Using patient-reported religious/spiritual concerns to identify patients who accept chaplain interventions in an outpatient oncology setting.

PURPOSE: The goals of this study were to (1) describe the prevalence and correlates of patient-reported religious/spiritual (R/S) needs in outpatient oncology patients and (2) estimate the associations of R/S concerns with acceptance of an R/S intervention offered by phone. METHODS: This was a retrospective analysis of data collected from distress screenings and spiritual care interventions at an outpatient cancer center from March 1, 2017 to May 9, 2017. Patients (n = 1249) used a tablet to self-report the following R/S concerns: spiritual or religious concern, isolation, struggle to find hope/meaning in life, concern for family, fear of death, shame/guilt, and doubts about faith. Patients were also screened for anxiety, depression, and distress. A chaplain contacted patients that reported one or more R/S concerns to offer R/S interventions via telephone or in person. RESULTS: Approximately one third (29.9%) of surveyed patients indicated at least one R/S need. Younger age, female gender, anxiety, depression, and distress were associated with indication of specific R/S concerns. Fear of death (OR 1.64 [1.02, 2.66], p = 0.043), struggle to find meaning/hope in life (OR 2.47 [1.39, 4.39], p = 0.002), and anxiety (p = 1.003) were associated with increased odds of intervention acceptance. CONCLUSION: Effective screening practices are needed for chaplains to prioritize patients most in need. This exploratory study suggests that screening for struggle to find meaning/hope in life, fear of death, and anxiety will help chaplains identify patients who have R/S concerns and will likely accept R/S interventions. Developing effective telehealth practices like this is an important direction for the field.

Pathologic Complete Response Rates After Neoadjuvant Treatment in Rectal Cancer: An Analysis of the National Cancer Database.

BACKGROUND: Pathologic complete response (pCR) of rectal cancer following neoadjuvant therapy is associated with decreased local recurrence and increased overall survival. This study utilizes a national dataset to identify predictors of pCR in patients with rectal cancer. METHODS: The National Cancer Database was queried for patients with nonmetastatic rectal cancer (2004-2014) who underwent neoadjuvant therapy and surgical resection. Unadjusted associations were assessed using rank-sum tests and χ 2 tests where appropriate. Backward elimination and forward selection multivariable logistic regression models were created to determine the relationship of annual surgical volume with pCR rate, adjusting for preoperative characteristics and radiation-surgery interval. Statistical tests were two-sided, with a significance level of p ≤ 0.05. Analyses were performed using SAS version 9.4. RESULTS: A total of 27,532 patients from 1179 participating hospitals met the inclusion criteria. Generalized linear mixed models demonstrated that the odds of achieving pCR was independently associated with more recent diagnosis, female sex, private insurance, lower grade, lower clinical T classification, lower clinical N classification, increasing interval between the end of radiation and surgery, and treatment at higher-volume institutions. CONCLUSIONS: pCR was associated with favorable tumor factors, insurance status, time between radiation and surgery, and institutional volume. It is not clear what is driving the higher rates of pCR at high-volume institutions. Research targeted at understanding processes that are associated with pCR in high-volume institutions is needed so that similar results can be achieved across the spectrum of facilities caring for patients in this population.

Changes in margin re-excision rates: Experience incorporating the "no ink on tumor" guideline into practice.

INTRODUCTION: Prior to the "no ink on tumor" SSO/ASTRO consensus guideline, approximately 20% of women with stage I/II breast cancers undergoing breast conservation surgery at our institution underwent margin re-excision. On May 20, 2013, our institution changed the definition of negative margins from 2 mm to "no ink on tumor." METHODS: A retrospective review was conducted of patients who had surgery at our institution with clinical stage I/II breast cancers between June 1, 2011 and May 1, 2015. In the pre-guideline cohort (pre) and post-guideline cohort (post), negative margins were 2 mm and "no ink on tumor," respectively. RESULTS: Implementation of the guideline resulted in a significant decrease in the positive/close margin rate (29.6% pre vs 10.1% post; P < 0.001) and numerical decrease in re-excision rate (20.4% pre vs 16.3% post; P = 0.104). No significant difference was found in local recurrence between the cohorts with limited follow-up (1.2% pre vs 1.5% post; P = 0.787). CONCLUSION: The implementation of the "no ink on tumor" guideline at our institution has resulted in a significant decrease in positive margin rates and a numerical decrease in margin re-excisions. In addition to margin status, surgeons continue to use individual patient and histologic factors to decide for or against margin re-excision.

Reporting of mitotic rate in cutaneous melanoma: A study using the national cancer data base.

BACKGROUND: The seventh edition of the American Joint Commission on Cancer staging manual (AJCC7, published 2009), updated thin cutaneous melanoma staging protocols with the incorporation of mitotic rate (MR). In these patients, higher MR is associated with decreased survival. This study utilizes the National Cancer Data Base (NCDB) to evaluate MR reporting since AJCC7. METHODS: The NCDB was queried for patients with primary cutaneous melanoma from 1998 to 2013. Because MR reporting was infrequent prior to implementing AJCC7, records from 2010 to 2013 were analyzed. Categorical variables were compared with chi-square tests; univariate and multivariate logistic regression models were constructed to determine the effects of covariates on MR reporting. RESULTS: A total of 107,134 patients met inclusion criteria. From 2010 to 2013, MR reporting increased dramatically (64.3-80.9%). On multivariate analysis, factors significantly related to increased MR reporting include later diagnosis year, T-classification (T1a and b vs. T1), facility type (academic vs. other specified types of cancer programs), facility volume, patient income, level of education, and county population (metropolitan vs. urban and rural). CONCLUSIONS: MR reporting increased dramatically after the introduction of AJCC7; however, disparities in reporting remain across facility types. Further investigation of procedures performed in academic settings that may influence reporting of MR is warranted. J. Surg. Oncol. 2017;115:281-286. © 2017 Wiley Periodicals, Inc.

Pediatric and Adolescent Melanoma: A National Cancer Data Base Update.

BACKGROUND: Studies suggest that the biology of pediatric and adolescent melanoma differs from that of adult disease. We report the largest series to date examining the natural history of pediatric and adolescent melanoma. We aim to elucidate the natural history of pediatric and adolescent melanoma and to examine the appropriateness of diagnostic and therapeutic modalities developed for adults and that are currently being used in children. METHODS: A retrospective cohort study was conducted of patients with an index diagnosis of cutaneous non-metastatic melanoma from 1998 to 2011 using the National Cancer Data Base (NCDB; n = 420,416). Three age-based cohorts were analyzed: 1-10 years (pediatric), 11-20 years (adolescent), and ≥21 years (adult). Multivariate analyses were used to identify factors associated with overall survival (OS). RESULTS: Pediatric melanoma patients have longer OS than their adolescent (hazard ratio [HR] 0.50, 95 % CI 0.25-0.98) and adult counterparts (HR 0.11, 95 % CI 0.06-0.21). Adolescents have longer OS than adults. No difference was found in OS in pediatric patients who are node-positive versus node-negative. In pediatric patients, sentinel lymph node biopsy and completion lymph node dissection are not associated with increased OS. In adolescents, nodal positivity is a significant negative prognostic indicator (HR 4.82, 95 % CI 3.38-6.87). CONCLUSIONS: Age-based differences in melanoma outcomes warrant different considerations for diagnostic and therapeutic approaches in each group in order to maximize quality of life while minimizing complications and costs. Prospective, multicenter studies should evaluate the role of diagnostic procedures for pediatric patients.

Surgical Decision Making in the BRCA-Positive Population: Institutional Experience and Comparison with Recent Literature.

A retrospective study was performed to document the uptake and extent of surgical intervention in patients with a known mutation in the BRCA1/2 genes and associated outcomes. Data were collected retrospectively on BRCA-positive patients with and without cancer at the time of genetic testing. Our findings were compared to those published in the current literature. Of patients with cancer at testing, 61% chose bilateral mastectomies. Of patients without cancer, 54% chose risk-reducing surgery (RRS) including risk-reducing mastectomy (RRM), risk-reducing salpingo-oophorectomy (RRSO), or both. Time to surgery was significantly shorter to RRSO than to RRM. The literature suggests and our data support that acceptance of RRM in the BRCA-positive population has gradually increased over time. Consistently high rates of RRSO uptake and short intervals from time-of-testing to RRSO demonstrate that RRSO is still more acceptable to this population than RRM.

Margin re-excision and local recurrence in invasive breast cancer: A cost analysis using a decision tree model.

BACKGROUND: SSO-ASTRO recently published guidelines defining adequate margins in breast conservation therapy (BCT) as no tumor on ink based on studies demonstrating little difference in local recurrence (LR) with wider margins. We hypothesize that not routinely re-excising close margins results in decreased costs without compromising care. METHODS: A decision tree model was developed for the management of margins after BCT for invasive cancer. Patients were compared among three margin status groups: positive, close (≤2 mm) and negative (>2 mm). Ten publications provided re-excision rates (RER) and LR rates. The model assumed 140,000 BCT/year. Sensitivity analyses determined the most cost-effective strategy. Surgical costs were estimated using 2013 Medicare reimbursement rates. RESULTS: Re-excising close margins was significantly more costly than the alternative, $233.1 million versus $214.3 million, per year in the United States. Total surgical cost was most sensitive to re-excision of close margins-increasing the RER from 0% to 100% resulted in an $18.8 million cost difference. CONCLUSIONS: The strategy of re-excising close margins resulted in a predicted cost of $18.8 million per year. This does not include hospital costs, the cost of surgical complications after re-excision, and underestimates the potential savings by using Medicare reimbursement rates.

Raltegravir pharmacokinetics in treatment-naive patients is not influenced by race: results from the raltegravir early therapy in African-Americans living with HIV (REAL) study.

Racial differences in antiretroviral treatment responses remain incompletely explained and may be a consequence of differential pharmacokinetics (PK) associated with race. Raltegravir, an inhibitor of HIV-1 integrase, is commonly used in the treatment of HIV-infected patients, many of whom are African-American. However, there are few data regarding the PK of raltegravir in African-Americans. HIV-infected men and women, self-described as African-American and naive to antiretroviral therapy were treated with raltegravir (RAL) at 400 mg twice a day, plus a fixed dose of tenofovir-emtricitabine (TDF/FTC) at 300 mg/200 mg once daily. Intensive PK sampling was conducted over 24 h at week 4. Drug concentrations at two trough values of 12 and 24 h after dosing (C(12) and C(24)), area under the concentration-curve values (AUC), maximum drug concentration (C(max)), and the time at which this concentration occurred (T(max)) in plasma were estimated with noncompartmental pharmacokinetic methods and compared to data from a subset of white subjects randomized to the RAL twice a day (plus TDF/FTC) arm of the QDMRK study, a phase III study of the safety and efficacy of once daily versus twice daily RAL in treatment naive patients. A total of 38 African-American participants were enrolled (90% male) into the REAL cohort with the following median baseline characteristics: age of 36 years, body mass index (BMI) of 23 kg/m(2), and a CD4 cell count of 339/ml. Plasma HIV RNA levels were below 200 copies/ml in 95% of participants at week 4. The characteristics of the 16 white QDMRK study participants were similar, although fewer (69%) were male, the median age was higher (45 years), and BMI was lower (19 kg/m(2)). There was considerable interindividual variability in RAL concentrations in both cohorts. Median C(12) in REAL was 91 ng/ml (range, 10 to 1,386) and in QDMRK participants was 128 ng/ml (range, 15 to 1,074). The C(max) median concentration was 1,042 ng/ml (range, 196 to 10,092) for REAL and 1,360 ng/ml (range, 218 to 9,701) for QDMRK. There were no significant differences in any RAL PK parameter between these cohorts of African-American and white individuals. Based on plasma PK, and with similar adherence rates, the performance of RAL among HIV-infected African-Americans should be no different than that of infected patients who are white.

Rationale for Mastectomy after Neoadjuvant Chemotherapy.

Neoadjuvant chemotherapy (NAC) reduces tumor size, facilitating the use of breast conservation surgery (BCS). However, mastectomy remains the surgical outcome for certain women. The goal of this study was to determine the rationale for mastectomy after NAC, particularly in women eligible for BCS. Retrospective data were reviewed on patients who received NAC between February 2006 and August 2010 at our institution. Demographics and tumor characteristics were compared between patients who received BCS and mastectomy after NAC. Of 149 patients meeting inclusion criteria, 102 (68%) underwent BCS and 47 (32%) underwent mastectomy. Patient preference was the most common rationale for mastectomy (n = 19; 40%), followed by extent of disease (n = 13; 28%), presence of a breast cancer susceptibility gene (BRCA) mutation (n = 9; 19%), persistent positive margins (n = 5; 11%), and wound complications (n = 1; 2%). Of the 47 patients who underwent mastectomy, 37 (79%) were eligible for BCS after NAC. Larger pathologic tumor size (2.05 vs 1.25 cm, P = 0.04) and lobular histology [invasive lobular carcinomas, n = 12/17 (70%) vs invasive ductal carcinomas, n = 36/133 (27%); P < 0.01] were associated with increased rate of mastectomy. After NAC, patient preference, extent of disease, and the presence of a BRCA mutation account for the vast majority of mastectomies. Interestingly, most of these patients were shown to be candidates for breast conservation. This highlights the importance of educating patients about their surgical choice and the lack of evidence, showing a benefit to more extensive surgery.

Genetic Testing for Hereditary Breast Cancer: The Decision to Decline.

Genetic testing is important for comprehensive cancer care. Commercial analysis of the BRCA1/2 genes has been available since 1996, and testing for hereditary breast and ovarian cancer syndrome is well established. The National Comprehensive Cancer Network (NCCN) guidelines identify individuals for whom BRCA1/2 analysis is appropriate and define management recommendations for mutation carriers. Despite recommendations, not all who meet NCCN criteria undergo genetic testing. We assess the frequency that individuals meeting NCCN criteria decline BRCA1/2 analysis, as well as factors that affect the decision-making process. A retrospective chart review was performed from September 2013 through August 2014 of individuals who received genetic counseling at the Levine Cancer Institute. A total of 1082 individuals identified through the retrospective chart review met NCCN criteria for BRCA1/2 analysis. Of these, 267 (24.7%) did not pursue genetic testing. Of the Nontested cohort, 59 (22.1%) were disinterested in testing and 108 (40.4%) were advised to gather additional genetic or medical information about their relatives before testing. The remaining 100 (37.5%) individuals were insured and desired to undergo genetic testing but were prohibited by the expense. Eighty five of these 100 patients were responsible for the total cost of the test, whereas the remaining 15 faced a prohibitive copay expense. Financial concerns are a major deterrent to the pursuit of BRCA1/2 analysis among those who meet NCNN criteria, especially in patients diagnosed with breast or ovarian cancer. These findings highlight the need to address financial concerns for genetic testing in this high-risk population.

Application of ACOSOG Z1071: Effect of Results on Patient Care and Surgical Decision-Making.

BACKGROUND: The ACOSOG (American College of Surgeons Oncology Group) Z1071 assessed the feasibility of performing sentinel lymph node biopsy (SLNB) in node-positive patients who completed neoadjuvant chemotherapy (NACT). Historically, adoption of clinical research into practice takes years. The goal of this study was to determine the effect of Z1071 on our practice. MATERIALS AND METHODS: This is a retrospective review of Z1071's influence on a single institution's practice. Patients with biopsy-proven positive axillary lymph nodes before NACT were eligible for the study. After NACT, patients with nodal response according to imaging and exam were candidates for SLNB. Two cohorts were stratified according to diagnosis date before and after Z1071 results were presented on December 5, 2012 at the San Antonio Breast Cancer Symposium. Fisher exact tests and nonparametric rank tests were used to compare cohorts. RESULTS: The pre-Z1071 cohort included 74 patients and the post-Z1071 cohort 56 for a total of 130 patients. Post-Z1071, 73% (41/56) underwent a SLNB with an average of 4 nodes removed. Moreover, 27% (15/56) of patients had an axillary lymph node dissection as first intervention post-Z1071, compared with 99% (73/74) pre-Z1071. Axillary pathologic complete response pre-Z1071 was 35% (26/74) and post-Z1071 was 27% (15/56) (P = .35). CONCLUSION: This report shows that meaningful practice changes can be implemented rapidly. Changes in practice generated by clinical trial results should be monitored and outcomes followed.

National Trends in Utilization of Endoscopic Ultrasound for Gastric Cancer: a SEER-Medicare Study.

INTRODUCTION: Accurate preoperative staging is important for patients with gastric cancer. This study identifies the rate of utilization of endoscopic ultrasound (EUS) and its associated factors in Medicare patients with gastric adenocarcinoma. METHODS: The linked Surveillance, Epidemiology, and End Results (SEER)-Medicare claims database was queried from 1996 to 2009 for patients with gastric cancer who underwent gastric resection. Analysis with univariate, multivariate, and Cochran-Armitage trend tests were performed. RESULTS: In 5826 patients with gastric cancer with an average age of 76.9 ± 6.62 years, 59.1% had regionalized spread of cancer. EUS utilization increased significantly during the study period from 2.6% to 22% (p < 0.0001). EUS patients were more likely to be male, white, married, have higher education and income quartiles, and live in large metropolitan areas compared to non-EUS patients (p < 0.0001). Even after controlling for confounding factors, patients who underwent EUS were more likely to have >15 lymph nodes examined (odds ratio (OR) 1.26, 95% confidence interval (CI) 1.04-1.53) and have the administration of both pre- and postoperative chemotherapy (OR 1.27, 95% CI 1.03-1.57). CONCLUSION: EUS is currently under-utilized but increasing. Patients who underwent EUS (12.9%) were more likely to receive other NCCN-recommended care, including perioperative chemotherapy and adequate nodal retrieval.

Comparison of cardiovascular disease risk markers in HIV-infected patients receiving abacavir and tenofovir: the nucleoside inflammation, coagulation and endothelial function (NICE) study.

BACKGROUND: The association between abacavir (ABC) and cardiovascular disease (CVD) risk in HIV-infected individuals is unclear. Putative mechanisms for an effect of ABC on CVD risk including endothelial dysfunction have been proposed; however, a biological mechanism has not been established. METHODS: This was a cross-sectional study of HIV-infected subjects with HIV RNA levels <400 copies/ml, who were randomly assigned to ABC or tenofovir (TDF) as initial therapy during a prior clinical trial. A small cohort of subjects on zidovudine (AZT; not randomly assigned) were studied to explore long-term exposure to this agent. All underwent brachial artery ultrasound for flow-mediated dilation (FMD), and D-dimer, high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6) and fasting lipids were measured. Between-arm differences were evaluated by multivariable linear or logistic regression modelling. RESULTS: There were 148 subjects (46 on ABC, 72 on TDF and 30 on AZT). Demographic characteristics were balanced across the groups except, as expected, AZT-treated participants were older, had higher CD4(+) T-cell counts, and longer antiretroviral therapy duration. After adjusting for age, brachial artery diameter, and treatment duration, FMD was similar in those on ABC (3.9%) and TDF (5.4%; P=0.181). FMD was higher in those on AZT (6.1%; P<0.005). Levels of IL-6, hsCRP and detectable D-dimer were similar between groups. CONCLUSIONS: Among individuals assigned to ABC or TDF in randomized clinical trials there were no significant differences in FMD or markers of inflammation and coagulation. Whether ABC contributes to risk of CVD remains unclear, but our results suggest that endothelial dysfunction, heightened inflammation, and altered coagulation are unlikely to be mechanisms by which the drug could increase CVD risk above that seen with TDF.