Cost-effectiveness of laparoscopic disease assessment in patients with newly diagnosed advanced ovarian cancer.

OBJECTIVE: To determine if laparoscopy is a cost-effective way to assess disease resectability in patients with newly diagnosed advanced ovarian cancer. METHODS: A cost-effectiveness analysis from a health care payer perspective was performed comparing two strategies: (1) a standard evaluation strategy, where a conventional approach to treatment planning was used to assign patients to either primary cytoreduction (PCS) or neoadjuvant chemotherapy with interval cytoreduction (NACT), and (2) a laparoscopy strategy, where patients considered candidates for PCS would undergo laparoscopy to triage between PCS or NACT based on the laparoscopy-predicted likelihood of complete gross resection. A microsimulation model was developed that included diagnostic work-up, surgical and adjuvant treatment, perioperative complications, and progression-free survival (PFS). Model parameters were derived from the literature and our published data. Effectiveness was defined in quality-adjusted PFS years. Results were tested with deterministic and probabilistic sensitivity analysis (PSA). The willingness-to-pay (WTP) threshold was set at $50,000 per year of quality-adjusted PFS. RESULTS: The laparoscopy strategy led to additional costs (average additional cost $7034) but was also more effective (average 4.1 months of additional quality-adjusted PFS). The incremental cost-effectiveness ratio (ICER) of laparoscopy was $20,376 per additional year of quality-adjusted PFS. The laparoscopy strategy remained cost-effective even as the cost added by laparoscopy increased. The benefit of laparoscopy was influenced by mitigation of serious complications and their associated costs. The laparoscopy strategy was cost-effective across a range of WTP thresholds. CONCLUSIONS: Performing laparoscopy is a cost-effective way to improve primary treatment planning for patients with untreated advanced ovarian cancer.

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.

Movement of Poly-ADP Ribose (PARP) Inhibition into Frontline Treatment of Ovarian Cancer.

The use of poly (ADP-ribose) polymerase (PARP) inhibitors in the front-line management of advanced ovarian cancer has recently emerged as an exciting strategy with the potential to improve outcomes for patients with advanced ovarian cancer. In this article, we review the results of four recently published Phase III randomised controlled trials evaluating the use of PARP inhibitors in the primary treatment of ovarian cancer (SOLO1, PRIMA, PAOLA-1, and VELIA). Collectively, the studies suggest that PARP maintenance in the upfront setting is most beneficial among patients with BRCA-associated ovarian cancers (hazard ratios range from 0.31 to 0.44), followed by patients with tumours that harbour homologous recombination deficiencies (hazard ratios range from 0.33 to 0.57). All three studies that included an all-comer population were able to demonstrate benefit of PARP inhibitors, regardless of biomarker status. The FDA has approved olaparib for front-line maintenance therapy among patients with BRCA-associated ovarian cancers, and niraparib for all patients, regardless of biomarker status. In determining which patients should be offered front-line maintenance PARP inhibitors, and which agent to use, there are multiple factors to consider, including FDA indication, dosing preference, toxicity, risks versus benefits for each patient population, and cost. There are ongoing studies further exploring the front-line use of PARP inhibitors, including the potential downstream effects of PARP-inhibitor resistance in the recurrent setting, combining PARP-inhibitors with other anti-angiogenic drugs, immunotherapeutic agents, and inhibitors of pathways implicated in PARP inhibitor resistance.

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.

Understanding the role of advanced practice providers in oncology in the United States.

PURPOSE: Advanced practice providers (APPs, which include NPs and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all APPs in oncology and, second, to understand personal and practice characteristics (including compensation) of those APPs. METHODS: We identified APPs who practice oncology from membership and claims data. We surveyed 3,055 APPs about their roles in clinical care. RESULTS: We identified at least 5,350 APPs in oncology and an additional 5,400 who might practice oncology. Survey respondents totaled 577 out of 3,055, which provided a 19% response rate. Results focused on 540 NPs and PAs. Greater than 90% reported satisfaction with career choice. Respondents identified predominately as white (89%) and female (94%). NPs and PAs spent the majority (80%) of time in direct patient care. The top four patient care activities were patient counseling (NPs, 94%; PAs, 98%), prescribing (NPs, 93%; PAs, 97%), treatment management (NPs, 89%; PAs, 93%), and follow-up visits (NPs, 81%; PAs, 86%). A majority of all APPs reported both independent and shared visits (65% hematology/oncology/survivorship/prevention/pediatric hematology/oncology; 85% surgical/gynecologic oncology; 78% radiation oncology). A minority of APPs reported that they conducted only shared visits. Average annual compensation was between $113,000 and $115,000, which is about $10,000 higher than average pay for APPs not in oncology. CONCLUSION: We identified 5,350 APPs in oncology and conclude that number may be as high as 7,000. Survey results suggest that practices that incorporate APPs routinely rely on them for patient care. Given the increasing number of patients with and survivors of cancer, APPs are important to ensure access to quality cancer care now and in the future.

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.

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.

Social factors affecting treatment of cervical cancer: ethical issues and policy implications.

Health care in the United States has become a privilege rather than a right. Patients who have the greatest need are the ones most likely to be denied this privilege. Despite recent advances in disease detection and treatment, many patients do not receive even the bare minimum of care. The high complexity of the health care system in the setting of patients with low levels of health literacy significantly affects the ability to seek and receive treatment in a timely fashion. In addition, lack of insurance, transportation, and social support further complicate access to care. To truly provide a standard of care to all patients, regardless of resources, our health care system must evolve to address the needs of the population. In this paper, we report a tragic case where social factors affected the outcome of a single mother with advanced cervical cancer.