Cost-effectiveness analysis of margin-controlled surgery for vulvar Paget's disease.

Objectives: To determine the cost of two surgical treatment approaches for vulvar Paget's disease and model the cost-effectiveness considering differences in recurrence and reoperation over time. Methods: We assessed cost-effectiveness between excision guided by Mohs micrographic surgery (MMS-E) and traditional wide local excision (WLE). We examined billing data from patients with vulvar Paget's disease who underwent MMS-E (cases, n = 24, 2018-2022) or WLE (controls, n = 64, 1990-2020). We created typical treatment bundles incorporating physician-administered services and facility costs standardized to Medicare reimbursements in 2022 United States Dollars (USD). The primary measure of effectiveness was disease-free years of life. A secondary analysis estimated quality-adjusted life years (QALY). A Markov model simulated treatment pathways over a 10-year time horizon. Transition probabilities were based on institutional recurrence rates (3-year RR 6.7 % for MMS-E vs 34.1 % for WLE). We used a willingness-to-pay threshold of 100,000 USD per QALY. Results: The cost of a single surgical episode was 34,664 USD for MMS-E and 14,969 USD for WLE. In the setting of lower recurrence rates with MMS-E, the incremental cost was 12,789 USD per disease-free year gained. A secondary analysis incorporating QALY showed an incremental cost of 72,820 USD per QALY. Conclusions: MMS-E appears to be a cost-effective treatment for vulvar Paget's disease compared to historic standard of care. Our ability to estimate quality of life gained by avoiding disease recurrence was limited by scant data for this rare condition; thus, future studies incorporating health utility values are needed to facilitate a more comprehensive analysis.

Implementing robotic surgery for uterine cancer in the United States: Better outcomes without increased costs.

OBJECTIVE: To examine the effect of robotic-assisted surgery implementation for treatment of endometrial cancer in the United States on 30-day clinical outcomes and costs. METHODS: We retrospectively reviewed data of adult patients who underwent total hysterectomy for endometrial cancer in the US hospitals in Premier Healthcare Database between January 1, 2008 and September 30, 2015. We conducted trend analyses comparing the proportions of surgical approaches with the associated clinical outcomes and costs over the study period using Mann-Kendall tests. Clinical outcomes and costs of robotic-assisted surgery, laparoscopic and open surgery have been compared after propensity score 1:1 matching in the most recent 3 years (January 1, 2013-September 30, 2015). RESULTS: Of a total of 35,224 patients, use of robotic-assisted surgery increased from 9.48% to 56.82% while open surgery decreased from 70.4% to 28.1% over the study period. A 2.5% decrease in major complications (P < .001), a 2.9% decrease in minor complications (P = .001), and a 2.0% decrease 30-day readmissions (P = .001) was observed across all surgical approaches. Perioperative 30-day total cost slightly decreased from US $11,048 to US $10,322 (P = .08). Among propensity-score matched patients, robotic-assisted surgery was associated with shorter hospitalization than open surgery (median [interquartile range], 2.0 [2.0-3.0] vs 4.0 [3.0-6.0] days) and laparoscopic surgery (2.0 [2.0-3.0] vs 3.0 [2.0-4.0] days), fewer 30-day complications (20.1% vs 33.7%) (all P < .001), and comparable perioperative 30-day total costs (median [interquartile range], US $12,200 [US $9,509-US $16,341] vs US $12,018 [US $8,996-US $17,162]; P = .34) with open surgery. CONCLUSION: Robotic-assisted surgery facilitated the widespread diffusion of a minimally invasive approach nationally for endometrial cancer, with reduction of perioperative morbidity and no increase in overall treatment-related 30-day costs at national level.

Multicenter study comparing oncologic outcomes after lymph node assessment via a sentinel lymph node algorithm versus comprehensive pelvic and paraaortic lymphadenectomy in patients with serous and clear cell endometrial carcinoma.

OBJECTIVES: To compare survival after nodal assessment using a sentinel lymph node (SLN) algorithm versus comprehensive pelvic and paraaortic lymphadenectomy (LND) in serous or clear cell endometrial carcinoma, and to compare survival in node-negative cases. METHODS: Three-year recurrence-free survival (RFS) and overall survival were compared between one institution that used comprehensive LND to the renal veins and a second institution that used an SLN algorithm with ultra-staging with inverse-probability of treatment weighting (IPTW) derived from propensity scores to adjust for covariate imbalance between cohorts. RESULTS: 214 patients were identified (118 SLN cohort, 96 LND cohort). Adjuvant therapy differed between the cohorts; 84% and 40% in the SLN and LND cohorts, respectively, received chemotherapy ± radiation therapy. The IPTW-adjusted 3-year RFS rates were 69% and 80%, respectively. The IPTW-adjusted 3-year OS rates were 88% and 77%, respectively. The IPTW-adjusted hazard ratio (HR) for the association of surgical approach (SLN vs LND) with progression and death was 1.46 (95% CI: 0.70-3.04) and 0.44 (95% CI: 0.19-1.02), respectively. In the 168 node-negative cases, the IPTW-adjusted 3-year RFS rates were 73% and 91%, respectively. The IPTW-adjusted 3-year OS rates were 88% and 86%, respectively. In this subgroup, IPTW-adjusted HR for the association of surgical approach (SLN vs LND) with progression and death was 3.12 (95% CI: 1.02-9.57) and 0.69 (95% CI: 0.24-1.95), respectively. CONCLUSION: OS was not compromised with the SLN algorithm. SLN may be associated with a decreased RFS but similar OS in node-negative cases despite the majority receiving chemotherapy. This may be due to differences in surveillance.

Multicenter study comparing oncologic outcomes between two nodal assessment methods in patients with deeply invasive endometrioid endometrial carcinoma: A sentinel lymph node algorithm versus a comprehensive pelvic and paraaortic lymphadenectomy.

OBJECTIVES: To compare oncologic outcomes in the staging of deeply invasive endometrioid endometrial carcinoma (EEC) using a sentinel lymph node algorithm (SLN) versus pelvic and paraaortic lymphadenectomy to the renal veins (LND); to compare outcomes in node-negative cases. METHODS: At two institutions, patients with deeply invasive (≥50% myometrial invasion) EEC were identified. One institution used LND (2004-2008), the other SLN (2005-2013). FIGO stage IV cases were excluded. Clinical characteristics and follow-up data were recorded. RESULTS: 176 patients were identified (LND, 94; SLN, 82). SLN patients were younger (p = 0.003) and had more LVSI (p < 0.001). 9.8% in the SLN and 29.8% in the LND cohorts, respectively, received no adjuvant therapy (p < 0.001). There was no association between type of assessment and recurrence; adjusted hazard ratio (aHR; LND vs. SLN) 0.87 (95%CI 0.40, 1.89) PFS. After controlling for age and adjuvant therapy, there was no association between assessment method and OS (aHR 2.54; 95%CI 0.81, 7.91). The node-negative cohort demonstrated no association between survival and assessment method: aHR 0.69 (95%CI 0.23, 2.03) PFS, 0.81 (95%CI 0.16, 4.22) OS. In the node-negative cohort, neither adjuvant EBRT+/-IVRT (HR 1.63; 95%CI 0.18, 14.97) nor adjuvant chemotherapy+/-EBRT+/-IVRT (HR 0.49; 95%CI 0.11, 2.22) were associated with OS, compared to no adjuvant therapy or IVRT-only. CONCLUSION: Use of an SLN algorithm in deeply invasive EEC does not impair oncologic outcomes. Survival is excellent in node-negative cases, irrespective of assessment method. Adjuvant chemotherapy in node-negative patients does not appear to impact outcome.

Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies.

OBJECTIVE: To investigate opioid use and pain scores associated with incisional injection of liposomal bupivacaine compared with bupivacaine hydrochloride after laparotomy for gynecologic malignancies. METHODS: A retrospective cohort study was conducted to compare abdominal incision infiltration with liposomal bupivacaine with bupivacaine hydrochloride after modification of a pre-existing enhanced recovery pathway. Patients undergoing staging laparotomy or complex cytoreductive surgery under the updated pathway were compared with patients treated under the original pathway (historic controls). Endpoints included cumulative opioid use (primary outcome) in oral morphine equivalents and cumulative pain score. RESULTS: In the complex cytoreductive cohort, median oral morphine equivalents were lower in the liposomal bupivacaine group through 24 hours (30 compared with 53.5 mg, P=.002), 48 hours (37.5 compared with 82.5 mg, P=.005), and the length of stay (62 compared with 100.5 mg, P=.006). Fewer liposomal bupivacaine patients required intravenous rescue opioids (28.9% compared with 55.6%, P<.001) or patient-controlled analgesia (4.1% compared with 33.3%, P<.001). Cumulative pain score was no different between groups through 48 hours (161 compared with 158, P=.69). Postoperative nausea and ileus were less frequent in patients receiving liposomal bupivacaine. Median hospital stay was 5 days in both groups. In the staging laparotomy cohort, cumulative opioids and cumulative pain score were no different between groups (through 48 hours: 162 compared with 161, P=.62; 38 compared with 38, P=.68, respectively). Intravenous rescue opioids (15.3% compared with 28.6%, P=.05) and patient-controlled analgesia (1.4% compared with 8.3%, P=.05) were used less frequently in the liposomal bupivacaine group. Median hospital stay was 4 days in both groups. Despite the higher cost of liposomal bupivacaine, total pharmacy costs did not differ between groups. CONCLUSION: Abdominal incision infiltration with liposomal bupivacaine was associated with less opioid and patient-controlled analgesia use with no change in pain scores compared with bupivacaine hydrochloride after complex cytoreductive surgery for gynecologic malignancies. Improvements were also seen in patients undergoing staging laparotomy.

Incorporating robotic-assisted surgery for endometrial cancer staging: Analysis of morbidity and costs.

OBJECTIVE: To evaluate how the introduction of robotic-assisted surgery affects treatment-related morbidity and cost of endometrial cancer (EC) staging. METHODS: We retrospectively reviewed the records of consecutive patients with stage I-III EC undergoing surgical staging between 2007 and 2012 at our institution. Costs (from surgery to 30days after surgery) were set based on the Medicare cost-to-charge ratio for each year and inflated to 2014 values. Inverse probability weighting (IPW) was used to decrease the allocation bias when comparing outcomes between surgical groups. RESULTS: We focused our analysis on the 251 EC patients who had robotic-assisted surgery and the 384 who had open staging. During the study period, the use of robotic-assisted surgery increased and open staging decreased (P<0.001). Correcting group imbalances by using IPW methodology, we observed that patients undergoing robotic-assisted staging had a significantly lower postoperative complication rate, lower blood transfusion rate, longer median operating time, shorter median length of stay, and lower readmission rate than patients undergoing open staging (all P<0.001). Overall 30-day costs were similar between the 2 groups, with robotic-assisted surgery having significantly higher median operating room costs ($2820 difference; P<0.001) but lower median room and board costs ($2929 difference; P<0.001) than open surgery. Increasing experience with robotic-assisted staging was significantly associated with a decrease in median operating time (P=0.002) and length of stay (P=0.003). CONCLUSIONS: The implementation of robotic-assisted surgery for EC staging improves patient outcomes. It provides women the benefits of minimally invasive surgery without increasing costs and potentially improves patient turnover.

Improving NCCN guideline-adherent care for ovarian cancer: Value of an intervention.

OBJECTIVE: To estimate the potential cost-effectiveness of an intervention to improve adherence to National Comprehensive Cancer Network (NCCN) guideline-based care for ovarian cancer. METHODS: A modified Markov model with a 5-year time horizon estimated the potential cost-effectiveness of an intervention (AD-INT) to improve NCCN-guideline adherence compared to status quo (SQ) levels of adherence. Data were obtained from a population-based analysis of National Cancer Data Base records for ovarian cancer diagnosed from 1998 to 2002 (N=47,160). Cohorts were defined by race and adherence to NCCN guideline-based care. Costs were estimated using 2014 Medicare reimbursements. Incremental cost-effectiveness ratios (ICERs) were calculated in 2014 US dollars per year of life saved (YLS) using the standard threshold of $50,000/YLS. We simulated an AD-INT that reduced non-adherence by 25% and cost at least $100 per patient. One-way sensitivity analyses were performed. RESULTS: Although the individual components of guideline-adherent care are more costly than non-adherent care, a reasonably effective AD-INT is also highly likely to be cost-effective. An AD-INT costing $100 per patient and reducing non-adherence by 25% is cost-effective with an ICER of $22/YLS compared with SQ, while interventions costing over $1000 remain cost-effective, up to a per-patient intervention cost of up to $8000 (targeting only blacks) or $4000 (targeting all patients). CONCLUSIONS: An ovarian cancer intervention that moderately decreases racial disparities in NCCN guideline adherent care or improves adherence for all is potentially cost-effective. Further research may determine which modifiable factors may be targeted to help reduce adherence disparities.

Assessment of published models and prognostic variables in epithelial ovarian cancer at Mayo Clinic.

OBJECTIVES: Epithelial ovarian cancer (EOC) is an aggressive disease in which first line therapy consists of a surgical staging/debulking procedure and platinum based chemotherapy. There is significant interest in clinically applicable, easy to use prognostic tools to estimate risk of recurrence and overall survival. In this study we used a large prospectively collected cohort of women with EOC to validate currently published models and assess prognostic variables. METHODS: Women with invasive ovarian, peritoneal, or fallopian tube cancer diagnosed between 2000 and 2011 and prospectively enrolled into the Mayo Clinic Ovarian Cancer registry were identified. Demographics and known prognostic markers as well as epidemiologic exposure variables were abstracted from the medical record and collected via questionnaire. Six previously published models of overall and recurrence-free survival were assessed for external validity. In addition, predictors of outcome were assessed in our dataset. RESULTS: Previously published models validated with a range of c-statistics (0.587-0.827), though application of models containing variables which are not part of routine practice were somewhat limited by missing data; utilization of all applicable models and comparison of results are suggested. Examination of prognostic variables identified only the presence of ascites and ASA score to be independent predictors of prognosis in our dataset, albeit with marginal gain in prognostic information, after accounting for stage and debulking. CONCLUSIONS: Existing prognostic models for newly diagnosed EOC showed acceptable calibration in our cohort for clinical application. However, modeling of prospective variables in our dataset reiterates that stage and debulking remains the most important predictors of prognosis in this setting.

Role of pelvic and para-aortic lymphadenectomy in endometrial cancer: current evidence.

The aim of the present review is to summarize the current evidence on the role of pelvic and para-aortic lymphadenectomy in endometrial cancer. In 1988, the International Federation of Obstetrics and Gynecology recommended surgical staging for endometrial cancer patients. However, 25 years later, the role of lymph node dissection remains controversial. Although the findings of two large independent randomized trials suggested that pelvic lymphadenectomy provides only adjunctive morbidity with no clear influence on survival outcomes, the studies have many pitfalls that limit interpretation of the results. Theoretically, lymphadenectomy may help identify patients with metastatic dissemination, who may benefit from adjuvant therapy, thus reducing radiation-related morbidity. Also, lymphadenectomy may eradicate metastatic disease. Because lymphatic spread is relatively uncommon, our main effort should be directed at identifying patients who may potentially benefit from lymph node dissection, thus reducing the rate of unnecessary treatment and associated morbidity. This review will discuss the role of lymphadenectomy in endometrial cancer, focusing on patient selection, extension of the surgical procedure, postoperative outcomes, quality of life and costs. The need for new surgical studies and efficacious systemic drugs is recommended.

Prospective assessment of the prevalence of pelvic, paraaortic and high paraaortic lymph node metastasis in endometrial cancer.

OBJECTIVE: To prospectively define the prevalence of lymph node metastasis (LNM) in at risk endometrial cancer (EC). METHODS: From 2004 to 2008, frozen section based Mayo Criteria prospectively identified patients "not at-risk" of LNM (30% EC population; grade I/II, <50% myometrial invasion and tumor diameter ≤ 2 cm) where lymphadenectomy was not recommended. The remaining 70% EC cohort was considered "at-risk" of LNM; where a systematic pelvic and infrarenal paraaortic lymphadenectomy was recommended. Patients were prospectively followed. The area between renal vein and inferior mesenteric artery (IMA) was labeled as high paraaortic area. For calculating the prevalence of LNM in high paraaortic area, the denominator was the population with known anatomic location of nodal tissue in relation to the IMA. RESULTS: Of the 742 patients, 514 were at risk; of which 89% underwent recommended lymphadenectomy. A mean (± standard deviation) of 36 (± 14) pelvic and 18 (± 9) paraaortic nodes were harvested. The prevalence of pelvic and paraaortic LNM was 17% and 12%, respectively. In presence of pelvic LNM, 51% had paraaortic LNM. In absence of pelvic LNM, 3% had paraaortic LNM; of which 67% was located exclusively in high paraaortic area. Among patients with paraaortic LNM, 88% had high paraaortic LNM; and 35% had only high paraaortic LNM. The cases of paraaortic LNM with negative pelvic nodes seemed to cluster in moderate to high grade endometrioid EC with ≥ 50% myometrial invasion. CONCLUSION: We present reference data for the prevalence of LNM in at-risk EC patients to guide lymphadenectomy decisions for clinical and research purposes.

Enhanced recovery in gynecologic surgery.

OBJECTIVE: To investigate the effects of enhanced recovery (a multimodal perioperative care enhancement protocol) in patients undergoing gynecologic surgery. METHODS: Consecutive patients managed under an enhanced recovery pathway and undergoing cytoreduction, surgical staging, or pelvic organ prolapse surgery between June 20, 2011, and December 20, 2011, were compared with consecutive historical controls (March to December 2010) matched by procedure. Wilcoxon rank-sum, χ, and Fisher's exact tests were used for comparisons. Direct medical costs incurred in the first 30 days were obtained from the Olmsted County Healthcare Expenditure and Utilization Database and standardized to 2011 Medicare dollars. RESULTS: A total of 241 enhanced recovery women in the case group (81 cytoreduction, 84 staging, and 76 vaginal surgery) were compared with women in the control groups. In the cytoreductive group, patient-controlled anesthesia use decreased from 98.7% to 33.3% and overall opioid use decreased by 80% in the first 48 hours with no change in pain scores. Enhanced recovery resulted in a 4-day reduction in hospital stay with stable readmission rates (25.9% of women in the case group compared with 17.9% of women in the control group) and 30-day cost savings of more than $7,600 per patient (18.8% reduction). No differences were observed in rate (63% compared with 71.8%) or severity of postoperative complications (grade 3 or more: 21% compared with 20.5%). Similar, albeit less dramatic, improvements were observed in the other two cohorts. Ninety-five percent of patients rated satisfaction with perioperative care as excellent or very good. CONCLUSIONS: Implementation of enhanced recovery was associated with acceptable pain management with reduced opioids, reduced length of stay with stable readmission and morbidity rates, good patient satisfaction, and substantial cost reductions. LEVEL OF EVIDENCE: II.

Predictors and costs of surgical site infections in patients with endometrial cancer.

OBJECTIVE: Technological advances in surgical management of endometrial cancer (EC) may allow for novel risk modification in surgical site infection (SSI). METHODS: Perioperative variables were abstracted from EC cases surgically staged between January 1, 1999, and December 31, 2008. Primary outcome was SSI, as defined by American College of Surgeons National Surgical Quality Improvement Program. Counseling and global models were built to assess perioperative predictors of superficial incisional SSI and organ/space SSI. Thirty-day cost of SSI was calculated. RESULTS: Among 1369 EC patients, 136 (9.9%) had SSI. In the counseling model, significant predictors of superficial incisional SSI were obesity, American Society of Anesthesiologists (ASA) score >2, preoperative anemia (hematocrit <36%), and laparotomy. In the global model, significant predictors of superficial incisional SSI were obesity, ASA score >2, smoking, laparotomy, and intraoperative transfusion. Counseling model predictors of organ/space SSI were older age, smoking, preoperative glucose >110 mg/dL, and prior methicillin-resistant Staphylococcus aureus (MRSA) infection. Global predictors of organ/space SSI were older age, smoking, vascular disease, prior MRSA infection, greater estimated blood loss, and lymphadenectomy or bowel resection. SSI resulted in a $5447 median increase in 30-day cost. CONCLUSIONS: Our findings are useful to individualize preoperative risk counseling. Hyperglycemia and smoking are modifiable, and minimally invasive surgical approaches should be the preferred surgical route because they decrease SSI events. Judicious use of lymphadenectomy may decrease SSI. Thirty-day postoperative costs are considerably increased when SSI occurs.

Disparities in ovarian cancer care quality and survival according to race and socioeconomic status.

BACKGROUND: The relationship between racial and socioeconomic status (SES) disparities and the quality of epithelial ovarian cancer care and survival outcome are unclear. METHODS: A population-based analysis of National Cancer Data Base (NCDB) records for invasive primary epithelial ovarian cancer diagnosed in the period from 1998 to 2002 was done using data from patients classified as white or black. Adherence to National Comprehensive Cancer Network (NCCN) guideline care was defined by stage-appropriate surgical procedures and recommended chemotherapy. The main outcome measures were differences in adherence to NCCN guidelines and overall survival according to race and SES and were analyzed using binomial logistic regression and multilevel survival analysis. RESULTS: A total of 47 160 patients (white = 43 995; black = 3165) were identified. Non-NCCN-guideline-adherent care was an independent predictor of inferior overall survival (hazard ratio [HR] = 1.43, 95% confidence interval [CI] = 1.38 to 1.47). Demographic characteristics independently associated with a higher likelihood of not receiving NCCN guideline-adherent care were black race (odds ratio [OR] = 1.36, 95% CI = 1.25 to 1.48), Medicare payer status (OR = 1.20, 95% CI = 1.12 to 1.28), and not insured payer status (OR = 1.33, 95% CI = 1.19 to 1.49). After controlling for disease and treatment-related variables, independent racial and SES predictors of survival were black race (HR = 1.29, 95% CI = 1.22 to 1.36), Medicaid payer status (HR = 1.29, 95% CI = 1.20 to 1.38), not insured payer status (HR = 1.32, 95% CI = 1.20 to 1.44), and median household income less than $35 000 (HR = 1.06, 95% CI = 1.02 to 1.11). CONCLUSIONS: These data highlight statistically and clinically significant disparities in the quality of ovarian cancer care and overall survival, independent of NCCN guidelines, along racial and SES parameters. Increased efforts are needed to more precisely define the patient, provider, health-care system, and societal factors leading to these observed disparities and guide targeted interventions.

Factors predictive of postoperative morbidity and cost in patients with endometrial cancer.

OBJECTIVE: To identify patient characteristics and perioperative factors predictive of 30-day morbidity and cost in patients with endometrial carcinoma. METHODS: Data of consecutive patients treated with hysterectomy for endometrial carcinoma between 1999 and 2008 were collected prospectively. Thirty predictors were chosen from more than 130 collected based on anticipated clinical relevance and prevalence (more than 3%). Complications were graded per the Accordion Classification. Multivariable models were developed using stepwise and backward variable selection methods. Thirty-day cost analyses were expressed in 2010 Medicare dollars. RESULTS: Of 1,369 patients, significant predictors (P<.01) of grade 2 and higher morbidity included American Society of Anesthesiologists physical status classification system class higher than 2 (odds ratio [OR] 2.1), preoperative white blood count (OR 2.1 per doubling), history of deep vein thrombosis (OR 2.1), pelvic and para-aortic lymphadenectomy (OR 2.3 compared with no lymphadenectomy), laparotomy (OR 2.8 compared with minimally invasive surgery), myometrial invasion more than 50% (OR 2.4), operating time (OR 1.9 per doubling), and grade 4 surgical complexity (OR 2.7 compared with grade 1). After controlling for patient factors in a multivariable model, laparotomy, pelvic, and para-aortic lymphadenectomy were associated with significant increases in cost compared with the use of minimally invasive surgery or hysterectomy alone. CONCLUSION: This analysis identifies patient and perioperative care factors predictive of 30-day morbidity and cost. These data are useful for preoperative counseling, for defining equitable reimbursement and factors critical for risk-adjustment when comparing outcomes, and for identifying areas for quality improvement in patients with endometrial carcinoma. Given the marked increases in morbidity and cost associated with laparotomy and lymphadenectomy, minimally invasive surgery and selective lymphadenectomy should be standard treatment for patients with endometrial carcinoma.

A prospective assessment of the reliability of frozen section to direct intraoperative decision making in endometrial cancer.

OBJECTIVE: To determine the reliability of intraoperative frozen sections (IFSs) for surgical staging of endometrial cancer (EC). METHODS: Data were collected prospectively on 784 consecutive patients with EC who were undergoing a hysterectomy at our institution from January 1, 2004, to December 31, 2008. The need for surgical staging was decided through IFS using 4 variables: tumor size, histologic grade, histologic subtype, and depth of myometrial invasion (MI). The IFS results were compared with the permanent paraffin sections (PSs) to assess for discordances. RESULTS: In 30 of the 784 cases (4%), the PS pathology report was amended with discordant results. In addition, a definitive diagnosis of the 4 parameters was deferred to PS in 53 cases (7%), of which 30 (4%) were concordant and 23 (3%) were discordant. IFS-related deviations from the prescribed surgical algorithm occurred in 10 cases (1.3%; 95% confidence interval, 0.6%-2.3%). Of these 10 cases, 3 were amendments after PS review and 7 were IFS deferrals for definitive PS interpretation. CONCLUSIONS: Clinically significant discordance between IFS and PS occurred in only 1.3% of cases. Despite skepticism expressed in the medical literature, IFS provides highly reliable data to guide intraoperative treatment decisions at institutions with sufficient pathologic expertise.

The impact of surgical guidelines and periodic quality assessment on the staging of endometrial cancer.

OBJECTIVE: To determine the impact of surgical guidelines and transparent periodic assessment of surgical quality on endometrial cancer (EC) staging by gynecologic oncologists in a single institution and to identify process-of-care, patient-specific, and disease-specific risk factors that influence surgical quality. METHODS: In January 2004, a prospective treatment algorithm was implemented for EC at our institution. The number of nodes harvested was a surrogate, and staging quality from 2004 to 2008 (quality assessment [QA] interval) was compared with the previous 5 years (pre-QA interval). Since 2004, low-risk cases based on frozen section examination had not undergone lymphadenectomy and were excluded. Independent patient-specific, disease-specific, and surgery-related risk factors influencing lymphadenectomy quality during both intervals were identified with multivariable logistic regression analysis. RESULTS: Pelvic and para-aortic lymph node dissection (LND) in surgical EC management before QA (n=420) were 77.9% and 48.8% vs 89.3% and 83.4% during the QA (n=561) (P<.001). The median number of pelvic and para-aortic nodes harvested in LND was 29 and 10 before QA vs 34 and 16 during the QA interval (P<.001). With acceptance of stringent criteria for defining systematic LND (mean node count-1 SD) during the QA, systematic pelvic (≥22 nodes) and para-aortic (≥10 nodes) LNDs occurred in 57.4% and 25.7% of cases before QA vs 77.9% and 70.7% during the QA interval (P<.001). In patients with LND, rates of systematic pelvic and para-aortic LND were 73.7% and 53.0% before vs 87.2% and 84.8% after QA (P<.001). Multivariable logistic regression analysis showed independent factors influencing systematic pelvic and para-aortic LND (P<.01): surgeon and stage during the pre-QA interval vs surgical approach; intraoperative ascites; body mass index; surgeon; patient age; and myometrial invasion after QA implementation. CONCLUSION: Inclusion of detailed surgical guidelines and transparent periodic assessment of surgical quality translated to dramatic improvement in quality of surgical EC staging. This implementation was associated with a transition to more patient-specific risk factors influencing systematic LND. Although surgical quality metrics were markedly enhanced during QA, persistent variability observed among surgeons and the change in surgical approach render continuous QA and improvement obligatory.

Aggressive and complex surgery for advanced ovarian cancer: an economic analysis.

INTRODUCTION: In an initial cohort we demonstrated that aggressive surgery correlates with improved survival in patients with advanced ovarian cancer yet the economic implications of maximal surgical efforts are unknown. OBJECTIVE: To evaluate inpatient costs, survival, and cost-effectiveness of alternative primary surgical approaches among advanced ovarian cancer patients. METHODS: All patients with a diagnosis of stage IIIC-IV ovarian cancer between 1994 and 2003 were identified and classified by surgical complexity score (SCS) (1=simple, 2=intermediate, and 3=complex). We used clinical and administrative data to estimate costs associated with inpatient stay, survival, and the 5-year cost-effectiveness of complex vs. simple surgery measured in costs per life-year gained. RESULTS: 486 consecutive patients were identified of whom 28%, 50%, and 22% were classified as SCS 1, 2, and 3, respectively. Kaplan-Meier estimated survival differed by SCS group (p<0.001) with an average survival gain of 1.32 years with complex vs. simple surgery (SCS group 3 vs. 1). Inpatient costs significantly differed between SCS groups (mean costs SCS 1: $21,914; SCS 2: $27,408; SCS 3: $33,678; p<0.001). Analyses suggest incremental cost-effectiveness ratios of $4950 and $8912 per life-year gained, comparing SCS groups 2 vs. 1 and 3 vs. 1 respectively. CONCLUSIONS: Complex surgery for ovarian cancer cytoreduction carries a survival benefit at increased direct medical cost. However, preliminary cost-effectiveness results suggest complex surgery provides good value for money spent. Future research on the cost and quality of life implications of surgical morbidity during follow-up is warranted to formally assess the cost-effectiveness of complex vs. simple surgical procedures.

Prospective assessment of lymphatic dissemination in endometrial cancer: a paradigm shift in surgical staging.

OBJECTIVE: To prospectively assess pelvic and para-aortic lymph node metastases in endometrial cancer with lymphatic dissemination, emphasizing the examination of para-aortic metastases relative to the inferior mesenteric artery (IMA). METHODS: Over 36 months, 422 consecutive patients were managed by predefined surgical guidelines differentiating low-risk patients from patients at risk for dissemination requiring systematic lymphadenectomy. Low risk was defined as grade 1 or 2 endometrioid type with myometrial invasion (MI) < or = 50% and primary tumor diameter (PTD) < or = 2 cm. Pelvic and para-aortic lymph nodes were submitted separately, with nodes identified from all 8 pelvic and 4 para-aortic node-bearing basins. Surgical quality assessments examined median node counts (primary surrogate for quality) and nodes harvested above and below the IMA and excised gonadal veins (secondary surrogates). RESULTS: Lymphadenectomy was not required in 27% of patients (all low risk) and in 33% (n=112) of endometrioid cases. However, 22 patients (20%) of this latter cohort had lymphadenectomy and all lymph nodes were negative. Sixty-three (22%) of 281 patients undergoing lymphadenectomy had lymph node metastases: both pelvic and para-aortic in 51%, only pelvic in 33%, and isolated to the para-aortic area in 16%. Therefore, 67% of patients with lymphatic dissemination had para-aortic lymph node metastases. Furthermore, 77% of patients with para-aortic node involvement had metastases above the IMA, whereas nodes in the ipsilateral para-aortic area below the IMA and ipsilateral common iliac basin were declared negative in 60% and 71%, respectively. Gonadal veins were excised in 25 patients with para-aortic node metastases; 7 patients (28%) had documented metastatic involvement of gonadal veins or surrounding soft tissue. CONCLUSIONS: The high rate of lymphatic metastasis above the IMA indicates the need for systematic pelvic and para-aortic lymphadenectomy (vs sampling) up to the renal vessels. The latter should include consideration of excision of the gonadal veins. Conversely, lymphadenectomy does not benefit patients with grade 1 and 2 endometrioid lesions with MI < or = 50% and PTD < or = 2 cm.

A new frontier for quality of care in gynecologic oncology surgery: multi-institutional assessment of short-term outcomes for ovarian cancer using a risk-adjusted model.

OBJECTIVE: To test the feasibility and utility of a risk-adjusted, multicenter outcomes model for ovarian cancer surgery as a tool for quality improvement. METHODS: Patient characteristics, intra-operative findings, procedures, and outcomes were assessed in primary advanced stage ovarian cancer cases from 3 independent centers. A surgical complexity score (SCS) was developed to adjust for extent of surgery. Outcomes measures were: 30-day morbidity (sepsis, thrombo-embolic, cardiac, readmission or re-operation), 3-month mortality, length of stay (LOS), and ability to receive chemotherapy. A multivariable risk-adjusted model was developed for all the outcomes. Observed-to-expected (O/E) outcome ratios were calculated from all data. RESULTS: 564 consecutive patients from 3 centers were analyzed. The strongest predictors of 30-day morbidity were endogenous [albumin (p<0.001) and ASA (p=0.008)] and complexity of surgery [SCS (p<0.001)]. Age (p=0.002) and ASA (p=0.001) independently predicted mortality. LOS independently correlated with age (p=0.007), albumin (p=0.004), SCS (p=0.002), and stage (p=0.024). ASA (p<0.001) and SCS (p=0.003) both impacted ability to receive chemotherapy. Observed to expected (O/E) ratios for dependent outcome variables were similar for all 3 institutions. CONCLUSIONS: We demonstrate the benefits of a national system for studying outcomes in gynecologic surgery using a risk-adjusted model. We specifically find that endogenous patient factors and complexity of surgery are primary drivers of morbidity in ovarian cancer surgery. These data can successfully be used to formulate expected, risk-adjusted rates of complications thus providing a meaningful mechanism to identify areas ripe for quality improvement.