Laura J Havrilesky

Duke University, Durham, North Carolina, United States

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Publications (195)850.52 Total impact

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    ABSTRACT: Objective: To assess if antiemetic doses of dexamethasone are associated with an increased risk of cancer recurrence in women who underwent surgery for endometrial cancer. Research design and methods: This is a retrospective study at an academic university medical center. Women who underwent surgery for endometrial cancer from 2003-2007 were identified from a prospectively collected endometrial cancer database. Perioperative records were reviewed to determine administration of dexamethasone. Patients were divided into two groups: those who received dexamethasone 4-10 mg for postoperative nausea and vomiting prophylaxis and those who did not receive dexamethasone. We collected information on patient demographics, cancer stage, cancer grade, histology, year of surgery, chemotherapy, radiation therapy, duration of surgery, perioperative blood transfusion, receipt of epidural analgesia, dose of dexamethasone given, follow up time, and co-morbidities. Main outcome measures: Primary endpoint was recurrence free survival. Secondary end points included progression free survival and overall survival. Results: 309 patients were included in the analysis. There were no significant differences between dexamethasone exposed (n=107) and non-exposed patients in recurrence free survival ([5-year estimate (95% CI)]=71 (62-82) % vs. 71 (64-78%), p=1.0), progression free survival (57 (47-68) % vs. 60 (53-68) %, p=0.9), or overall survival (68 (59-79) % vs. 71 (64-79) %, p=1.0). In univariate analysis, significant predictors of recurrence free survival were tumor stage (p=0.02), tumor grade (0.003) and receipt of adjuvant chemotherapy (p<0.001). In the multivariable model, higher tumor grade [hazard ratio (HR) (95% CI)= 2.3 (1.4-3.9), p=0.002] and receipt of adjuvant chemotherapy [3.2 (1.8-5.8), p<0.001], but not dexamethasone [0.9 (0.5-1.5), p=0.7], were significant predictors of recurrence free survival Conclusions: Dexamethasone administration was not associated with an increased risk of recurrence in women having surgery for endometrial cancer. Limitations of the study include its retrospective single center design and the fact that administration of dexamethasone was not randomized.
    Current Medical Research and Opinion 11/2015; DOI:10.1185/03007995.2015.1123146 · 2.65 Impact Factor
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    ABSTRACT: Objective: To evaluate the association between body mass index (BMI) and mortality in women with endometrial cancer. Methods: A systematic review was performed utilizing a Medline search with Mesh keywords 'endometrial neoplasms' and ('body mass index' or 'obesity') and ('survival analysis' or 'mortality' or 'survivor' or 'survival') for studies published prior to June 2013. Inclusion criteria included studies that assessed associations between BMI and survival in endometrial cancer patients. Two investigators independently reviewed the title and abstract and full-text of articles for inclusion or exclusion decision; discordant decisions were adjudicated by a third reviewer. A random-effects model was constructed that was comparable to the standard random-effects models used in the meta-analysis of odds ratios. The model was fitted using SAS PROC NLMIXED. Results: 1451 studies were identified and reviewed in duplicate, 18 met inclusion criteria. A random-effects meta-analysis demonstrated significantly higher odds of mortality with increasing BMI in endometrial cancer patients. Specifically the odds ratios were 1.01, 1.17, 1.26, and 1.66 for BMI categories of 25-29.9, 30-34.9, 35-39.9, and 40+, respectively. The odds ratio for all-cause mortality in endometrial cancer patients with a BMI≥40 compared to those with a BMI<25 was 1.66 (CI: 1.10-2.51, p=0.02). A single dose-response model indicated that a 10% increase in BMI resulted in a 9.2% increase in the odds of all-cause mortality (p=0.007). Conclusion: Increased BMI is significantly associated with increased all-cause mortality in women with endometrial cancer, with the highest risk for those with a BMI≥40.
    Gynecologic Oncology 11/2015; DOI:10.1016/j.ygyno.2015.10.020 · 3.77 Impact Factor
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    ABSTRACT: Importance: Patients need to consider both benefits and harms of breast cancer screening. Objective: To systematically synthesize available evidence on the association of mammographic screening and clinical breast examination (CBE) at different ages and intervals with breast cancer mortality, overdiagnosis, false-positive biopsy findings, life expectancy, and quality-adjusted life expectancy. Evidence review: We searched PubMed (to March 6, 2014), CINAHL (to September 10, 2013), and PsycINFO (to September 10, 2013) for systematic reviews, randomized clinical trials (RCTs) (with no limit to publication date), and observational and modeling studies published after January 1, 2000, as well as systematic reviews of all study designs. Included studies (7 reviews, 10 RCTs, 72 observational, 1 modeling) provided evidence on the association between screening with mammography, CBE, or both and prespecified critical outcomes among women at average risk of breast cancer (no known genetic susceptibility, family history, previous breast neoplasia, or chest irradiation). We used summary estimates from existing reviews, supplemented by qualitative synthesis of studies not included in those reviews. Findings: Across all ages of women at average risk, pooled estimates of association between mammography screening and mortality reduction after 13 years of follow-up were similar for 3 meta-analyses of clinical trials (UK Independent Panel: relative risk [RR], 0.80 [95% CI, 0.73-0.89]; Canadian Task Force: RR, 0.82 [95% CI, 0.74-0.94]; Cochrane: RR, 0.81 [95% CI, 0.74-0.87]); were greater in a meta-analysis of cohort studies (RR, 0.75 [95% CI, 0.69 to 0.81]); and were comparable in a modeling study (CISNET; median RR equivalent among 7 models, 0.85 [range, 0.77-0.93]). Uncertainty remains about the magnitude of associated mortality reduction in the entire US population, among women 40 to 49 years, and with annual screening compared with biennial screening. There is uncertainty about the magnitude of overdiagnosis associated with different screening strategies, attributable in part to lack of consensus on methods of estimation and the importance of ductal carcinoma in situ in overdiagnosis. For women with a first mammography screening at age 40 years, estimated 10-year cumulative risk of a false-positive biopsy result was higher (7.0% [95% CI, 6.1%-7.8%]) for annual compared with biennial (4.8% [95% CI, 4.4%-5.2%]) screening. Although 10-year probabilities of false-positive biopsy results were similar for women beginning screening at age 50 years, indirect estimates of lifetime probability of false-positive results were lower. Evidence for the relationship between screening and life expectancy and quality-adjusted life expectancy was low in quality. There was no direct evidence for any additional mortality benefit associated with the addition of CBE to mammography, but observational evidence from the United States and Canada suggested an increase in false-positive findings compared with mammography alone, with both studies finding an estimated 55 additional false-positive findings per extra breast cancer detected with the addition of CBE. Conclusions and relevance: For women of all ages at average risk, screening was associated with a reduction in breast cancer mortality of approximately 20%, although there was uncertainty about quantitative estimates of outcomes for different breast cancer screening strategies in the United States. These findings and the related uncertainty should be considered when making recommendations based on judgments about the balance of benefits and harms of breast cancer screening.
    JAMA The Journal of the American Medical Association 10/2015; 314(15):1615-1634. DOI:10.1001/jama.2015.13183 · 35.29 Impact Factor
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    ABSTRACT: Objectives: Changes in cognitive function have been identified in and reported by many cancer survivors. These changes have the potential to impact patient quality of life and functional ability. This prospective longitudinal study was designed to quantify the incidence of change in cognitive function in newly diagnosed ovarian cancer patients throughout and following primary chemotherapy. Methods: Eligible patients had newly diagnosed, untreated ovarian cancer and had planned to receive chemotherapy. Web-based and patient reported cognitive assessments and quality of life questionnaires were conducted prior to chemotherapy, prior to cycle four, after cycle six, and six months after completion of primary therapy. Results: Two-hundred-thirty-one evaluable patients entered this study between May 2010 and October 2011. At the cycle 4 time point, 25.2% (55/218) of patients exhibited cognitive impairment in at least one domain. At the post-cycle 6 and 6-month follow up time points, 21.1% (44/208) and 17.8% (30/169) of patients, respectively, demonstrated impairment in at least one domain of cognitive function. There were statistically significant, but clinically small, improvements in processing speed (p<0.001) and attention (p<0.001) but not in motor response time (p=0.066), from baseline through the six-month follow up time period. Conclusions: This was a large, prospective study designed to measure cognitive function in ovarian cancer. A subset of patients had evidence of cognitive decline from baseline during chemotherapy treatment in this study as measured by the web-based assessment; however, changes were generally limited to no more than one domain.
    Gynecologic Oncology 10/2015; DOI:10.1016/j.ygyno.2015.10.003 · 3.77 Impact Factor
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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
  • N.T. Phippen · L.J. Havrilesky · J.C. Barnett · C.A. Hamilton · M. Stany · W.J. Lowery ·

    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
  • C.R. Miller · N.P. Chappell · C.A. Leath · N.T. Phippen · L.J. Havrilesky · J.C. Barnett ·

    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
  • 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; 137:111. DOI:10.1016/j.ygyno.2015.01.276 · 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
  • 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
  • J.A. Ehrisman · A.A. Secord · A. Berchuck · P.S. Lee · N. Di Santo · F.A. Valea · L.J. Havrilesky ·

    Gynecologic Oncology 04/2015; 137. DOI:10.1016/j.ygyno.2015.01.229 · 3.77 Impact Factor

Publication Stats

4k Citations
850.52 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
    • The Ohio State University
      Columbus, Ohio, United States
    • University of North Carolina at Chapel Hill
      • Department of Obstetrics and Gynecology
      North Carolina, United States
  • 2009
    • The Princess Margaret Hospital
      Toronto, Ontario, Canada