Laura J Havrilesky

Duke University, Durham, North Carolina, United States

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Publications (191)805.03 Total impact

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    ABSTRACT: Objective: To evaluate the use of adjuvant therapy after primary surgery for Stage I-III uterine carcinosarcoma (CS). Methods: A multi-institutional retrospective study of women with Stage I-III CS was conducted. Analyses were stratified by Stage (I/II and III). Patients were categorized according to adjuvant therapy: observation (OBS), radiation (RT), chemotherapy (CT) or multimodal therapy (CT+RT). Overall survival (OS) and progression-free survival (PFS) were analyzed using log-rank tests and Cox proportional hazards models. Results: 303 patients were identified across four institutions: 195 with Stage I/II and 108 with Stage III disease. In Stage I/II disease, 75 (39.9%) received OBS, 33 (17.6%) CT, 37 (19.7%) RT, and 43 (22.9%) CT+RT. OBS was associated with a fourfold increased risk of death compared to CT (adjusted hazard ratio (aHR)=4.48, p=0.003). Patients receiving CT+RT had significantly improved PFS compared to those receiving CT alone (aHR=0.43, p=0.04), but no difference in OS. In the Stage III cohort, 16 (15.0%) received OBS, 34 (31.8%) CT, 20 (18.7%) RT, and 37 (34.6%) CT+RT. OBS was associated with worse OS and PFS compared to CT (OS: aHR=2.46, p=0.04; PFS: aHR=2.39, p=0.03, respectively). A potential improvement in PFS was seen for those treated with CT+RT compared to CT alone, however it was not statistically significant (aHR=0.53, p=0.09). Conclusions: Observation after surgery was associated with poor outcomes in uterine CS compared to CT and RT alone. Multimodality therapy for women with Stage I/II disease was associated with improved PFS compared to chemotherapy alone. Novel treatment options are needed to improve outcomes in this aggressive disease.
    Gynecologic Oncology 09/2015; DOI:10.1016/j.ygyno.2015.09.002 · 3.77 Impact Factor
  • Robert Neff · Laura J Havrilesky · Junzo Chino · David M O'Malley · David E Cohn
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    ABSTRACT: To estimate the cost-effectiveness and utility of a strategy of offering weight loss surgery (WLS) to women with low risk stage I endometrial cancer (EC) and BMI≥40kg/m(2). A modified Markov state transition model was designed to compare routine care to WLS for women with low risk stage I endometrioid EC, age<70, with a mean BMI 40. A time horizon of 15years was used to simulate the overall survival (OS) of 96,232 women treated from 1988-2010 from SEER*Stat data. To simulate the effects of WLS on OS, a hazard ratio (0.76, 95% CI 0.59-0.99) representing the OS improvement achieved from this intervention (derived from a prospective trial) was modeled. We assumed that 90% of women undergoing bariatric procedures would experience a reduction in BMI. We assumed that 5% of women not undergoing WLS would achieve weight loss to a BMI of 35. Costs of treatment for obesity-related chronic diseases and quality of life (QOL)-related utilities were modeled from published reports. The mean cost-effectiveness for each strategy was: $69,295 and 8.10 quality-adjusted life years (QALYs) for routine care versus $100,675 and 9.30 QALYs for WLS. WLS had an incremental cost-effectiveness ratio (ICER) of $26,080/QALY compared to routine care. At a willingness to pay threshold of $50,000/QALY, WLS was the strategy of choice in 100% of simulations. WLS is a potentially cost-effective intervention in women with low risk, early stage EC, at least in part due to improved quality of life with weight reduction. Copyright © 2015. Published by Elsevier Inc.
    Gynecologic Oncology 07/2015; 138(3). DOI:10.1016/j.ygyno.2015.07.002 · 3.77 Impact Factor
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    ABSTRACT: To determine the degree of consensus regarding the probabilities of outcomes associated with IP/IV and IV chemotherapy. A survey was administered to an expert panel using the Delphi method. Ten ovarian cancer experts were asked to estimate outcomes for patients receiving IP/IV or IV chemotherapy. The clinical estimates were: 1) probability of completing six cycles of chemotherapy, 2) probability of surviving five years, 3) median survival, and 4) probability of ER/hospital visits during treatment. Estimates for two patients, one with a low comorbidity index (patient 1) and the other with a moderate index (patient 2), were included. The survey was administered in three rounds, and panelists could revise their subsequent responses based on review of the anonymous opinions of their peers. The ranges were smaller for IV compared with IP/IV therapy. Ranges decreased with each round. Consensus converged around outcomes related to IP/IV chemotherapy for: 1) completion of 6cycles of therapy (type 1 patient, 62%, type 2 patient, 43%); 2) percentage of patients surviving 5years (type 1 patient, 66%, type 2 patient, 47%); and 3) median survival (type 1 patient, 83months, type 2 patient, 58months). The group required three rounds to achieve consensus on the probabilities of ER/hospital visits (type 1 patient, 24%, type 2 patient, 35%). Initial estimates of survival and adverse events associated with IP/IV chemotherapy differ among experts. The Delphi process works to build consensus and may be a pragmatic tool to inform patients of their expected outcomes. Copyright © 2015. Published by Elsevier Inc.
    Gynecologic Oncology 07/2015; 138(3). DOI:10.1016/j.ygyno.2015.07.014 · 3.77 Impact Factor
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    ABSTRACT: Objective: The Lumbee Indian tribe is the largest Native American tribe in North Carolina, with about 55,000 enrolled members who mostly reside in southeastern counties. We evaluated whether Lumbee heritage is associated with high-risk histologic subtypes of endometrial cancer. Methods: We retrospectively analyzed the available records from IRB-approved endometrial cancer databases at two institutions of patients of Lumbee descent (year of diagnosis range 1980-2014). Each Lumbee case was matched by age, year of diagnosis, and BMI to two non-Lumbee controls. Chi-square test was used to compare categorical associations. Kaplan-Meier methods and log-rank test were used to display and compare disease-free survival (DFS) and overall survival (OS). Multivariate Cox proportional hazards regression was used to adjust for age and BMI while testing cohort as a predictor of DFS and OS. Results: Among 108 subjects, 10/35 (29%) Lumbee and 19/72 (26%) non-Lumbee subjects had high-risk (serous/clear cell/carcinosarcoma) histologic types (p = 0.8). 12/35 (34%) Lumbee and 24/72 (33%) non-Lumbee subjects had grade 3 tumors (p = 0.9). 5/33 (15%) Lumbee and 13/72 (18%) non-Lumbee had advanced stage endometrial cancer at diagnosis (p = 0.7). Lumbee ancestry was not associated with worse survival outcomes. OS (p = 0.054) and DFS (p = 0.01) were both worse in Blacks compared to Lumbee and White subjects. Conclusion: In this retrospective cohort analysis, Lumbee Native American ancestry was not a significant independent predictor of rates of high-risk histological subtypes of endometrial cancer or poor survival outcomes.
    06/2015; 121. DOI:10.1016/j.gore.2015.06.004
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    ABSTRACT: To estimate the potential cost-effectiveness of an intervention to improve adherence to National Comprehensive Cancer Network (NCCN) guideline-based care for ovarian cancer. A modified Markov model with a 5-year time horizon estimated the potential cost-effectiveness of an intervention (AD-INT) to improve NCCN-guideline adherence compared to status quo (SQ) levels of adherence. Data were obtained from a population-based analysis of National Cancer Data Base records for ovarian cancer diagnosed from 1998 to 2002 (N=47,160). Cohorts were defined by race and adherence to NCCN guideline-based care. Costs were estimated using 2014 Medicare reimbursements. Incremental cost-effectiveness ratios (ICERs) were calculated in 2014 US dollars per year of life saved (YLS) using the standard threshold of $50,000/YLS. We simulated an AD-INT that reduced non-adherence by 25% and cost at least $100 per patient. One-way sensitivity analyses were performed. Although the individual components of guideline-adherent care are more costly than non-adherent care, a reasonably effective AD-INT is also highly likely to be cost-effective. An AD-INT costing $100 per patient and reducing non-adherence by 25% is cost-effective with an ICER of $22/YLS compared with SQ, while interventions costing over $1,000 remain cost-effective, up to a per-patient intervention cost of up to $8,000 (targeting only blacks) or $4,000 (targeting all patients). An ovarian cancer intervention that moderately decreases racial disparities in NCCN guideline adherent care or improves adherence for all is potentially cost-effective. Further research may determine which modifiable factors may be targeted to help reduce adherence disparities. Copyright © 2015. Published by Elsevier Inc.
    Gynecologic Oncology 06/2015; 138(3). DOI:10.1016/j.ygyno.2015.06.013 · 3.77 Impact Factor
  • Gynecologic Oncology 06/2015; 137(3):594-595. DOI:10.1016/j.ygyno.2015.03.027 · 3.77 Impact Factor
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    ABSTRACT: To retrospectively evaluate perioperative pain, analgesic and anti-emetic use in patients who underwent surgical staging for endometrial cancer using traditional versus robotic-assisted laparoscopy. We identified women a single institution who underwent minimally hysterectomy for endometrial cancer from 2008-2012. Patient characteristics and perioperative outcomes, including analgesic and antiemetic use and pain scores, were analyzed. Following univariate analysis, a multivariate linear regression model was generated to determine factors associated with narcotic use in the post anesthesia care unit (PACU). Classification: II-3 SETTING: A single academic institution in the United States from 2008-2012. Women undergoing total laparoscopic hysterectomy or robotic-assisted laparoscopic hysterectomy for endometrial cancer. Laparoscopic or robotic-assisted laparoscopic hysterectomy Main RESULTS: 335 women were included (213 laparoscopy and 122 robotic-assisted laparoscopy). There was no difference in pain scores at 0-6 and 6-12 hours following surgery; at 12-24 hours, robotic-assisted surgery was associated with higher median pain scores (5/10 versus 4/10, p = 0.012). Robotic-assisted surgery was associated with longer anesthesia time (289 versus 255 minutes, p < 0.001), similar anti-emetic use (p = 0.40), and lower narcotic use in PACU (1.3 mg versus 2.5 mg morphine equivalents, p = 0.003). There was no difference in narcotic use on the post-operative floor (p = 0.46). In multivariate analysis controlling for age, menopausal status, anesthesia duration, and local anesthetic use, hysterectomy type was not a significant predictor of PACU narcotic use (p = 0.86). In a retrospective analysis, a robotic-assisted approach to endometrial cancer was not associated with a reduced PACU narcotic or antiemetic use compared to the traditional laparoscopic approach. Twenty-four hour narcotic and anti-emetic use were also not different between the two approaches. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.
    Journal of Minimally Invasive Gynecology 05/2015; 22(6). DOI:10.1016/j.jmig.2015.05.003 · 1.83 Impact Factor
  • Gynecologic Oncology 05/2015; 138. DOI:10.1016/j.ygyno.2015.04.019 · 3.77 Impact Factor
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    ABSTRACT: To identify patient and physician factors related to enrollment onto Gynecologic Oncology Group (GOG) trials. Prospective study of women with primary or recurrent cancer of the uterus or cervix treated at a GOG institution from July 2010 to January 2012. Logistic regression examined probability of availability, eligibility and enrollment in a GOG trial. Odds ratios (OR) and 95% confidence intervals (CI) for significant (p<0.05) results reported. Sixty institutions, 781 patients, and 150 physicians participated, 300/780 (38%) had a trial available, 290/300 had known participation status. Of these, 150 women enrolled (59.5%), 102 eligible did not enroll (35%), 38 (13%) were ineligible. Ethnicity and specialty of physician, practice type, data management availability, and patient age were significantly associated with trial availability. Patients with > 4 comorbidities (OR 4.5; CI 1.7-11.8) had higher odds of trial ineligibility. Non-White patients (OR 7.9; CI 1.3-46.2) and patients of Black physicians had greater odds of enrolling (OR 56.5; CI 1.1- 999.9) in a therapeutic trial. Significant patient therapeutic trial enrollment factors: belief trial may help (OR 76.9; CI 4.9- >1000), concern about care if not on trial (OR12.1; CI 2.1-71.4), pressure to enroll (OR .27; CI 0.12-.64), caregiving without pay (OR 0.13; CI.02-.84). Significant physician beliefs were: patients would not do well on standard therapy (OR 3.6; CI 1.6-8.4), and trial would not be time consuming (OR 3.3; CI 1.3-8.1). Trial availability, patient and physician beliefs were factors identified that if modified could improve enrollment in cancer cooperative group clinical trials. Copyright © 2015. Published by Elsevier Inc.
    Gynecologic Oncology 04/2015; 138(1). DOI:10.1016/j.ygyno.2015.04.033 · 3.77 Impact Factor
  • B. Forde · J. Wallbillich · L.J. Havrilesky · D.E. Cohn
    Gynecologic Oncology 04/2015; 137. DOI:10.1016/j.ygyno.2015.01.056 · 3.77 Impact Factor
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    ABSTRACT: We compared the estimated clinical outcomes, costs, and physician workload resulting from available strategies for deciding which women with an adnexal mass should be referred to a gynecologic oncologist. We used a microsimulation model to compare five referral strategies: 1) American Congress of Obstetricians and Gynecologists (ACOG) guidelines, 2) Multivariate Index Assay (MIA) algorithm, 3) Risk of Malignancy Algorithm (ROMA), 4) CA125 alone with lowered cutoff values to prioritize test sensitivity over specificity, 5) referral of all women (Refer All). Test characteristics and relative survival were obtained from the literature and data from a biomarker validation study. Medical costs were estimated using Medicare reimbursements. Travel costs were estimated using discharge data from Surveillance, Epidemiology and End Results-Medicare and State Inpatient Databases. Analyses were performed separately for pre- and postmenopausal women (60 000 "subjects" in each), repeated 10 000 times. Refer All was cost-effective compared with less expensive strategies in both postmenopausal (incremental cost-effectiveness ratio [ICER] $9423/year of life saved (LYS) compared with CA125) and premenopausal women (ICER $10 644/YLS compared with CA125), but would result in an additional 73 cases/year/subspecialist. MIA was more expensive and less effective than Refer All in pre- and postmenopausal women. If Refer All is not a viable option, CA125 is an optimal strategy in postmenopausal women. Referral of all women to a subspecialist is an efficient strategy for managing women with adnexal masses requiring surgery, assuming sufficient capacity for additional surgical volume. If a test-based triage strategy is needed, CA125 with lowered cutoff values is a cost-effective strategy. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail:
    JNCI Journal of the National Cancer Institute 04/2015; 107(1). DOI:10.1093/jnci/dju322 · 12.58 Impact Factor
  • Gynecologic Oncology 04/2015; 137:170. DOI:10.1016/j.ygyno.2015.01.427 · 3.77 Impact Factor
  • Gynecologic Oncology 04/2015; 137:171. DOI:10.1016/j.ygyno.2015.01.429 · 3.77 Impact Factor
  • Gynecologic Oncology 04/2015; 137:111. DOI:10.1016/j.ygyno.2015.01.276 · 3.77 Impact Factor
  • J.A. Dottino · B.A. Cliby · E.R. Myers · R.E. Bristow · L.J. Havrilesky
    Gynecologic Oncology 04/2015; 137:188-189. DOI:10.1016/j.ygyno.2015.01.473 · 3.77 Impact Factor
  • Gynecologic Oncology 04/2015; 137. DOI:10.1016/j.ygyno.2015.01.229 · 3.77 Impact Factor
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    ABSTRACT: Patient-reported outcome (PRO) measures, such as quality of life, have been associated with relevant clinical end points and are prognostic for survival outcomes in a variety of solid cancers in adults. In the past few years, PROs have garnered a greater influence as established and clinically relevant measures that could alter the current paradigm of practice-changing therapeutic advances, as it has been recognized that classic clinical end points do not accurately portray a full appreciation of the benefits, risks and costs of therapy. In this Review, we comprehensively assess the correlation of PROs with treatment response and survival, and explore tumour-related and patient-centric composite end points in patients with cancer participating in clinical trials. Comparisons or composite end points that consider tumour-related and PRO components might help health-care providers, patients with cancer and decision makers to better understand the total clinical benefit of therapeutic interventions.
    Nature Reviews Clinical Oncology 03/2015; 12(6). DOI:10.1038/nrclinonc.2015.29 · 14.18 Impact Factor
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    ABSTRACT: The study objective was to examine the safety and cost savings of selective cardiac surveillance (CS) during treatment with pegylated liposomal doxorubicin (PLD). A retrospective, dual institution study of women receiving PLD for the treatment of a gynecologic malignancy was performed. The study period was 2002-2014. At both institutions, a selective strategy for CS was implemented in which only high-risk women with a cardiac history or with symptoms suggestive of cardiac toxicity during PLD treatment underwent a cardiac evaluation. Patient demographics, clinical and treatment history were evaluated. Cost analyses were performed utilizing professional/technical fee rates for echocardiogram and multi-gated acquisition scan for each state. PLD was administered in 184 women. The mean patient age was 62.7 years, and 79% were treated for recurrent ovarian or peritoneal carcinoma. The median cumulative administered dose of PLD was 300 mg/m(2); 24 received >550 mg/m(2). The median follow-up time was 20 months. Of the 184 patients, the majority (n=157, 85.3%) did not undergo either an initial cardiac evaluation or surveillance during or post-PLD treatment. Fifty-three patients considered high risk for anthracycline-induced cardiotoxicity underwent CS. Only three patients (1.6%) in the entire cohort developed CHF that was possibly related to PLD treatment; all had significant pre-existing cardiac risk factors. Selective instead of routine use of CS in the study population resulted in a cost savings of $182,552.28. Utilizing cardiac surveillance in select women undergoing PLD treatment for gynecologic malignancies resulted in significant health care cost savings without adversely impacting clinical outcomes. Copyright © 2015. Published by Elsevier Inc.
    Gynecologic Oncology 02/2015; 137(3). DOI:10.1016/j.ygyno.2015.02.020 · 3.77 Impact Factor
  • Georgia A McCann · David E Cohn · Elizabeth L Jewell · Laura J Havrilesky
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    ABSTRACT: Sentinel lymph node biopsy (SLNB) is an acceptable method of evaluating groin lymph nodes in women with vulvar cancer. The purpose of this study is to assess the cost and effectiveness of SLNB compared to universal inguinofemoral lymphadenectomy (LND) for vulvar cancer. A modified Markov decision model was generated to compare two surgical approaches for newly diagnosed, early-stage vulvar cancer: (1) radical vulvectomy+LND; (2) radical vulvectomy+SLNB. Published data were used to estimate survival outcomes, probability of positive lymph nodes and lymphedema. Costs of surgery, radiation and lymphedema therapy were estimated from published data. Lymphedema's effect on quality of life (QOL) was extrapolated from other disease sites and assigned a utility score of 0.84. Multiple sensitivity analyses were performed. SLNB was less costly ($13,449 versus $14,261) and more effective (4.16 quality-adjusted life years (QALYs) versus 4.00 QALYs) than LND. The model was sensitive to the impact of lymphedema on QOL. Unless the impact of lymphedema on QOL was minimal (utility score>0.975) SLNB dominated LND. Variations in the rate of positive SLNB and probability of lymphedema over clinically reasonable ranges did not alter the results. SLNB is a cost-effective strategy for the treatment of newly diagnosed vulvar cancer, mainly due to the impact of lymphedema on QOL. Copyright © 2014. Published by Elsevier Inc.
    Gynecologic Oncology 12/2014; 136(2). DOI:10.1016/j.ygyno.2014.11.079 · 3.77 Impact Factor
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    ABSTRACT: BACKGROUND The objective of this study was to elucidate relative preferences of women with ovarian cancer for symptoms, treatment-related side effects, and progression-free survival (PFS) relevant to choosing a treatment regimen.METHODS Women with advanced or recurrent ovarian cancer participated in a survey that included 3 methods to measure patient preferences (ratings, rankings, and a discrete-choice experiment) for 7 attributes: mode of administration, visit frequency, peripheral neuropathy, nausea and vomiting, fatigue, abdominal discomfort, and PFS. Participants were asked to choose between 2 unlabeled treatment scenarios that were characterized using the 7 attributes. Each participant completed 12 choice questions in which attribute levels were assigned according to an experimental design and a fixed-choice question representing 2 chemotherapy regimens for ovarian cancer.RESULTSIn total, 95 women completed the survey. Participants' ratings and rankings revealed greater concern and importance for PFS than for any other attribute (P < .0001 for all). The discrete-choice experiment revealed that the relative odds that a participant would choose a scenario with 18 months, 21 months, and 24 months of PFS versus 15 months of PFS were 1.5 (P = .01), 3.4 (P < .001), and 7.5 (P < .001), respectively. However, participants' choices indicated that they were willing to accept a shorter PFS to avoid severe side effects: 6.7 months to reduce nausea and vomiting from severe to mild, 5.0 months to reduce neuropathy from severe to mild, and 3.7 months to reduce abdominal symptoms from severe to moderate.CONCLUSIONSPFS is the predominant driver of patient preferences for chemotherapy regimens. However, women in the current study were willing to trade significant PFS time for reductions in treatment-related toxicity. Cancer 2014. © 2014 American Cancer Society.
    Cancer 12/2014; 120(23). DOI:10.1002/cncr.28940 · 4.89 Impact Factor

Publication Stats

3k Citations
805.03 Total Impact Points


  • 2005–2015
    • Duke University
      Durham, North Carolina, United States
  • 1995–2015
    • Duke University Medical Center
      • Department of Obstetrics and Gynecology
      Durham, North Carolina, United States
  • 2014
    • Massachusetts General Hospital
      Boston, Massachusetts, United States
  • 2013
    • Brooke Army Medical Center
      Houston, Texas, United States
    • University of North Carolina at Chapel Hill
      • Department of Obstetrics and Gynecology
      North Carolina, United States
    • The Ohio State University
      Columbus, Ohio, United States