Laura Havrilesky

Overview:

I am interested in using health economic models to inform decisions related to gynecologic cancers. Specific models have addressed the decision to administer intraperitoneal chemotherapy for newly diagnosed advanced ovarian cancer following optimal cytoreduction, the choice of chemotherapy regimen for recurrent platinum-sensitive ovarian cancer, and the exploration of screening strategies for ovarian cancer. The ovarian cancer screening model examines the effects of test cost, sensitivity, specificity, and screen frequency on ovarian cancer mortality, the lifetime false positive rate of testing, the positive predictive value of the test, and its cost effectiveness. This type of model is potentially useful in informing the design trials of novel screening tests for ovarian cancer. I am also conducting a prospective study to quantify the effects of screening for, diagnosis of, and treatment for ovarian cancer on the quality of life of women.

Positions:

Professor of Obstetrics and Gynecology

Obstetrics and Gynecology, Gynecologic Oncology
School of Medicine

Professor in Population Health Sciences

Population Health Sciences
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 1995

Duke University

Residency, Obstetrics And Gynecology

Duke University

Gynecology Oncology Fellowship, Obstetrics And Gynecology

Duke University School of Medicine

Grants:

Tissue and Data Acquisition Activity for the Study of Gynecologic Disease

Administered By
Obstetrics and Gynecology, Gynecologic Oncology
Awarded By
Henry M. Jackson Foundation
Role
Principal Investigator
Start Date
End Date

Tissue and Data Acquisition Activity for the Study of Gynecologic Disease

Administered By
Obstetrics and Gynecology, Gynecologic Oncology
Awarded By
United States Army Medical Research and Materiel Command
Role
Principal Investigator
Start Date
End Date

Tissue and Data Acquisition Activity for the Study of Gynecologic Disease

Administered By
Obstetrics and Gynecology, Gynecologic Oncology
Role
Principal Investigator
Start Date
End Date

Genomics Tests for Ovarian Cancer Detection and Management

Administered By
Institutes and Centers
Awarded By
Agency for Healthcare Research and Quality
Role
Investigator
Start Date
End Date

Cancer Tx with a PARP Inhibitor VS Standard

Administered By
Duke Clinical Research Institute
Awarded By
TESARO
Role
Co Investigator
Start Date
End Date

Publications:

Surveillance for gestational trophoblastic neoplasia following molar pregnancy: a cost-effectiveness analysis.

<h4>Background</h4>Historically, published guidelines for care after molar pregnancy recommended monitoring human chorionic gonadotropin levels for the development of gestational trophoblastic neoplasia until normal and then for 6 months after the first normal human chorionic gonadotropin. However, there are little data underlying such recommendations, and recent evidence has demonstrated that gestational trophoblastic neoplasia diagnosis after human chorionic gonadotropin normalization is rare.<h4>Objective</h4>We sought to estimate the cost-effectiveness of alternative strategies for surveillance for gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after complete and partial molar pregnancy.<h4>Study design</h4>A Markov-based cost-effectiveness model, using monthly cycles and terminating after 36 months/cycles, was constructed to compare alternative strategies for asymptomatic human chorionic gonadotropin surveillance after the first normal (none; monthly testing for 1, 3, 6, and 12 months; or every 3-month testing for 3, 6, and 12 months) for both complete and partial molar pregnancy. The risk of reduced surveillance was modeled by increasing the probability of high-risk disease at diagnosis. Probabilities, costs, and utilities were estimated from peer-reviewed literature, with all cost data applicable to the United States and adjusted to 2020 US dollars. The primary outcome was cost per quality-adjusted life year ($/quality-adjusted life year) with a $100,000/quality-adjusted life year willingness-to-pay threshold.<h4>Results</h4>Under base-case assumptions, we found no further surveillance after the first normal human chorionic gonadotropin to be the dominant strategy from both the healthcare system and societal perspectives, for both complete and partial molar pregnancy. After complete mole, this strategy had the lowest average cost (healthcare system, $144 vs maximum $283; societal, $152 vs maximum $443) and highest effectiveness (2.711 vs minimum 2.682 quality-adjusted life years). This strategy led to a slightly higher rate of death from gestational trophoblastic neoplasia (0.013% vs minimum 0.009%), although with high costs per gestational trophoblastic neoplasia death avoided (range, $214,000 to >$4 million). Societal perspective costs of lost wages had a greater impact on frequent surveillance costs than rare gestational trophoblastic neoplasia treatment costs, and no further surveillance was more favorable from this perspective in otherwise identical analyses. No further surveillance remained dominant or preferred with incremental cost-effectiveness ratio of <$100,000 in all analyses for partial mole, and most sensitivity analyses for complete mole. Under the assumption of no disutility from surveillance, surveillance strategies were more effective (by quality-adjusted life year) than no further surveillance, and a single human chorionic gonadotropin test at 3 months was found to be cost-effective after complete mole with incremental cost-effectiveness ratio of $53,261 from the healthcare perspective, but not from the societal perspective (incremental cost-effectiveness ratio, $288,783).<h4>Conclusion</h4>Largely owing to the rare incidence of gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after molar pregnancy, prolonged surveillance is not cost-effective under most assumptions. It would be reasonable to reduce, and potentially eliminate, current recommendations for surveillance after human chorionic gonadotropin normalization after molar pregnancy, particularly among partial moles. With any reduction in surveillance, patients should be counseled on symptoms of gestational trophoblastic neoplasia and established in routine gynecologic care.
Authors
Albright, BB; Myers, ER; Moss, HA; Ko, EM; Sonalkar, S; Havrilesky, LJ
MLA Citation
Albright, Benjamin B., et al. “Surveillance for gestational trophoblastic neoplasia following molar pregnancy: a cost-effectiveness analysis.American Journal of Obstetrics and Gynecology, May 2021. Epmc, doi:10.1016/j.ajog.2021.05.031.
URI
https://scholars.duke.edu/individual/pub1484608
PMID
34058170
Source
epmc
Published In
American Journal of Obstetrics and Gynecology
Published Date
DOI
10.1016/j.ajog.2021.05.031

Real-world treatment patterns of maintenance therapy in platinum-sensitive recurrent ovarian cancer.

OBJECTIVES: The clinical utility of maintenance therapy (MT) for patients with platinum-sensitive recurrent ovarian cancer has been validated in several clinical trials. We assessed "real-world" treatment patterns using an electronic health record (EHR) database. METHODS: A retrospective study of patients diagnosed with ovarian cancer between January 1, 2011 and July 31, 2019 was conducted using the US nationwide Flatiron Health (EHR)-derived de-identified database. Patients were included if they received second- or third-line (2 L or 3 L) platinum-based chemotherapy (PBCT). Information regarding biomarker status was obtained. RESULTS: 2292 patients with ovarian cancer received at least two lines of therapy. 222 patients completed PBCT on or after March 1, 2017 and had ≥2 months of active surveillance or received MT with poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPi) or bevacizumab. 46 (20%) had BRCA mutations (BRCAm), 132 (59%) had a wildtype BRCA (BRCAwt) gene, and 47 (21%) were unknown. Of patients with BRCAm, 63% received a PARPi, 17% received bevacizumab, and 20% underwent active surveillance. Of patients with BRCAwt, 40% received a PARPi, 23% received bevacizumab, and 36% underwent active surveillance. MT was more common in those with younger age and a BRCA mutation. PARPi use increased on average by 1.3% every 3 months (p = .02) with no statistically significant change in use of bevacizumab. CONCLUSIONS: In this real-world population, MT is becoming progressively more common following 2 L or 3 L PBCT regardless of biomarker status. The results provide insight into the shifting treatment patterns for patients with recurrent ovarian cancer.
Authors
MLA Citation
Moss, Haley A., et al. “Real-world treatment patterns of maintenance therapy in platinum-sensitive recurrent ovarian cancer.Gynecol Oncol, vol. 163, no. 1, Oct. 2021, pp. 50–56. Pubmed, doi:10.1016/j.ygyno.2021.07.026.
URI
https://scholars.duke.edu/individual/pub1489791
PMID
34301411
Source
pubmed
Published In
Gynecol Oncol
Volume
163
Published Date
Start Page
50
End Page
56
DOI
10.1016/j.ygyno.2021.07.026

Catastrophic health expenditures, insurance churn, and nonemployment among gynecologic cancer patients in the United States.

BACKGROUND: In recent years, there has been growing recognition of the financial burden of severe illness, including associations with higher rates of nonemployment, uninsurance, and catastrophic out-of-pocket health spending. Patients with gynecologic cancer often require expensive and prolonged treatments, potentially disrupting employment and insurance coverage access, and putting patients and their families at risk for catastrophic health expenditures. OBJECTIVE: This study aimed to describe the prevalence of insurance churn, nonemployment, and catastrophic health expenditures among nonelderly patients with gynecologic cancer in the United States, to compare within subgroups and to other populations and assess for changes associated with the Affordable Care Act. STUDY DESIGN: We identified respondents aged 18 to 64 years from the Medical Expenditure Panel Survey, 2006 to 2017, who reported care related to gynecologic cancer in a given year, and a propensity-matched cohort of patients without cancer and patients with cancers of other sites, as comparison groups. We applied survey weights to extrapolate to the US population, and we described patterns of insurance churn (any uninsurance or insurance loss or change), catastrophic health expenditures (>10% annual family income), and nonemployment. Characteristics and outcomes between groups were compared with the adjusted Wald test. RESULTS: We identified 683 respondents reporting care related to a gynecologic cancer diagnosis from 2006 to 2017, representing an estimated annual population of 532,400 patients (95% confidence interval, 462,000-502,700). More than 64% of patients reported at least 1 of 3 primary negative outcomes of any uninsurance, part-year nonemployment, and catastrophic health expenditures, with 22.4% reporting at least 2 of 3 outcomes. Catastrophic health spending was uncommon without nonemployment or uninsurance reported during that year (1.2% of the population). Compared with patients with other cancers, patients with gynecologic cancer were younger and more likely with low education and low family income (≤250% federal poverty level). They reported higher annual risks of insurance loss (8.8% vs 4.8%; P=.03), any uninsurance (22.6% vs 14.0%; P=.002), and part-year nonemployment (55.3% vs 44.6%; P=.005) but similar risks of catastrophic spending (12.6% vs 12.2%; P=.84). Patients with gynecologic cancer from low-income families faced a higher risk of catastrophic expenditures than those of higher icomes (24.4% vs 2.9%; P<.001). Among the patients from low-income families, Medicaid coverage was associated with a lower risk of catastrophic spending than private insurance. After the Affordable Care Act implementation, we observed reductions in the risk of uninsurance, but there was no significant change in the risk of catastrophic spending among patients with gynecologic cancer. CONCLUSION: Patients with gynecologic cancer faced high risks of uninsurance, nonemployment, and catastrophic health expenditures, particularly among patients from low-income families. Catastrophic spending was uncommon in the absence of either nonemployment or uninsurance in a given year.
Authors
Albright, BB; Nitecki, R; Chino, F; Chino, JP; Havrilesky, LJ; Aviki, EM; Moss, HA
MLA Citation
Albright, Benjamin B., et al. “Catastrophic health expenditures, insurance churn, and nonemployment among gynecologic cancer patients in the United States.Am J Obstet Gynecol, Sept. 2021. Pubmed, doi:10.1016/j.ajog.2021.09.034.
URI
https://scholars.duke.edu/individual/pub1498609
PMID
34597606
Source
pubmed
Published In
American Journal of Obstetrics and Gynecology
Published Date
DOI
10.1016/j.ajog.2021.09.034

Associations of Insurance Churn and Catastrophic Health Expenditures With Implementation of the Affordable Care Act Among Nonelderly Patients With Cancer in the United States.

Importance: Health insurance coverage is dynamic in the United States, potentially changing from month to month. The Patient Protection and Affordable Care Act (ACA) aimed to stabilize markets and reduce financial burden, particularly among those with preexisting conditions. Objective: To describe the risks of insurance churn (ie, gain, loss, or change in coverage) and catastrophic health expenditures among nonelderly patients with cancer in the United States, assessing for changes associated with ACA implementation. Design, Setting, and Participants: This retrospective, cross-sectional study uses data from the Medical Expenditure Panel Survey, a representative sample of the US population from 2005 to 2018. Respondents included were younger than 65 years, identified by health care use associated with a cancer diagnosis code in the given year. Statistical analysis was conducted from July 30, 2020, to January 5, 2021. Exposures: The Patient Protection and Affordable Care Act. Main Outcomes and Measures: Survey weights were applied to generate estimates for the US population. Annual risks of insurance churn (ie, any uninsurance or insurance change or loss) and catastrophic health expenditures (spending >10% income) were calculated, comparing subgroups with the adjusted Wald test. Weighted multivariable linear regression was used to assess for changes associated with ACA implementation. Results: From 6069 respondents, we estimated a weighted mean of 4.78 million nonelderly patients (95% CI, 4.55-5.01 million; female patients: weighted mean, 63.9% [95% CI, 62.2%-65.7%]; mean age, 50.3 years [95% CI, 49.7-50.8 years]) with cancer annually in the United States. Patients with cancer experienced lower annual risks of insurance loss (5.3% [95% CI, 4.5%-6.1%] vs 7.6% [95% CI, 7.4%-7.8%]) and any uninsurance (14.6% [95% CI, 13.3%-16.0%] vs 24.1% [95% CI, 23.5%-24.7%]) but increased risk of catastrophic health expenditures (expenses alone: 12.4% [95% CI, 11.2%-13.6%] vs 6.3% [95% CI, 6.2%-6.5%]; including premiums: 26.6% [95% CI, 25.0%-28.1%] vs 16.5% [95% CI, 16.1%-16.8%]; P < .001) relative to the population without cancer. Patients with cancer from low-income families and with full-year private coverage were at particularly high risk of catastrophic health expenditures (including premiums: 81.7% [95% CI, 74.6%-88.9%]). After adjustment, low income was the factor most strongly associated with both insurance churn and catastrophic spending, associated with annual risk increases of 6.5% (95% CI, 4.2%-8.8%) for insurance loss, 17.3% (95% CI, 13.4%-21.2%) for any uninsurance, and 37.4% (95% CI, 33.3%-41.6%) for catastrophic expenditures excluding premiums (P < .001). In adjusted models relative to 2005-2009, full ACA implementation (2014-2018) was associated with a decreased annual risk of any uninsurance (-4.2%; 95% CI, -7.4% to -1.0%; P = .01) and catastrophic spending by expenses alone (-3.0%; 95% CI, -5.3% to -0.8%; P = .008) but not including premiums (0.4%; 95% CI, -2.8% to 4.5%; P = .82). Conclusions and Relevance: In this cross-sectional study, US patients with cancer faced significant annual risks of insurance churn and catastrophic health spending. Despite some improvements with ACA implementation, large burdens remained, and further reform is needed to protect this population from excessive hardship.
Authors
Albright, BB; Chino, F; Chino, JP; Havrilesky, LJ; Aviki, EM; Moss, HA
MLA Citation
Albright, Benjamin B., et al. “Associations of Insurance Churn and Catastrophic Health Expenditures With Implementation of the Affordable Care Act Among Nonelderly Patients With Cancer in the United States.Jama Netw Open, vol. 4, no. 9, Sept. 2021, p. e2124280. Pubmed, doi:10.1001/jamanetworkopen.2021.24280.
URI
https://scholars.duke.edu/individual/pub1496499
PMID
34495338
Source
pubmed
Published In
Jama Network Open
Volume
4
Published Date
Start Page
e2124280
DOI
10.1001/jamanetworkopen.2021.24280

Primary cytoreductive surgery for advanced stage endometrial cancer: a systematic review and meta-analysis.

OBJECTIVE: Endometrial cancer uncommonly presents at an advanced stage and little prospective evidence exists to guide the management thereof. We aimed to summarize the evidence about primary cytoreductive surgery in the treatment of advanced stage endometrial cancer. DATA SOURCES: MEDLINE, Embase, and Scopus databases were searched from inception to September 11, 2020, using search terms representing the themes "endometrial cancer," "advanced stage," and "primary cytoreductive surgery." STUDY ELIGIBILITY CRITERIA: We included full-text, English reports that included ≥10 patients undergoing primary cytoreductive surgery for advanced stage endometrial cancer and that reported on the outcomes of primary cytoreductive surgery and survival rates based on the residual disease burden. METHODS: Two reviewers independently screened the studies and with disagreements between the reviewers resolved by a third reviewer. Data were extracted using a standardized form. The percentage of cases reaching maximal (no gross residual disease) and optimal (<1 cm or <2 cm residual disease) cytoreduction were assessed by summing binomials proportions, and the association with survival was assessed using an inverse variance-weighted meta-analysis of logarithmic hazard ratios. RESULTS: From 1219 unique records identified, 34 studies were selected for inclusion. Studies consisted of single or multi-institutional cohorts of patients collected over a period of 6 to 24 years and included various mixes of histologies (endometrioid, serous, clear cell, and carcinosarcoma) and disease stages (III or IV). In a meta-analysis of the extent of residual disease after primary cytoreductive surgery, we found that 52.1% of cases reached no gross residual disease status (n=18 studies; 1329 patients) and 75% reached <1 cm residual disease status (n=27 studies; 2343 patients). The proportion of cytoreduction for both thresholds was lower for studies of stage IV vs stage III to IV disease (41.4% vs 69.8% for no gross residual disease; 63.2% vs 82.2% for <1 cm residual disease) but did not vary notably by histology. In a meta-analysis of the reported hazard ratios, submaximal (any gross residual disease vs no gross residual disease) and suboptimal (≥1 cm vs <1 cm) cytoreduction thresholds were associated with worse progression-free survival (submaximal hazard ratio, 2.16; 95% confidence interval, 1.45-3.21; I2=68%; suboptimal hazard ratio, 2.55; 95% confidence interval, 1.93-3.37; I2=63%) and overall survival rates (submaximal hazard ratio, 2.57; 95% confidence interval, 2.13-3.10; I2=1%; suboptimal hazard ratio, 2.62; 95% confidence interval, 2.20-3.11; I2=15%). Sensitivity analyses limited to high-quality studies demonstrated consistent results. CONCLUSION: Among cases of advanced stage endometrial cancer undergoing primary cytoreductive surgery, a significant proportion of patients are left with residual disease, which is associated with worse survival outcomes. Further investigations about the roles of neoadjuvant chemotherapy and primary cytoreductive surgery in prospective trials is warranted in this population.
Authors
Albright, BB; Monuszko, KA; Kaplan, SJ; Davidson, BA; Moss, HA; Huang, AB; Melamed, A; Wright, JD; Havrilesky, LJ; Previs, RA
MLA Citation
Albright, Benjamin B., et al. “Primary cytoreductive surgery for advanced stage endometrial cancer: a systematic review and meta-analysis.Am J Obstet Gynecol, vol. 225, no. 3, Sept. 2021, pp. 237.e1-237.e24. Pubmed, doi:10.1016/j.ajog.2021.04.254.
URI
https://scholars.duke.edu/individual/pub1482001
PMID
33957111
Source
pubmed
Published In
American Journal of Obstetrics and Gynecology
Volume
225
Published Date
Start Page
237.e1
End Page
237.e24
DOI
10.1016/j.ajog.2021.04.254