Utility of cell salvage in women undergoing abdominal myomectomy.

OBJECTIVE: We examined the use and cost of autologous blood cell salvage in women who undergo abdominal myomectomy. STUDY DESIGN: Patients who underwent abdominal myomectomy from 2007-2011 were identified. Use of the cell salvage system and reinfusion of autologous blood in women who had the system set-up were analyzed. Cost was examined by directly reported data. RESULTS: We identified 607 patients who underwent abdominal myomectomy. Four hundred twenty-five women (70%) had the set-up of the cell salvage system. Cell-salvaged blood was processed and reinfused into 85 of these subjects (20%). In a multivariable model, performance of myomectomy by a gynecologic-specific surgeon (odds ratio [OR], 2.14; 95% confidence interval [CI], 1.28-3.59), >5 myomas (OR, 2.49; 95% CI, 1.27-4.89), and larger uterine size statistically were associated significantly with cell-salvage device set-up. Conversely, having a reproductive-endocrinology-infertility specialist as the surgeon was associated with a significant reduction in cell-salvage system set-up (OR, 0.37; 95% CI, 0.21-0.66). For the women who had cell-salvage system set-up, uterine size of >15-19 weeks of gestation (OR, 3.22; 95% CI, 1.56-8.95) or ≥20 weeks of gestation (OR, 4.62; 95% CI, 1.45-14.73), operating time of >120 minutes (OR, 3.98; 95% CI, 1.70-9.29), and intraoperative blood loss of >1000 mL (OR, 26.31; 95% CI, 10.49-65.99) were associated significantly with a higher incidence of reinfusion of cell-salvaged blood. CONCLUSION: The routine use of cell salvage in women who undergo abdominal myomectomy does not appear to be warranted. Cell-salvage set-up appears to be cost-effective only when reinfused, but clinical characteristics cannot predict accurately which women will require reinfusion of cell-salvaged blood.

A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma.

OBJECTIVES: Sorafenib, an oral multikinase inhibitor of the VEGFR/PDGFR/Raf/MEK/ERK pathway, has shown potential activity in patients with recurrent ovarian cancer (OC). One strategy to prolong disease control and survival in patients with OC is maintenance therapy after achieving a complete response. A double-blind, randomized, placebo-controlled, phase II study to assess the efficacy and safety of maintenance therapy with sorafenib in the treatment of OC is presented. METHODS: Patients with epithelial OC or primary peritoneal cancer in complete remission were randomized to sorafenib 400mg BID or matching placebo. The primary endpoint was progression-free survival (PFS). RESULTS: Of 246 randomized patients, 93% had OC; baseline characteristics were balanced between treatment arms. There was no significant difference between sorafenib and placebo arms for PFS (median 12.7 vs 15.7 months; hazard ratio 1.09; 95% CI 0.72-1.63), although there was a notable imbalance in early censoring. The most common ≥ grade 3 adverse events (AEs) were hand-foot skin reaction (39.0% vs 0.8%) and rash (14.6% vs 0%). More patients receiving sorafenib versus placebo required dose reductions (67.5% vs 30.1%), resulting in a lower than planned median daily dose (median 584.6 vs 800.0mg). Treatment with sorafenib was of shorter duration (median 17.6 vs 51.9 weeks) with more frequent discontinuations due to AEs (37.4% vs 6.5%). CONCLUSIONS: Sorafenib 400mg BID cannot be recommended as maintenance therapy for patients with OC in complete remission. Assessment of efficacy was limited by the high rate of dose reductions and early discontinuations.

Biologic therapies and personalized medicine in gynecologic malignancies.

Through advances in human genomic sequencing, the unique molecular biology that predisposes certain individuals to either health or disease has now been illuminated. Although many malignancies behave similarly on a phenotypic level, biologically there exist multiple layers of interconnected molecular and cellular pathways that may make each patient's disease significantly more unique than previously appreciated. In gynecologic oncology, the most progress in developing targeted biologics has been in the treatment of ovarian cancers. Future investigations will see further development in endometrial and cervical cancers. Technology such as whole genome sequencing can theoretically identify the individual tumor's genetic profile; however, identifying the priority pathways for therapeutic interventions and subsequent complex interactions remains a significant challenge. New therapeutic technologies such as siRNA and immune modulators will also play a promising role in the movement toward individualized therapies. It is hoped that the identification and use of targeted agents will lead to individualized care that in turn will lead to significantly improved outcomes manifested by more cures and better quality of life through amelioration of toxicities.

A review of the current evidence for maintenance therapy in ovarian cancer.

OBJECTIVES: Ovarian cancer (OC) typically is diagnosed at advanced stages, in which the primary goal of therapy is to prolong progression-free survival (PFS) and overall survival (OS). In recent years, maintenance therapy has been tested for this purpose in advanced OC (AOC). Literature on maintenance therapy in AOC was systematically reviewed to assess current knowledge regarding the impact of this therapeutic approach. METHODS: A MEDLINE search was performed 2/2009 for articles published 1/2001-1/2009 pertaining to OC maintenance therapy guidelines, patterns, and outcomes. A second search used keywords specific to maintenance and included primary studies published in the last 10 years. Of 406 sources identified, 36 primary studies and 16 review articles were included in this systematic review. A third search used the keyword "consolidation" to find maintenance articles not identified through other searches; of 48 additional sources, 13 primary studies and 6 reviews were included. A fourth search of non-MEDLINE-indexed sources yielded 14 additional relevant publications from the same time period. RESULTS: Among practice guidelines identified, only the National Comprehensive Cancer Network (NCCN) 2008 guidelines provide recommendations regarding maintenance therapy, assigning it a category 2B recommendation. No studies were identified that reported current treatment patterns or economic outcomes in maintenance therapy; quality of life data were reported in one study. A variety of agents have been tested for maintenance, with paclitaxel the most commonly evaluated. The Southwest Oncology Group-Gynecologic Oncology Group 178 trial has found that 12 cycles of paclitaxel extend PFS (by 7 months) compared to 3 months paclitaxel, but could not adequately evaluate OS. CONCLUSIONS: Maintenance therapy may improve clinical outcomes in AOC, but additional research is needed to demonstrate an OS advantage. Future studies should investigate the long-term clinical benefit of maintenance treatment and its impact on resource utilization and health-related quality of life.

Synchronous ovarian metastases at the time of laparotomy for colon cancer.

OBJECTIVE: The aim of the study was to identify clinical features, define prognostic factors and optimize treatment in patients with colorectal cancer with synchronous ovarian metastases at the time of initial diagnosis. METHODS: A retrospective analysis of patients treated by the gynecologic oncology service at Barnes Jewish Hospital between 1990 and 2001 was performed. Twenty-eight patients with colorectal carcinomas with synchronous ovarian metastases at the time of diagnosis were identified. Clinical and pathological characteristics were evaluated, and survival was analyzed by the method of Kaplan and Meier. RESULTS: Abdominal pain was the most common symptom at presentation. Only 14% of the patients presented with gastrointestinal bleeding. Fifty-four percent of patients who underwent barium enema had intrinsic colonic lesions, while 40% of patients who had endoscopies performed had their colonic tumors identified. Preoperatively colon cancer was considered in the differential diagnosis of 71% of the patients. At exploration, the ovarian metastases were significantly larger than the primary colon tumors. Overall, 68% of patients had intraperitoneal nodal metastasis and 86% had transmural extension of their tumors. The only pathological variable associated with survival was tumor grade. The median disease-free survival was 10.3 months while the median overall survival was 18.4 months. CONCLUSION: Most patients with colon cancer with synchronous ovarian metastases present with vague symptoms. At exploration, locally advanced tumors and other distant metastases such as in the liver are common. Surgical management should include extirpation of the primary tumor and any bulky ovarian metastases. Cytoreduction may be considered in highly selected patients.

Utility and cost-effectiveness of preoperative autologous blood donation in gynecologic and gynecologic oncology patients.

OBJECTIVE: To evaluate utility and cost-effectiveness of preoperative autologous blood donation in gynecologic and gynecologic oncology patients. METHODS: Pheresis unit records were retrospectively reviewed to identify all women who performed autologous blood donation. Clinical charts were abstracted. Use rate (number of units used/number of units donated) and quality-adjusted life years were calculated. Statistical analysis consisted of chi(2), Student t, and Fisher exact tests. RESULTS: A total of 106 women with benign (n = 63) and malignant disease (n = 43) donated 143 units (1.4 units per patient) of which 126 (88%) were discarded. Fifteen patients (14%) were transfused a total of 24 units, 17 autologous (71%) and seven allogeneic (29%). Those transfused had a significantly higher estimated blood loss (700 mL versus 275 mL, P <.001), lower nadir hemoglobin (7.9 versus 9.6, P <.001), and longer hospital stay (4.9 days versus 4.0 days, P =.05). Despite similar estimated blood loss (370 mL versus 310 mL), the use rate for malignant versus benign disease was significantly greater (0.31 versus 0.07, P =.005). Radical versus nonradical surgery had a significantly higher estimated blood loss (620 mL versus 250 mL, P =.001) and use rate (0.26 versus 0.11, P =.001) as well. Estimated cost per quality-adjusted life years for autologous blood donation for each category exceeded $1,000,000. CONCLUSION: Autologous blood donation is an expensive medical practice and does not guarantee that exposure to allogeneic blood will not occur. If pursued, it should be directed towards those who have a known malignancy or those for whom radical surgery is anticipated. Other methods of blood conservation may be safer and more cost-effective.

Use of complementary and alternative medicine among women with gynecologic cancers.

OBJECTIVE: The aim of this study was to determine the prevalence and types of complementary and alternative medicine (CAM) usage by women with gynecologic cancer in an outpatient midwestern university practice. METHODS: Any patient with a gynecologic cancer seen in the outpatient clinic of the gynecologic oncology division at Washington University over a 3-month period was eligible, excluding those patients with a new cancer diagnosis. Subjects completed a questionnaire anonymously. Two by two comparisons were made using the Fisher exact test and P was considered significant at P < 0.05. RESULTS: Nearly half (49.6%) of 113 respondents had used CAM since being diagnosed with cancer. Characteristics significantly associated with CAM use include annual income greater than $30,000, cancer site of origin other than the cervix, and use of CAM prior to cancer diagnosis. Users with annual incomes greater than $30,000 were significantly more likely to use CAM in the "other" category that included acupuncture, reflexology, and electromagnetic therapy. Fewer than 25% of CAM users received information regarding CAM from a physician, nurse, or practitioner of CAM. Women used CAM in hopes of achieving a wide range of potential benefits including both improved well-being and anti-cancer effects. The most common actual benefit these women perceived was an improvement in psychosocial well-being, including increased hope or optimism. CONCLUSIONS: American patients with gynecologic cancer frequently use CAM in addition to standard medical therapy. Oncologists caring for women with gynecologic cancer should initiate a dialogue about usage of CAM, discussing the potential adverse effects of CAM and the patient's therapeutic goals.