Surgical treatments for vulvar and vaginal dysplasia - A randomized controlled trial
aspiration; carbon-dioxide laser; carcinoma; excision; imiquimod cream; intraepithelial neoplasia-iii; management; Obstetrics & Gynecology; therapy; vaginectomy; vaporization
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, X-2, 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.
Von Gruenigen V E; Gibbons H E; Gibbins K; Jenison E L; Hopkins M P
Obstetrics and Gynecology
2007
2007-04
Journal Article
<a href="http://doi.org/10.1097/01.AOG.0000258783.49564.5c" target="_blank" rel="noreferrer noopener">10.1097/01.AOG.0000258783.49564.5c</a>
Assessment of Factors That Contribute to Decreased Quality of Life in Gynecologic Oncology Group Ovarian Cancer Trials
carcinoma; chemotherapy; clinical interventions; cytoreduction; fatigue; functional assessment; Functional Assessment of Cancer Therapy; intervention; intraperitoneal; Oncology; psychosocial support; quality-of-life domains; survivors; symptom management
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 (01) 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 01 versus Q2 through 04 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. Cancer 2009;115:4857-64. (C) 2009 American Cancer Society.
Von Gruenigen V E; Huang H Q; Gil K M; Gibbons H E; Monk B J; Rose P G; Armstrong D K; Cella D; Wenzel L
Cancer
2009
2009-10
Journal Article
<a href="http://doi.org/10.1002/cncr.24520" target="_blank" rel="noreferrer noopener">10.1002/cncr.24520</a>
A Comparison of Quality-of-Life Domains and Clinical Factors in Ovarian Cancer Patients: A Gynecologic Oncology Group Study
carcinoma; chemotherapy; cytoreduction; functional assessment; General & Internal Medicine; Health Care Sciences & Services; intraperitoneal; Neurosciences & Neurology; ovarian-cancer; quality-of-life; scale; scores; therapy; trials
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 [Cl] 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. J Pain Symptom Manage 2010;39:839-846. (C) 2010 US. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved
Von Gruenigen V E; Huang H Q; Gil K M; Gibbons H E; Monk B J; Rose P G; Armstrong D K; Cella D; Wenzel L
Journal of Pain and Symptom Management
2010
2010-05
Journal Article
<a href="http://doi.org/10.1016/j.jpainsymman.2009.09.022" target="_blank" rel="noreferrer noopener">10.1016/j.jpainsymman.2009.09.022</a>