Regionalizing ovarian cancer cytoreduction to high-volume centers and the impact on patient travel in New York State.

OBJECTIVE: To evaluate the theoretical impact of regionalizing cytoreductive surgery for ovarian cancer (OC) to high-volume facilities on patient travel. METHODS: We retrospectively identified patients with OC who underwent cytoreduction between 1/1/2004-12/31/2018 from the New York State Cancer Registry and Statewide Planning and Research Cooperative System. Hospitals were stratified by low-volume (<21 cytoreductive surgical procedures for OC annually) and high-volume centers (≥21 procedures annually). A simulation was performed; outcomes of interest were driving distance and time between the centroid of the patient's residence zip code and the treating facility zip code. RESULTS: Overall, 60,493 patients met inclusion criteria. Between 2004 and 2018, 210 facilities were performing cytoreductive surgery for OC in New York; 159 facilities (75.7%) met low-volume and 51 (24.3%) met high-volume criteria. Overall, 10,514 patients (17.4%) were treated at low-volume and 49,979 (82.6%) at high-volume facilities. In 2004, 78.2% of patients were treated at high-volume facilities, which increased to 84.6% in 2018 (P < .0001). Median travel distance and time for patients treated at high-volume centers was 12.2 miles (IQR, 5.6-25.5) and 23.0 min (IQR, 15.2-37.0), and 8.2 miles (IQR, 3.7-15.9) and 16.8 min (IQR, 12.4-26.0) for patients treated at low-volume centers. If cytoreductive surgery was centralized to high-volume centers, median distance and time traveled for patients originally treated at low-volume centers would be 11.2 miles (IQR, 3.8-32.3; P < .001) and 20.2 min (IQR, 13.6-43.0; P < .001). CONCLUSIONS: Centralizing cytoreductive surgery for OC to high-volume centers in New York would increase patient travel burden by negligible amounts of distance and time for most patients.

Incidence and Risk Assessment of Capsular Contracture in Breast Cancer Patients following Post-Mastectomy Radiotherapy and Implant-Based Reconstruction.

Our study aims to identify the risk factors and dosimetry characteristics associated with capsular contracture. METHODS: We retrospectively analyzed 118 women with breast cancer who underwent PMRT following an IBR between 2010 and 2022. Patients were treated with PMRT of 50.0-50.4 Gy in 25-28 fractions. Capsular contracture was categorized according to the Baker Classification for Reconstructed Breasts. RESULTS: After a median follow-up of 22 months, the incidence of clinically relevant capsular contracture (Baker III-IV) was 22.9%. Overall, capsular contracture (Baker I-IV) occurred in 56 patients (47.5%) after a median of 9 months after PMRT. The rate of reconstruction failure/implant loss was 25.4%. In the univariate analysis, postoperative complications (prolonged pain, prolonged wound healing, seroma and swelling) and regional nodal involvement were associated with higher rates of capsular contracture (p = 0.017, OR: 2.5, 95% CI: 1.2-5.3 and p = 0.031, respectively). None of the analyzed dosimetric factors or the implant position were associated with a higher risk for capsular contracture. CONCLUSION: Postoperative complications and regional nodal involvement were associated with an increased risk of capsular contracture following breast reconstruction and PMRT, while none of the analyzed dosimetric factors were linked to a higher incidence. Additional studies are needed to identify further potential risk factors.

Bridging Communication Gaps Between Radiologists, Referring Physicians, and Patients Through Standardized Structured Cancer Imaging Reporting: The Experience with Female Pelvic MRI Assessment Using O-RADS and a Simulated Cohort Patient Group.

RATIONALE AND OBJECTIVES: This study aimed to evaluate whether implementing structured reporting based on Ovarian-Adnexal Reporting and Data System (O-RADS) magnetic resonance imaging (MRI) in women with sonographically indeterminate adnexal masses improves communication between radiologists, referrers, and patients/caregivers and enhances diagnostic performance for determining adnexal malignancy. MATERIALS AND METHODS: We retrospectively analyzed prospectively issued MRI reports in 2019-2022 performed for characterizing adnexal masses before and after implementing O-RADS MRI; 56 patients/caregivers and nine gynecologic oncologists ("referrers") were surveyed about report interpretability/clarity/satisfaction; responses for pre- and post-implementation reports were compared using Fisher's exact and Chi-squared tests. Diagnostic performance was assessed using receiver operating characteristic curves. RESULTS: A total of 123 reports from before and 119 reports from after O-RADS MRI implementation were included. Survey response rates were 35.7% (20/56) for patients/caregivers and 66.7% (6/9) for referrers. For patients/caregivers, O-RADS MRI reports were clearer (p < 0.001) and more satisfactory (p < 0.001) than unstructured reports, but interpretability did not differ significantly (p = 0.14), as 28.0% (28/100) of postimplementation and 38.0% (38/100) of preimplementation reports were considered difficult to interpret. For referrers, O-RADS MRI reports were clearer, more satisfactory, and easier to interpret (p < 0.001); only 1.3% (1/77) were considered difficult to interpret. For differentiating benign from malignant adnexal lesions, O-RADS MRI showed area under the curve of 0.92 (95% confidence interval [CI], 0.85-0.99), sensitivity of 0.81 (95% CI, 0.58-0.95), and specificity of 0.91 (95% CI, 0.83-0.96). Diagnostic performance of reports before implementation could not be calculated due to many different phrases used to describe the likelihood of malignancy. CONCLUSION: Implementing standardized structured reporting using O-RADS MRI for characterizing adnexal masses improved clarity and satisfaction for patients/caregivers and referrers. Interpretability improved for referrers but remained limited for patients/caregivers.

Cost-effectiveness of hyperthermic intraperitoneal chemotherapy at primary cytoreduction of epithelial ovarian cancer based on residual disease status.

Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin when used at the time of interval cytoreductive surgery (ICS) after neoadjuvant chemotherapy (NACT) has been shown to provide a survival advantage compared to interval cytoreduction alone for patients with advanced epithelial ovarian cancer in a cost-effective manner. A recent large multi-center retrospective cohort study showed a survival advantage with HIPEC given during primary debulking surgery compared to surgery alone. While there is an ongoing randomized controlled trial examining HIPEC at the time of primary cytoreductive surgery (PCS) before chemotherapy (OVHIPEC-2), there is currently no study of this practice in the United States or cost data to inform incorporation of this practice. To help guide the use of HIPEC in the upfront setting until the results of the OVHIPEC-2 are available in 2026, a decision-analytic cost-effectiveness model of the US healthcare sector was developed for patients undergoing PCS with or without HIPEC. Effectiveness inputs were extracted from a Chinese retrospective cohort study of 425 patients who underwent PCS with HIPEC and 159 patients who underwent PCS alone. We found incremental cost effectiveness ratios (ICER) of $9,789 per life year saved (LYS) for optimal PCS, $18,164/LYS for suboptimal PCS, and $7,854/LYS for all patients. Our findings provide preliminary data to support that HIPEC at the time of primary cytoreductive surgery can be considered cost-effective regardless of residual disease status when using a standard willingness to pay threshold.

Assessment of wound perfusion with near-infrared angiography: A prospective feasibility study.

OBJECTIVE: To assess the feasibility of quantitatively measuring skin perfusion before and after suture or staple skin closure of vertical laparotomies using indocyanine green (ICG) uptake with near-infrared angiography. METHODS: This was a prospective, non-randomized feasibility study of patients undergoing surgery with a gynecologic oncology service from 2/2018-8/2019. Feasibility was defined as the ability to quantitatively measure ICG uptake adjacent to the wound at the time of skin closure in ≥ 80% of patients. Patients were assigned suture or staple skin closure in a sequential, non-randomized fashion. Skin perfusion was recorded using a near-infrared imaging system after ICG injection and measured by video analysis at predefined points before and after skin closure. Clinicodemographic, pre- and intraoperative details, and surgical secondary events were recorded. RESULTS: Of 20 participants, 10 were assigned staple closure and 10 suture closure. Two patients (10%) achieved objective quantification of ICG fluorescence before and after laparotomy closure, failing the predefined feasibility threshold of ≥ 80%. Reasons for failed quantification included overexposure (12), insufficient ICG signal uptake (6), and insufficient video quality (2). Near-infrared angiography wound perfusion was subjectively appreciated intraoperatively in 85% (17/20) of patients before and after wound closure. CONCLUSIONS: Objective assessment of laparotomy skin closure with near-infrared angiography-measured perfusion did not meet the pre-specified feasibility threshold. Adjustments to the protocol to minimize overexposure may be warranted. The ability to subjectively appreciate ICG perfusion with near-infrared angiography suggests a possible role for near-infrared angiography in the real-time intraoperative assessment of wound perfusion, particularly in high-risk patients.

Risk factors for financial toxicity in patients with gynecologic cancer.

BACKGROUND: The cost of cancer care is high and rising. Evidence of increased patient cost burden is prevalent in the medical literature and has been defined as "financial toxicity," the financial hardship and financial concerns experienced by patients because of a disease and its related treatments. With targeted therapies and growing out-of-pocket costs, patient financial toxicity is a growing concern among patients with gynecologic cancer. OBJECTIVE: This study aimed to determine the prevalence of financial toxicity and identify its risk factors in patients with gynecologic cancer treated at a large cancer center using objective data. STUDY DESIGN: Using institutional databases, we identified patients with gynecologic cancer treated from January 2016 to December 2018. Patients with a preinvasive disease were excluded. Financial toxicity was defined according to institutionally derived metrics as the presence of ≥1 of the following: ≥2 bills sent to collections, application or granting of a payment plan, settlement, bankruptcy, financial assistance program enrollment, or a finance-related social work visit. Clinical characteristics were gathered using a 2-year look-back from the time of the first financial toxicity event or a randomly selected treatment date for those not experiencing toxicity. Risk factors were assessed using chi-squared tests. All significant variables on univariate analysis were included in the logistic regression model. RESULTS: Of the 4655 patients included in the analysis, 1155 (25%) experienced financial toxicity. In the univariate analysis, cervical cancer (35%), stage 3 or 4 disease (24% and 30%, respectively), younger age (35% for age <30 years), nonpartnered marital status (31%), Black (45%) or Hispanic (37%) race and ethnicity, self-pay (48%) or commercial insurance (30%), clinical trial participation (31%), more imaging studies (39% for ≥9), ≥1 emergency department visit (36%), longer inpatient stays (36% for ≥20 days), and more outpatient clinician visits (41% for ≥20 visits) were significantly associated with financial toxicity (P<.01). In multivariate analysis, younger age, nonpartnered marital status, Black and Hispanic race and ethnicity, commercial insurance, more imaging studies, and more outpatient physician visits were significantly associated with financial toxicity. CONCLUSION: Financial toxicity is an increasing problem for patients with gynecologic cancer. Our analysis, using objective measures of financial toxicity, has suggested that demographic factors and healthcare utilization metrics may be used to proactively identify at-risk patients for financial toxicity.

Society of Gynecologic Oncology Future of Physician Payment Reform Task Force report: The Endometrial Cancer Alternative Payment Model (ECAP).

Health care in the United States is in the midst of a significant transformation from a "fee for service" to a "fee for value" based model. The Medicare Access and CHIP Reauthorization Act of 2015 has only accelerated this transition. Anticipating these reforms, the Society of Gynecologic Oncology developed the Future of Physician Payment Reform Task Force (PPRTF) in 2015 to develop strategies to ensure fair value based reimbursement policies for gynecologic cancer care. The PPRTF elected as a first task to develop an Alternative Payment Model for thesurgical management of low risk endometrial cancer. The history, rationale, and conceptual framework for the development of an Endometrial Cancer Alternative Payment Model are described in this white paper, as well as directions forfuture efforts.

A multicenter assessment of the ability of preoperative computed tomography scan and CA-125 to predict gross residual disease at primary debulking for advanced epithelial ovarian cancer.

OBJECTIVE: To assess the ability of preoperative computed tomography scan and CA-125 to predict gross residual disease (RD) at primary cytoreduction in advanced ovarian cancer. METHODS: A prospective, non-randomized, multicenter trial of patients who underwent primary debulking for stage III-IV epithelial ovarian cancer previously identified 9 criteria associated with suboptimal (>1cm residual) cytoreduction. This is a secondary post-hoc analysis looking at the ability to predict any RD. Four clinical and 18 radiologic criteria were assessed, and a multivariate model predictive of RD was developed. RESULTS: From 7/2001-12/2012, 350 patients met eligibility criteria. The complete gross resection rate was 33%. On multivariate analysis, 3 clinical and 8 radiologic criteria were significantly associated with the presence of any RD: age≥60years (OR=1.5); CA-125≥600U/mL (OR=1.3); ASA 3-4 (OR=1.6); lesions in the root of the superior mesenteric artery (OR=4.1), splenic hilum/ligaments (OR=1.4), lesser sac >1cm (OR=2.2), gastrohepatic ligament/porta hepatis (OR=1.4), gallbladder fossa/intersegmental fissure (OR=2); suprarenal retroperitoneal lymph nodes (OR=1.3); small bowel adhesions/thickening (OR=1.1); and moderate-severe ascites (OR=2.2). All ORs were significant with p<0.01. A 'predictive score' was assigned to each criterion based on its multivariate OR, and the rate of having any RD for patients who had a total score of 0-2, 3-5, 6-8, and ≥9 was 45%, 68%, 87%, and 96%, respectively. CONCLUSIONS: We identified 11 criteria associated with RD, and developed a predictive model in which the rate of having any RD was directly proportional to a predictive score. This model may be helpful in treatment planning.

Impact of Robotic Platforms on Surgical Approach and Costs in the Management of Morbidly Obese Patients with Newly Diagnosed Uterine Cancer.

BACKGROUND: Minimally invasive surgery (MIS) is associated with decreased complication rates, length of hospital stay, and cost compared with laparotomy. Robotic-assisted surgery-a method of laparoscopy-addresses many of the limitations of standard laparoscopic instrumentation, thus leading to increased rates of MIS. We sought to assess the impact of robotics on the rates and costs of surgical approaches in morbidly obese patients with uterine cancer. METHODS: Patients who underwent primary surgery at our institution for uterine cancer from 1993 to 2012 with a BMI ≥40 mg/m(2) were identified. Surgical approaches were categorized as laparotomy (planned or converted), laparoscopic, robotic, or vaginal. We identified two time periods based on the evolving use of MIS at our institution: laparoscopic (1993-2007) and robotic (2008-2012). Direct costs were analyzed for cases performed from 2009 to 2012. RESULTS: We identified 426 eligible cases; 299 performed via laparotomy, 125 via MIS, and 2 via a vaginal approach. The rates of MIS for the laparoscopic and robotic time periods were 6 % and 57 %, respectively. The rate of MIS was 78 % in this morbidly obese cohort in 2012; 69 % were completed robotically. The median length of hospital stay was 5 days (range 2-37) for laparotomy cases and 1 day (range 0-7) for MIS cases (P < 0.001). The complication rate was 36 and 15 %, respectively (P < 0.001). The rate of wound-related complications was 27 and 6 %, respectively (P < 0.001). Laparotomy was associated with the highest cost. CONCLUSIONS: The robotic platform provides significant health and cost benefits by increasing MIS rates in this patient population.

Incidence and management of bevacizumab-associated gastrointestinal perforations in patients with recurrent ovarian carcinoma.

OBJECTIVE: The objective of this study was to examine the incidence and management of bevacizumab-associated gastrointestinal (GI) perforations in patients with recurrent ovarian carcinoma. METHODS: We identified all patients who received bevacizumab off protocol from August 2004-August 2008. We examined their medical records for reports of confirmed GI perforation, associated clinicopathological factors, treatment, and outcomes. RESULTS: Six (4%) of 160 patients with ovarian carcinoma who had been treated with bevacizumab developed GI perforations, with a median of 4 (range, 2-8) previous cytotoxic regimens. The median serum CA-125 at the start of treatment was 228 U/mL (range, 50-3106 U/mL). The median number of bevacizumab cycles prior to perforation was 10.5 (range, 2-20). The median time from the last bevacizumab dose to diagnosis of GI perforation was 13 days (range, 1-28 days). Four (67%) patients underwent an exploratory surgery. At laparotomy, one had a gastric perforation and one had an appendiceal perforation; the site of perforation could not be identified in the other 2 Two patients (33%) were managed conservatively-one with a PEG tube and the other with supportive care. The median time of death from the date of diagnosis of GI perforation was 27 days (range, 4-326 days). Only two patients-one with a gastric and the other with an appendiceal perforation-survived >65 days. The 30-day mortality rate following a bevacizumab-associated GI perforation was 50%. CONCLUSION: Bevacizumab-associated GI perforations in patients with recurrent ovarian carcinoma occurred in 4% of our patients. The prognosis of patients diagnosed with bevacizumab-associated GI perforations in this study was poor, and treatment should be individualized.

Prognostic factors for patients with stage IV epithelial ovarian cancer receiving intraperitoneal chemotherapy after second-look assessment: results of long-term follow-up.

BACKGROUND: The aim was to determine the long-term outcome for patients with FIGO stage IV epithelial ovarian carcinoma (EOC) treated with intraperitoneal (IP) chemotherapy after second-look assessment. METHODS: By using data from a retrospective cohort of 433 patients who received IP therapy after second-look assessment after primary surgery and initial systemic therapy for EOC between 1984 and 1998 at our institution, all FIGO stage IIIC and IV patients were identified. Standard statistical methods were used. RESULTS: Overall, 297 patients met study criteria (246 stage IIIC; 51 stage IV). The median survival for patients with stage IV disease was 34 months compared with 42 months for patients with stage IIIC disease (P=.02). The only significant predictor of overall survival in patients with stage IV disease was the presence of gross residual disease at initiation of IP therapy (P=.027). When comparing stage IV patients with and without pleural effusions to all stage IIIC patients, there was a significant trend toward improved survival in the patients with pleural effusions only compared with other stage IV patients (P=.01). CONCLUSIONS: Prolonged overall survival was observed in patients with no gross residual disease at the time of IP chemotherapy initiation. When compared with similarly treated stage IIIC patients, stage IV patients with malignant pleural effusions appear to have a better outcome than those with other sites of metastasis. Future prospective trials should evaluate the use of IP therapy for patients with stage IV EOC by virtue of malignant pleural effusions only who responded to initial systemic therapy.