory of the disease. CONCLUSIONS: As new treatment strategies for ovarian cancer are developed, research efforts should identify how therapeutics will affect QoL and include interventions to prevent or minimize the detrimental effects.

Endometrial cancer and obesity: epidemiology, biomarkers, prevention and survivorship.

Endometrial cancer is the most common gynecologic malignancy in the Western world and is strongly associated with obesity. Despite the fact that most cases are diagnosed in early, more favorable stages, endometrial cancer incidence and mortality rates are on the rise. Morbidly obese women with endometrial cancer are more likely to die of their co-morbidities and also of their cancers when compared to their leaner cohorts. Given the increasing rates of morbid obesity in the United States, it is essential to develop appropriate screening tools and guidelines to reduce cancer morbidity and death amongst this group. Through an analysis of the existing literature, we present a review of the epidemiologic trends in obesity and endometrial cancer, discuss the promising role of screening biomarker studies, review prevention efforts and modifiable risk factors, and ways in which health outcomes and quality of life for endometrial cancer survivors may be optimized.

An updated clinicopathologic study of early-stage uterine papillary serous carcinoma (UPSC).

OBJECTIVES: Stage I-II uterine papillary serous carcinoma (UPSC) patients have a significant risk for extrapelvic recurrence. However, clinicopathologic risk factors for recurrence are not well understood. This study was undertaken to define the prognostic factors for recurrence and survival in patients with early-stage UPSC. METHODS: A retrospective, multi-institution analysis of surgically staged I-II UPSC patients was performed. Patients were treated by various adjuvant modalities. Age, race, sub-stage, percentage UPSC histology, lymphvascular space invasion (LVSI), tumor size and adjuvant treatment modality were evaluated for their effect on recurrence and survival outcomes. RESULTS: We identified 206 patients. Forty patients (19.4%) had 5-49% UPSC, 55 (26.7%) had 50-99% and 111 patients (53.9%) had 100% UPSC in their respective uterine specimens. Twenty one percent of patients experienced a primary recurrence. On univariate analysis, age, increasing %UPSC, LVSI, and tumor size were not significantly associated with recurrence or progression-free survival (PFS). However, substage (p=0.005) and treatment with platinum/taxane-based chemotherapy (p=0.001) were associated with recurrence/PFS. On multivariate analysis, only chemotherapy (p=0.01) was a significant factor affecting PFS, whereas age (p=0.05), substage (p=0.05), and chemotherapy (p=0.02) were associated with overall survival. CONCLUSIONS: Traditional risk factors for recurrence and survival in patients with early-stage endometrial cancer may not be relevant in patients with UPSC. Patients with any percentage UPSC in their uterine specimens are at a significant risk for recurrence and poor survival outcomes. Given that current clinicopathologic data does not accurately identify women most likely to benefit from adjuvant therapy, alternative prognostic markers based on novel techniques should be explored.

The impact of obesity and age on quality of life in gynecologic surgery.

OBJECTIVE: This study was undertaken to prospectively evaluate the effect of early stage endometrial cancer, age, and obesity on quality of life (QOL). STUDY DESIGN: Women undergoing surgery for endometrial cancer or an adnexal mass determined at surgery to be benign (controls) were enrolled preoperatively and followed for 6 months. RESULTS: Seventy-nine women completed the study. Functional Assessment of Cancer Therapy (FACT-G) scores increased significantly in all women; however, significant differences by patient weight and age were obtained. Obesity was associated with decreased physical FACT-G and SF-36 scores. Older women had lower SF-36 physical scores, higher emotional scores, and less change over time. CONCLUSION: Women with early endometrial cancer had similar changes in QOL as those who received surgery for benign disease. Obese and elderly women had domain alterations. Given the aging population and rising incidence of obesity, these results emphasize the need for QOL interventions in postoperative gynecologic care of these patients.

Effect of method of administration on longitudinal assessment of quality of life in gynecologic cancer: an exploratory study.

BACKGROUND: Longitudinal assessments of quality of life are needed to measure changes over the course of a disease and treatment. Computer versions of quality of life instruments have increased the feasibility of obtaining longitudinal measurements. However, there remain occasions when patients are not able to complete these questionnaires. This study examined whether changes measured using a computer version of the Functional Assessment of Cancer Therapy - General (FACT-G) on two occasions would be obtained if patients completed a paper version on one of the two occasions. METHODS: Gynecologic oncology patients completed a computer version of the FACT-G pre-operatively and at six months. Patients were given the option of using the paper version instead of the computer at either time point. Repeated measures analysis of variance was used. RESULTS: One hundred nineteen patients completed the FACT-G at both time points. Seventy-one (60%) patients used the computer at both visits, 26 (21.8%) used the computer followed by the paper version, 17 (14.3%) used the paper version followed by the computer version, and five patients (4.2%) used the paper version at both visits. Significant effects over time were obtained in the physical, functional, and emotional well-being domains, and in total scores, but there were no effects of method of administration of the questionnaires and no interaction between method of administration and changes over time. CONCLUSIONS: These data indicate that women are responding to the content of the questionnaire and not method of data collection. Although using the same method of administration of instruments over time is desirable, using alternate methods is preferable to forgoing data collection entirely. Large scale studies should be conducted to determine if the multiple methods of data collection that are becoming increasingly available are producing interchangeable information.