Laura J Havrilesky

Duke University, Durham, North Carolina, United States

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Publications (150)613.18 Total impact

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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).
    Gynecologic Oncology. 02/2015;
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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: journals.permissions@oup.com.
    JNCI Journal of the National Cancer Institute 01/2015; 107(1). · 15.16 Impact Factor
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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). · 3.69 Impact Factor
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    ABSTRACT: Bevacizumab added to paclitaxel and cisplatin in advanced, recurrent or persistent carcinoma of the cervix has an ICER/QALY of $155 K•Bevacizumab use in this setting is more cost-effective than in any other gynecologic malignancy to date•Marginally discounting the cost of bevacizumab by > 37.5% results in an ICER/QALY of $100 K
    Gynecologic Oncology 11/2014; · 3.69 Impact Factor
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    ABSTRACT: Bevacizumab is not cost effective in the adjuvant and maintenance treatment of advanced ovarian cancer.•Prospective collection of cost and quality of life data is critical to a well-executed cost–utility analysis.
    Gynecologic Oncology 10/2014; 136(2). · 3.69 Impact Factor
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    ABSTRACT: Studies have shown that in the curative setting patients with cancer receiving chemotherapy at higher relative dose intensity (RDI) had better clinical outcomes than those receiving treatment at lower RDI. However, the impact of RDI in advanced/metastatic disease remains unclear. A review of the literature was performed to evaluate the relationship between RDI and survival in patients with metastatic lung, breast, or ovarian cancer receiving chemotherapy. Few studies attempted to specifically associate RDI with survival in a systematic way. Findings from studies that analyzed overall survival with a prespecified RDI threshold support the emerging perception that maintaining an RDI ≥ 85% has a favorable impact on survival. Nonetheless, these studies were limited by their retrospective nature. More studies are needed to further evaluate the impact of maintaining planned chemotherapy dose intensity on outcomes in metastatic solid tumors.
    Critical Reviews in Oncology/Hematology 10/2014; · 4.05 Impact Factor
  • Der Gynäkologe 10/2014;
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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 07/2014; · 5.20 Impact Factor
  • Gynecologic Oncology 06/2014; 133:169-170. · 3.69 Impact Factor
  • Gynecologic Oncology 06/2014; 133:133. · 3.69 Impact Factor
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    ABSTRACT: Objective To determine whether a minimally invasive approach to hysterectomy is associated with an increased rate of lymph vascular space invasion (LVSI) and/or malignant pelvic peritoneal cytology in endometrial cancer. Methods We performed a single institution analysis of 458 women with endometrial cancer who underwent either total abdominal hysterectomy (TAH) or minimally invasive hysterectomy (MIH) with use of a disposable uterine manipulator. All patients had endometrial cancer diagnosed by endometrial biopsy at a single academic institution between 2002 and 2012. Exclusion criteria were pre-operative D&C and/or hysteroscopy, uterine perforation or morcellation, and conversion to laparotomy. Multivariate logistic regression models to determine if type of hysterectomy predicts either LVSI or presence of abnormal cytology were controlled for grade, stage, depth of invasion, tumor size, cervical and adnexal involvement. Results LVSI was identified in 39/214 (18%) MIH and 44/242 (18%) TAH (p = 0.99). Pelvic washings were malignant in 14/203 (7%) MIH and 16/241 (7%) TAH (p = 1.0). Washings were atypical or inconclusive in 16/203 (8%) MIH and 6/241 (2.5%) TAH (p = 0.014). In multivariate analyses, type of hysterectomy was not a significant predictor of either LVSI (p = 0.29) or presence of malignant washings (p = 0.66), but was a predictor of atypical or inconclusive washings (p = 0.03). Conclusion Minimally invasive hysterectomy with use of a uterine manipulator for endometrial cancer is not associated with LVSI or malignant cytology. Algorithms that better determine the etiology and implications of inconclusive or atypical pelvic cytology are needed to inform the possible additional risk associated with a minimally invasive approach to endometrial cancer.
    Gynecologic Oncology 05/2014; · 3.69 Impact Factor
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    ABSTRACT: Background We examined the distribution of obesity, diabetes, and race in Type I and Type II endometrial cancers (EC) and their associations with clinical outcomes. Methods A multi-institutional retrospective analysis of Type I and II EC cases from January 2005 to December 2010 was conducted. Type I (endometrioid), Type II (serous and clear cell), low grade (LG) (grade 1 and 2 endometrioid), and high grade (HG) (grade 3 endometrioid, serous, clear cell) cohorts were compared. Univariate and multivariate analyses were used to determine time-to-recurrence (TTR), recurrence-free survival (RFS), and overall survival (OS). Results Type I EC patients were more frequently obese than Type II (66% versus 51%, p < 0.0001) and had similar rates of diabetes (25% versus 23%, p = 0.69). African-Americans (AA) had higher median BMI than Caucasians in both Type I (p < 0.001) and II (p < 0.001) ECs, and were twice as likely to have diabetes (p < 0.001). In Type I EC, DM was associated with worse RFS and OS in unadjusted and adjusted models (RFS HR 1.38, 95%CI 1.01–1.89; OS HR 1.86, 95%CI 1.30–2.67), but not with TTR. BMI was associated with improved TTR in the adjusted analysis for Type I EC (HR 0.98, 95%CI 0.95–1.0), but not with RFS or OS. There was no association between DM or BMI and outcomes in Type II or HG EC. AA race was not associated with RFS or OS on adjusted analyses in any group. Conclusions Obesity and diabetes are highly prevalent in Type I and II ECs, especially in AA. DM was associated with worse RFS and OS in Type I EC. Neither DM nor BMI was associated with outcomes in Type II or HG EC.
    Gynecologic Oncology 04/2014; 133(1):28–32. · 3.69 Impact Factor
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    ABSTRACT: We wished to determine the reduction in the rate of wound complications that would render the use of prophylactic negative pressure wound vacuum therapy (NPWT) cost saving compared to routine incision care (RC) following laparotomy for gynecologic malignancy. A decision tree was designed from a payer perspective to compare strategies for incision management following laparotomy for gynecologic malignancy: (1) RC; (2) prophylactic NPWT. Rates of wound complication, antibiotic use, re-hospitalization, re-operation, and home health use were obtained from a published cohort of 431 women who underwent laparotomy for endometrial cancer 2002-2007. Costs were estimated using Medicare reimbursements; cost of NPWT ($200) was obtained from hospital financial department. A 50% reduction in wound complications using NPWT was assigned initially and varied for sensitivity analysis. The mean BMI was 36. The wound complication rate was 31% (37% for BMI>30, 41% for BMI>40). The overall cost of incision care was $104 lower for NPWT than for RC. At the lowest cost of NPWT ($200), the risk of wound complication must be reduced by 33% (relative risk= 0.67) for NPWT to achieve cost savings in this cohort. Modeling obese and morbidly obese cohorts, the NPWT resulted in overall cost savings of $163 and $203, respectively, and the risk of wound complication must be reduced by 28% and 25%, respectively, for NPWT to achieve cost savings. If the wound complication rate can be reduced by one-third, prophylactic NPWT is potentially cost saving in high-risk women undergoing laparotomy for gynecologic malignancy.
    Gynecologic Oncology 01/2014; · 3.69 Impact Factor
  • Laura J Havrilesky
    Gynecologic Oncology 01/2014; 132(1):1-2. · 3.69 Impact Factor
  • Laura J Havrilesky, Cynthia Fountain
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    ABSTRACT: Value is defined as desirable health outcomes achieved per monetary unit spent. Comparative effectiveness research and cost-effectiveness research are methods that have been developed to quantify effectiveness and value to inform management decisions. In this article we review the comparative and cost-effectiveness literature in the field of ovarian cancer treatment. Studies have shown that improved ovarian cancer survival is associated with complete primary surgical cytoreduction, with treatment at high volume facilities by subspecialist providers (gynecologic oncologists) and with National Comprehensive Cancer Network (NCCN) guideline-adherent care in both surgical staging and chemotherapy regimens. Intraperitoneal/intravenous chemotherapy (compared with intravenous alone) has been associated with improved survival and cost-effectiveness. Bevacizumab for primary and maintenance therapy has been found to not be cost-effective (even in selective subsets) despite a small progression-free survival (PFS) advantage. For platinum-sensitive recurrent ovarian cancer, secondary cytoreduction and platinum-based combinations are associated with improved overall survival (OS); several platinum-based combinations have also been found cost-effective. For platinum-resistant recurrence, single agent therapy and supportive care are cost-effective compared with combination therapies. Although little prospective clinical research has been done around end-of-life care, one study reported that for platinum-resistant ovarian cancer, palliative intervention would potentially reduce costs and increase quality adjusted life years compared with usual care (based on improvement in quality of life [QOL]). Overall, cost comparisons of individual chemotherapy regimens are highly dependent on market prices of novel therapeutic agents.
    American Society of Clinical Oncology educational book / ASCO. American Society of Clinical Oncology. Meeting. 01/2014; 34:e268-75.
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    ABSTRACT: Preclinical evidence suggests that metformin exhibits anti-tumorigenic effects in endometrial cancer. We sought to investigate the association of metformin on endometrial cancer outcomes. A multi-institutional IRB-approved retrospective cohort analysis was conducted comparing endometrial cancer patients with diabetes mellitus who used metformin (based on medication review at the time of diagnosis) to those who did not use metformin from 2005-2010. Metformin use on treatment related outcomes (TTR: Time to recurrence; RFS: Recurrence Free survival; OS: Overall Survival) were evaluated using univariate and multivariate modeling. 24% (363/1495) endometrial cancer patients were diabetic, of whom 54% used metformin. Metformin users were younger and heavier than non-users, though nearly all were postmenopausal and obese. 75% of both groups had endometrioid histology. Stage, grade, and adjuvant therapy distributions were similar. Metformin users had improved RFS and OS. Non-metformin users had 1.8 times worse RFS (95%CI: 1.1-2.9, p=0.02) and 2.3 times worse OS (95%CI: 1.3-4.2, p=0.005) after adjusting for age, stage, grade, histology and adjuvant treatment. Metformin use was not associated with TTR. Metformin use was associated with improved RFS and OS but not TTR, most likely due to improving all-cause mortality. Its role in modifying cancer recurrence remains unclear. Prospective studies that capture metformin exposure prior to, during and post endometrial cancer treatment may help define the role of metformin upon cancer specific and overall health outcomes.
    Gynecologic Oncology 11/2013; · 3.69 Impact Factor
  • Article: In reply.
    Laura J Havrilesky, Evan R Myers, Walter L Thomas
    Obstetrics and Gynecology 11/2013; 122(5):1114. · 4.37 Impact Factor
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    ABSTRACT: To estimate the risks of ovarian cancer and breast cancer associated with oral contraceptive (OC) use among women at elevated risk owing to mutations in BRCA1/2 or a strong family history. We searched PubMed, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov for studies published 2000 to 2012 that evaluated associations between OC use and breast or ovarian cancer among women who are carriers of a BRCA1/2 mutation or have a family history of breast or ovarian cancer. From 6,476 unique citations, we identified six studies examining ovarian cancer risk in BRCA1/2 mutation carriers and eight studies examining breast cancer risk in BRCA1/2 mutation carriers. For BRCA1/2 mutation carriers combined, meta-analysis showed an inverse association between OC use and ovarian cancer (odds ratio [OR], 0.58; 95% CI, 0.46 to 0.73) and a nonstatistically significant association with breast cancer (OR, 1.21; 95% CI, 0.93 to 1.58). Findings were similar when examining BRCA1 and BRCA2 mutation carriers separately. Data were inadequate to perform meta-analyses examining duration or timing of use. For women with a family history of ovarian or breast cancer, we identified four studies examining risk for ovarian cancer and three for breast cancer, but differences between studies precluded combining the data for meta-analyses, and no overall pattern could be discerned. Our analyses suggest that associations between ever use of OCs and ovarian and breast cancer among women who are BRCA1 or BRCA2 mutation carriers are similar to those reported for the general population.
    Journal of Clinical Oncology 10/2013; · 17.88 Impact Factor
  • Gynecologic Oncology 10/2013; 131(1):277. · 3.69 Impact Factor
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    ABSTRACT: These NCCN Guidelines Insights focus on the major updates to the 2013 NCCN Guidelines for Ovarian Cancer. Four updates were selected based on recent important updates in the guidelines and on debate among panel members about recent clinical trials. The topics include 1) intraperitoneal chemotherapy, 2) CA-125 monitoring for ovarian cancer recurrence, 3) surveillance recommendations for less common ovarian histopathologies, and 4) recent changes in therapy for recurrent epithelial ovarian cancer. These NCCN Guidelines Insights also discuss why some recommendations were not made.
    Journal of the National Comprehensive Cancer Network: JNCCN 10/2013; 11(10):1199-209. · 4.24 Impact Factor

Publication Stats

2k Citations
613.18 Total Impact Points

Institutions

  • 2010–2014
    • Duke University
      Durham, North Carolina, United States
  • 1995–2014
    • Duke University Medical Center
      • Department of Obstetrics and Gynecology
      Durham, North Carolina, United States
  • 2013
    • Memorial Sloan-Kettering Cancer Center
      • Department of Surgery
      New York, New York, United States
    • Moffitt Cancer Center
      Tampa, Florida, United States
  • 2012–2013
    • San Antonio Military Medical Center
      Texas City, Texas, United States
    • University of Virginia
      • Division of Gynecologic Oncology
      Charlottesville, Virginia, United States
  • 2009
    • Roswell Park Cancer Institute
      Buffalo, New York, United States
    • University Health Network
      • Division of Gynecologic Oncology
      Toronto, Ontario, Canada