A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study.

CONTEXT: Women diagnosed with ovarian cancer are at risk for reduced quality of life (QOL). It is imperative to further define these declines to interpret treatment outcomes and design appropriate clinical interventions. OBJECTIVES: The primary objective of this study was to compare data obtained from ovarian cancer patients with normative data to assess the degree to which QOL differs from the norm. Secondary objectives were to examine demographic variables and determine if there was a correlation between physical/functional and social/emotional scores during chemotherapy. METHODS: Patients with Stage III/IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent surgery followed by intravenous paclitaxel and cisplatin completed the Functional Assessment of Cancer Therapy-Ovarian. The Functional Assessment of Cancer Therapy scale includes the four domains of physical, functional, social, and emotional well-being (PWB, FWB, SWB, and EWB, respectively). RESULTS: Ovarian cancer patients had a total QOL (Functional Assessment of Cancer Therapy-General) score similar to the U.S. female adult population. However, the reported subscale scores were 2.0 points (95% confidence interval [CI] 1.4-2.5, P<0.001, effect size=0.37) lower in PWB, 0.9 points (95% CI 0.3-1.5, P=0.005, effect size=0.13) lower in FWB, 5.0 points (95% CI 4.6-5.3, P<0.001, effect size=0.74) higher in SWB, and 0.8 points (95% CI 0.3-1.2, P<0.001, effect size=0.16) lower in EWB. Correlation between the sum of PWB and FWB and the sum of SWB and EWB was r=0.53 (P<0.001). Age was positively correlated with EWB (r=0.193; 95% CI 0.09-0.29). CONCLUSION: Ovarian cancer patients have decreased QOL in physical, functional, and emotional domains; however, they may compensate with increased social support. At the time of diagnosis and treatment, patients' QOL is affected by inherent characteristics. Assessment of treatment outcomes should take into account the effect of these independent variables.

Comparison of 3- and 2-dimensional sonographic techniques for counting ovarian follicles.

OBJECTIVE: The purpose of this study was to compare 3-dimensional (3D) and 2-dimensional (2D) ovarian follicle counts and 3D counts using stored volumes between experienced and inexperienced operators. METHODS: Follicles larger than 5 mm were counted on 1 randomly selected ovary. Two-dimensional follicle counts were compared with stored 3D volumes by the same experienced operator (registered diagnostic medical sonographer [RDMS]). Counts using 3D stored data were compared between the experienced operator and inexperienced operator (principal investigator [PI]). The mean difference in follicle counts was computed, and a 1-sample Student t test was performed to test the hypothesis that the mean of the differences was 0. Comparison of the 2 methods and observers by Bland-Altman plots was used to determine any systematic differences based on the total number of follicles per selected ovary. RESULTS: Mean differences differed from 0 (P < .005) for all 3 comparisons: 2D RDMS versus 3D RDMS, 2D RDMS versus 3D PI, and 3D RDMS versus 3D PI. For the comparison of 2D versus 3D counts done by the RDMS, 5 ovaries (10%) had a difference of more than 5 follicles counted; for the 2D RDMS versus 3D PI, 11 ovaries (22%) had a difference of more than 5 follicles; for the 3D RDMS versus 3D PI, 8 ovaries (16%) had a difference of more than 5 follicles. Mean differences in counts ranged 0.29 to 1.04 for ovaries with 10 or fewer follicles compared with 3.94 to 9.00 for ovaries with more than 10 follicles. CONCLUSIONS: Follicle counts using 3D volumes were similar to 2D counts, and 3D follicle counts done by an inexperienced operator were similar to counts done by an experienced sonographer.

Assessment of factors that contribute to decreased quality of life in Gynecologic Oncology Group ovarian cancer trials.

BACKGROUND: The objective of this study was to assess which quality-of-life (QOL) line items on the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) were associated with low QOL in women who were receiving chemotherapy for ovarian cancer. METHODS: Patients with stage III or IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent primary surgery followed by intravenous paclitaxel and cisplatin completed the FACT-O. The FACT scale includes the 4 domains of physical, functional, social, and emotional well being (PWB, FWB, SWB, EWB, respectively). Women who had overall FACT-O scores in the lowest quartile (Q1) were compared with women in the upper 3 quartiles (Q2-Q4). The proportions of women in each group that selected the 2 worst categories for each item were compared. The level of significance was set at P<.005. RESULTS: Before Cycle 4, 361 patients (86.4%) provided valid QOL assessments. For PWB, a significantly greater proportion of women in Q1 versus Q2 through Q4 selected the 2 worst categories of several physical symptoms (nausea, pain, feeling ill, and being bothered by the side effects of treatment). For FWB, significant differences included being able to work, being content with the quality of their life, and sleeping well. For EWB, there were significant differences in feeling nervous and worrying about dying. There were virtually no differences between groups in SWB. Low interest in sex was reported by 56% to 88% of all patients (Q1-Q4). CONCLUSIONS: A large proportion of women with FACT-O scores in the lowest quartile reported problems that potentially were amenable to clinical interventions, such as symptom management and psychosocial support.

Radiation therapy compared with pelvic node resection for node-positive vulvar cancer: a randomized controlled trial.

OBJECTIVES: To report long-term survival and toxicity of radiation compared with pelvic node resection for patients with groin node-positive vulvar cancer. METHODS: A Gynecologic Oncology Group protocol enrolled 114 patients randomly allocated to postoperative pelvic and groin radiation (45-50 Gy, n=59) or to ipsilateral pelvic node resection (n=55) after radical vulvectomy and inguinal lymphadenectomy. Retrospective analyses for 114 enrolled patients included both risk of progression and death after treatment and assessment of toxicity. RESULTS: Median age was 70 years. Median survivor follow-up was 74 months. The relative risk of progression was 39% in radiation patients (95% confidence interval [CI] 0.17-0.88, P=.02). Fourteen intercurrent deaths occurred after radiation as compared with only two after pelvic node resection, narrowing 6-year overall survival (51% compared with 41%, hazard ratio 0.61 [95% CI 0.30-1.3], P=.18). However, the cancer-related death rate was significantly higher for pelvic node resection compared with radiation (51% compared with 29% at 6 years, hazard ratio 0.49 [95% CI 0.28-0.87], P=.015). Six-year overall survival benefit for radiation in patients with clinically suspected or fixed ulcerated groin nodes (P=.004) and two or more positive groin nodes (P<.001) persisted. A ratio of more than 20% positive ipsilateral groin nodes (number positive/number resected) was significantly associated with contralateral lymph node metastasis, relapse, and cancer-related death. Late chronic lymphedema (16% compared with 22%) and cutaneous desquamation (19% compared with 15%) were balanced after radiation and pelvic node resection. CONCLUSION: Radiation after radical vulvectomy and inguinal lymphadenectomy significantly reduces local relapses and decreases cancer-related deaths. Late toxicities remained similar after radiation or pelvic node resection. LEVEL OF EVIDENCE: I.

Activation of P2X(7)-mediated apoptosis Inhibits DMBA/TPA-induced formation of skin papillomas and cancer in mice.

BACKGROUND: The study tested the hypothesis that apoptosis can prevent and control growth of neoplastic cells. Previous studies in-vitro have shown that the pro-apoptotic P2X(7) receptor regulates growth of epithelial cells. The specific objective of the present study was to understand to what degree the P2X(7) system controls development and growth of skin cancer in vivo, and what cellular and molecular mechanisms are involved in the P2X(7) action. METHODS: Skin neoplasias in mice (papillomas, followed by squamous spindle-cell carcinomas) were induced by local application of DMBA/TPA. Experiments in-vitro utilized cultured epidermal keratinocytes generated from wild-type or from P2X(7)-null mice. Assays involved protein immunostaining and Western blots; mRNA real-time qPCR; and apoptosis (evaluated in situ by TUNEL and quantified in cultured keratinocytes as solubilized DNA or by ELISA). Changes in cytosolic calcium or in ethidium bromide influx (P2X(7) pore formation) were determined by confocal laser microscopy. RESULTS: (a) Co-application on the skin of the P2X7 specific agonist BzATP inhibited formation of DMBA/TPA-induced skin papillomas and carcinomas. At the completion of study (week 28) the proportion of living animals with cancers in the DMBA/TPA group was 100% compared to 43% in the DMBA/TPA+BzATP group. (b) In the normal skin BzATP affected mainly P2X(7)-receptor - expressing proliferating keratinocytes, where it augmented apoptosis without evoking inflammatory changes. (c) In BzATP-treated mice the degree of apoptosis was lesser in cancer than in normal or papilloma keratinocytes. (d) Levels of P2X(7) receptor, protein and mRNA were 4-5 fold lower in cancer tissues than in normal mouse tissues. (e) In cultured mouse keratinocytes BzATP induced apoptosis, formation of pores in the plasma membrane, and facilitated prolonged calcium influx. (f) The BzATP-induced apoptosis, pore-formation and augmented calcium influx had similar dose-dependence for BzATP. (g) Pore formation and the augmented calcium influx were depended on the expression of the P2X(7) receptor, while the BzATP-induced apoptosis depended on calcium influx. (h) The BzATP-induced apoptosis could be blocked by co-treatment with inhibitors of caspase-9 and caspase-3, but not of caspase-8. CONCLUSION: (a) P2X(7)-dependent apoptosis is an important mechanism that controls the development and progression of epidermal neoplasia in the mouse. (b) The P2X(7)-dependent apoptosis is mediated by calcium influx via P2X(7) pores, and involves the caspase-9 (mitochondrial) pathway. (c) The diminished pro-apoptotic effect of BzATP in mouse cancer keratinocytes is possibly the result of low expression of the P2X(7) receptor. (d) Activation of P2X(7)-dependent apoptosis, e.g. with BzATP could be a novel chemotherapeutic growth-preventive modality for papillomas and epithelial cancers in vivo.

Platinum/taxane-based chemotherapy with or without radiation therapy favorably impacts survival outcomes in stage I uterine papillary serous carcinoma.

BACKGROUND: A study was undertaken to determine recurrence patterns and survival outcomes of stage I uterine papillary serous carcinoma (UPSC) patients. METHODS: A retrospective, multi-institutional study of stage I UPSC patients diagnosed from 1993 to 2006 was performed. Patients underwent comprehensive surgical staging; postoperative treatment included observation (OBS); radiotherapy alone (RT); or platinum/taxane-based chemotherapy (CT) +/- RT. RESULTS: The authors identified 142 patients with a median follow-up of 37 months (range, 7-144 months). Thirty-three patients were observed, 20 received RT alone, and 89 received CT +/- RT. Twenty-five recurrences (17.6%) were diagnosed, and 60% were extrapelvic. Chemotherapy-treated patients experienced significantly fewer recurrences than those treated without chemotherapy (P = .013). Specifically, CT +/- RT patients had a lower risk of recurrence (11.2%) compared with patients who received RT alone (25%, P = .146) or OBS (30.3%, P = .016). This effect was most pronounced in stage IB/IC (P = .007). CT- and CT + RT-treated patients experienced similar recurrence. After multivariate analysis, treatment with chemotherapy was associated with a decreased risk of recurrence (P = .047). The majority of recurrences (88%) were not salvageable. Progression-free survival (PFS) and cause-specific survival (CSS) for chemotherapy-treated patients were more favorable than for those who did not receive chemotherapy (P = .013 and .081). Five-year PFS and CSS rates were 81.5% and 87.6% in CT +/- RT, 64.1% and 59.5% in RT alone, and 64.7% and 70.2% for OBS. CONCLUSIONS: Stage I UPSC patients have significant risk for extrapelvic recurrence and poor survival. Recurrence and survival outcomes are improved in well-staged patients treated with platinum/taxane-based chemotherapy. This multi-institutional study is the largest to support systemic therapy for early stage UPSC patients.

A randomized trial of a lifestyle intervention in obese endometrial cancer survivors: quality of life outcomes and mediators of behavior change.

BACKGROUND: To examine the effects of a 6 month lifestyle intervention on quality of life, depression, self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors. METHODS: Early stage endometrial cancer survivors were randomized to intervention (n = 23) or usual care (n = 22) groups. Chi-square, Student's t-test and repeated measures analysis of variance were used in intent-to-treat analyses. Outcomes were also examined according to weight loss. RESULTS: Morbidly obese patients had significantly lower self-efficacy, specifically when feeling physical discomfort. There was a significant improvement for self-efficacy related to social pressure (p = .03) and restraint (p = .02) in the LI group. There was a significant difference for emotional well-being quality of life (p = .02), self-efficacy related to negative emotions (p < .01), food availability (p = .03), and physical discomfort (p = .01) in women who lost weight as compared to women who gained weight. Improvement in restraint was also reported in women who lost weight (p < .01). CONCLUSION: This pilot lifestyle intervention had no effect on quality of life or depression but did improve self-efficacy and some eating behaviors. TRIAL REGISTRATION: http://www.clinicaltrials.gov; NCT00420979.

Stage II uterine papillary serous carcinoma: Carboplatin/paclitaxel chemotherapy improves recurrence and survival outcomes.

OBJECTIVES: To determine recurrence patterns and survival outcomes of stage II uterine papillary serous carcinoma (UPSC) patients treated by various modalities with an emphasis on carboplatin/paclitaxel-based chemotherapy (CT)+/-radiotherapy (RT). METHODS: A retrospective, multi-institution study of women with stage II UPSC diagnosed from 1992 to 2006 was performed. All patients underwent comprehensive surgical staging. Treatment included observation (OBS), RT (vaginal brachytherapy, whole pelvic and/or whole abdominal therapy), or >or=3 cycles carboplatin/paclitaxel alone or with RT. Recurrence and survival outcomes were determined. RESULTS: We identified 55 subjects: 10 treated with OBS, 26 with RT alone and 19 with CT+/-RT. After a median follow-up of 33 mos (range, 10-119), 20 recurrences (36%) were observed. There was an overall difference in recurrence based upon treatment (p=.013). Specifically, all CT+/-RT treated patients had a lower risk of recurrence (11%) compared to patients treated by RT alone (50%) or OBS (50%). No patients treated with both CT+RT (n=12) experienced a recurrence. Treatment with CT was also associated with a decreased risk of recurrence on multivariate analysis (p=.015). Most recurrences were extra-pelvic (70%), occurred within 2 years (85%) and were not salvageable (84%). Five-year progression-free survival was 86% in chemotherapy-treated patients versus 41% in those not receiving chemotherapy (p=.010); overall survival was 88% in chemotherapy-treated patients versus 64% in those not receiving chemotherapy (p=.115). CONCLUSIONS: Stage II UPSC patients have a significant risk for unsalvageable, extra-pelvic recurrence. However, treatment with platinum/taxane therapy+/-RT appears to reduce this risk and is associated with improved progression free survival outcomes.

Indicators of survival duration in ovarian cancer and implications for aggressiveness of care.

BACKGROUND: Ovarian cancer patients frequently receive chemotherapy near the end of life. The purpose of the current study was to develop indicators that characterize those ovarian cancer patients who have a short life span. METHODS: The medical charts of deceased epithelial ovarian cancer patients were retrospectively reviewed from 2000 through 2006. All patients received primary debulking surgery and adjuvant chemotherapy. Aggressiveness of cancer care within the last month of life was measured by chemotherapy regimens, emergency room visits, and hospitalizations. Significant clinical events (SCE) were defined as ascites, bowel obstruction, and pleural effusion. Survival quartiles were compared using chi-square and Student t test statistics. Multiple regression analysis was performed using survival duration as a dependent variable. RESULTS: In all, 113 patients with epithelial ovarian cancer were reviewed. Patients had increased hospitalizations (P < .001) and SCE (P < .001) as they approached the end of life. There was no difference in the pattern of hospitalizations and SCE between the top and bottom survival quartiles. Patients with a shorter survival time had a trend toward increased chemotherapy during their last 3 months of life (P = .057) and had increased overall aggressiveness of care (P = .013). In patients with a disease remission, the length of initial remission time was found to be significant in predicting survival (P < .01). Time to second disease recurrence was also significant in predicting survival time (P < 0.01). CONCLUSIONS: Patients who received aggressive care did not have improvement in survival. Short disease remissions and increasing hospitalizations with SCE should be indicators of the appropriateness of reducing cure-oriented therapies and increasing palliative interventions.

Improved tolerance of primary chemotherapy with reduced-dose carboplatin and paclitaxel in elderly ovarian cancer patients.

OBJECTIVE: Elderly cancer patients are less likely to tolerate chemotherapy. We sought to compare the toxicity profiles and outcomes of elderly ovarian cancer patients treated with standard versus reduced-dose i.v. carboplatin/paclitaxel. METHODS: A retrospective, multi-center analysis of women > or = 70 years with papillary serous ovarian/primary peritoneal cancers diagnosed from 1994-2005 was performed. Reduced-dose (RD) patients received carboplatin AUC 4-5 and paclitaxel 135 mg/m(2); standard-dose (SD) patients received carboplatin AUC 5-6 and paclitaxel 175 mg/m(2). Patient variables collected included age, stage, performance status (PS), cytoreductive status, Charlson comorbidity scores, and growth factor administration. RESULTS: One-hundred patients met the study criteria. RD patients (n=26) were significantly older than SD patients (n=74; median age 77.0 versus 74.7, respectively, p=0.014). No differences were noted in stage, comorbidity scores, cytoreductive status or growth factor administration between cohorts. Incidence of grade 3-4 neutropenia was higher in the SD group (54.1% versus 19.2%; p=0.002). SD patients were more likely to experience cumulative toxicity (p=0.003) and required delays in therapy (p=0.05). Although PS was poorer in SD patients (p=0.02), on multivariate analysis, only the administration of the SD regimen predicted toxicity (p=0.008). There were no differences in progression-free or overall survival between cohorts (median follow-up: 34 months). On multivariate analysis, age (p=0.004) and PS (p=0.008) had a significant impact on survival. CONCLUSION(S): This preliminary data suggests that reduced-dose carboplatin/paclitaxel may be better tolerated but equally effective as the standard regimen in elderly ovarian cancer patients. Age, performance status and other geriatric parameters should be considered when dosing chemotherapy in the elderly.

Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial.

OBJECTIVE: The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to assess feasibility of a lifestyle intervention program for promoting weight loss, change in eating behaviors, and increased physical activity in obese ECS. STUDY DESIGN: Early stage ECS (n=45) were randomized to a 6-month lifestyle intervention (LI; n=23) or usual care (UC; n=22). The LI group received group and individual counseling for 6 months. The primary endpoint was weight change. Secondary endpoints were physical activity, [Leisure score index (LSI)] and nutrient intake (3-day food records). Quantitative vitamin C and folate intake were used to assess fruit/vegetable intake. RESULTS: Recruitment was 29%, adherence (LI group) was 73% and 84% of participants completed follow-up assessments. At 12 months, the intervention group lost 3.5 kg compared to a 1.4 kg gain in the control group [mean difference=-4.9 kg; 95% CI: -9.0 to -0.9 kg; p=.018] and had an increased LSI score of 16.4 versus -1.3 in the control group from baseline [mean group difference=17.8; 95% CI=7.1 to 28.4; p=.002]. There were no differences in vitamin C and folate intake. The LI group had lower intake of kilocalories, although differences were not significant. CONCLUSION(S): A lifestyle intervention program in obese ECS is feasible and can result in sustained behavior change and weight loss over a 1-year period.

Adjuvant treatment and survival in obese women with endometrial cancer: an international collaborative study.

OBJECTIVE: The purpose of this study was to determine the impact of patient weight on the frequency of surgical staging lymphadenectomy and pelvic radiation. Adverse effects, disease relapse, and survival outcomes were investigated. STUDY DESIGN: Records of 766 women who underwent surgery for presumed corpus-confined endometrial cancer were reviewed. Body mass index (BMI) was calculated to categorize women as obese (BMI, > or = 30 kg/m2) or nonobese (BMI, < 30 kg/m2). Radiation-related toxicity was scored retrospectively. Median duration of follow-up period was 38 months. Chi2, logistic regression, correlation, Kaplan-Meier, and Cox multivariate proportional hazards were used for analysis. RESULTS: Lymphadenectomy was completed as often in nonobese as obese women (P = .24). Adjuvant pelvic radiation treatment was administered more often in nonobese women (P = .01). Among 681 women with endometrioid histopathologic findings, 4-year cancer-related survival in obese women was 10% higher than all cause deaths, compared with 6% in nonobese women. CONCLUSION: Obesity was not a barrier to lymphadenectomy, but did influence adjuvant pelvic radiation use.

Chemotherapy Administration during Pelvic Radiation for Cervical Cancer Patients Aged >/=55 Years in the SEER-Medicare Population.

Our study evaluated whether 1999 National Cancer Institute (NCI) chemoradiation guidelines for cervical cancer impacted treatment of women >/=55 years. We identified 385 women >/=55 years (median, 72 years) diagnosed with stage II-IVA cervical cancer between January, 1998 and December, 2002 in the United States Surveillance, Epidemiology, and End Results (SEER)-Medicare registries. Chemoradiation frequency tables were constructed for age, race, community setting, socioeconomic status, and comorbidity index. Of 385 women, 166 (43%) received chemoradiation as primary treatment. Prior to the 1999 NCI clinical alert, 5/43 (12%) in 1998 and 24/54 (44%) in 1999 received chemoradiation. The chemoradiation proportion was 41% (36/87) in 2000, 48% (51/107) in 2001, and 53% (50/94) in 2002 (trend, P < .01). Women >/=71 years had significantly lower odds of chemoradiation (P = .04). While SEER-Medicare data indicated an increasing trend for chemoradiation after the 1999 NCI clinical alert, chemoradiation was less frequent in elderly women with cervical cancer.

Baseline characteristics influencing quality of life in women undergoing gynecologic oncology surgery.

BACKGROUND: Quality of life (QoL) measurements are important in evaluating cancer treatment outcomes. Factors other than cancer and its treatment may have significant effects on QoL and affect assessment of treatments. Baseline data from longitudinal studies of women with endometrial or ovarian cancer or adnexal mass determined at surgery to be benign were analyzed to determine the degree to which QoL is affected by baseline differences in demographic variables and health. METHODS: This study examined the effect of independent variables on domains of the Functional Assessment of Cancer Therapy (FACT-G) pre-operatively in gynecologic oncology patients undergoing surgery for pelvic mass suspected to be malignant or endometrial cancer. Patients also completed the Short Form Medical Outcomes Survey (SF-36) questionnaire (a generic health questionnaire that measures physical and mental health). Independent variables were surgical diagnosis (ovarian or endometrial cancer, benign mass), age, body mass index (BMI), educational level, marital status, smoking status, physical (PCS) and mental (MCS) summary scores of the SF-36. Multiple regression analysis was used to determine the influence of these variables on FACT-G domain scores (physical, functional, social and emotional well-being). RESULTS: Data were collected on 157 women at their pre-operative visit (33 ovarian cancer, 45 endometrial cancer, 79 determined at surgery to be benign). Mean scores on the FACT-G subscales and SF-36 summary scores did not differ as a function of surgical diagnosis. PCS, MCS, age, and educational level were positively correlated with physical well-being, while increasing BMI was negatively correlated. Functional well-being was positively correlated with PCS and MCS and negatively correlated with BMI. Social well-being was positively correlated with MCS and negatively correlated with BMI and educational level. PCS, MCS and age were positively correlated with emotional well-being. Models that included PCS and MCS accounted for 30 to 44% of the variability in baseline physical, emotional, and functional well-being on the FACT-G. CONCLUSION: At the time of diagnosis and treatment, patients' QoL is affected by inherent characteristics. Assessment of treatment outcome should take into account the effect of these independent variables. As treatment options become more complex, these variables are likely to be of increasing importance in evaluating treatment effects on QoL.

Surgical treatments for vulvar and vaginal dysplasia: a randomized controlled trial.

OBJECTIVE: To compare pain, adverse effects and recurrence of dysplasia in patients with vaginal intraepithelial neoplasia or vulvar intraepithelial neoplasia prospectively treated by carbon dioxide laser or ultrasonic surgical aspiration. METHODS: Patients were randomly assigned to receive treatment by laser or ultrasonic surgical aspiration from 2000-2005. Preoperative biopsy was done to confirm presence of dysplasia. Patients completed a visual analog scale regarding pain and were evaluated at 2-4 weeks to assess scarring, wound healing, and adverse effects. Patients returned every 3 months for 1 year for pelvic examination and cytology to assess recurrence. Follow-up colposcopy and biopsy were used at the discretion of the treating physician. Student t test, chi2, analysis of variance and multiple logistic regression were used for analysis. RESULTS: One hundred ten patients were randomly assigned. Ninety-six (87.3%) patients completed 1 year follow-up. Mean age of patients was 48.5 years. Mean visual analog scale score was significantly lower in patients treated by ultrasonic surgical aspiration (20.7 compared with 35.1; P=.032). For patients with vulvar lesions, there was less scarring with ultrasonic surgical aspiration (P<.01). Recurrence overall was 25% and was similar for ultrasonic surgical aspiration compared with laser (relative risk 0.96, 95% confidence interval 0.64-1.50, number needed to treat 95.6). Recurrence was associated with younger age (P<.01). CONCLUSION: Patients treated with ultrasonic surgical aspiration for vulvar and vaginal dysplasia reported less postoperative pain. Vulvar scarring was more common in patients treated by the laser. There was no difference in recurrence of dysplasia during a 1-year follow-up period between the two surgical modalities. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00394758 LEVEL OF EVIDENCE: I.

Gynecologic oncology patients' satisfaction and symptom severity during palliative chemotherapy.

BACKGROUND: Research on quality and satisfaction with care during palliative chemotherapy in oncology patients has been limited. The objective was to assess the association between patient's satisfaction with care and symptom severity and to evaluate test-retest of a satisfaction survey in this study population. METHODS: A prospective cohort of patients with recurrent gynecologic malignancies receiving chemotherapy were enrolled after a diagnosis of recurrent cancer. Patients completed the Quality of End-of-Life care and satisfaction with treatment scale (QUEST) once upon enrollment in an outpatient setting and again a week later. Patients also completed the Mini-Mental Status Exam, the Hospital Anxiety/Depression Scale, a symptom severity scale and a demographic survey. Student's t-test, correlation statistics and percent agreement were used for analysis. RESULTS: Data from 39 patients were analyzed. Mean (SD) quality of care summary score was 41.95 (2.75) for physicians and 42.23 (5.42) for nurses (maximum score was 45; p = 0.76 for difference in score between providers). Mean (SD) satisfaction of care summary score was 29.03 (1.92) for physicians and 29.28 (1.70) for nurses (maximum score was 30; p = 0.49 for difference between providers). Test-retest for 33 patients who completed both QUEST surveys had high percent agreement (74-100%), with the exception of the question regarding the provider arriving late (45 and 53%). There was no correlation between quality and satisfaction of care and symptom severity. Weakness was the most common symptom reported. Symptom severity correlated with depression (r = 0.577 p < 0.01). There was a trend towards a larger proportion of patients reporting pain who had three or more prior chemotherapy regimens (p = 0.075). Prior number of chemotherapy regimens or time since diagnosis was not correlated with symptom severity score. Anxiety and depression were correlated with each other (r = 0.711, p < 0.01). There was no difference in symptom severity score at enrollment between those patients who have since died (n = 19) versus those who are still alive. CONCLUSION: The QUEST Survey has test-retest reliability when used as a written instrument in an outpatient setting. However, there was no correlation between this measure and symptom severity. Patient evaluation of care may be more closely related to the interpersonal aspects of the health care provider relationship than it is to physical symptoms.