bluuebunny/crossref_metadata_2025 huggingface dataset:
Improving infusion therapy efficiency at the Woodlands Regional Care Center (RCC).
Authors: Meade Jeremy
Published: February 2017

84

Background: The Woodlands RCC opened the Ambulatory Treatment Center in September 2010. The center houses 14 infusion units. Within 1 year, the demand for its infusion therapy services had more than doubled with continued rapid growth expected. The perception was that more patients could not be accommodated without additional space and staff. Therefore, a performance improvement team was formed in August 2011 with the goal to increase operational efficiency to satisfy patient demand, while maintaining the highest level of quality care. The increased access for patients allows for treatment to start sooner. Methods: The six sigma Define-Measure-Analyze-Improve-Control methodology was used to manage the project, and several lean and six sigma tools were utilized. The project commenced with a project charter with a measureable AIM statement to increase infusion volumes from 1.7 to 2.4 patients/unit per 9 hour day. Historical data was extracted, and all patients’ movements were timed for 3 weeks. Benchmarking, observations, and process mapping were also performed. Baseline performance was measured using SPC charts. Sources of variation were uncovered using statistical quality tools, brainstorming techniques, and cause/effect analysis. Key interventions consisted of standardized scheduling practices, development of a scheduling template, creation of a fast track room, new processes for overbooks and preschedules, and work balancing of nursing staff using an acuity rating system. In addition, staff workload was redistributed, and the lab was reorganized. Results: Within 3 months, the center met targeted capacity and provided regional care access to 41% more patients without additional staff, space, or working hours. By March 2012, the center accommodated 67% more patients (2.9/unit or 40/day) without adversely affecting patient wait time. Infusion room utilization increased by 15%. Conclusions: Although space constrained, The Woodlands RCC was presented with the challenge to provide patients’ open access to infusion therapy services. The team successfully applied lean and six sigma principles to evaluate the current state, perform a gap analysis, and deploy interventions to support quality and operate more efficiently.
Prospective quality review of breast care navigation and treatment: Fox Chase Cancer Center Partners’ (FCCCP) initiative.
Authors: Goldstein Lori J. , Bleicher Richard J. , Cohen Steven J. , Sein Elaine , O’Grady Margaret Anne , Keeley Patricia A. , Miller Bonnie J. , Slater Elyse , Li Tianyu
Published: February 2017

85

Background: There is increasing emphasis on quality metrics and process improvement for breast cancer treatment. FCCC designed a study to measure compliance with NCCN breast cancer guidelines at 11 FCCCP institutions. Methods: A relational data base was created to track indicators for operational timing, access, treatment modalities, and variance data in a population of breast cancer patients diagnosed and receiving first course of treatment at participating FCCCP institutions for 2009 calendar year. Pilot was conducted to ensure integrity of data collection tool in the previous year. Activation workshop, quarterly on site quality monitoring plan, real time quarterly reports to cancer committee, and benchmarking data were embedded in study. The primary objective was to benchmark participating institutions against each other and national benchmarks. Secondary objectives were to assess causes for variance and explore the role nurse navigation plays in real time quality metrics. Results: See Table. Conclusions: This novel prospective quality study demonstrated significant compliance with established breast cancer metrics across a large community hospital affiliate program. The impact of navigation appears greatest in reducing time between screening and diagnostic testing, demonstrating that navigation’s benefits extend beyond patient satisfaction to improvement of quality metrics. [Table: see text]
Community oncology care delivery staffing model.
Authors: Fryefield David C. , Kafora Roberta , Bradshaw-Hucko Lori , Tribble Chris , Jensen Terry , Chentnik Tom , Beveridge Roy
Published: February 2017

87

Background: In 2010, the US Oncology Network’s Clinical Advisory Council (CAC), a practice-based clinical leadership team, reviewed the care delivery process at 5 pilot community oncology clinics to determine how licensed and unlicensed clinical resources were used. The Lean Six Sigma methodology, which employs statistical analysis within a structured approach to problem-solving, was used to understand the required clinical activities of the practices within 3 primary areas. The objective of this pilot was to ensure patients receive timely, effective treatment from qualified personal in a cost-efficient model. Methods: A team led by a certified Master Black Belt studied tasks performed by licensed vs. non-licensed staff in the areas of physician services, treatment services and triage services at each practice. Based on the findings, tasks were realigned to maintain quality of care but to deliver care more efficiently. Results: Care Delivery processes comprised 95 tasks at baseline vs. 80 tasks in the redefined model. Within physician services, changes to workflow included rooming and clinic support (vitals, cleaning, and patient comfort) to be provided by Medical Assistants (MAs) instead of RN. RN duties were changed to MA supervision and tasks that require licensure. Changes to triage services included use of RNs to coordinate care and MAs for phone call screening, centralized triage (non-patient facing), and normal lab follow-up. Increased clarity of tasks and re-assignment of responsibilities reduced RN work load by 17% or 16.6 hours/day based on 120 patient visits. Each pilot site realized an annualized labor savings in excess of $100,000. This prospective, patient volume-based Care Delivery Staffing Model was adopted by the CAC as Network standard after completion of the pilot. Conclusions: Using Lean Six Sigma methods, the care delivery process was successfully re-designed such that clinical staff were re-aligned to better utilize each resource’s core competencies. Implementation of this care delivery model resulted in improved cost effectiveness while maintaining quality of care and also enabled prospective staff planning so that costs can be kept competitive in the future.
Can equitable care eliminate colon cancer disparities?
Authors: Patel Manali I. , Ma Yifei , Rhoads Kim Felder
Published: February 2017

91

Background: Previous studies suggest lack of insurance and variations in quality of care may drive disparities in colon cancer (CC), but equitable care may close these gaps. To clarify the role of equitable care on racial disparities, we compared CC survival in one of California’s largest Health Maintenance Organization (HMO) to survival in all other hospitals across the state. We hypothesized that disparities would be less pronounced in the HMO. Methods: All CC cases treated from 1996-2006 were identified in the California Cancer Registry linked to hospital discharge abstracts from the Office of Statewide Health Planning and Development. Enrollees in the state’s largest HMO were identified as such. Five year mortality was compared between HMO enrollees and all other patients using Cox proportional hazard models. Results: 62,184 CC records were included. 25% were HMO enrollees. The HMO treated a higher percent of black patients (9.2% versus 5.5%) and fewer Medicaid patients (2.1% versus 4.5%). There was no disparity in the HMO setting blacks as compared with whites (HR 0.90 95% CI 0.79-1.02); but black patients fared worse in the non-HMO settings (HR 1.15 95% CI 1.07-1.23). Conclusions: CC disparities are differentially distributed across California hospitals systems. Since there were no disparities in California’s large HMO, where care is typically protocol-driven, our findings suggest delivery of equitable care may eliminate disparities. These findings are consistent with other studies in the literature. Future research should assess the effect of emerging Accountable Care Organizations on the elimination of racial disparities in other cancers and diseases.
Improving detection of Lynch syndrome using a reflex immunohistochemistry algorithm for all patients with newly diagnosed colorectal cancer.
Authors: Pan Minggui , Hoodfar Elizabeth , Bergoffen JoAnn , Fulton Regan , Hofmeister Laura , Chavez Annette , Li Dan
Published: February 2017

98

Background: Identifying patients with Lynch syndrome has profound impact on the clinical care of patients and their families. Previous guidelines based on family history alone have shown low sensitivity. In our medical center, the detection rate of Lynch syndrome was <1% among colorectal cancer cases. Methods: We have developed a system-based algorithm using centralized testing by immunohistochemistry (IHC) for four mismatched repair (MMR) proteins (MLH1, MSH2, MSH6, and PMS2) as a screening method for all newly diagnosed colorectal cancer patients, followed by step wise testing of BRAF mutation, MLH1 promoter hypermethylation, +/- microsatellite instability, and germline mutation. Results: From April 1, 2011, to July 11, 2012, we have screened 116 patients. IHC detected absent expression of at least one of the MMR proteins in 18 cases. Three cases showed missing expression of MSH2/MSH6 and the presence of a germline mutation in MSH6 was confirmed in two cases. The newest case is still being investigated for germline mutation. Of the remaining 15 cases, 10 showed the presence of BRAF V600E mutation, two showed hypermethylation of the MLH1 promoter, and one showed germline MLH1 mutation. Two cases showed no BRAF V600E mutation, no MLH1 promoter hypermethylation or germline gene mutation. Overall, of 116 cases, three cases have confirmed Lynch syndrome with the detection of a germline mutation, two cases most likely have Lynch syndrome but without any detectable germline mutation of MLH1 or PMS2 using the current detecting methods. Conclusions: Our system-based screening algorithm using reflex immunohistochemistry of four MMR proteins has resulted in excellent detection rate of approximately 4% to 5% (5 out of 116 cases), consistent with the expected Lynch syndrome prevalence rate in the population. This represents a marked improvement over our previous family history-based approach in Lynch syndrome screening.
Molecular predictors of outcome and response to bevacizumab (BEV) based on analysis of RTOG 0825, a phase III trial comparing chemoradiation (CRT) with and without BEV in patients with newly diagnosed glioblastoma (GBM).
Authors: Sulman Erik P. , Won Minhee , Blumenthal Deborah T. , Vogelbaum Michael A. , Colman Howard , Jenkins Robert B. , Chakravarti Arnab , Jeraj Robert , Brown Paul D. , Jaeckle Kurt A. , Schiff David , Dignam James , Atkins James Norman , Brachman David , Werner-Wasik Maria , Komaki Ritsuko , Gilbert Mark R. , Mehta Minesh P. , Aldape Kenneth D.
Published: February 2017

LBA2010

Background: RTOG 0825 evaluated the addition of BEV to standard CRT in the treatment of GBM and included molecular stratification that assessed the degree of mesenchymal (MES) gene enrichment. We investigated the ability of the MES signature to predict response to BEV. Methods: Sufficient FFPE tissue for molecular analysis was available for 650 registered, eligible patients. TaqMan PCR was performed prospectively using the molecular stratifier on all patients and an expanded 43 member MES set on 234 cases. A subset of specimens was subjected to whole genome expression profiling (GEP). Predictive models were evaluated for their ability to predict survival (overall, OS, and progression-free, PFS) in the training cohort of the BEV arm after adjusting for prognostic factors and treatment arm. Unsupervised clustering of GEP data was used to identify molecular subsets and gene set enrichment analysis (GSEA) performed to evaluate for MES enrichment. Results: We observed a significant association between increasing MES signature and worse PFS and OS in the BEV arm (p=0.036 and p=0.032, respectively). Based on the association between high MES expression and poor outcome in the BEV arm, we sought to optimize a predictor using an expanded set of MES genes. Unbiased gene selection from a total of 43 genes followed by radial basis machine modeling identified a 10-gene predictor of outcome in the BEV arm (p<0.001/HR 4.04 for OS and p<0.001/HR 2.21 for PFS). To further support the association of MES enrichment and poor outcome in the BEV arm, we performed GEP. Unsupervised clustering identified a subtype of tumors with MES enrichment associated with the 10-gene predictor survival probability (p=0.0124, t-test). Ongoing studies will determine the extent to which this represents a predictive marker for BEV. Conclusions: We developed a 10-gene predictor specific to BEV treatment and suitable for FFPE that may serve to identify subsets of patients with newly diagnosed GBM who benefit from BEV. Supported by RTOG grant U10 CA21661, CCOP grant U10 CA37422, and Brain SPORE P50 CA127001 from the NCI and Genentech. Clinical trial information: NCT00884741.
A phase III trial of personalized chemotherapy based on serum tumor marker decline in poor-prognosis germ-cell tumors: Results of GETUG 13.
Authors: Fizazi Karim , Pagliaro Lance C. , Flechon Aude , Mardiak Jozef , Geoffrois Lionnel , Kerbrat Pierre , Chevreau Christine , Delva Remy , Rolland Frederic , Theodore Christine , Roubaud Guilhem , Gravis Gwenaelle , Eymard Jean-Christophe , Malhaire Jean-pierre , Linassier Claude , Habibian Muriel , Journeau Florence , Logothetis Christopher , Culine Stephane , Laplanche Agnes
Published: February 2017

LBA4500

Background: Poor-prognosis GCT (IGCCCG, J Clin Oncol 1997) remains a challenge with no improvement in the 50% survival demonstrated in phase III trials for 25 years. Day 21 serum tumor marker decline rate identified a subgroup of patients (pts) with a better outcome (J Clin Oncol 2004, 22: 3868-76). The hypothesis we tested in this study is that treatment allocation based on early tumor marker decline will improve the progression-free survival (PFS). Methods: Pts with IGCCCG poor-prognosis GCT were treated with a first cycle of BEP. AFP and hCG were assessed at day 18–21: 1) Pts with a favorable decline continued BEP for a total of 4 courses (Fav-BEP); 2) Pts with an unfavorable decline were randomized to receive either BEP (Unfav-BEP) or a dose-dense regimen (Unfav-dose-dense), consisting of paclitaxel-BEP plus day-10 oxaliplatin x 2 cycles, followed by 2 cycles of cisplatin, ifosfamide, and continuous infusion bleomycin (depending on lung function) + G-CSF. The primary endpoint was PFS (hypothesis: 20% difference, type 1 error: 5%, power 80%, 196 randomized pts needed). Results: 263 pts were enrolled and 254 were evaluable at day 21 (6 early deaths, 3 withdrawals): 51 pts (20%) had favorable tumor marker decline and 203 had unfavorable decline (randomized: 105 Unfav-dose-dense arm, 98 Unfav-BEP). The prognostic value of early tumor marker decline (Fav-BEP vs Unfav-BEP) was confirmed: 70% vs 48% for 3-year PFS (p=0.01), and 84% vs 65% for overall survival (OS) (p=0.02). The 3-year PFS was 59% in the Unfav-dose-dense arm vs 48% in the Unfav-BEP arm (p=0.05; HR: 0.66 [0.44-1.00]). 3-year OS was 73% and 65%, respectively. More ≥ grade 2 neurotoxicity (21% vs 4%) and more hematotoxicity occurred in the dose-dense arm, with no excess febrile neutropenia (17% each arm) or toxic deaths (1 each arm). Salvage high-dose chemotherapy + stem-cell transplant were required in 6% in the Unfav-dose-dense arm and 16% in the Unfav-BEP arm (p=0.01). Conclusions: An algorithm of individualized treatment intensification determined by the rate of early tumor marker decline reduces the risk of progression or death in men with poor-prognosis GCT. Clinical trial information: NCT00104676.
Randomized proteomic stratified phase III study of second-line erlotinib (E) versus chemotherapy (CT) in patients with inoperable non-small cell lung cancer (PROSE).
Authors: Lazzari Chiara , Novello Silvia , Barni Sandro , Aieta Michele , De Marinis Filippo , De Pas Tommaso , Grossi Francesco , Mencoboni Manlio , Bearz Alessandra , Floriani Irene , Torri Valter , Bulotta Alessandra , Grigorieva Julia , Roder Joanna , Doglioni Claudio , Roder Heinrich , Righi Luisella , Foti Silvia , Bachi Angela , Gregorc Vanesa
Published: February 2017

LBA8005

Background: Second-line therapy for advanced NSCLC patients (pts) after progression on platinum-based regimens typically employs CT or E. Improved PFS in E-treated pts is associated with EGFR sensitizing mutations. However, a test for optimizing treatment in pts with wild-type or unknown EGFR mutation status or squamous histology is of clinical value. VeriStrat (VS) is a serum protein test that assigns "good" (VSG) or "poor" (VSP) classification and has demonstrated prognostic and predictive utility. PROSE is a multicenter prospective randomized biomarker validation trial, designed to evaluate the ability of VS to predict survival in second-line NSCLC pts treated with E or CT. It is the first completed prospective randomized biomarker validation trial following the MARVEL design (Freidlin et al. JNCI. 2010). Methods: 285 pts, stratified by ECOG-PS, smoking, and blinded pretreatment VS classification, were randomized 1:1 to receive E or CT at standard doses. Primary endpoint was overall survival (OS) and the primary hypothesis was significant interaction between VS status and treatment. Sample size was calculated based on an estimated 65%/35% VSG:VSP ratio and hazard ratio (HR) for interaction of 2.35, with a 2-sided α=0.05 and 90% power. Results: 285 pts were randomized and 263 (129 CT, 134 E) included in the per protocol primary analysis. 68% of pts in CT arm and 72% in E arm were classified as VSG. Analysis was performed at 226 events. The trial reached its primary objective of significant interaction between treatment and VeriStrat classification with an interaction p value of 0.037. Pts in the VSP group performed worse on E compared to CT (HR: 1.72, 95% CI: 1.08-2.74); there was no significant difference in OS between treatments in the VSG group (HR: 1.09, 95% CI:0.79-1.50). 194/198 pts with histologic diagnosis had tissue available for EGFR and KRAS mutations. Conclusions: The results suggest that VS status is predictive of differential OS benefit for E versus CT in second line setting, complementing the result from a retrospective analysis of NCIC BR.21 where the prognostic behavior of VS was established (Carbone et al. JTO. 2012). Clinical trial information: NCT00989690.
Phase III study of NEPA, a fixed-dose combination of netupitant (NETU) and palonosetron (PALO), versus PALO for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC).
Authors: Aapro Matti S. , Rossi Giorgia , Rizzi Giada , Palmas Marco , Grunberg Steven
Published: February 2017

LBA9514

Background: Management of CINV has been refined over the past several decades and CINV can now be managed with targeted prophylactic medications aimed at inhibiting several molecular pathways involved in emesis. NEPA, a fixed-dose combination of netupitant (NETU), a new NK1 receptor antagonist (RA) and palonosetron (PALO), a pharmacologically distinct 5-HT3RA, targets these dual antiemetic pathways and has been shown to uniquely work synergistically in vitro. Methods: This was a multinational, randomized, double-blind, parallel group study assessing the efficacy and safety of a single oral dose of NEPA (NETU 300mg + PALO 0.50 mg) versus a single oral 0.50 mg dose of PALO in 1,455 chemotherapy-naive patients (pts) receiving anthracycline-based chemotherapy (all pts received oral dexamethasone (DEX) 12 mg (NEPA) or 20 mg (PALO) on Day 1). The primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) during the delayed (25-120h) phase. Results: Treatment groups had comparable demographic characteristics with the majority of the population being female (98%) and white (80%), with a mean age of 54 yrs; 97% pts had breast cancer. NEPA showed superior CR rates compared to PALO during the delayed, acute, and overall phases. NEPA was also superior to PALO during the delayed/overall phases for complete protection, no emesis, and no significant nausea. Most frequently reported study drug-related adverse events (AEs) for NEPA included headache (3.3%) and constipation (2.1%). The majority of adverse events for NEPA-treated pts were mild/moderate and there were very few (0.7%) severe drug-related AEs. The type and frequency of AEs were comparable between NEPA and PALO. There was no evidence of any cardiac safety concerns for NEPA or PALO. Conclusions: NEPA, a novel single-day fixed-dose combination targeting dual antiemetic pathways, is superior to PALO (both associated with DEX) in preventing CINV in pts receiving MEC. Clinical trial information: NCT01339260. [Table: see text]
Quantitative gene expression by RT-PCR in the tubular, cribriform, mucinous, and papillary histologic subtypes of invasive breast cancer.
Authors: Tan Vivian , Yoshizawa Carl N. , Anderson Joseph Michael , Shak Steven , Baehner Frederick L.
Published: February 2017

10

Background: ER+ special histologic breast cancer subtypes are prognostically significant. Here we report the special histologic subtypes of ER+ breast carcinoma and associated patterns of observed gene expression as measured by the 21 gene OncotypeDX assay. Methods: All tumors from 6/1/04-5/31/12 were included in analyses. Central path used WHO criteria. Ductal NOS (DC), tubular (TC), cribriform (CC), mucinous (MC) and papillary (PC) carcinomas were included. Quantitative expression of 16 cancer related genes was measured on a scale from 2 to 15 (relative to reference genes) where a 1 unit increment is associated with ~2-fold change in expression. Recurrence Score (RS) was calculated as published. Descriptive stats for the RS and individual genes [ER, PR, invasion gene group (IGG) and proliferation gene group (PGG)] were obtained. Comparisons of means were adjusted to control the overall error rate under any complete or partial null hypothesis. Results: DC accounted for 95.1%, TC 0.7% , CC 0.3%, MC 3.1% and PC 0.7% of 246,555 cases. For all types a wide continuous range of RS was noted. DC had the highest mean RS, followed in decreasing order by MC, TC, CC and PC. PC had the highest ER and PC and CC the highest PR. TC had the lowest ER. ER was not different between CC and MC but PR was. The proportion with ER+/PR- phenotype was different among the subtypes: TC (8.1%) and CC (7.1%) had the lowest incidence whereas MC (12.9%) and PC (10.3%) were more similar to DC (14.1%). TC had lowest PGG expression. MC and PC had lower IGG expression compared to other subtypes. Conclusions: The special subtypes had a wide continuous range of RS: DC had the highest mean RS, followed in decreasing order by MC, TC, CC and PC. PC had the highest ER and PC and CC the highest PR. TC had the lowest ER (may reflect submission bias). ER was not different between CC and MC but PR was. The proportion with ER+/PR- phenotype was different among the subtypes: TC and CC had the lowest incidence, MC and PC were more similar to DC. TC had the lowest PGG expression. MC and PC had lower IGG expression. [Table: see text]
Heart exposure in 100 consecutive, unselected patients treated with adjuvant 3D conformal radiotherapy for left-sided breast cancer.
Authors: Lonardi Federico , Gioga Gloria , Coeli Manuela , Campostrini Franco
Published: February 2017

103

Background: Women treated with radiotherapy for left-sided breast cancer may have their heart exposed to doses ranging from 1 to 7 Gy on the average. This was confirmed by a recent study* focusing on the ischemic risk based on medical records dating back to 1950s. Modern 3D conformal radiotherapy (3D-CRT), however, may play a major role in heart-sparing irradiation. Methods: We reviewed the treatment planning records and dose-volume histograms of 100 consecutive, unselected patients (pts) affected with left-sided breast cancer who underwent adjuvant 3D-CRT after either quadrantectomy (90 pts) or mastectomy (10 pts) in our center during the year 2011. Median age was 52 (range 42-90). The whole breast (or chest wall) received 50 Gy / 25 fractions in 66 pts and 45 Gy / 18 fractions in 34. Boost to surgical bed (10 Gy / 4-5 fractions) was delivered by photons in 10 pts. Median number of tangential fields was 2 (range 2-4). All treatments were performed in the supine position. Results: The average of the median doses to the whole heart was 2.89 Gy (range 0.8 to 13.05). Median doses were: 1.15 to 1.99 Gy in 21 pts; 2.01 to 3.00 Gy in 32 pts; 3.06 to 3.98 Gy in 16 pts; 4.16 to 4.83 Gy in 13 pts. Median dose only exceeded 5 Gy in 17 pts. One pt received less than 1 Gy and one pt more than 13 Gy. Median volumes (mV) of heart exposed to 5 Gy, 10 Gy and 15 Gy were: mV5 ≤ 4% (range 1 to 42%), mV10 ≤ 3% (0 to 30%), mV15 ≤ 2% (0 to 24%). Conclusions: The average doses we registered are lower than those (4.9 Gy, range 0.03 to 27.72) reported in the large investigation by Darby et al.*. Although related to a small case series, our data confirm that contemporary 3D conformal techniques allow reduced median doses to the whole heart with potential favorable impact on the risk of radiation-induced cardiac disease in the coming decades. Estimate of cardiac involvement in breast cancer radiotherapy based on older case series and outdated treatment techniques may be misleading. *Darby SC et al. Risk of ischemic heart disease in women after radiotherapy for breast cancer. NEJM 368, 11, 2013.
Breast cancer disparities in Duval County, Florida.
Authors: Samiian Laila , Kraemer Dale F. , Butterfield Ryan , Osian Sarah Rausch
Published: February 2017

117

Background: The age-adjusted death rate from breast cancer in Duval County is higher than the national average, with 26 deaths per 100,000 for all women. Breast cancer mortality is 38% higher for black women (37 per 100,000) in Duval County, than for white women (24 per 100,000). We sought to evaluate county specific breast cancer disparity data, in an effort to begin designing effective targeted interventions to reduce the disparities. Methods: Data on female breast cancer cases from 2004-2010 was extracted using the Florida Cancer Data System (FCDS). This data was analyzed using traditional descriptive statistics. Additional classification included health zones within Duval County, race, insurance, and age. Government (Tricare) and private or commercial insurance were combined in one group. The primary outcome was Stage at diagnosis, and time from diagnosis to treatment. Results: Using the FCDS, 6,502 new breast cancers were identified in Duval County from 2004–2010. Of these women, 73% were white, 24% black, 5% Hispanic, 2% Asian, and 2% unknown/other. Health Zone 1 which represents the urban core, has the largest population of Black women with breast cancer (76%), followed by health zone 5 and 4 (35% and 19%). Health Zone 1 has the highest volume of uninsured (10% vs 4% average for zones 2-6), and Medicaid breast cancer patients (8% vs 4% average for zones 2-6), and the lowest number of breast cancer patients with Government/Private insurance (33% vs 56%). Black women had higher percentage of advanced stage IV disease than any other race (8 % vs 4 %, p< .001). Women in Health Zone 1 are more likely to present with stage IV breast cancer than any other health zone in Duval County (10% vs 5%, p<0.01). Medicaid patients followed by the uninsured had the highest rate of stage IV at diagnosis (20% and 12% vs 4%, p<.001). Time from diagnosis to treatment was found to be longest in Black women (29 days vs 26 days, p< .001), Health Zone 1 (30 days vs county average 27 days, p<. 001), and those who were uninsured or had Medicaid (34 days vs 25 days for private insurance, p<0.001). Conclusions: Living in the urban core, black race, lack of insurance, and Medicaid funding was significantly associated with advanced stage at diagnosis and longer time from diagnosis to treatment in Duval County, Florida.
Bone mineral density and FRAX as predictors of fracture risk in women with breast cancer.
Authors: Edwards Beatrice J. , Gradishar William John , Smith Maureen , Pacheco Jennifer A. , Holbrook Jaimee S , Mckoy June M , Nardone Beatrice , Godinez-Puig Victoria , Bunta Andrew , Rosen Steven T. , West Dennis P.
Published: February 2017

121

Background: The number of cancer survivors is rising in the USA, the 2007 CDC analysis of the SEER database estimated 11 million cancer survivors, with 90% being over the age of 65 years. Of these, 70% are women, and the most common cancer in survivors is breast cancer. Cancer therapy induced bone loss (CTIBL) contributes to an increase in fracture risk in women with breast cancer. Fractures are responsible for considerable morbidity, disability, hopitalizations and mortality in older adults. Fractures are often the cause for nursing home placement in seniors. Our objective was to analyze the prevalence of fractures after breast cancer therapy and to assess the effect of cancer therapy, clinical risk factors, bone density and the World Health Oragnization (WHO) fracture risk assessment [FRAX] as predictors of fracture occurrence. Methods: The study population consisted of breast cancer patients with invasive breast cancer who participated in a genetic databank within a NCI-Comprehensive Cancer Center. Demographic and clinical characteristics were abstracted from the EMR. Participants were followed for 6-12 years. Results: A total of 439 women with breast cancer were assessed; 79 had sustained fractures during the observation period (116 fractures), fractures occurred at multiple skeletal sites in 27 cases. The prevalence of fractures was 18%. Baseline characteristics revealed that women who sustained fractures were mostly Caucasian (91%, p=0.08), and had a family history of osteoporosis (36.9%, p=0.03). The time to fracture was 4.0 years (range 0-12 years) from diagnosis. Fracture cases had lower BMD at the femoral neck 0.86 ± 0.13 gm/cm2 (T-score= -1.0, p=0.04) than non- fracture cases, although BMD was in the low normal range. Eight cases of hip fractures were identified with a median age of 55 years (32-67 years) Median T-score -0.75. Cox proportional hazard analysis failed to identify any specific risk factors for fractures. Conclusions: Fractures occur shortly after commencing cancer therapy. BMD and FRAX risk calculation were not able to identify women who fractured. Occurrence of fractures in breast cancer raises the possibility of cancer-induced impairment in bone quality.
Ethnic disparities in adherence to breast cancer survivorship care.
Authors: Gole Pragati , Ying Jun , Theriault Richard L. , Melhem-Bertrandt Amal , Moulder Stacy L. , Tereffe Welela , Pini Tunghi May , Brewster Abenaa M.
Published: February 2017

122

Background: Two major components of breast cancer survivorship care include surveillance with mammograms and clinic visits after completion of definitive treatment. Identifying disparities in adherence to survivorship care is critical for improving the care delivery and outcomes of patients. Methods: We evaluated adherence to survivorship care among 4,212 racially/ethnically diverse Texan residents who underwent surgery for stage I-III breast cancer at the MD Anderson Cancer Center between January, 1997 and December, 2006 and completed one year of survivorship care. We used generalized estimating equations (GEE) method to evaluate race/ethnicity differences in missed mammograms and clinic visits up to 4 years of survivorship care. Results: The mean age of the cohort was 53 years (range 22-91); 72% white, 11% black, 11% Hispanic and 5% other race/ethnicity. Over four years, 36% of patients missed an annual mammogram and 21% of patients did not have a minimum of 1 clinic visit per year. For the entire study cohort, the trend of missed annual mammograms per year of survivorship care follow-up was 6% (year 1), 17% (year 2), 19% (year 3) and 22% (year 4) (p-trend <0.0001). In multivariable GEE model adjusted for survivorship year, age, stage, chemotherapy, endocrine therapy, radiation therapy and county of residence, Hispanic (OR 1.48 95% CI 1.22-1.80) and black (OR 1.41, 95% CI 1.15-1.72) patients were more likely be nonadherent with annual mammograms compared to white patients. Hispanic (OR 1.58, 95% CI 1.25-2.00) and black (OR 1.45, 95% CI 1.14-1.84) patients were also more likely to be nonadherent with clinic visits compared to white patients. There was a significant interaction between ethnicity and non-receipt of adjuvant endocrine therapy on clinic visit nonadherence (p-interaction=0.04) and annual mammogram nonadherence (p-interaction=0.001) among Hispanic compared to white patients. Conclusions: Drop out of breast cancer survivorship care increases over time and black and Hispanic women are more likely to be nonadherent. Better characterization of the reasons for nonadherence is needed to design interventions to improve retention in breast cancer survivorship care, especially for patients not receiving adjuvant endocrine therapy.
Elevated extracellular fluid in the "at risk" arm from taxane-based chemotherapies in women treated for early breast cancer.
Authors: Kilbreath Sharon Lynn , Beith Jane McNeil , Refshauge Kathryn M. , Ward Leigh C. , Ung Owen , French James , Koelmeyer Louise , Kastanias Katrina , Simpson Judy M. , Yee Jasmine
Published: February 2017

126

Background: Taxane-based regimes has improved survival in early breast cancer and now is used routinely. A common side effect is oedema which potentially increases the risk of lymphoedema in the arm after surgery. This has not been assessed prospectively. The aim of this study was to determine the effect of taxane-based regimens on extracellular fluid (ECF) in the arm on the side of surgery. Methods: Women (n=441) aged 56.8 (SD 11.2) years enrolled prior to surgery for early breast cancer and were reassessed within 1 month and 6, 12, and 18 months following surgery. Assessment included bioimpedance spectroscopy which quantifies ECF in each arm and used to derive the ECF ratio. Based on the ECF ratio, women were categorised as having, or not, swelling preferentially in their at risk arm at each time point and having no taxane-based chemotherapy (n=269), paclitaxel (n=73) or docetaxel chemotherapy (n=88). Results: Pre-surgery, the ECF ratio was not significantly different in women who later did or did not receive taxane-based chemotherapy. Following surgery but prior to commencing chemotherapy, 45 (11%) women had increased ECF in their at-risk arm. Both taxane-based chemotherapies and elevated postoperative arm swelling were associated with swelling at each follow-up timepoint (Table). Conclusions: In addition to pre-existing swelling, both taxel chemotherapies were associated with swelling preferentially in the at-risk arm between 6 and 18 months following surgery. Strategies to prevent or minimise this swelling need to be developed. [Table: see text]
Patient navigation for breast cancer patients with disabilities.
Authors: Fenton Mary Anne
Published: February 2017

130

Background: Patient navigator programs (PNP) aid in evaluation and treatment of cancer in underserved populations. Along a patient’s journey obstacles to medical care can include cultural, financial, language, physical and transportation barriers, fear and anxiety, comprehension and retention of critical information and coordination of visits. PNP research has focused on addressing ethnic and racial barriers, with scant attention paid to the impact of PNP in the disabled. The Americans with Disabilities Amendments Act of 2008 defines as a “physical or mental impairment that substantially impairs one or more of major life activities." Methods: A retrospective analysis was performed of patients with stage I-III breast cancer under age 70 with disabilities enrolled in the PNP at Rhode Island Hospital or the Miriam Hospital (RIH/MH) from 2006-2012. Charts were reviewed and assessed for quality measures as defined by the National Comprehensive Cancer Center (NCCN) guidelines and American Society of Medical Oncology Quality Practice Initiative (QOPI) benchmarks, for demographics, stage at diagnosis, treatment recommended and received, and patient outcomes. Results: 44 patients were identified. All patients were recommended treatment in accordance with NCCN guidelines. Compliance with radiation and endocrine therapy guidelines was excellent. In the smaller cohort of patients for whom adjuvant chemotherapy was indicated, there was a higher rate of nonconcordance (25%) compared to 13% in the NCCN database. All nonconcordance was attributed to patient refusal (6) or delay due to comorbid conditions (3). Conclusions: Our analysis suggests PNP may enhance compliance with recommended treatment and thus quality care in breast cancer patients with disabilities. Integration of PNP in cancer care serves as a valuable adjunct in removing obstacles to cancer care for the disabled. [Table: see text]
Prevalence of self-reported cognitive dysfunction in breast cancer patients.
Authors: Skirbe Heidi , Hohn Gabriela , Klein Paula , Juliano Mary Ann , Winell Jeremy , Rosenwald Victoria , Boolbol Susan K. , Festa Joanne
Published: February 2017

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Background: In 2011 a series of four time-limited, psycho-educational workshops was conducted by a neuropsychologist at a major urban academic medical center, providing information, coping strategies, and resources to women who had been treated for breast cancer (BrCa) and who then sought cognitive treatment. Based on positive evaluations of these workshops, we assessed the prevalence of self-reported cognitive dysfunction in BrCa patients with the goal of expanding cognitive services to all affected cancer patients. Methods: The study was IRB approved. We surveyed a convenience sample of 50 BrCa patients in a single medical oncology waiting room over several weeks. Subjects completed a 16 item questionnaire assessing potential cognitive problems on a 4 point-scale. Results: Fifty patients completed the survey, of whom 46% were currently employed. Sixty-eight percent of respondents were currently receiving cancer treatment and of those, 61.8% had also received prior treatment. Conclusions: An unexpectedly large proportion of BrCa patients perceived cognitive difficulties that may have been compounded by fatigue and emotional dysfunction. Others may have failed to report cognitive difficulties, unaware of their onset. Quality of life of cancer patients is diminished by cognitive decline. The current data indicate a need for formal assessment and intervention programs that will identify patients with cognitive and emotional dysfunction and remediate the difficulties via workshops and therapy. Formal neuropsychological assessment and treatment resourcestargeting cognitive changes associated with cancer should be expanded to meet documented need. Further research will optimize the scheduling and structure of therapeutic interventions. [Table: see text]
Integrative model for breast cancer survivorship.
Authors: Reinbolt Raquel E. , Shapiro Charles L. , Garrett Julia , Basinger Heidi , Lester Joanne L. , Muscari Nicole , Ries Kathleen , Lustberg Maryam B.
Published: February 2017

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Background: Efforts to better address needs of survivors, summative care plans, and point of delivery are ongoing at academic, research, and community institutions. Lacking are empiric data to support one method over another. Methods: A quasi-experimental approach was used to measure a multidisciplinary integrative care model that involved the primary nurse, nurse practitioner, and medical oncologist to determine the best time, method, and application of cancer survivorship care planning. A concomitant cross-sectional study was ongoing in which patients completed the Distress Thermometer (0-10 analog score) plus a problem list (34 items) in early survivorship (e.g. during treatment, at its end, at 3- and 6-months later). Results: As a result of our teamwork, data from the electronic medical record (EMR) was integrated into end-of-treatment summaries and care plans; ‘smart-phrases’ provided links to personalized patient data which resulted in individualized care plans. The average self-reported distress level in early survivorship was 4.8, indicating a moderate to severe level of distress. Patients stated practical problems (e.g. finances, work) were of highest concern, followed by physical symptoms (e.g. fatigue, aches/pains), then emotional and family issues were prime distressors. The integrative model allowed our work teams to provide personalized services with a greater understanding of each individual patient. Data is presently being collected to quantify these services. Through this multidisciplinary approach, team-driven initiatives, and EMR integration, the preparation, delivery and follow up required for survivorship encounters was greatly streamlined. Conclusions: An integrative care model that is linked to the electronic medical record provides personalized care in a timely manner that is neither time nor resource intensive. We ‘listened’ to our patients and have diligently worked to increase and expand resources. Future initiatives include group educational sessions, earlier discussion of survivorship goals, and treatment summary generation at diagnosis. We believe this model will serve as the foundation for survivorship care expansion in our breast program, and can potentially be generalized to other institutions.
Group medical appointments: A novel approach in patient education for adjuvant endocrine therapy.
Authors: Vlahadamis Ann , Danilak Melanie , Rawson Krista M. , King Karen M. , Pituskin Edith
Published: February 2017

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Background: Group medical appointments (GMA) are currently practiced for a wide range of medical conditions such as diabetes, hypertension, asthma, and cardiovascular disease. Previously, postmenopausal estrogen receptor positive breast cancer patients (ERBCP) attended individual physician clinic appointments to learn about their options for adjuvant endocrine therapy. This resulted in variable education provided, lengthy medical oncologist (MO) clinic visits and significant wait-lists to attend clinic. Accordingly, we embarked on a pilot program to determine the feasibility and acceptability of GMA in this patient population. Methods: Since 2010, ERBCP requiring endocrine therapy were referred and scheduled in the biweekly GMA program. Education regarding choices, risks, benefits and side effects of endocrine therapy were provided by a nurse practitioner (NP) and/or pharmacist (RX). After questions were solicited from the group, individual ERBCP were provided with prescriptions and scheduled for guideline-based follow-up. Results: Approximately 900 ERBCP have attended GMA, with 100% of MOs referring eligible patients. Surveys indicate high levels of satisfaction with the information provided and the GMA format. Conclusions: GMA provided by NP and/or RX is feasible and acceptable to both ERBCP and MOs. Health system benefits include increased efficiency and reduced cost, with MO clinic reserved for complex patient needs. Patient benefits include timely access to care and high levels of reported satisfaction. Future work will examine the effects of GMA on patient compliance and medication reconciliation with endocrine therapy.
Heart failure and mortality risk in patients undergoing high-dose chemotherapy with autologous stem cell transplant for breast cancer after radiotherapy.
Authors: Singhvi Aditi , Garikapati Kiran , Khoulani Dania , Hassan Syed , Qureshi Waqas
Published: February 2017

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Background: High-dose chemotherapy (HDCT) with autologous hematopoietic stem cell transplant (HSCT) has been used as part of the treatment of metastatic breast cancer. However, the evidence behind this approach continues to be controversial. We hypothesize that previous radiation therapy (RT) may increase the risk of cardiomyopathy and mortality in these patients. Methods: Patients who underwent HSCT after HDCT for breast cancer treatment during 1988-2012 were included. The patients that underwent HSCT for indications other than breast cancer were matched 1:2 based on age and gender. The data was analyzed using the cox proportional hazard model, looking at time-to-survival with adjustments made for cardiotoxic chemotherapeutics, histology of cancer, ER/PR status, EGFR mutation status, number of RT sessions, age, and functional status. Results: Sixty-six patients with metastatic breast cancer underwent HSCT. Patients with breast cancer were more likely to develop systolic heart failure (10% vs. 6.1%, p=0.002). There were 29 (43.9%) patients who underwent whole breast RT (WBRT). Prior WBRT was an independent predictor of developing post-transplant systolic heart failure (HR 3.77; 95% CI 1.29–10.75, p=0.007). The Kaplan–Meier curve shows a better survival for patients without a previous WBRT (Log rank p=0.009). Patients with prior WBRT were found to have decreased survival (HR 1.59; 95% CI 1.16–2.17, p=0.004). Conclusions: Patients with a history of WBRT who underwent HSCT were more likely to develop new onset systolic heart failure than patients without WBRT. This might be due to the effects of RT on the coronary arteries and the cardiac myocytes, leading to worse outcomes. Future studies are needed to evaluate outcomes of HSCT in patients with metastatic breast cancer without prior WBRT.
Radiation therapy for breast cancer (BC) with central nervous system (CNS) metastases: A contemporary experience at Memorial Sloan-Kettering Cancer Center (MSKCC).
Authors: Morikawa Aki , Diab Adi , Patil Sujata , Forte Victoria , Blum Brian , Young Robert J. , Beal Kathryn , Hudis Clifford , Seidman Andrew David , McArthur Heather L.
Published: February 2017

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Background: Many of the well-studied prognostic factors for patients with breast cancer (BC) brain metastases (BM) are based on data from an era when stereotactic radiosurgery (SRS) was not commonly used. In this study, we examined patient characteristics and outcomes for patients with CNS metastases who recently underwent cranial radiation at MSKCC. Methods: 173 consecutive BC patients with CNS metastases receiving SRS or WBRT from January 2009 to December 2011 were identified. Clinico-pathologic and treatment information was obtained by retrospective review. Patient characteristics and associations were evaluated. Time from BM to death was evaluated by Kaplan-Meier and log-rank tests. Results: Of 173 patients (2 missing HER2 status), the subgroups were: HR+HER2-: 77 (45%), HR+HER2+: 28 (16%), HR-HER2+: 17(10%), and HR-HER2-(TNBC): 49 (29%). 121 had whole brain radiotherapy (4 with prior SRS), and 50 had SRS only. The use of SRS differed by subtype (overall Fisher’s exact p=0.02): 59% (HR-HER2+), 33% (TNBC), 29% (HR+HER2+), 21% (HR+HER2-). There were a total of 110 deaths. The median follow-up for survivors was 19mo (range: 6-67mo). The median time from BM to death for all patients was 17.5mo (95% confidence interval: 14-20mo): 41mo (HR-HER2+), 63mo (HR+HER2+), 14.5mo (HR+HER2-), 14mo (TNBC; log-rank test p=0.0001). Conclusions: Although HER2+ and TNBC subtypes are associated with a higher risk of BM, we noted a higher prevalence of HR+HER2- disease in BC patients with CNS metastasis, a group currently understudied. The prognostic information for time from BM to death differs according to subtype and may be important for future planning of clinical trials. Further evaluation of factors related to these outcomes is ongoing.