bluuebunny/crossref_metadata_2025 huggingface dataset:
Exercise training, inflammatory cytokines, and other markers of low-grade inflammation in breast cancer survivors: A systematic review and meta-analysis.
Authors: Meneses-Echavez Jose F , Ramirez-Velez Robinson , Gonzalez-Jimenez Emilio , Schmidt Rio-Valle Jacqueline , Sanchez Perez Maria Jose , Molina Montes Esther
Published: February 2017

121

Background: Low-grade inﬂammation, characterized by high cytokine activity, plays a crucial role in tumorigenesis. Further, cytokines and other inflammatory biomarkers are closely implicated in tumor growth, angiogenesis, and metastasis. This metaanalysis of randomized controlled trials estimates the effects of exercise training in the control of the serum levels of cytokines and other inflammatory markers in breast cancer survivors. Methods: PRISMA statement and the Cochrane Handbook were followed. We searched MEDLINE, CENTRAL, EMBASE, Scopus and DARE database to retrieve randomized controlled trials published between 1980- March 2014 providing effect estimates of exercise interventions in the serum levels of cytokines, such as interleukin (IL) -2, IL-6, IL-8, tumoral necrosis factor alpha (TNF-α) and C-reactive protein (CRP) in breast cancer survivors. An Inverse of variance (IV) fixed-effects model was conducted in absence of heterogeneity (I2<50%); otherwise a random-effects model was selected. Mean Differences (MD) were calculated to estimate differences between groups (p<0.05 with 95% Confidence interval). Heterogeneity was measured with the Chi2 test (p<0.10) and I2 statistics. Results: A total of 15 studies were included (n=1,447; mean age= 51.6 years old). Exercise interventions resulted in positive effects for CRP (MD= 0.37, 95%CI, 0.04 to 0.71; p= 0.03; I2=15%), IL-2 (MD= -6.04, 85%CI, -11.41 to -0.67; p=0.03; I2=0%), IL-10 (-22.90, 95%CI, -41.27 to -4.53; p=0.001, I2=0%) and waist circumference as indicator of body composition (MD= -1.12, 95%CI, -2.06 to -0.18; p=0.02; I2=45%). Non-significant differences were observed for IL-6 and TNF-α. There was no evidence of publication bias. Conclusions: These findings suggest that exercise training improves the systemic pro-inflammatory profile in breast cancer survivors and consequently the immunological responses and the carcinogenic processes related to tumoral environment. The effects observed for IL-10 provide a novel focus of evidence for the role of exercise as an effective anti-inflammatory intervention in cancer survivors.
Value of routine staging imaging studies (RSIS) for patients with stage III breast cancer (BC).
Authors: Piatek Caroline Irene , Ji Lingyun , Kaur Chandanpreet , Church Terry , Spicer Darcy V. , Tripathy Debu , Russell Christy Ann , Lang Julie E. , Macdonald Heather R. , Sener Stephen Francis , Silberman Howard , Sposto Richard , Garcia Agustin A.
Published: February 2017

122

Background: RSIS (CT, bone and PET scan) in pts with stage I or II BC is not recommended by NCCN and is considered optional in stage III BC. 10-15% of pts with stage III BC have occult metastases by RSIS, but it is unclear if this finding affects pt management or outcome. The addition of PET scans to conventional imaging (CT and bone scans) is of little added value (Niikura, et al. Oncologist 2011; 16: 772-82). We hypothesized that the use of RSIS in pts with stage III BC does not lead to changes in treatment or pt outcomes. Methods: After IRB approval, we retrospectively identified 875 women with stage III or stage IV BC from 2000-2010 through the Los Angeles County-University of Southern California and Norris Comprehensive Cancer Center cancer registries. Pts with clinically apparent stage IV disease, pregnancy at time of diagnosis, a history of prior malignancy, or incomplete medical records were excluded. Pts who underwent RSIS prior to planned treatment (before surgery, neoadjuvant or adjuvant therapy) were identified. RSIS results and the treatment plan in response to the results were recorded. Results: 424 pts were identified with clinical or pathologic stage III BC: 197 pts (46%) were < 50 years old, 224 (53%) had ER+ or PR+/HER2- tumors, 111 (26%) had ER-/PR-/HER2+ tumors, 74 (17%) had triple negative tumors, 15 (4%) had missing biomarker data, and 61 (14%) had inflammatory BC. 365 pts (86%) underwent RSIS. RSIS were negative for metastatic disease in 266 (73%), indeterminate in 75 (21%), and positive in 24 (7%). Treatment was altered in 21 pts (6%) based on RSIS (20 with metastatic disease, 1 with indeterminate disease). Median follow-up was 3.8 years (range: 0.1 to 13.3). When controlled for age, stage, or biomarker status, no differences in progression-free survival (PFS) were observed between the pts who underwent RSIS compared to those that did not. Conclusions: Most pts with stage III BC undergo RSIS. However, the results of RSIS infrequently affect treatment decisions. We did not observe a difference in PFS between pts who underwent RSIS and those who did not. Our findings suggest RSIS in stage III BC has limited value. A prospective study of this research question is warranted.
Primary analysis of the prospective, randomized, phase II trial of GP2+GM-CSF vaccine versus GM-CSF alone administered in the adjuvant setting to high-risk breast cancer patients.
Authors: Schneble Erika J , Perez Sonia A. , Murray James L. , Berry John S. , Trappey Alfred F. , Vreeland Timothy J. , Hale Diane F. , Greene Julia M. , Clifton Guy T. , Ardavanis Alexandros , Litton Jennifer Keating , Ponniah Sathibalan , Shumway Nathan M. , Papamichail Michael , Peoples George Earl , Mittendorf Elizabeth Ann
Published: February 2017

134

Background: GP2 is a HER2 derived, HLA-A2+-restricted immunogenic peptide designed to stimulate CD8+T cells to recognize tumor cells with any level of HER2 expression (IHC 1-3+). Accrual to a prospective, randomized, multi-center, phase II trial of the GP2 vaccine for prevention of breast cancer recurrence has completed. Here, the planned primary analysis of disease-free survival (DFS) is presented. Methods: HLA-A2+ node positive or high-risk node negative breast cancer patients (pts) with any level of HER2 expression rendered disease-free by standard of care therapy (to include trastuzumab where appropriate) were randomized to receive GP2+GM-CSF (VG) or GM-CSF (CG) alone. Pts received 6 monthly inoculations (primary vaccine series = PVS) followed by 4 boosters administered every 6 months. The Kaplan Meier method was used for statistical analysis. The intention-to-treat (ITT) population is defined as the entire randomly assigned population. The per-treatment (PT) group excluded pts who recurred during the PVS or developed a second malignancy. A pre-specified subgroup analysis was performed based on HER2 expression level. HER2 overexpression (OE) is defined as IHC 3+or FISH >2.2. Results: With 89 VG and 91 CG pts enrolled and vaccinated, there are no differences between groups with respect to age, node positivity, tumor size, grade, ER/PR status, and HER2 expression (p>0.05). The vaccine has been well tolerated with toxicities comparable between the VG and CG. Only one grade 3 local and systemic toxicity reaction has been reported in the VG. At 34 (1-60) month median follow-up, DFS was compared in the ITT (85% VG v 81% CG, p = 0.57) and PT (94% VG v 85% CG, p = 0.17) populations. In OE patients (51 VG and 50 CG) DFS was 94% VG v 89% CG, p = 0.86 (ITT) and 100% VG v 89% CG, p = 0.08 (PT). Conclusions: GP2+GM-CSF is a novel vaccine that is safe and well tolerated. This phase II trial demonstrates potentially greater benefit in pts with HER2 OE tumors, in whom there have been no recurrences in the PT group. This may be due to synergism with trastuzumab therapy, thus justifying a phase III trial evaluating GP2 administered in the adjuvant setting to a HER2 OE population. Clinical trial information: NCT00524277.
Stomatitis incidence and its relationship with efficacy: A meta-analysis of everolimus clinical studies.
Authors: Rugo Hope S. , Yao James C. , Pavel Marianne , Ravaud Alain , Franz David Neal , Taran Tanya , Gallo Jorge , Rouyrre Nicolas , Anak Oezlem , Motzer Robert J.
Published: February 2017

151

Background: The most common adverse event (AE) with everolimus (EVE) is stomatitis. This meta-analysis evaluated the incidence, severity, and possible impact of stomatitis on efficacy in patients (pts) with cancer or tuberous sclerosis complex (TSC) who received EVE. Methods: Stomatitis events from 7 randomized, double-blind, phase 3 EVE studies included: RECORD-1 (RCC), RADIANT-2 (NET), RADIANT-3 (pNET), BOLERO-2 (HR+/HER2- breast cancer [BC]), BOLERO-3 (HER2+BC), and EXIST-1 and -2 (TSC). Time to first stomatitis occurrence and recurrence were analyzed using Kaplan-Meier (KM) methods. Stratified Cox regression analysis adjusted for baseline prognostic factors and corrected for confounding effect of duration of exposure was used to analyze association between stomatitis occurrence (≤ 8 wks of EVE start) and PFS in pts with cancer and response rate in pts with TSC. Results: This evaluation included EVE-treated pts with cancer (n = 1,455) and TSC (n = 157). Pts with cancer had stomatitis incidence of 66.9%, which occurred early, median 0.82 mo (95% CI, 0.7-1.0; 2-mo KM estimate 60.8%). 8.6% were grade 3/4 events. 1.7% of pts discontinued due to stomatitis. Stomatitis recurred in 40% of pts and appeared gradually. In pts with TSC similar results were observed. In EVE-treated pts, development of stomatitis was associated with longer PFS (corrected HR [95% CI]) in BOLERO-2 (0.78 [0.62-1.00]) and RADIANT-3 (0.70 [0.48-1.01]), and similar trend was observed in RECORD-1 (0.90 [0.66-1.22]) and RADIANT-2 (0.87 [0.61-1.22]), but not in BOLERO-3. In TSC, probably due to few pts, relationship between stomatitis and response was not conclusive. In all trials, pts on EVE had longer PFS vs placebo irrespective of stomatitis incidence. Conclusions: Stomatitis is observed frequently in initial wks of EVE therapy. Most AEs were grade 1/2 and manageable, rarely led to pt discontinuation. Stomatitis recurred in < 50% of pts. EVE-treated pts with cancer who had stomatitis achieved stable benefit similar to overall population, suggesting that continuing EVE is helpful. The importance of prophylactic measures in reducing EVE-induced stomatitis incidence and improving its management is being determined by ongoing studies.
Refractory granulomas of breast: Benign or malignant disease.
Authors: Freeman Christopher Mark , Lewis Jaime D , Lower Elyse E. , Khan Shagufta , Shaughnessy Elizabeth
Published: February 2017

21

Background: Idiopathic granulomatous mastitis (IGM) is an uncommon benign inflammatory breast disease of unknown etiology that may mimic malignancy, infectious diseases, or autoimmune conditions requiring a diagnosis of exclusion. Because the differential diagnosis includes benign as well as malignant disease, an organized approach to the diagnosis and its symptom management is needed. Treatment may include corticosteroids, immunosuppression, or in severe refractory cases, surgery. Methods: This IRB-approved single tertiary referral center study was performed to better characterize the presentation, risk factors, differential diagnosis, and treatment options for IGM. All patients identified in a pathology database with a biopsy consistent with IGM were studied. Data collected included demographics, duration and quality of symptoms, imaging results, microbiology, pathology, systemic and surgical therapies, and outcomes. Results: Between 2006 and 2014, 16 eligible patients were identified. Patients with a prior history of IGM, cancer, or other granulomatous diseases were excluded. Twelve patients were evaluable, and four patients were excluded due to insufficient records. The mean age was 31.9 years (23 to 54) with 50% of patients black and 25% Hispanic. Pregnancy occurred within 5 years of biopsy in 67% of patients. The most common presenting symptom was mass (83%) with focal pain (75%), and the mean duration of symptoms was 5.1 months (0.5 to 16). All microbial cultures were negative. Following diagnosis, systemic treatment included antibiotics (58%), corticosteroids (25%), and methotrexate (17%). Due to refractory symptoms and toxicity despite steroids and methotrexate, surgical intervention was necessary in 67%. Partial mastectomy was performed in 50% and total mastectomy in 17%, with one patient requesting mastectomy for palliation. Conclusions: Although rare, IGM is difficult to diagnose and manage, and an accurate diagnosis must exclude malignancy and other granulomatous processes. Despite the benign nature of the disease, surgical intervention may be required. Systemic treatment with corticosteroids and methotrexate may decrease the need for surgical intervention.
Diagnostic, prognostic, and treatment monitoring value of plasma X in patients with metastatic breast cancer.
Authors: Peng Cike , Yang Rongxi , Madhavan Dharanija , Wallwiener Markus , Rudolph Anja , Chang-Claude Jenny , Burwinkel Barbara
Published: February 2017

37

Background: Metastasis is the main course of death in breast cancer (BC) patients. Reliable prognostic markers are very much appreciated to evaluate possible outcome of patients. Circulating tumor cells (CTC) is a circulating prognostic tumor marker of metastatic breast cancer patients. Despite the big technical challenges in CTC detection, the reliability of CTC enumeration for the prognosis of BC is still on debate. Some studies have proved that the plasma level of X, a major component in extracellular matrix, was increased in patients with metastatic breast cancer. However, the association between the plasma X level and the prognosis of metastatic breast cancer is still unknown. Methods: Plasma X was measured by ELISA in 60 healthy controls, 48 primary breast cancer (PBC) patients, and 212 metastatic breast cancer (MBC) patients. Progression free survival (PFS) and overall survival (OS) were analyzed. An independent cohort with 210 primary and 69 patients with metastatic breast cancer were further investigated to validate our findings. Results: A 2-fold elevation was presented in MBC patients when compared with PBC patients and controls, regardless of their CTC status. A multivariate Cox regression demonstrated that lower X level at base line was associated with longer PFS (HR: 2.50, 95% CI: 1.72–3.63, p = 1.607 × 10-6), as well as longer OS (HR: 3.74, 95% CI: 1.65 – 8.51, p = 0.002). After 1stcycle of chemotherapy, plasma X level was still prognostic and was dramatically decreased in patients who had responded to the treatment (54%, IQR: 36%–64%). In the independent validation round, a 2-fold increase of plasma X was observed again in MBC patients, compared with PBC patients. The prognostic value was also validated for PFS (HR: 2.12, 95% CI: 1.43– 3.84, p = 0.001) and OS (HR: 2.91, 95% CI: 1.73–7.65, p = 0.002) in MBC patients. Conclusions: Plasma X could be used as a diagnostic and prognostic marker for metastatic breast cancer. Its reduction after 1st cycle of chemotherapy could be an indicator of treatment efficacy. This finding may further prevent unnecessary systemic therapy by facilitating personalized medicine in the treatment of metastatic breast cancer.
Family history and breast cancer subtype among women of Mexican descent.
Authors: Anderson Kristin , Thompson Patricia , Wertheim Betsy , Martin Lorena , Komenaka Ian K. , Bondy Melissa , Daneri-Navarro Adrian , Meza-Montenegro Maria Mercedes , Gutierrez-Millan Luis Enrigue , Brewster Abenaa M. , Madlensky Lisa , Martinez Maria Elena
Published: February 2017

41

Background: A family history of breast cancer in a first-degree relative is associated with a 2-fold increase in breast cancer risk; however, breast cancer is a heterogeneous disease and there may be differences in risk profiles driven by tumor subtype or by racial/ethnic group. Methods: We assessed prevalence of familial breast cancer and its association with tumor subtype among 914 women with breast cancer of Mexican descent enrolled in the Ella Study, a case-only, binational (U.S.-Mexico) breast cancer study. Logistic regression was conducted to compare odds of triple negative breast cancers to non triple-negative breast cancers according to family history. Results: The prevalence of family history of breast cancer in a first- or second-degree relative was 24.1%, with 13.1% having an affected first-degree relative. Among participants who were diagnosed at age < 50, prevalence of family history of breast cancer in a first- or second-degree relative was 27.4%. After adjustment for age and country of residence, women with a first-degree relative with breast cancer were significantly more likely to be diagnosed with triple-negative breast cancers compared to non triple-negative breast cancers (OR = 1.98; 95% CI, 1.26-3.11). Similar results were seen for odds of triple-negative breast cancers compared to non-triple negative breast cancers for women with affected first- or second-degree relatives (OR=2.04; 95% CI, 1.40–2.98). The odds of triple-negative breast cancer compared to non-triple negative breast cancer was 1.93 (95% CI, 1.26–2.97) for women with first-degree relatives affected with breast or ovarian cancer. Conclusions: Findings suggest that familial cancers are most likely to be associated with triple negative subtype, supporting etiologic heterogeneity by tumor subtype in this population of Hispanic women. This association may be related to the prevalence of BRCA1 founder mutations in this population, which are strongly associated with triple-negative breast cancers. Identification of such differences in risk factors can help personalize screening and prevention approaches.
Does biologic subtype and pathologic response after neoadjuvant chemotherapy predict locoregional recurrence?
Authors: Yang T. Jonathan , Morrow Monica , Modi Shanu , Krause Kate , Siu Chun , Gupta Gaorav P. , McCormick Beryl , Powell Simon N. , Ho Alice Y.
Published: February 2017

65

Background: The relative contribution of biological subtype and response to neoadjuvant chemotherapy (NAC) to locoregional recurrence (LRR) is uncertain. We aim to determine if these factors identify a high risk population for LRR. Methods: 233 patients received anthracycline/taxane-based NAC, mastectomy and postmastectomy radiation therapy (PMRT) in 2000-2009 for Stage II-III breast cancer. 53% (n=123) were HR+ (ER or PR+/HER2-), 23% (53) HER2+ (HER2+/HR+ or HR-), and 24% (57) TN (HR-/HER2-). 76% of HER2+ received trastuzumab. Median PMRT dose was 50 Gy to chest wall and regional nodes. Pathologic complete response (pCR) rates were compared using Fisher's exact test. Rates of LRR and distant recurrence (DR) were estimated by Kaplan-Meier methods. Cox regression analysis was performed. Results: Median follow-up was 62 months (range 7-161) with 21 LRR, 84 DR and 58 deaths. pCR rate and 5-year LRR rates were 14% and 7% in the entire cohort, respectively. Significantly more TN and HER2+ patients achieved pCR than HR+ patients (Table 1, p=0.003). TN patients had higher 5-year LRR rate compared to HR+ and HER2+ patients (18% vs. 4% and 6%, p=0.02). The 5-year LRR rate was 0% in pCR patients versus 9% in non-pCR patients (p=0.06). In patients without pCR, TN subtype was associated with increased LRR (23% at 5-year vs. 4% HR+ and 7% HER2+; p=0.001). TN patients without pCR were also associated with increased DR (48% at 5-year vs. 29% HR+ and 30% HER2+, p=0.02). On univariate analysis, TN subtype (HR=2.0, p=0.008), pathologic stage (HR=2.2, p=0.02), and pN+ status (HR=9.3, p=0.03) were associated with increased LRR. Conclusions: Although response to NAC strongly correlates with breast cancer subtype, patients with HR+ and HER2+ breast cancer had favorable rates of LRR regardless of response to NAC, perhaps because of additional postoperative targeted therapy. In contrast, while no LRR was seen in TN patients with pCR, those with poor response to NAC had significantly higher LRR risk, underscoring the need for potential new treatment strategies to improve local control in this population. [Table: see text]
Predicting the biologic classification of phyllodes tumors from preoperative core needle biopsy and imaging findings.
Authors: Yasir Saba , Martin-Macintosh Erica L , Onkendi Edwin O , Jimenez Rafael E. , Fazzio Robert T. , Spears Grant M. , Jenkins Sarah , Hieken Tina J.
Published: February 2017

86

Background: Phyllodes tumors (PT) are rare breast neoplasms confounding their systematic study and evidence-based management guidelines. There is little data on the sensitivity of preoperative core needle biopsy (CNB) and imaging findings in establishing a correct preoperative diagnosis. We undertook this study to evaluate the sensitivity of CNB histologic findings and imaging findings in preoperatively categorizing tumors as benign or borderline/malignant. Methods: We identified 47 patients who underwent surgical resection of a PT at our institution after a preoperative CNB between 6/2000-3/2012. Statistical analysis utilized Wilcoxon rank-sum, chi-square or Fisher’s exact tests, and 95% confidence intervals (CI) are reported. Results: 30 patients had a final diagnosis of benign and 17 of borderline/malignant PT. The latter were significantly more often palpable (76.5% vs 36.7%, p=0.01). No other clinical or radiologic feature predicted borderline/malignant subtype, although irregular shape on US was suggestive (70.6% vs 44.8%, p= 0.09). CNB diagnosis by tumor type is summarized in the table. No benign PT had ≥10 mitoses, necrosis or marked stromal atypia on CNB. No case with absent mitoses on preoperative CNB was a borderline/malignant PT; however 77% of benign PT did exhibit mitoses on CNB. Sensitivity of CNB for PT overall was 48.9% (95% CI: 35.3-62.8%) while it was 40% (24.6-57.7%) for benign PT and 17.6% (6.2-41.0%) for borderline/malignant PT. Conclusions: Marked stromal atypia, ≥10 mitoses and necrosis were rare on CNB, but suggestive of malignancy. No imaging or histology feature reliably distinguished between tumor types. Over one-third of borderline/malignant PT had a preoperative CNB diagnosis of fibroadenoma or cellular fibroepithelial lesion emphasizing the low sensitivity of CNB and the need for judicious consideration of definitive surgical excision. [Table: see text]
Dosimetric evaluation of organs at risk to toxicities between multicatheter accelerated partial-breast irradiation and whole-breast external beam radiotherapy.
Authors: Chan Tabitha Y , Tan Poh Wee , Tan Chek Wee , Tang Johann I
Published: February 2017

94

Background: This study aims to quantify the dosimetric reduction to the heart and lung when comparing Whole Breast External Beam Radiotherapy(WBEBRT) with Multicatheter Accelerated Partial Breast Irradiation(MCAPBI) for early stage left sided breast cancer. Methods: Planning CT data sets of 13 patients with left breast cancer receiving multicatheter brachytherapy post breast conserving surgery were used to create two independent treatment plans – WBEBRT prescribed to 50Gy/25fractions and MCAPBI prescribed to 34Gy/10fractions. Dose parameters for (i) heart, (ii) left anterior descending(LAD) artery and (iii) ipsilateral lung were calculated and compared between the two treatment modalities. Results: After adjusting for Equivalent Dose in 2Gy Fractions(EQD2), comparing MCAPBI with WBEBRT, the largest dose reduction was for the LAD artery whose point dose differed by a factor of 4.9. Although somewhat less pronounced, this was also true for the mean lung dose of the ipsilateral lung and mean heart dose with a factor of 3.8 and 2.1 respectively. Compared to WBEBRT, the mean MCAPBI heart D0.1cc (representing the dose received by the most highly exposed 0.1 cc of the risk organ, i.e. the dose peak) was significantly lower(16.43Gy vs 48.82Gy;p<0.01) as well as mean heart dose(MHD) was significantly lower(2.33Gy vs 4.85Gy; p<0.01). Similarly, mean point dose for MCAPBI LAD was significantly lower compared to WBEBRT(9.85Gy vs 47.92Gy; p<0.05). Peak dose and mean lung dose(MLD) for ipsilateral lung was also lower for MCAPBI compared to WBEBRT (Peak dose: 22.19Gy vs 50.45Gy(p<0.05); MLD: 2.31Gy vs 8.73Gy(p<0.05). Conclusions: Compared to WBEBRT, MCAPBI showed a significant reduction in radiation dose for the heart and lung. This may translate into better cardiac and pulmonary toxicities for patients undergoing MCAPBI.
Raising the safety bar: The hematology/oncology patient safety committee.
Authors: Nahas Myrna Rita , Zerillo Jessica A. , Cannistra Stephen A. , Totte Cheryle
Published: February 2017

144

Background: Enhancing patient safety can prevent unintended outcomes arising from defects in healthcare delivery systems. The Hematology/Oncology Patient Safety Committee (HOPSC) at Beth Israel Deaconess Medical Center (BIDMC) is a multidisciplinary team of healthcare providers that meets monthly to review inpatient and outpatient adverse events, near misses, and medical errors that impact patient safety. Methods: Our aim was to quantify and qualify the cases that the HOPSC has reviewed from 2012-2013. In order to identify trends in event reporting, we reviewed the number of events reported to the HOPSC in both the inpatient and outpatient settings. We further subdivided events into two categories: medication-related and non-medication related. Additionally, we delineated which healthcare provider initiated the reporting of each event. Results: Over the two-year period, a total number of 1,061 events were reported to the HOPSC. Of these, 259 were medication-related events. Of the events reported, 40 were by a physician/NP and 1,021 were by a nurse. There was a discrepancy in the type of event reported (24.4% medication vs. 75.6% non-medication related) as well as in the type of reporter (3.8% physician/NP vs. 96.2% nurse). Of all the events reported, 8 were escalated to the Department of Medicine Peer Review Committee. Conclusions: Through review of healthcare provider event reports, the HOPSC has identified several types of adverse events and near misses in the Hematology/Oncology division at BIDMC. The events are mostly reported by inpatient nurses and are primarily medication-related. Given this skewed reporting pattern, we will investigate the reasons why reporting by physicians, especially in the outpatient setting, is limited. Our reported outline of the HOPSC operations may also guide oncology practices elsewhere in their own development of patient safety peer review committees. [Table: see text]
Does insurance mix impact utilization of published care practices and guidelines among breast imaging sites?
Authors: Murphy Anne Marie , Weldon Christine B. , Trosman Julia Rachel , Schink Julian C. , Ansell David , Simon Melissa A.
Published: February 2017

150

Background: Significant variation exists across Metropolitan Chicago in the quality and timeliness measures for breast cancer detection (Rauscher GH 2014). We examined utilization of published care practices and guidelines at breast imaging sites in Chicago and compared them based on insurance mix. Methods: We conducted an IRB approved web survey of all 58 breast imaging sites in Chicago. Using guidelines (NCCN, NAPBC, ACR) and peer-reviewed literature (38 studies) we developed a survey of breast diagnostic practices. Results analyzed using simple frequencies and Fisher's exact test. Results: We achieved a response rate of 91% (53/58 sites): 27 sites with over 40% privately insured (PI) patients and 26 sites with over 60% Medicare, Medicaid, charity and self pay (MM) patients (IDPH 2012). Utilization of practices vary (Table). The use of breast MRI for diagnostic patients is 81% (17/21) of PI vs. 47% (8/17) of MM sites, p=0.04. Image guided biopsy is used by 81% (17/21) of PI vs. 25% (3/12) of MM sites, p=0.03. Clip placement at biopsy is done at 86% (18/21) of PI vs. 50% (6/12) of MM sites, p=0.04. Conclusions: Sites with higher rates of private insurance show better utilization of three published breast cancer diagnostic care practices. However, improvement is needed across sites, regardless of insurance mix, to provide care to all patients that is up-to-date on published breast cancer screening and diagnostic practices. [Table: see text]
Emergency department (ED) utilization and hospital admission rates among oncology patients at a large academic center and the need for improved urgent care access.
Authors: Adelson Kerin B. , Dest Vanna , Velji Salimah , Lisitano Richard , Lilenbaum Rogerio
Published: February 2017

19

Background: In the US, 30% of the total cancer expenditure is spent in the last year of life and 55% of this is spent on inpatient care. For patients with advanced cancer, most hospitalizations arise from expected disease progression. With the ultimate goal reducing hospital admissions at the Smilow Cancer Hospital at Yale New Haven, we sought to understand our patterns of ED referral, hospital admission, and length-of-stay. Methods: An analysis of all oncology patients coming to the Yale New Haven Hospital (YNHH) ED was performed by executing reports through our EPIC electronic medical record. We looked at a 5-month time frame from January 1, 2014, through May 31, 2014. Results: A total of 391 oncology patients from each of our disease groups presented to the ED and 90% were admitted. Mean length of stay (LOS) was 6.74 days. 62% of patients arrived during the hours of 9:00AM-5:00PM. The average daily cost per admission was $1886 per day/ $12,711.64 for the mean hospitalization (largely spent on nursing, pharmacy, and laboratory). At least 50% of these presentations could have been addressed in the ambulatory setting including but not limited to dehydration, abdominal pain and failure-to-thrive. Conclusions: Despite a 6-day/wk ambulatory oncology practice, our patients are presenting to the ED during standard daytime hours resulting in admission and prolonged length-of-stay. We will launch a same-day visit program with access to urgent palliative care consultation, pharmacy and infusion chairs. We will treat dehydration, nausea, vomiting, pain, DVT, and other urgent presentations. This cultural change will require education of physicians, nurses, staff, patients and caregivers. We estimate that a 50% reduction in admissions would yield a cost savings of approximately $6 million annually. [Table: see text]
Patient satisfaction with doctor and nurse communication varies with patient education level, age, gender, and primary language.
Authors: McFarland Daniel Curtis , Holcombe Randall F.
Published: February 2017

198

Background: Hospital Consumer Assessments of Healthcare Providers and Systems (HCAHPS) surveys are used to enhance quality care. Non-random patient satisfaction variance is evident from HCAHPS scores which could be due to varying perception of quality care across demographically heterogeneous areas of the USA. Methods: HCAHPS, hospital bed, and county demographic data were obtained from the Hospital Compare, American Hospital Directory, and US Census Bureau websites, respectively. Multivariate regression modeling was performed for all ten dimensions of HCAHPS scores. Standardized partial regression coefficients were used to assess strengths of predictors (Table). Results: HCAHPS scores were obtained from 3,192 hospitals and demographic data collected from all 3,144 county or county equivalents. While most predictors were significant, ‘bachelor’s degree’ most strongly predicted for favorable satisfaction for MD communication and ‘white alone percent’ most strongly predicted favorable satisfaction for RN communication. Age (over 65), non-English speaking, female, average household size and high school education predicted worse satisfaction with both MD and RN communication. Conclusions: In conclusion, a communication quality gap exists for less educated, non-white, elderly, non-English speaking and female sections of the population. Research should focus on enhancing delivery of quality communication for these subpopulations. [Table: see text]
Characterization of aggressive interventions within 30 days of death in lung cancer patients at Smilow Cancer Hospital (SCH).
Authors: Zhang Bingnan , Adelson Kerin B. , Velji Salimah , Rimar Joan , Longley Peter , Keane Brian , Chiang Anne C. , Lilenbaum Rogerio
Published: February 2017

20

Background: Multiple studies have demonstrated that patients with advanced cancer receive overly aggressive care at the end-of-life. With the goal of ultimately reducing overutilization, we sought to characterize the care we provide and identify if the Rothman Index (RI), a validated EMR tool which displays patients’ clinical condition, could predict those in whom aggressive interventions might be futile. Methods: We performed a retrospective chart review on 118 patients with advanced lung cancer who died at SCH in the fiscal year 2012. We extracted: 1. Rates of aggressive interventions including ICU stay, chemotherapy, non-palliative radiation and surgery within 30 days of death; 2. Rate of palliative care (PC) consultation; 3. RI. 4. Readmission rates. Results: 118 lung cancer patients were identified: 88% stage IV, 12% stage III or unstaged. Results are characterized in the Table. Conclusions: Consistent with national trends, utilization of aggressive interventions near the end-of-life is high amongst SCH advanced lung cancer patients. Discordant with ASCO and IOM guidelines, which call for PC in all patients with advanced cancer, PC was involved in only 29% of our study population, which is an opportunity for quality improvement. A RI of 40 appears to be associated with death within 30 days. Further validation of RI may serve as a trigger to direct care toward palliative measures. Going forward we will expand this analysis to our entire cancer population to provide a baseline for future quality interventions. [Table: see text]
Patient characteristics and survival outcomes associated with early versus delayed molecular testing in metastatic NSCLC.
Authors: Smith David A. , Reynolds Craig H. , Patt Debra A. , Smith Gregory , Harrell Robyn K. , Horblyuk Ruslan , Rembert Debra , Mardekian Jack , Yap Mark , James Leonard Philip
Published: February 2017

211

Background: Evidence-based guidelines recommend molecular testing for appropriate patients with advanced NSCLC at the time of diagnosis of adenocarcinoma. This study evaluated patient demographics, clinical characteristics and survival outcomes associated with early molecular testing (EMT) as compared to delayed molecular testing (DMT) in patients with metastatic NSCLC. Methods: Retrospective analysis of patients’ electronic medical records from The US Oncology Network Practices that utilize iKnowMed (iKM). Patients with a diagnosis of metastatic NSCLC between March 2011 and June 2012, >2 visits and >6 months of follow-up were eligible. EMT and DMT was defined as occurring <45 days and >45 days of diagnosis, respectively. Patient characteristics were compared using t-test and chi-square tests as appropriate. Logistic regression was used to predict the likelihood of higher performance status in the cohorts. Progression-free survival (PFS) and overall survival (OS) were compared using Cox proportional hazards models controlling for age, gender, stage at diagnosis, performance status and comorbidities. Results: A total of 350 patients were eligible and had a median follow-up of 17.3 months. Average age was 64, majority were female (55%) and diagnosed with adenocarcinoma (93%). There were no significant differences in demographic characteristics between EMT and DMT cohorts, however DMT patients were more likely to have ECOG 0 or 1 (OR=2.95, 95%CI=1.33-6.54, p=0.008). No difference in OS or PFS was observed between EMT and DMT patients, p>0.05 (log-rank test). However, poor performance status was found to increase risk of progression/death in multivariate OS and PFS analysis, p<0.02 and p<0.01, respectively. Conclusions: While patients undergoing EMT were nearly three times more likely to exhibit poorer performance status as compared to DMT cohort, their survival outcomes were no different, reinforcing the importance of molecular testing in these patients who may otherwise be less likely to receive treatment. Although limited to small sample size, results of this analysis call for further investigation of potential benefits of EMT in metastatic NSCLC in real-world setting.
Peer review in radiotherapy (RT): A national quality improvement initiative.
Authors: Brundage Michael Donald , Bass Brenda H , Foxcroft Sophie , Halperin Ross , McGowan Thomas , Milosevic Michael F. , Parliament Matthew , Warde Padraig Richard ,   The National Peer Review Initiative Steering Committee
Published: February 2017

221

Background: Peer review (PR) in Radiation Oncology has been shown to be effective in improving quality of treatment by detecting and correcting deficiencies in proposed treatment plans prior to treatment. PR is also effective in: guiding departmental treatment planning policies and processes; reducing variation in practice; providing a venue for multi-disciplinary communication, and increasing staff and trainee awareness of evolving treatment processes. The importance of PR is reflected in the inclusion of 3 PR-specific quality indicators in the Canadian Partnership for Quality Radiotherapy QA Guidelines for Radiation Oncology programs. Given this endorsement, we aim to enhance PR implementation across all Canadian cancer centres using a knowledge-translation and implementation framework. Methods: This project will facilitate increased uptake of PR in Canadian RT programs by implementing the top-down model used with success in Ontario. This model has several key components, including: a) engaging the leadership of provincial cancer agencies to promote PR at every Provincial cancer centre; b) providing modest financial support for the acquisition of the required hardware and/or staff time for coordinating PR activities; c) systematic collection of each centre’s baseline PR activities, perceived barriers and potential facilitators of PR at each centre; d) creation of a continuous quality improvement cycle by monitoring PR quality indicators over time; e) systematic knowledge and information sharing regarding effective PR processes. Results: Funding for this initiative was obtained from the Canadian Partnership against Cancer (CPAC) in April 2014. A steering committee consisting of stakeholders from across Canada has been struck and provincial launches, based on the tenets used in Ontario, have commenced in 7 of 13 provinces with others expressing interest. A national survey to obtain baseline data relating to PR activities, perceived barriers, and facilitators is underway and will be reported. Conclusions: Preliminary evidence suggests a “snowball effect” of increasing PR uptake across Canada. The implementation model could be applied in other jurisdictions interested in increasing PR in radiation oncology.
Data accuracy and financial cost of conducting retrospective ontological clinical trials using ICD-9-CM in the age of ICD-10-CM.
Authors: Shergill Ardaman , Dorestani Parvaneh , Boyd Andrew D. , Venepalli Neeta K.
Published: February 2017

229

Background: Estimates of the 1 year implementation delay of ICD-10-CM (I10) range upto $6.6 billion with the majority of cost attributable to I10 implementation. Little attention has been paid to post implementation costs and management strategies for data accuracy within longitudinal cancer related databases spanning both ICD-9-CM (I9) and I10. The objective of our study was to quantify financial impact and compare data quality of I10 transition in cancer clinical trials through backward I10 to I9 mapping via two tools. Methods: Cancer related original research articles published in NEJM, Blood and JCO between Jan 1st 2013 and Dec 31st 2013 were reviewed for I9 utilization. Each I9 code was mapped forward to I10 via the Motif web portal tool. The I10 codes were manually reviewed with additional clinically relevant I10 codes added. The final I10 code list was mapped backward to I9 using two tools, the Motif web portal and CMS GEMs. Generated I9 codes were compared to the original I9 list to identify ‘lost’ codes. To assess financial implications of lost data, lost I9 codes were assessed in 2010 Illinois Medicaid data. Results: Of 1,567 original articles reviewed, 7 articles were included and yielded 412 I9 codes which mapped to 1437 I10 codes. Upon manual review, 416 I10 codes were added. Backward mapping by Motif web and CMS GEMs respectively yielded 652 and 551 I9 codes; 16 of the original I9codes were absent from the CMS GEMs list while Motif tool yielded 100% of original codes. Of these 16, 12 codes were present in 2010 Illinois Medicaid data, and accounted for 7,490 patient encounters (0.52%) and $1.1 million (0.35%) of total Medicaid reimbursements. Conclusions: We report significant differences in data quality of I9 generated by backward coding via CMS GEMs and the Motif web tool, with major financial impact. Longitudinal data analyses upto 5 years post ICD-10-CM transition will require backward coding, and comparison of ICD-9-CM codes for accuracy. The bridging methodology and analytic tools presented can be replicated by organizations and clinical researchers to increase data fidelity spanning the upcoming transition.
Improving the patient experience for cancer patients in Ontario through real-time measurement.
Authors: Kraetschmer Nancy , Glazer Alysha , Green Esther , Macdougall Laura , Singh Simron
Published: February 2017

240

Background: Cancer Care Ontario (CCO) is an Ontario government agency that drives system wide quality improvement in disease prevention and screening, the delivery of care and the patient experience (PE), for cancer, chronic kidney disease and access to care for key health services. CCO partners with 14 Regional Cancer Programs across the province. CCO measures the cancer PE retrospectively through a paper-based Ambulatory Oncology Patient Satisfaction Survey but there are limitations such as the delay in reporting of results. CCO is developing and implementing a province-wide electronic real-time PE survey to measure PE. An electronic survey tool will enable the collection, analysis and reporting of PE data more quickly to drive quality improvement. Methods: A current state assessment was undertaken in fall 2013 to understand support for and readiness of CCO’s Regional Cancer Centres (RCCs) to move forward with measuring PE in real-time, at point of care. 14 semi-structured interviews were conducted with RCCs Regional Vice Presidents (RVP); over 800 patients participated in focus groups in 11 of 14 regions; a targeted online survey was completed by 16 administrators in 14 regions. Results: Interest in a real-time measurement (RTM) approach was overwhelmingly positive – 94% of patients and 100% of RVPs thought that measuring PE in real-time is important. Patients want the real-time survey to be short - 61% of patients reported that the number of questions they are willing to answer is 5-10, with 18% indicating 15 questions. 62% of patients reported that they were willing to spend 2-6 minutes answering a survey, with 24% reporting 10 minutes. 36% of the RCCs have ad hoc RTM strategies and 21% have utilized an electronic tool. There was no co-ordination or data sharing between RCPs. Conclusions: CCO is implementing a province-wide RTM strategy which includes the validation of a RTM PE survey and procurement of an electronic solution to capture, analyze and report PE data. CCO will initially pilot the survey and electronic tool with the intention of a provincial rollout to cancer centres upon a post-pilot evaluation.
The cancer imaging program quality framework at Cancer Care Ontario: The first five years.
Authors: Dobranowski Julian , Melamed Saul , Langer Deanna , Bedford Colleen
Published: February 2017

244

Background: The Cancer Imaging Program (CIP) at Cancer Care Ontario was established in 2009 to improve the quality of cancer imaging in Ontario. Methods: After initial selection of a Provincial clinical lead in 2009, fourteen regional clinical leads were selected to represent all geographical regions of the province. Through a stakeholder survey and a priority setting process the following four high-level areas of priority emerged to support quality improvement of cancer imaging: (1) Developing and Fostering an Imaging Community of Practice, (2) Imaging Appropriateness, (3) Timely Access to Imaging, and (4) Standardized/Synoptic Reporting. Results: (1) An Imaging Community of Practice was established with the regional clinical leads, who participate in monthly meetings to build and strengthen inter-regional relationships and share information on regional activities and priorities; (2) Best practice standards for imaging in lung and colorectal cancer have been developed by consolidating and endorsing national and international guidelines. New imaging guidelines are being developed by the Program in Evidence-Based Care. Evidence-based recommendations being developed for focal tumour ablation procedures; (3) Three Interventional Radiology procedures (CT-guided lung biopsies, peripherally inserted central catheters and portacaths) have been selected for an ongoing wait time collection that captures monthly point-in-time data. The data has initiated discussions on appropriate benchmarks and identification of factors that may contribute wait times; and (4) Synoptic Radiology Reporting enables the collection of uniform and complete data to improve the information available to referring clinicians for diagnosis and treatment planning. Work is underway in the development of: implementation roadmap, evidence-based clinical checklists, infrastructure to store and share synoptic reports, and international standards for synoptic radiology reporting. Conclusions: The establishment of the CIP as a clinical program under a provincial cancer agency has enabled the development of an Imaging Community of Practice and allowed for work on provincial-wide initiatives that enable quality improvement of cancer imaging.
Predictors of guideline treatment nonadherence and the impact on survival in patients with colorectal cancer.
Authors: Hines Robert B. , Barrett Alina , Twumasi-Ankrah Philip , Broccoli Dominique , Engelman Kimberly K. , Baranda Joaquina Celebre , Ablah Elizabeth , Jacobson Lisette , Redmond Michelle , Tu Wei , Collins Tracie
Published: February 2017

254

Background: We investigated the effect of comorbidity, age, health insurance payer status, and race on the risk of nonadherence with National Comprehensive Cancer Network (NCCN) treatment guidelines for colorectal cancer (CRC) patients. In addition, the prognostic impact of NCCN treatment nonadherence on survival was assessed. Methods: Colon and rectal cancer patients who received primary treatment at Memorial University Medical Center in Savannah, GA from 2003 to 2010 were eligible for this study (final N = 679). Modified Poisson regression was used to obtain risk ratios for the outcome of nonadherence with NCCN treatment guidelines. Hazard ratios (HRs) for the relative risk of CRC-related death were obtained by Cox regression. Results: Guideline-adherent treatment was received by 82.5% of patients. Moderate/severe comorbidity, being uninsured, having rectal cancer, older age, and increasing tumor stage were associated with increased risks of receiving nonadherent treatment. Treatment nonadherence was associated with 4.5 times the risk of CRC-related death (HR, 4.53; 95% CI, 2.56-8.00) in the first year following diagnosis and 2.0 times the risk of death (HR, 1.97; 95% CI, 1.20-3.25) in years 2 to 5. The detrimental effect of nonadherence was demonstrated across all levels of comorbidity and age. Conclusions: Although there are medically justifiable reasons to deviate from NCCN treatment guidelines in CRC patients, patients who received nonadherent treatment had much higher risks of CRC-related death, especially in the first year following diagnosis. This study’s results highlight the importance of cancer health services research to drive quality improvement efforts in cancer care for CRC patients. [Table: see text]