Laura Havrilesky

OBJECTIVE(S): Risk-stratified thromboprophylaxis is recommended for oncology patients with a Khorana risk score (KS) ≥ 2 receiving cancer-directed therapy. We describe a quality improvement (QI) initiative designed to increase adherence to thromboprophylaxis guidelines for patients with gynecologic malignancies initiating outpatient treatment. METHODS: Provider awareness and documentation of venous thromboembolism (VTE) risk assessment and thromboprophylaxis eligibility were identified as key QI drivers. Starting May 2021, a KS calculator and thromboprophylaxis algorithm were incorporated into outpatient documentation templates. Patients with gynecologic malignancies initiating outpatient therapy from January - December 2021 were eligible. The primary process measure was the percentage of patients with KS eligibility documented each month during the baseline (Jan - Apr) versus implementation (May - Dec) periods. Rate of appropriate thromboprophylaxis initiation and incidence of VTE served as outcome measures. Incidence of adverse bleeding events served as the balancing measure. RESULTS: 337 patients accounted for the initiation of 383 treatment regimens, including 128 in the baseline period and 255 in the implementation period. KS documentation increased significantly between the baseline and implementation periods (7% vs 62.4%, p < 0.001). 73 of the 177 eligible patients (46.2%; 166 unique patients) had appropriate documentation; of these, 57 initiated thromboprophylaxis. There was no difference in VTE rates or adverse bleeding events between eligible patients who initiated thromboprophylaxis compared with those who did not (12.3% vs 15.6%; p = 0.65 and 7.0% vs 8.2%; p = 1.0, respectively). CONCLUSION(S): This QI initiative resulted in greater adherence to risk-stratified thromboprophylaxis guidelines. No bleeding signals were identified. Studies addressing cost, medication adherence, and long-term outcomes are necessary.

OBJECTIVES: Patients with recurrent platinum-resistant ovarian cancer often present with inoperable malignant bowel obstruction (MBO) from a large burden of abdominal disease. Interventions such as total parenteral nutrition (TPN) and chemotherapy may be used in this setting. We aim to describe the relative cost-effectiveness of these interventions to inform clinical decision making. METHODS: Four strategies for management of platinum-resistant recurrent ovarian cancer with inoperable MBO were compared from a societal perspective using a Monte Carlo simulation: (1) hospice, (2) TPN, (3) chemotherapy, and (4) TPN + chemotherapy. Survival, hospitalization rates, end-of-life (EOL) setting, and MBO-related utilities were obtained from literature review: hospice (survival 38 days, 6% hospitalization), chemotherapy (42 days, 29%), TPN (55 days, 25%), TPN + chemotherapy (74 days, 47%). Outcomes were the average cost per strategy and incremental cost-effectiveness ratios (ICERs) in US dollars per quality-adjusted life year (QALY) gained. RESULTS: In the base case scenario, TPN + chemotherapy was the most costly strategy (mean; 95% CI) ($49,741; $49,329-$50,162) and provided the highest QALYs (0.089; 0.089-0.090). The lowest cost strategy was hospice ($14,591; $14,527-$14,654). The TPN alone and chemotherapy alone strategies were dominated by a combination of hospice and TPN + chemotherapy. The ICER of TPN + chemotherapy was $918,538/QALY compared to hospice. With a societal willingness to pay threshold of $150,000/QALY, hospice was the strategy of choice in 71.6% of cases, chemotherapy alone in 28.4%, and TPN-containing strategies in 0%. CONCLUSIONS: TPN with or without chemotherapy is not cost-effective in management of inoperable malignant bowel obstruction and platinum-resistant ovarian cancer.

Objectives: A risk assessment model for metastasis in endometrioid endometrial cancer (EEC) was developed using molecular and clinical features, and prognostic association was examined. Methods: Patients had stage I, IIIC, or IV EEC with tumor-derived RNA-sequencing or microarray-based data. Metastasis-associated transcripts and platform-centric diagnostic algorithms were selected and evaluated using regression modeling and receiver operating characteristic curves. Results: Seven metastasis-associated transcripts were selected from analysis in the training cohorts using 10-fold cross validation and incorporated into an MS7 classifier using platform-specific coefficients. The predictive accuracy of the MS7 classifier in Training-1 was superior to that of other clinical and molecular features, with an area under the curve (95% confidence interval) of 0.89 (0.80-0.98) for MS7 compared with 0.69 (0.59-0.80) and 0.71 (0.58-0.83) for the top evaluated clinical and molecular features, respectively. The performance of MS7 was independently validated in 245 patients using RNA sequencing and in 81 patients using microarray-based data. MS7 + MI (myometrial invasion) was preferrable to individual features and exhibited 100% sensitivity and negative predictive value. The MS7 classifier was associated with lower progression-free and overall survival (p ≤ 0.003). Conclusion: A risk assessment classifier for metastasis and prognosis in EEC patients with primary tumor derived MS7 + MI is available for further development and optimization as a companion clinical support tool.

OBJECTIVE: Scoring systems have been developed to identify low risk patients with febrile neutropenia (FN) who may be candidates for outpatient management. We sought to validate the predictive accuracy of the Clinical Index of Stable Febrile Neutropenia (CISNE) score alone and in conjunction with alternative scoring systems for risk of complications among gynecologic oncology patients. METHODS: We conducted a single institution retrospective cohort study of patients admitted to an academic gynecologic oncology service for FN. We examined the performance characteristics (sensitivity, specificity, positive and negative predictive value) of three scoring systems (Multinational Association of Supportive Care in Cancer (MASCC), CISNE cut-off 1 (Low risk = 0), CISNE cut-off 2 (Low risk = <3)), and the combination of MASCC and CISNE to predict complications: inpatient death, ICU admission, hypotension, respiratory/renal failure, mental status change, cardiac failure, bleeding, and arrhythmia. RESULTS: Fifty patients were identified for study inclusion. No low-risk CISNE patients died during hospitalization. Fewer CISNE low-risk patients experienced complications compared to high-risk patients, regardless of cut-off. Sensitivity, specificity, positive and negative predictive values of the scoring systems were: CISNE 1-37.1%, 86.7%, 86.7%, 37.1%; CISNE 2-85.7%, 46.7%, 78.9%, 58.3%; MASCC-82.9%, 66.7%, 85.3%, 62.5%; MASCC + CISNE 1-37.1%, 93.3%, 92.9%, 38.9%; MASCC + CISNE 2-80%, 73.3%, 87.5%, 61.1%. CONCLUSIONS: The CISNE scoring system is an appropriate tool for the identification of patients with gynecologic cancers and FN who may benefit from close outpatient management. CISNE cut-off 2 performed comparably to the MASCC, but CISNE cut-off 1 had a higher specificity and positive predictive value.