Maintenance with mirvetuximab soravtansine plus bevacizumab vs bevacizumab in FRα-high platinum-sensitive ovarian cancer.

At first recurrence, platinum-sensitive ovarian cancer (PSOC) is frequently treated with platinum-based chemotherapy doublets plus bevacizumab, then single-agent bevacizumab. Most patients' disease progresses within a year after chemotherapy, emphasizing the need for novel strategies. Mirvetuximab soravtansine-gynx (MIRV), an antibody-drug conjugate, comprises a folate receptor alpha (FRα)-binding antibody and tubulin-targeting payload (maytansinoid DM4). In FRα-high PSOC, MIRV plus bevacizumab previously showed promising efficacy (objective response rate, 69% [95% CI: 41-89]; median progression-free survival, 13.3 months [95% CI: 8.3-18.3]; median duration of response, 12.9 months [95% CI: 6.5-15.7]) and safety. The Phase III randomized GLORIOSA trial will evaluate MIRV plus bevacizumab vs. bevacizumab alone as maintenance therapy in patients with FRα-high PSOC who did not have disease progression following second-line platinum-based doublet chemotherapy plus bevacizumab.Clinical Trial Registration: ClinicalTrials.gov ID: NCT05445778; GOG.org ID: GOG-3078; ENGOT.ESGO.org ID: ENGOT-ov76.

Most patients with ovarian cancer are initially treated with platinum-based chemotherapy. If the cancer reappears/recurs after more than 6 months following this therapy, it is called platinum-sensitive ovarian cancer (PSOC). Patients with PSOC usually receive additional platinum-based chemotherapy along with bevacizumab, a drug that reduces tumor growth by decreasing its blood supply. If patients improve or are stable on this therapy, they are usually kept on bevacizumab alone for 'maintenance therapy'. Unfortunately, this maintenance therapy does not work long-term in all patients, so better long-term treatments are needed. The GLORIOSA (NCT05445778) clinical trial will compare maintenance therapy with bevacizumab alone to maintenance therapy with bevacizumab plus a drug called mirvetuximab soravtansine-gynx (MIRV) to determine which therapy leads to better results in patients with PSOC. MIRV is made up of an antibody that binds to a specific protein (folate receptor alpha [FRα]) on cancer cells to directly deliver a cancer-killing drug. MIRV received US FDA approval to be used as a therapy for patients with ovarian cancer who are resistant to platinum-based chemotherapy and express high levels of FRα. The GLORIOSA trial will study maintenance therapy with MIRV plus bevacizumab in patients with PSOC who have not had cancer progression after second-line platinum-based chemotherapy plus bevacizumab, and whose cancer expresses high amounts of FRα. The main purpose of this trial is to determine if MIRV plus bevacizumab leads to better patient survival and decreases cancer growth and spread when compared with bevacizumab alone.

Association of ß-hCG Surveillance with Emotional, Reproductive, and Sexual Health in Women Treated for Gestational Trophoblastic Neoplasia.

BACKGROUND: To assess the emotional, reproductive, sexual health, and relationship concerns of women treated for gestational trophoblastic neoplasia (GTN) and examine associations with ß-hCG surveillance. METHODS: This institutional review board approved study surveyed GTN survivors (n = 51) who received treatment from 1996 to 2008. Fifty-one women, including those actively followed or formerly treated, were surveyed. The survey consisted of background/medical information, the Reproductive Concerns Scale, the Female Sexual Function Index, an item from the Abbreviated Dyadic Adjustment Scale, the Center for Epidemiologic Studies-Depression scale, the Menopausal Symptom Checklist, the Impact of Life Events Scale, and exploratory items. RESULTS: Mean age at diagnosis was 37.1 years; 41.6 years at study enrollment. Twenty-seven patients (56%) expressed worry about treatment harm and 30 (60%) about recurrence. Twenty percent reported significant depressive symptomatology. Mild cancer-related distress, reproductive concerns, sexual dysfunction, and bothersome menopausal symptoms were noted. Nineteen patients (40%) rated their ß-hCG surveillance worry as "high." Among patients who attempted conception after treatment, 3 of 12 (25%) succeeded in the ß-hCG high-worry group versus 13 of 19 (68%) in the ß-hCG low-worry group. Survivors with high ß-hCG worry had greater reproductive concerns than those with low worry (p = 0.002) and reported less sexual desire (p = 0.025). There was no difference in the number of low-worry versus high-worry participants in active surveillance (p = 0.09). CONCLUSION: Our study suggests that cancer-specific distress, sexual health, and reproductive concerns continue to impact women years after treatment. High worry about ß-hCG surveillance is negatively associated with the emotional well-being of GTN survivors and possibly influences reproductive attempts and success.

An economic analysis of robotically assisted hysterectomy.

OBJECTIVE: To perform an econometric analysis to examine the influence of procedure volume, variation in hospital accounting methodology, and use of various analytic methodologies on cost of robotically assisted hysterectomy for benign gynecologic disease and endometrial cancer. METHODS: A national sample was used to identify women who underwent laparoscopic or robotically assisted hysterectomy for benign indications or endometrial cancer from 2006 to 2012. Surgeon and hospital volume were classified as the number of procedures performed before the index surgery. Total costs as well as fixed and variable costs were modeled using multivariable quantile regression methodology. RESULTS: A total of 180,230 women, including 169,324 women who underwent minimally invasive hysterectomy for benign indications and 10,906 patients whose hysterectomy was performed for endometrial cancer, were identified. The unadjusted median cost of robotically assisted hysterectomy for benign indications was $8,152 (interquartile range [IQR] $6,011-10,932) compared with $6,535 (IQR $5,127-8,357) for laparoscopic hysterectomy (P<.001). The cost differential decreased with increasing surgeon and hospital volume. The unadjusted median cost of robotically assisted hysterectomy for endometrial cancer was $9,691 (IQR $7,591-12,428) compared with $8,237 (IQR $6,400-10,807) for laparoscopic hysterectomy (P<.001). The cost differential decreased with increasing hospital volume from $2,471 for the first 5 to 15 cases to $924 for more than 50 cases. Based on surgeon volume, robotically assisted hysterectomy for endometrial cancer was $1,761 more expensive than laparoscopy for those who had performed fewer than five cases; the differential declined to $688 for more than 50 procedures compared with laparoscopic hysterectomy. CONCLUSION: The cost of robotic gynecologic surgery decreases with increased procedure volume. However, in all of the scenarios modeled, robotically assisted hysterectomy remained substantially more costly than laparoscopic hysterectomy.

Safety and tolerance of radical hysterectomy for cervical cancer in the elderly.

BACKGROUND: Despite institutional studies that suggest that radical hysterectomy for cervical cancer is well tolerated in the elderly, little population-level data are available on the procedure's outcomes in older women. We performed a population-based analysis to determine the morbidity, mortality, and resource utilization of radical hysterectomy in elderly women with cervical cancer. METHODS: Patients recorded in the Nationwide Inpatient Sample with invasive cervical cancer who underwent abdominal radical hysterectomy between 1998 and 2010 were analyzed. Patients were stratified by age: <50, 50-59, 60-69, and ≥70 years. We examined the association between age and the outcomes of interest using chi square tests and multivariable generalized estimating equations. RESULTS: A total of 8199 women were identified, including 768 (9.4%) women age 60-69 and 462 (5.6%) women ≥70 years of age. All cause morbidity increased from 22.1% in women <50, to 24.7% in those 50-59 years, 31.4% in patients 60-69 years and 34.9% in women >70years of age (P<0.0001). Compared to women<50, those >70 were more likely to have intraoperative complications (4.8% vs. 9.1%, P=0.0003), surgical site complications (10.9% vs. 17.5%, P<0.0001), and medical complications (9.9% vs. 19.5%, P<0.0001). The risk of non-routine discharge (to a nursing facility) was 0.5% in women <50 vs. 12.3% in women ≥70 (P<0.0001). Perioperative mortality women ≥70 years of age was 30 times greater than that of women <50 (P<0.0001). CONCLUSION: Perioperative morbidity and mortality are substantially greater in elderly women who undergo radical hysterectomy for cervical cancer. Non-surgical treatments should be considered in these patients.

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.

Patterns of use of hemostatic agents in patients undergoing major surgery.

BACKGROUND: Although a number of prohemostatic agents that are applied intraoperatively have been introduced to minimize bleeding, little is known about the patterns of use and the factors that influence use. We examined the use of hemostatic agents in patients undergoing major surgery. METHODS: All patients who underwent major general, gynecologic, urologic, cardiothoracic, or orthopedic surgery from 2000-2010 who were recorded in the Perspective database were analyzed. RESULTS: Among 3,633,799 patients, hemostatic agents were used in 30.3% (n = 1,102,267). The use of hemostatic agents increased from 28.5% in 2000 to 35.2% in 2010. Over the same period, the rates of transfusion declined for pancreatectomy (-14.4%), liver resection (-15.0%), gastrectomy (-11.7%), prostatectomy (-6.6%), nephrectomy (-4.6%), hip arthroplasty (-10.4%), and knee arthroplasty (-6.6%). Over the same time period, the transfusion rate increased for colectomy (6.0%), hysterectomy (3.7%), coronary artery bypass graft (8.4%), valvuloplasty (4.2%), lung resection (1.9%), and spine surgery (1.6%). Transfusion remained relatively stable for thyroidectomy (0.2%). CONCLUSIONS: The use of hemostatic agents has increased rapidly even for surgeries associated with a small risk of transfusion and bleeding complications. In addition to patient characteristics, surgeon and hospital factors exerted substantial influence on the allocation of hemostatic agents.

Use of guideline-based antibiotic prophylaxis in women undergoing gynecologic surgery.

OBJECTIVE: To examine guideline-based use of prophylactic antibiotics in patients who underwent gynecologic surgery. METHODS: We identified women who underwent gynecologic surgery between 2003 and 2010. Procedures were stratified as antibiotic-appropriate (abdominal, vaginal, or laparoscopically assisted vaginal hysterectomy) or antibiotic-inappropriate (oophorectomy, cystectomy, tubal ligation, dilation and curettage, myomectomy, and tubal ligation). Antibiotic use was examined using hierarchical regression models. RESULTS: Among 545,332 women who underwent procedures for which antibiotics were recommended, 87.1% received appropriate antibiotic prophylaxis, 2.3% received nonguideline-recommended antibiotics, and 10.6% received no prophylaxis. Use of antibiotics increased from 88.0% in 2003 to 90.7% in 2010 (P<.001). Among 491,071, who underwent operations for which antibiotics were not recommended, antibiotics were administered to 197,226 (40.2%) women. Use of nonguideline-based antibiotics also increased over time from 33.4% in 2003 to 43.7% in 2010 (P<.001). Year of diagnosis, surgeon and hospital procedural volume, and area of residence were the strongest predictors of guideline-based and nonguideline-based antibiotic use. CONCLUSION: Although use of antibiotics is high for women who should receive antibiotics, antibiotics are increasingly being administered to women for whom the drugs are of unproven benefit. LEVEL OF EVIDENCE: : III.

Safety of conservative management of ovarian masses during pregnancy.

OBJECTIVE: To determine the clinical outcomes and risk factors for persistence of ovarian cysts in pregnant women. With the increased use of ultrasound in pregnancy, the identification of incidental ovarian masses is becoming more common. STUDY DESIGN: An observational study of women with ovarian masses identified before 24 weeks of pregnancy was performed. Only women who underwent follow-up imaging or surgery were included. Factors associated with persistence and outcomes of women who underwent surgery were analyzed. RESULTS: Of the 803 women with available follow-up, the cysts resolved in 707 (88.1%) patients. Fifty (6.2%) women underwent surgical intervention. Women with persistent cysts were younger, more often Hispanic, detected at a later gestational age, had larger cysts, and more often had complex or solid components (p < 0.05 for all). Overall, 1 (0.1%) malignancy was diagnosed (a patient with a B-cell lymphoma), while 3 (0.4%) women had borderline epithelial ovarian tumors. CONCLUSION: Ovarian masses identified during pregnancy have a low risk of malignancy. The majority of women can be serially monitored without intervention.

Utilization and safety of sodium hyaluronate-carboxymethylcellulose adhesion barrier.

BACKGROUND: Little is known about the use and toxicity of antiadhesion substances such as sodium hyaluronate-carboxymethylcellulose. OBJECTIVE: We analyzed the patterns of use and safety of sodium hyaluronate-carboxymethylcellulose in patients undergoing colectomy and gynecologic surgery. DESIGN: This is a retrospective cohort study. SETTING: This study covered hospitals nationwide. PATIENTS: All patients in the Premier Perspective database who underwent colectomy or hysterectomy from 2000 to 2010 were included in the analyses. MAIN OUTCOME MEASURE: Hyaluronate-carboxymethylcellulose use was determined by billing codes. For the primary outcome, we used hierarchical mixed-effects logistic regression models to determine the factors associated with the use of hyaluronate-carboxymethylcellulose, whereas a propensity score-matched analysis was used to secondarily assess the association between hyaluronate-carboxymethylcellulose use and toxicity (abscess, bowel and wound complications, peritonitis). RESULTS: We identified 382,355 patients who underwent hysterectomy and 267,368 who underwent colectomy. For hysterectomy, hyaluronate-carboxymethylcellulose use was 5.0% overall, increasing from 1.1% in 2000 to 9.8% in 2010. Hyaluronate-carboxymethylcellulose was used in 8.1% of those who underwent colectomy and increased from 6.2% in 2000 to 12.4% in 2010. The year of diagnosis and procedure volume of the attending surgeon were the strongest predictors of hyaluronate-carboxymethylcellulose use. After matching and risk adjustment, hyaluronate-carboxymethylcellulose use was not associated with abscess formation (1.5% vs 1.5%) (relative risk = 0.97; 95% CI, 0.84-1.12) in those who underwent hysterectomy. A patient receiving hyaluronate-carboxymethylcellulose had a 13% increased risk of abscess (17.4% vs 15.0%) (relative risk = 1.13; 95% CI, 1.08-1.17) after colectomy. LIMITATIONS: This was an observational study. CONCLUSION: Hyaluronate-carboxymethylcellulose use has increased over the past decade for colectomy and hysterectomy. Although there is no association between hyaluronate-carboxymethylcellulose use and abscess following hysterectomy, hyaluronate-carboxymethylcellulose use was associated with a small increased risk of abscess after colectomy.

Prognostic significance of mucinous differentiation of endometrioid adenocarcinoma of the endometrium.

Using Surveillance, Epidemiology, and End Results database we identified 43,882 (97.0%) women with endometrioid adenocarcinomas and 1,374 (3.0%) with mucinous adenocarcinomas. Women with mucinous tumors were older (P < .0001), more often white (P = .04), and more often to present at advanced stage (P = .001). Survival was similar for both histologies; the hazard ratio for cancer-specific survival for mucinous compared to endometrioid tumors was 0.90 (95% CI, 0.74-1.09) while the hazard ratio for overall survival was 0.95 (95% CI, 0.85-1.07). Five-year survival for stage I mucinous tumors was 89.9% (95% CI, 87.6-91.9%) compared to 89.0% (95% CI, 88.6-89.4%) for endometrioid tumors.

Failure to rescue after major gynecologic surgery.

OBJECTIVE: There is growing recognition that, in addition to occurrence of perioperative complications, the treatment of patients with complications influences outcome. We examined complications, failure to rescue (death in patients with a complication), and mortality rates for women who underwent abdominal hysterectomy. STUDY DESIGN: Women who underwent abdominal hysterectomy from 1998-2010 and whose data were recorded in the Nationwide Inpatient Sample were identified. Hospitals were stratified based on risk-adjusted mortality rates into 5 quintiles, and rates of complications and failure to rescue were examined. RESULTS: A total of 664,229 women who had been treated at 741 hospitals were identified. The overall mortality rate for the cohort was 0.17%. The risk-adjusted, hospital-level mortality rate ranged from 0-1.12%. The complication rate was 6.5% at the hospitals with the lowest mortality rates, 9.9% at the second quintile hospitals, 9.5% at both the third and fourth quintile hospitals, and 7.9% at the hospitals with the highest mortality rates. In contrast to complications, the failure-to-rescue rate increased with each successive risk-adjusted mortality quintile. The failure-to-rescue rate was 0% at the hospitals with the lowest mortality rates and increased with each successive quintile to 1.1%, 2.1%, 2.7%, and 4.4% in the hospitals with the highest mortality rates (P < .0001). CONCLUSION: For women who underwent abdominal hysterectomy, hospital complication rates correlated poorly with mortality rates; failure-to-rescue is strongly associated with in-hospital mortality rates. The treatment of complications, not the actual development of a complication, is the most important factor to use to predict death after major gynecologic surgery.

Nationwide trends in the performance of inpatient hysterectomy in the United States.

OBJECTIVE: To examine the use of inpatient hysterectomy and explore changes in the use of various routes of hysterectomy and patterns of referral. METHODS: The Nationwide Inpatient Sample was used to identify all women aged 18 years or older who underwent inpatient hysterectomy between 1998 and 2010. Weighted estimates of national trends were calculated and the number of procedures performed estimated. Trends in hospital volume and across hospital characteristics were examined. RESULTS: After weighting, we identified a total 7,438,452 women who underwent inpatient hysterectomy between 1998 and 2010. The number of hysterectomies performed annually rose from 543,812 in 1998 to a peak of 681,234 in 2002; it then declined consistently annually and reached 433,621 cases in 2010. Overall, 247,973 (36.4%) fewer hysterectomies were performed in 2010 compared with 2002. From 2002 to 2010 the number of hysterectomies performed for each of the following indications declined: leiomyoma (-47.6%), abnormal bleeding (-28.9%), benign ovarian mass (-63.1%), endometriosis (-65.3%), and pelvic organ prolapse (-39.4%). The median hospital case volume decreased from 83 procedures per year in 2002 to 50 cases per year in 2010 (P<.001). CONCLUSION: The number of inpatient hysterectomies performed in the United States has declined substantially over the past decade. The median number of hysterectomies per hospital has declined likewise by more than 40%. LEVEL OF EVIDENCE: III.

Contemporary clinical management of endometrial cancer.

Although the contemporary management of endometrial cancer is straightforward in many ways, novel data has emerged over the past decade that has altered the clinical standards of care while generating new controversies that will require further investigation. Fortunately most cases are diagnosed at early stages, but high-risk histologies and poorly differentiated tumors have high metastatic potential with a significantly worse prognosis. Initial management typically requires surgery, but the role and extent of lymphadenectomy are debated especially with well-differentiated tumors. With the changes in surgical staging, prognosis correlates more closely with stage, and the importance of cytology has been questioned and is under evaluation. The roles of radiation in intermediate-risk patients and chemotherapy in high-risk patients are emerging. The therapeutic index of brachytherapy needs to be considered, and the best sequencing of combined modalities needs to balance efficacy and toxicities. Additionally novel targeted therapies show promise, and further studies are needed to determine the appropriate use of these new agents. Management of endometrial cancer will continue to evolve as clinical trials continue to answer unsolved clinical questions.

Trends in hospital volume and patterns of referral for women with gynecologic cancers.

OBJECTIVE: To estimate trends in hospital volume and referral patterns for women with uterine and ovarian cancer. METHODS: The Surveillance, Epidemiology, and End Results-Medicare database was used to identify women aged 65 years or older with ovarian and uterine cancer who underwent surgery from 2000 to 2007. "Volume creep," when a greater number of patients undergo surgery at the same hospitals, and "market concentration," when a similar overall number of patients undergo a procedure but at a smaller number of hospitals, were analyzed. RESULTS: Among 4,522 patients with ovarian cancer, mean hospital volume increased from 3.1 cases during 2000-2001 to 3.4 cases during 2006-2007 (P=.62) suggesting minimal volume creep. Similarly, there was little evidence of market concentration. In 2000-2001, 37.8% of women were treated at the top decile by volume hospitals compared with 41.4% in 2006-2007 (P=.14). In 2006-2007, 201 (63.2%) of the hospitals had an ovarian cancer surgery volume of two or fewer cases. Among 9,908 women with uterine cancer, the mean hospital volume increased slightly from 4.5 in 2000-2001 to 5.4 in 2006-2007 (P=.10). The percentage of patients treated at the top decile by volume of hospitals increased from 40.4% in 2000-2001 to 44.7% in 2006-2007 (P<.001). In 2006-2007, 243 (49.3%) of the hospitals had a uterine cancer surgery volume of two or fewer cases. CONCLUSION: There have been only modest changes in the referral patterns of women with ovarian and uterine cancer. A large number of hospitals have a very low procedural volume.

Carcinosarcoma of the ovary: natural history, patterns of treatment, and outcome.

OBJECTIVE: Ovarian carcinosarcomas (OCS) are rare tumors composed of both malignant epithelial and mesenchymal elements. We compared the natural history and outcomes of OCS to serous carcinoma of the ovary. METHODS: Patients with OCS and serous carcinomas registered in the Surveillance, Epidemiology, and End Results (SEER) database between 1988 and 2007 were analyzed. Demographic and clinical characteristics were compared using chi square tests while survival was analyzed using Cox proportional hazards models and the Kaplan-Meier method. RESULTS: A total of 27,737 women, including 1763 (6.4%) with OCS and 25,974 (93.6%) with serous carcinomas, were identified. Patients with carcinosarcomas tended to be older and have unstaged tumors (P<0.0001). After adjusting for other prognostic factors, women with carcinosarcomas were 72% more likely to die from their tumors (HR=1.72; 95% CI, 1.52-1.96). Five-year survival for stage I carcinosarcomas was 65.2% (95% CI, 58.0-71.4%) vs. 80.6% (95% CI, 78.9-82.2%) for serous tumors. Similarly, five-year survival for stage IIIC patients was 18.2% (95% CI, 14.5-22.4%) for carcinosarcomas compared to 33.3% (95% 32.1-34.5%) for serous carcinomas. CONCLUSIONS: Ovarian carcinosarcomas are aggressive tumors with a natural history that is distinct from serous cancers. The survival for both early and late stage carcinosarcoma is inferior to serous tumors.

Quantitative X-ray computed tomography peritoneography in malignant peritoneal mesothelioma patients receiving intraperitoneal chemotherapy.

BACKGROUND: Intraperitoneal chemotherapy is used to treat peritoneal surface-spreading malignancies. We sought to determine whether volume and surface area of the intraperitoneal chemotherapy compartments are associated with overall survival and posttreatment glomerular filtration rate (GFR) in malignant peritoneal mesothelioma (MPM) patients. METHODS: Thirty-eight MPM patients underwent X-ray computed tomography peritoneograms during outpatient intraperitoneal chemotherapy. We calculated volume and surface area of contrast-filled compartments by semiautomated computer algorithm. We tested whether these were associated with overall survival and posttreatment GFR. RESULTS: Decreased likelihood of mortality was associated with larger surface areas (p = 0.0201) and smaller contrast-filled compartment volumes (p = 0.0341), controlling for age, sex, histologic subtype, and presence of residual disease >0.5 cm postoperatively. Larger volumes were associated with higher posttreatment GFR, controlling for pretreatment GFR, body surface area, surface area, and the interaction between body surface area and volume (p = 0.0167). DISCUSSION: Computed tomography peritoneography is an appropriate modality to assess for maldistribution of intraperitoneal chemotherapy. In addition to identifying catheter failure and frank loculation, quantitative analysis of the contrast-filled compartment's surface area and volume may predict overall survival and cisplatin-induced nephrotoxicity. Prospective studies should be undertaken to confirm and extend these findings to other diseases, including advanced ovarian carcinoma.

Variation in ovarian conservation in women undergoing hysterectomy for benign indications.

OBJECTIVE: Emerging data suggest that oophorectomy at the time of hysterectomy for benign indications may increase long-term morbidity and mortality. We performed a population-based analysis to estimate the rates of oophorectomy in women undergoing hysterectomy for benign indications. METHODS: The Perspective database was used to estimate the rate of ovarian preservation in women aged 40-64 years who underwent hysterectomy for benign indications. Hierarchical mixed-effects regression models were developed to estimate the influence of patient, procedural, physician, and hospital characteristics on ovarian conservation. Between-hospital variation in ovarian preservation also was estimated. RESULTS: Among 752,045 women, 348,972 (46.4%) underwent bilateral oophorectomy, whereas 403,073 (53.6%) had ovarian conservation. Stratified by age, the rate of ovarian conservation was 74.3% for those younger than 40 years of age; 62.7% for those 40-44 years of age; 40.8% for those 45-49 years of age; 25.2% for those 50-54 years of age; 25.5% for those 55-59 years of age; and 31.0% for those 60-64 years of age. Younger age and more recent year of surgery had the strongest association with ovarian conservation. The observed patient, procedural, physician, and hospital characteristics accounted for only 46% of the total variation in the rate of ovarian conservation; 54% of the variability remained unexplained, suggesting a large amount of intrinsic between-hospital variation in the decision to perform oophorectomy. CONCLUSION: The rate of ovarian conservation is increasing, particularly among women younger than 50 years old. Although demographic and clinical factors influence the decision to perform oophorectomy, there appears to be substantial between-hospital variation in performance of oophorectomy that remains unexplained by measurable patient, physician, or hospital characteristics. LEVEL OF EVIDENCE: II.

Patterns of care for locally advanced vulvar cancer.

OBJECTIVE: Patients with locally advanced vulvar carcinoma can be treated with primary surgery or neoadjuvant chemoradiation. Neoadjuvant treatment appears to be associated with decreased morbidity and acceptable long-term outcomes. We examined the patterns of care for women with locally advanced vulvar cancer. STUDY DESIGN: Data from the Surveillance, Epidemiology, and End Results (SEER) database was used to examine women with stage III-IVA vulvar cancer treated from 1988 to 2008. Primary therapy was classified as surgery or radiation. Multivariable logistic regression models were developed to examine the use of primary radiotherapy. RESULTS: We identified a total of 2292 women including 1757 who underwent primary surgery (76.7%) and 535 treated with primary radiation (23.3%). The use of primary radiation increased with time from 18.0% in 1988 to 30.1% in 2008. In a multivariable model, older women (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.03-1.72), black women (OR, 1.59; 95% CI, 1.14-2.23), and patients with stage IVA tumors (OR, 2.23; 95% CI, 1.78-2.81) were more likely to receive primary radiation. Among women treated with primary radiotherapy, only 17.8% ultimately underwent surgical resection. CONCLUSION: The use of primary radiation for locally advanced vulvar cancer is limited but has increased over time. Multiple patient and tumor factors influence use. The majority of patients with stage III-IVA vulvar cancer treated with primary radiation therapy did not undergo surgical resection.

Uptake and outcomes of intensity-modulated radiation therapy for uterine cancer.

OBJECTIVE: While intensity-modulated radiation therapy (IMRT) allows more precise radiation planning, the technology is substantially more costly than conformal radiation and, to date, the benefits of IMRT for uterine cancer are not well defined. We examined the use of IMRT and its effect on late toxicity for uterine cancer. METHODS: Women with uterine cancer treated from 2001 to 2007 and registered in the SEER-Medicare database were examined. We investigated the extent and predictors of IMRT administration. The incidence of acute and late-radiation toxicities was compared for IMRT and conformal radiation. RESULTS: We identified a total of 3555 patients including 328 (9.2%) who received IMRT. Use of IMRT increased rapidly and reached 23.2% by 2007. In a multivariable model, residence in the western U.S. and receipt of chemotherapy were associated with receipt of IMRT. Women who received IMRT had a higher rate of bowel obstruction (rate ratio=1.41; 95% CI, 1.03-1.93), but other late gastrointestinal and genitourinary toxicities as well as hip fracture rates were similar between the cohorts. After accounting for other characteristics, the cost of IMRT was $14,706 (95% CI, $12,073 to $17,339) greater than conformal radiation. CONCLUSION: The use of IMRT for uterine cancer is increasing rapidly. IMRT was not associated with a reduction in radiation toxicity, but was more costly.

Deviations from guideline-based therapy for febrile neutropenia in cancer patients and their effect on outcomes.

IMPORTANCE: Although febrile neutropenia (FN) is a major source of morbidity and mortality for patients with solid tumors, little is known about the use of guideline-based care. OBJECTIVES: To examine compliance with guideline-based recommendations for FN treatment, explore the factors that influence adherence to consensus guidelines, and analyze how the use of guideline-based care affects the outcomes. DESIGN: The Perspective database was used to examine the treatment of cancer patients with FN from January 1, 2000, through March 31, 2010. To capture initial decision making, we examined treatment within 48 hours of hospital admission. We determined use of guideline-based antibiotics and nonguideline-based treatments, vancomycin, and granulocyte colony-stimulating factors (GCSF). Hierarchical models were developed to examine the factors associated with treatment. Patients were stratified into low- and high-risk groups, and the effect of the initial treatment on outcome (nonroutine hospital discharge and death) was examined. SETTING AND PARTICIPANTS: Twenty-five thousand two hundred thirty-one patients with solid tumors hospitalized for neutropenia. MAIN OUTCOME MEASURE: Use of guideline-based antibiotics, vancomycin, and GCSF and their affect on outcome. RESULTS: Among 25 231 patients admitted with FN, guideline-based antibiotics were administered to 79%, vancomycin to 37%, and GCSF to 63%. Patients treated at high FN-volume hospitals (odds ratio [OR], 1.56; 95% CI, 1.34-1.81) by high FN-volume physicians (OR, 1.19; 95% CI, 1.03-1.38) and patients managed by hospitalists (OR, 1.49; 95% CI, 1.18-1.88) were more likely to receive guideline-based antibiotics (P < .05). Vancomycin use increased from 17% in 2000 to 55% in 2010, while GCSF use only decreased from 73% to 55%. Among low-risk patients with FN, prompt initiation of guideline-based antibiotics decreased discharge to a nursing facility (OR, 0.77; 95% CI, 0.65-0.92) and death (OR, 0.63; 95% CI, 0.42-0.95). CONCLUSIONS AND RELEVANCE: While use of guideline-based antibiotics is high, use of the nonguideline-based treatments, vancomycin, and GCSF is also high. Physician and hospital factors are the strongest predictors of both guideline- and nonguideline-based treatment.