Correlation of surgeon radiology assessment with laparoscopic disease site scoring in patients with advanced ovarian cancer.

BACKGROUND: Radiographic triage measures in patients with new advanced ovarian cancer have yielded inconsistent results. OBJECTIVE: To determine the correlation between surgeon radiology assessment and laparoscopic scoring by disease sites in patients with newly diagnosed advanced stage ovarian cancer. METHODS: Fourteen gynecologic oncology surgeons from a single institution performed a blinded review of pre-operative contrast-enhanced CT imaging from patients with advanced stage ovarian cancer. Each of the patients had also undergone laparoscopic scoring assessment, between April 2013 and December 2017, to determine primary resectability using the validated Fagotti scoring method, and assigned a predictive index value score. Surgeons were asked to provide expected predictive index value scores based on their blinded review of the antecedent CT imaging. Linear mixed models were conducted to calculate the correlation between radiologic and laparoscopic score for surgeons individually, and as a group. Once the model was fit, the inter-class correlation and 95% CI were calculated. RESULTS: Radiology review was performed on 20 patients with advanced stage ovarian cancer who underwent laparoscopic scoring assessment. Surgeon faculty rank included assistant professor (n=5), associate professor (p=4), and professor (n=5). The kappa inter-rater agreement was -0.017 (95% CI -0.023 to -0.005), indicating low inter-rater agreement between radiology review and actual laparoscopic score. The inter-class correlation in this model was 0.06 (0.02-0.21), indicating that surgeons do not score the same across all the images. When using a clinical cut-off point for the predictive index value of 8, the probability of agreement between radiology and actual laparoscopic score was 0.56 (95% CI 0.49 to 0.73). Examination of disease site sub-scales showed that the probability of agreement was as follows: peritoneum 0.57 (95% CI 0.51 to 0.62), diaphragm 0.54 (95% CI 0.48 to 0.60), mesentery 0.51 (95% CI 0.45 to 0.57), omentum 0.61 (95% CI 0.55 to 0.67), bowel 0.54 (95% CI 0.44 to 0.64), stomach 0.71 (95% CI 0.65 to 0.76), and liver 0.36 (95% CI 0.31 to 0.42). The number of laparoscopic scoring cases, tumor reductive surgery cases, or faculty rank was not significantly associated with overall or sub-scale agreement. CONCLUSIONS: Surgeon radiology review did not correlate highly with actual laparoscopic scoring assessment findings in patients with advanced stage ovarian cancer. Our study highlights the limited accuracy of surgeon radiographic assessment to determine resectability.

Implementation of a sentinel lymph node mapping algorithm for endometrial cancer: surgical outcomes and hospital charges.

INTRODUCTION: The purpose of this study was to compare operative times, surgical outcomes, resource utilization, and hospital charges before and after the implementation of a sentinel lymph node (SLN) mapping algorithm in endometrial cancer. METHODS: All patients with clinical stage I endometrial cancer were identified pre- (2012) and post- (2017) implementation of the SLN algorithm. Clinical data were summarized and compared between groups. Total hospital charges incurred on the day of surgery were extracted from the hospital financial system for each patient and all charges were adjusted to 2017 US dollars. RESULTS: A total of 203 patients were included: 71 patients in 2012 and 130 patients in 2017. There was no difference in median age, body mass index, or stage. In 2012, 35/71 patients (49.3%) underwent a lymphadenectomy. In 2017, SLN mapping was attempted in 120/130 patients (92.3%) and at least one SLN was identified in 110/120 (91.7%). Median estimated blood loss was similar between groups (100 mL vs 75 mL, p=0.081). There was a significant decrease in both median operative time (210 vs 171 min, p=0.007) and utilization of intraoperative frozen section (63.4% vs 14.6%, p<0.0001). No significant differences were noted in intraoperative (p=1.00) or 30 day postoperative complication rates (p=0.30). The median total hospital charges decreased by 2.73% in 2017 as compared with 2012 (p=0.96). DISCUSSION: Implementation of an SLN mapping algorithm for high- and low-risk endometrial cancer resulted in a decrease in both operative time and intraoperative frozen section utilization with no change in surgical morbidity. While hospital charges did not significantly change, further studies are warranted to assess the true cost of SLN mapping.

Three Lymphadenectomy Strategies in Low-Risk Endometrial Carcinoma: A Cost-Effectiveness Analysis.

OBJECTIVE: To evaluate the cost-utility of three lymphadenectomy strategies in the management of low-risk endometrial carcinoma. METHODS: A decision analysis model compared three lymphadenectomy strategies in women undergoing minimally invasive surgery for low-risk endometrial carcinoma: 1) routine lymphadenectomy in all patients, 2) selective lymphadenectomy based on intraoperative frozen section criteria, and 3) sentinel lymph node mapping. Costs and outcomes were obtained from published literature and Medicare reimbursement rates. Costs categories consisted of hospital, physician, operating room, pathology, and lymphedema treatment. Effectiveness was defined as 3-year disease-specific survival adjusted for the effect of lymphedema (utility=0.8) on quality of life. A cost-utility analysis was performed comparing the different strategies. Multiple deterministic sensitivity analyses were done. RESULTS: In the base-case scenario, routine lymphadenectomy had a cost of $18,041 and an effectiveness of 2.79 quality-adjusted life-years (QALYs). Selective lymphadenectomy had a cost of $17,036 and an effectiveness of 2.81 QALYs, whereas sentinel lymph node mapping had a cost of $16,401 and an effectiveness of 2.87 QALYs. With a difference of $1,005 and 0.02 QALYs, selective lymphadenectomy was both less costly and more effective than routine lymphadenectomy, dominating it. However, with the lowest cost and highest effectiveness, sentinel lymph node mapping dominated the other modalities and was the most cost-effective strategy. These findings were robust to multiple sensitivity analyses varying the rates of lymphedema and lymphadenectomy, surgical approach (open or minimally invasive surgery), lymphedema utility, and costs. For the estimated 40,000 women undergoing surgery for low-risk endometrial carcinoma each year in the United States, the annual cost of routine lymphadenectomy, selective lymphadenectomy, and sentinel lymph node mapping would be $722 million, $681 million, and $656 million, respectively. CONCLUSION: Compared with routine and selective lymphadenectomy, sentinel lymph node mapping had the lowest costs and highest quality-adjusted survival, making it the most cost-effective strategy in the management of low-risk endometrial carcinoma.

Prospective assessment of patient-reported outcomes in gynecologic cancer patients before and after pelvic exenteration.

OBJECTIVE: Pelvic exenteration (PE) is a surgical procedure associated with significant morbidity offered to select women with locally advanced or recurrent gynecologic cancers. This ongoing study examines an array of patient-reported outcomes and satisfaction with PE. METHODS: Since February 2009, prospectively enrolled participants completed questionnaires evaluating body image (BIS), depression (CESD), social support (DUFSS), symptoms (MDASI), sexual function (SAQ), functional status (SF-12), quality of life (The Stoma-QOL), satisfaction with decision (SWD) and an investigator-designed survey at baseline, 6, and 12months after PE. Mann-Whitney and Wilcoxon signed-rank tests were used to evaluate the data. RESULTS: Fifty-four women enrolled. Median age was 56years (31, 85). Median BMI was 30.7kg/m2 (16.8, 54.4). The majority of patients (78%) were white. Cancer diagnoses included 41% cervix, 22% uterus, 19% vagina, 17% vulva and 2% ovary. Most surgeries were total PEs (76%). Patients were satisfied with their decision to undergo PE at 6 and 12months. One year after exenteration, 79% of women stated they would have a PE again. Sexual pleasure decreased from baseline to 12months after PE (p=0.02), while sexual discomfort remained unchanged (p=0.42). Body image worsened over time (p=0.003). Physical functioning (SF-12) declined (p=0.001), while mental functioning remained stable (p=0.46). There were no significant changes in stoma-related QOL, social support, or depression scores. CONCLUSIONS: Despite a decrease in physical functioning, persistent low body image and sexual pleasure, most women were satisfied with their decision and would undergo pelvic exenteration again. This study identifies survivorship issues that should be addressed after PE.

Impact of body mass index and operative approach on surgical morbidity and costs in women with endometrial carcinoma and hyperplasia.

OBJECTIVE: To assess the impact of body mass index (BMI) and operative approach on surgical morbidity and costs in patients with endometrial carcinoma (EC) and hyperplasia (EH). METHODS: All women with BMI data who underwent surgery for EC or EH from 2008 to 2014 were identified from MarketScan, a healthcare claims database. Differences in 30-day complications and costs were compared between BMI groups and stratified by surgical modality. RESULTS: Of 1112 patients, 35%, 36%, and 29% had a BMI of ≤29, 30-39, and ≥40kg/m2, respectively. Compared to patients with a BMI of 30-39 and ≤29, women with a BMI ≥40 had higher rates of venous thromboembolism (3% vs 0.2% vs 0.3%, p<0.01) and wound infection (7% vs 3% vs 3%, p=0.02). This increase was driven by the subset of patients who had laparotomy and was not seen in those undergoing minimally invasive surgery (MIS). Median total costs for women with a BMI ≥40, 30-39, and ≤29 were U.S. $17.3k, $16.8k, and $16.6k respectively (p=0.53). Costs were higher for patients who had laparotomy than those who had MIS across all BMI groups, with the cost difference being highest in morbidly obese women (≥40: $21.6k vs $14.9k, p<0.01; 30-39: $18.9k vs $16.1k, p=0.01; ≤29: $19.3k vs $15k, p<0.01). Patients who had complications had higher costs compared to those who did not, with a higher cost difference in the laparotomy group ($27.7k vs $16.4k, p<0.01) compared to the MIS group ($19.9k vs $15k, p<0.01). CONCLUSIONS: MIS may increase the value of care by minimizing complications and decreasing costs. This may be most pronounced in morbidly obese women.

Feasibility of a reduced field-of-view diffusion-weighted (rFOV) sequence in assessment of myometrial invasion in patients with clinical FIGO stage I endometrial cancer.

PURPOSE: To compare the clinical usefulness of reduced field-of-view diffusion-weighted imaging (rFOV) with other imaging techniques in determining the depth of myometrial invasion (DMI) in endometrial cancer. MATERIALS AND METHODS: In this prospective study we reviewed 3T magnetic resonance images of 51 patients with clinical Stage I endometrial cancer who underwent total abdominal hysterectomy with bilateral salphingoopherectomy within 3 days after imaging. rFOV with apparent diffusion coefficient reconstruction was obtained in three standard planes followed by sagittal T2 -weighted (T2 WI) images and 3D dynamic T1 -weighted and contrast-enhanced imaging (DCE MRI). Two radiologists with expertise in imaging gynecologic cancers evaluated images independently. The DMI was recorded on imaging and correlated with surgical pathology results. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for DMI were calculated (<50% vs. >50%). RESULTS: Compared with sagittal T2 WI + DCE MRI, rFOV imaging yielded greater specificity (82.2% vs. 90.0%, positive predictive value (42.8% vs. 60.0%), and accuracy (84.0% vs. 92%) for DMI determined by reader 1 and greater the sensitivity (83.3% vs. 100%) for DMI determined by reader 2. The error of measurement of DMI as a continuous variable in millimeters did not differ significantly between the rFOV and pathology results (P < 0.21). However, there was a statistically significant difference for the DMI measured on the dynamic sequence. The DMI on DCE was greater than that seen on pathology at P = 0.02. CONCLUSION: rFOV can be used to assess DMI in clinical Stage I endometrial cancer.

Successful incorporation of robotic surgery into gynecologic oncology fellowship training.

BACKGROUND: The increasing role of robotic surgery in gynecologic oncology may impact fellowship training. The purpose of this study was to review the proportion of robotic procedures performed by fellows at the console, and compare operative times and lymph node yields to faculty surgeons. METHODS: A prospective database of women undergoing robotic gynecologic surgery has been maintained since 2008. Intra-operative datasheets completed include surgical times and primary surgeon at the console. Operative times were compared between faculty and fellows for simple hysterectomy (SH), bilateral salpingo-oophorectomy (BSO), pelvic (PLND) and paraaortic lymph node dissection (PALND) and vaginal cuff closure (VCC). Lymph nodes counts were also compared. RESULTS: Times were recorded for 239 SH, 43 BSOs, 105 right PLNDs, 104 left PLNDs, 34 PALND and 269 VCC. Comparing 2008 to 2011, procedures performed by the fellow significantly increased; SH 16% to 83% (p<0.001), BSO 7% to 75% (p=0.005), right PLND 4% to 44% (p<0.001), left PLND 0% to 56% (p<0.001), and VCC 59% to 82% (p=0.024). Console times (min) were similar for SH (60 vs. 63, p=0.73), BSO (48 vs. 43, p=0.55), and VCC (20 vs. 22, p=0.26). Faculty times (min) were shorter for PLND (right 26 vs. 30, p=0.04, left 23 vs. 27, p=0.02). Nodal counts were not significantly different (right 7 vs. 8, p=0.17 or left 7 vs. 7, p=0.87). CONCLUSIONS: Robotic surgery can be successfully incorporated into gynecologic oncology fellowship training. With increased exposure to robotic surgery, fellows had similar operative times and lymph node yields as faculty surgeons.

Unverifiable accomplishments and publications on applications for gynecologic oncology fellowships.

OBJECTIVE: Selection of physicians for fellowships in obstetrics and gynecology subspecialties has become increasingly competitive. The number and quality of research publications is an important factor in the selection process. We sought to estimate the incidence of unverifiable publications among gynecologic oncology fellowship applicants. METHODS: We reviewed the applications to a single gynecologic oncology fellowship program during 2004-2008. Articles and book chapters reported as published, in press, submitted, or in progress were searched for systematically by three reviewers using PubMed and Google. χ2 analysis was used to evaluate associations between demographic factors and unverifiable publications. RESULTS: Two hundred forty-three applications met the inclusion criteria. Of the 35 applicants who listed membership in Alpha Omega Alpha, four (11%) were not listed on the organization's web site as inductees. Of the 464 articles reported as published or in press, only 387 (83%) could be verified. Of the 148 applicants who reported at least one published or in press article, 44 (30%) had at least one unverifiable publication. On multivariable analysis, only male gender increased the likelihood of unverifiable ("ghost") publications (odds ratio 2.1, 95% confidence interval 1.1-4.1). Of the 282 manuscripts reported as submitted or in progress, only 126 (45%) were published. Of the 124 applicants who reported at least one submitted or in progress manuscript, 88 (71%) had at least one unverifiable manuscript. CONCLUSION: The proportion of unverifiable publications listed on gynecologic oncology fellowship applications is concerning. Stringent review of applications before interview invitations and match list submission is warranted.

Laparoscopy training in gynecologic oncology fellowship programs.

OBJECTIVE: To assess the adequacy of laparoscopic surgical training as perceived by gynecologic oncology fellows-in-training and to compare current opinions to those on a 2003 survey. STUDY DESIGN: Fellows were surveyed via mail or an internet website. RESULTS: Seventy-eight (64%) of 121 fellows responded. One-hundred percent now state that laparoscopy is important or very important in gynecologic oncology practice compared to 86% in 2003. Ninety-five percent reported that much or maximum emphasis should be placed on laparoscopic training compared to 70% previously. Currently, 69% believe that their fellowship training in laparoscopy is very good or good compared to only 25% who felt this way 4 years ago. Importantly, fellows now believe they are getting better laparoscopic training in fellowship than they did in residency. Seventy-eight percent stated that their perceived laparoscopic skills were good or very good. Upon completion of fellowship, 94% plan to perform >/=6 cases per month laparoscopically. CONCLUSIONS: Respondents believe that laparoscopic training should be emphasized in fellowship training and perceive their laparoscopic training to be significantly improved compared to 2003. They also envision a key role for laparoscopy in their future practice.

A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer.

STUDY OBJECTIVE: Cervical cancer is a significant health problem in countries of the developing world. Although case series suggest advantages of total laparoscopic radical hysterectomy (TLRH) compared with total abdominal radical hysterectomy (TARH), no randomized controlled trial is currently available to establish TLRH as the new standard treatment. In this study, TLRH or total robotic radical hysterectomy (TRRH) will be performed without a vaginally assisted portion of the procedure. DESIGN: A biphasic randomized controlled trial was designed to test feasibility of recruitment and equivalence in regard to disease-free survival (Canadian Task Force classification I). SETTING: Tertiary referral hospital. PATIENTS: Patients with histologically confirmed invasive squamous cell carcinoma or adenocarcinoma of the cervix, stage IA1 (with lymphovascular space invasion), IA2, and IB1 are eligible. INTERVENTIONS: During the first phase, 100 patients will be randomized (1:1) to receive either TLRH/TRRH or TARH, with the primary end point being the rate of enrollment. During the second phase, recruitment will be extended by another 640 patients in a 1:1 TLRH/TRRH:TARH allocation, to determine equivalence with respect to disease-free survival with 80% power and alpha=0.05. MEASUREMENTS AND MAIN RESULTS: Equivalence will be assumed if the difference in disease-free survival does not exceed 7% at 4 years. Secondary outcomes include treatment-related morbidity, costs and cost effectiveness, patterns of recurrence, quality of life, pelvic floor function, feasibility of intraoperative sentinel node sampling, and overall survival. All data from this multicenter study will be entered using online electronic case report forms, allowing real-time assessment of data completeness and patient follow-up. CONCLUSION: This prospective trial aims to show the equivalence of a TLRH/TRRH versus TARH approach for patients with early stage cervical cancer following a 2-phase protocol. This trial was developed and designed with the input and approval of the members of the Gynecologic Oncology Committee from the American Association of Gynecologic Laparoscopists.