Jonathan T. Unkart

Risk Factors for Surgical Recurrence after Ileocolic Resection of Crohn's Disease

PurposeWe evaluated the effect of potential clinical factors on surgical recurrence of ileal Crohn’s disease after initial ileocolic resection.MethodsOne hundred seventy-six patients with ileal Crohn’s disease who underwent an ileocolic resection with anastomosis were identified from our database. The outcome of interest was time from first to second ileocolic resection. Survival analysis was used to assess the significance of the Montreal phenotype classification, smoking habit, a family history of inflammatory bowel disease and other clinical variables.ResultsIn our final Cox model, a family history of inflammatory bowel disease (hazard ratio 2.24, 95 percent confidence interval 1.16–4.30, P = 0.016), smoking at time of initial ileocolic resection (hazard ratio 2.08, 95 percent confidence interval 1.11–3.91, P = 0.023) was associated with an increased risk of a second ileocolic resection while postoperative prescription of immunomodulators (hazard ratio 0.40, 95 percent confidence interval 0.18–0.88, P = 0.022) was associated with a decreased risk of a second ileocolic resection.ConclusionsBoth a family history of inflammatory bowel disease and smoking at the time of the initial ileocolic resection are associated with an increased risk of a second ileocolic resection. Postoperative prescription of immunomodulators is associated with a reduced risk of surgical recurrence. This study supports the concept that both genetic and environmental factors influence the risk of surgical recurrence of ileal Crohn’s disease.

Prognostic significance of marital status in breast cancer survival: A population-based study

Research shows that married cancer patients have lower mortality than unmarried patients but few data exist for breast cancer. We assessed total mortality associated with marital status, with attention to differences by race/ethnicity, tumor subtype, and neighborhood socioeconomic status (nSES). We included, from the population-based California Cancer Registry, women ages 18 and older with invasive breast cancer diagnosed between 2005 and 2012 with follow-up through December 2013. We estimated mortality rate ratios (MRR) and 95% confidence intervals (CI) for total mortality by nSES, race/ethnicity, and tumor subtype. Among 145,564 breast cancer cases, 42.7% were unmarried at the time of diagnosis. In multivariable-adjusted models, the MRR (95% CI) for unmarried compared to married women was 1.28 (1.24–1.32) for total mortality. Significant interactions were observed by race/ethnicity (P<0.001), tumor subtype (P<0.001), and nSES (P = 0.009). Higher MRRs were observed for non-Hispanic whites and Asians/Pacific Islanders than for blacks or Hispanics, and for HR+/HER2+ tumors than other subtypes. Assessment of interactive effect between marital status and nSES showed that unmarried women living in low SES neighborhoods had a higher risk of dying compared with married women in high SES neighborhoods (MRR = 1.60; 95% CI: 1.53–1.67). Unmarried breast cancer patients have higher total mortality than married patients; the association varies by race/ethnicity, tumor subtype, and nSES. Unmarried status should be further evaluated as a breast cancer prognostic factor. Identification of underlying causes of the marital status associations is needed to design interventions that could improve survival for unmarried breast cancer patients.

Treatment of Breast Cancer in Women Aged 80 and Older

Background: The elderly population is growing in the United States. Most clinical trials exclude patients over 80, therefore there is a paucity of data regarding the correct treatment of this group. The purpose of this systematic review was to investigate the treatment patterns for women with primary breast cancer aged 80 years old and older - modalities include surgery, chemotherapy, radiation and hormonal treatment, alone or in combination. Methods: A formal systematic review was performed with the support of the medical research librarian at the University of California San Diego Biomedical Library. PubMed and Web of Science were the databases used. A patient population of 2,947 was derived from the 16 papers reviewed. Results: Patients diagnosed over 80 were more likely to be diagnosed by clinical exam. Patients who had standard surgical treatment had an improved disease free survival. Surgical resection and radiation had a low morbidity. Conclusion: Multimodality treatment is safe in elderly women and is associated with better breast cancer specific survival outcomes.

Treatment of Post-Latissimus Dorsi Flap Breast Reconstruction Pain With Continuous Paravertebral Nerve Blocks: A Retrospective Review

Objectives The addition of a perioperative continuous paravertebral nerve block (cPVB) to a single-injection thoracic paravertebral nerve block (tPVB) has demonstrated improved analgesia in breast surgery. However, its use following isolated post-mastectomy reconstruction using a latissimus dorsi flap (LDF) has not previously been examined. Methods We performed a retrospective review of patients who underwent salvage breast reconstruction with a unilateral LDF by a single surgeon. Preoperatively, all patients received a single-injection tPVB with 0.5% ropivacaine. Additionally, patients had the option for catheter placement to receive a continuous 0.2% ropivacaine infusion with intermittent boluses. Infusions commenced in the recovery room and the catheters were removed on the morning of discharge. The primary endpoint was the mean pain numeric rating scale (NRS) scores for the 24-hour period beginning at 7:00 on post-operative day 1. Results A total of 22 patients were included in this study (11-cPVB and 11-tPVB). The mean NRS pain score of cPVB patients (3.5 (standard deviation (SD) 1.8) was lower than that of the single-injection tPVB patients (4.4 (SD 2.1), however this difference was not statistically significant (P = 0.31). The length of hospital stay and opioid use was not statistically different between groups. Conclusions Patients receiving a cPVB in addition to tPVB after LDF reconstruction experienced similar pain to those receiving tPVB alone. A larger, randomized clinical trial is warranted to fully determine the benefits of using cPVB in addition to tPVB for this procedure.

Outcomes of “one-day” vs “two-day” injection protocols using Tc-99m tilmanocept for sentinel lymph node biopsy in breast cancer

No prior studies have compared Tc‐99m tilmanocept (TcTM) one‐day and two‐day injection protocols for sentinel lymph node (SLN) biopsy in breast cancer (BC). We retrospectively identified patients with clinically node‐negative BC undergoing SLN biopsy at our institution. Patients received a single, intradermal peritumoral injection of TcTM on day of surgery or day prior to surgery in addition to an intraoperative injection of isosulfan blue dye. Univariable and multivariable Poisson regression count models were constructed to assess the effects of injection timing, radiologist, patient and surgeon characteristics on the number of removed SLNs. A total of 617 patients underwent SLN biopsy with TcTM and blue dye. Sixty‐seven (10.9%) patients were injected with the two‐day protocol. Patients in the one‐day protocol had a mean of 3.0 (standard deviation (SD) 1.9) SLNs removed compared with 2.7 (SD 1.4) SLNs in the two‐day protocol, P‐value = .13. On multivariable analysis, patient age and operating surgeon significantly affected the number of removed SLNs; however, the injection timing and the nuclear radiologist did not influence the number of removed SLNs. The performance of Tc‐99m tilmanocept did not differ significantly between one‐day and two‐day injection protocols. These results are similar to other radiotracers used for SLN biopsy in BC.

Tc‐99m tilmanocept versus Tc‐99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial

No prior trials have compared sentinel lymph node (SLN) identification outcomes between Tc‐99m tilmanocept (TcTM) and Tc‐99m sulfur colloid (TcSC) in breast cancer (BC).

Use of 99mTc-Tilmanocept as a Single Agent for Sentinel Lymph Node Identification in Breast Cancer: A Retrospective Pilot Study

99mTc-tilmanocept received recent Food and Drug Administration approval for lymphatic mapping in 2013. However, to our knowledge, no prior studies have evaluated the use of 99mTc-tilmanocept as a single agent in sentinel lymph node (SLN) biopsy in breast cancer. Methods: We executed this retrospective pilot study to assess the ability of 99mTc-tilmanocept to identify sentinel nodes as a single agent in clinically node-negative breast cancer patients. Patients received a single intradermal injection overlying the tumor of either 18.5 MBq (0.5 mCi) of 99mTc-tilmanocept on the day of surgery or 74.0 MBq (2.0 mCi) on the day before surgery by a radiologist. Immediate 3-view lymphoscintigraphy was performed. Intraoperatively, SLNs were identified with a portable γ-probe. A node was classified as hot if the count (per second) of the node was more than 3 times the background count. Descriptive statistics are reported. Results: Nineteen patients underwent SLN biopsy with single-agent 99mTc-tilmanocept. Immediate lymphoscintigraphy identified at least 1 sentinel node in 13 of 17 patients (76.5%). Intraoperatively, at least 1 (mean, 1.7 ± 0.8; range, 1–3) hot node was identified in all patients. Three patients (15.8%) had 1 disease-positive SLN. Conclusion: In this small, retrospective pilot study, 99mTc-tilmanocept performed well as a single agent for intraoperative sentinel node identification in breast cancer. A larger, randomized clinical trial is warranted to compare 99mTc-tilmanocept as a single agent with other radiopharmaceuticals for sentinel node identification in breast cancer.

Abstract C30: Mortality Differences in Younger and Older Breast Cancer Patients according to Insurance, Race/Ethnicity, and Neighborhood Socioeconomic Status in the California Cancer Registry

Introduction: In the U.S., approximately 25% of all breast cancer cases occur before the age of 50 years. Younger age at diagnosis of breast cancer is associated with lower survival when compared to older cases. Data on sociodemographic predictors of mortality in younger vs. older breast cancer patients are scarce. We assessed differences in risk of total mortality between women 50 years and younger vs. those >50 years, according to health insurance status, race/ethnicity, and neighborhood socioeconomic status (nSES). Methods: We used data from the population-based California Cancer Registry including invasive female breast cancer cases 18 years of age and older diagnosed between 2005 and 2012 with follow-up through December 31, 2013 and identified 145,564 women. We estimated hazard ratios (HR) and 95% confidence intervals (CI) for total mortality for younger (≤years) and older (>50 years) patients. Multivariable models were stratified by stage, allowing baseline hazards to vary by stage, and adjusted for year of diagnosis, single year age, race/ethnicity, nSES, insurance status, tumor subtype, grade, histology, tumor size, lymph node status, as well as treatment modalities (surgery, chemotherapy, and radiation therapy). Results: Among 145,564 breast cancer cases, 3971 total deaths occurred in patients ≤50 years of age and 18,639 deaths in those >50 years. Significant interactions by age group were observed for race/ethnicity ( Conclusions: Our results show differences in total mortality associated with important sociodemographic factors comparing younger to older breast cancer patients. Specifically, higher risks of dying were observed for non-privately vs. privately insured patients and for Blacks vs. NHWs in younger compared to older women, even after accounting for clinical and other sociodemographic factors. These results suggest that access to care is possibly a more important driver in mortality outcome in younger vs. older women, and additional analyses will evaluate the extent to which treatment explains these differences. The findings are important given the higher rates of recurrence and less favorable survival in younger compared to older breast cancer patients. Citation Format: Li Tao, Scarlett Lin Gomez, Caroline Thompson, Ming-Hsiang Tsou, Joseph Gibbons, Jesse N. Nodora, Ian Komenaka, Richard Schwab, Jonathan Unkart, James Murphy, Maria Elena Martinez. Mortality Differences in Younger and Older Breast Cancer Patients according to Insurance, Race/Ethnicity, and Neighborhood Socioeconomic Status in the California Cancer Registry. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr C30.

Abstract PR07: Can the Affordable Care Act result in increasing enrollment of minority patients into therapeutic clinical trials at NCI-designated Cancer Centers?

Introduction The Affordable Care Act (ACA) in California has resulted in the substantial reduction of uninsured individuals, including among Hispanics. The UC San Diego Moores Cancer Center (MCC) is located in a predominantly affluent, non-Hispanic white (NHW) region of San Diego County, resulting in challenges in providing care for underserved, low-income patients as well as in recruitment of under-represented cancer patients into clinical trials. Despite both the large Hispanic population in San Diego County (~35%) and proportion of cancer patients (17%), Hispanics are under-represented among clinical trial patients. This study assesses the potential effect of the ACA on the proportion of Hispanic women among total breast cancer patients cared for at MCC, and among women enrolled in the ISPY2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and molecular Analysis 2) clinical trial, a phase II neoadjuvant chemotherapy trial for women with locally advanced breast cancer. Methods We assessed the relative proportion of Hispanic women receiving care for a new breast cancer diagnosis at the MCC before and after January 2014, when implementation of the ACA began in California, using 2x2 chi square contingency tables. The specific time periods examined were January 2010 through December 2013 and January 2014 through December 2015. We also conducted analyses on the cohort of patients who signed screening consent for the ISPY2 clinical trial (n=236) during the same time periods, to compare Hispanic enrollment prior to and following January 2014. Results We observed a significant increase in the proportion of Hispanic women with breast cancer presenting to the MCC for care after implementation of the ACA. From January 2010 until January 2014, Hispanic women made up 10.1% of total breast cancer diagnoses, with no annual increase over this time period. Following January 2014, Hispanic women accounted for 13.7% of breast cancer diagnoses (p=0.002), with evidence of an increasing trend over this time period (11.5% in 2014 and 16.0% in 2015). The proportion of Hispanic women in the clinical trial group also increased significantly after January 2014, from 11.7% to 22.2% (p=0.030). Of interest, there was a near 6-fold increase between the two time periods in the proportion of consents provided by Hispanics who were Spanish-speaking (2.3% to 13.9%; p=0.0009). Discussion/Conclusions Our findings show that for NCI-designated Comprehensive Cancer Centers that are not located in or near underserved communities, implementation of the ACA might result in an increase of their patient population who was previously uninsured. If those patients represent a racial/ethnic minority group, this could result in increased participation in therapeutic clinical trials, another beneficial consequence of the ACA. We encourage other NCI-designated Cancer Centers to examine their data for such effects, and to explore language, culture, and related preparations to better serve these patients. Citation Format: Chloe Lalonde, Jonathan Unkart, Anne Wallace, Sarah Blair, Giovanna Perez, Jesse Nodora, Maria Elena Martinez. Can the Affordable Care Act result in increasing enrollment of minority patients into therapeutic clinical trials at NCI-designated Cancer Centers? [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr PR07.