Non-low Risk Research Articles

International comparison of cosmetic outcomes of breast conserving surgery and radiation therapy for women with ductal carcinoma in situ of the breast

PurposeTo assess the cosmetic impact of breast conserving surgery (BCS), whole breast irradiation (WBI) fractionation and tumour bed boost (TBB) use in a phase III trial for women with ductal carcinoma in situ (DCIS) of the breast. Materials and methodsBaseline and 3-year cosmesis were assessed using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System and digital images in a randomised trial of non-low risk DCIS treated with postoperative WBI +/− TBB. Baseline cosmesis was assessed for four geographic clusters of treating centres. Cosmetic failure was a global score of fair or poor. Cosmetic deterioration was a score change from excellent or good at baseline to fair or poor at three years. Odds ratios for cosmetic deterioration by WBI dose-fractionation and TBB use were calculated for both scoring systems. Results1608 women were enrolled from 11 countries between 2007 and 2014. 85–90% had excellent or good baseline cosmesis independent of geography or assessment method. TBB (16 Gy in 8 fractions) was associated with a >2-fold risk of cosmetic deterioration (p < 0.001). Hypofractionated WBI (42.5 Gy in 16 fractions) achieved statistically similar 3-year cosmesis compared to conventional WBI (50 Gy in 25 fractions) (p ≥ 0.18). The adverse impact of a TBB was not significantly associated with WBI fractionation (interaction p ≥ 0.30). ConclusionsCosmetic failure from BCS was similar across international jurisdictions. A TBB of 16 Gy increased the rate of cosmetic deterioration. Hypofractionated WBI achieved similar 3-year cosmesis as conventional WBI in women treated with BCS for DCIS.

Radiomics signature on 3T dynamic contrast-enhanced magnetic resonance imaging for estrogen receptor-positive invasive breast cancers: Preliminary results for correlation with Oncotype DX recurrence scores.

To evaluate the ability of a radiomics signature based on 3T dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) to distinguish between low and non-low Oncotype DX (OD) risk groups in estrogen receptor (ER)-positive invasive breast cancers.Between May 2011 and March 2016, 67 women with ER-positive invasive breast cancer who performed preoperative 3T MRI and OD assay were included. We divided the patients into low (OD recurrence score [RS] <18) and non-low risk (RS ≥18) groups. Extracted radiomics features included 8 morphological, 76 histogram-based, and 72 higher-order texture features. A radiomics signature (Rad-score) was generated using the least absolute shrinkage and selection operator (LASSO). Univariate and multivariate logistic regression analyses were performed to investigate the association between clinicopathologic factors, MRI findings, and the Rad-score with OD risk groups, and the areas under the receiver operating characteristic curves (AUC) were used to assess classification performance of the Rad-score.The Rad-score was constructed for each tumor by extracting 10 (6.3%) from 158 radiomics features. A higher Rad-score (odds ratio [OR], 65.209; P <.001), Ki-67 expression (OR, 17.462; P = .007), and high p53 (OR = 8.449; P = .077) were associated with non-low OD risk. The Rad-score classified low and non-low OD risk with an AUC of 0.759.The Rad-score showed the potential for discrimination between low and non-low OD risk groups in patients with ER-positive invasive breast cancers.

Early decision-making in acute pulmonary embolism: a retrospective clinical audit.

There is increasing evidence supporting early discharge of patients with acute pulmonary embolism (aPE) deemed 'low prognostic risk' as a safe and viable alternative to admission if identified correctly by guideline algorithms. To determine if risk stratification guidelines were followed accurately in an Australian tertiary hospital. Patients admitted to the emergency department with a diagnosis of PE were included from December 2012 to December 2017. The 272 patients were retrospectively assessed for prognostic risk prior to and after release of the 2014 European Society of Cardiology (ESC) guidelines. This included the simplified Pulmonary Embolism Severity Index (sPESI), and evidence of right heart dysfunction. Thereafter, patients were dichotomised into low (i.e. sPESI = 0) and non-low (i.e. sPESI ≥1 with or without the evidence of right heart dysfunction) prognostic risk groups. Prior to ESC guideline release, 52 (65%) of the 80 patients diagnosed with PE were non-low risk and 12 (23%) of these were discharged home; 11 (91.7%) of the 12 discharges had unrecognised sPESI medical history components. After ESC guideline release, 122 (63.5%) of the 192 patients were non-low risk and 20 (16.4%) of these were discharged home; 18 (90%) of the 20 discharges had unrecognised sPESI medical history components. We found that the sPESI score is not adequately applied in determining prognostic risk for acute PE. In cases of non-low-risk discharge, both prior to and after ESC guideline release, the medical history components of the sPESI score are under-recognised as a marker of increased prognostic risk.

Monoclonal Gammopathy of Undetermined Significance (MGUS): Indications for Pre-Diagnostic Testing, Subsequent Diagnoses, and Follow-up Practice

Introduction: MGUS is generally an incidental finding in the diagnostic work-up for clinical signs and symptoms suggestive of lymphoplasmacytic malignancies (multiple myeloma, light chain amyloidosis, and Waldenström macroglobulinemia), which are relatively rare (<35,000 annual new cases in the US). While much is known about the natural history of MGUS, information regarding the pre- and post-diagnostic part of MGUS patient care is lacking. Our study objectives were to determine the following: 1) indications for monoclonal protein testing; 2) subsequent diagnoses found for those indications; 3) specialty of ordering clinicians; 4) follow-up patterns after MGUS diagnosis.Methods: We identified MGUS patients residing in southeastern Minnesota who were diagnosed from 2011-2014 and followed at the Mayo Clinic. Medical records were reviewed to confirm the diagnosis and obtain relevant clinical data. Laboratory tests and visits were identified using Current Procedural Terminology-4th edition (CPT-4) codes from billing data. We defined a follow-up visit as: 1) any face-to-face encounter linked to MGUS diagnosis 30 days after the date of MGUS diagnosis regardless of whether ancillary test was performed or not; and 2) MGUS-specific tests or laboratory tests linked to an MGUS diagnosis claim performed without a face-to-face encounter. Based on the Mayo Clinic MGUS risk stratification model, we classified our cohort into either low-risk or non-low risk. Criteria for low-risk used were: serum monoclonal protein <1.5 g/dL, IgG subtype, and normal serum free light chain ratio. Follow-up patterns were analyzed according to year of diagnosis, demographics, and the specialty of clinicians performing the follow-up.Results: 330 MGUS patients were included in the study. The median age at diagnosis was 73 years (range, 21-98) and most were males (59.7%). The common indications for monoclonal protein studies were neuropathy (19.6%), kidney disease (13.6%), anemia (12.7%), bone symptoms/signs (12.7%), cutaneous disorders (5.8%), congestive heart failure (4.8%), and hypercalcemia (2.7%). The most common subsequent diagnoses for these indications were neuropathy not otherwise specified (NOS;100%), chronic kidney disease NOS (35.5%), anemia of chronic kidney disease (19%), osteopenia/osteoporosis (45.2%), congestive heart failure NOS (57.1%), and dermatitis NOS (100%), respectively. The practice specialties that most commonly diagnosed MGUS were internal medicine (31.3%), neurology (13.7%), nephrology (10.3%), family medicine (6.1%), and hematology (5.8%).Low risk MGUS comprised 44.8% of the cohort. After a median follow-up of 53.5 months (range, 13.0-77.4; IQR, 40.8-77.4), the total number of follow-up visits was 937. Majority (85.5%) of the visits were a combination of office visit with laboratory testing, while the rest were either office visit (11.2%) or laboratory tests (3.3%) only. The distribution of patients by mean interval between visits was: every <6 months (7.9%); every 6-12 months (19.4%); every 13-24 months (15.2%), and every >24 months or no follow-up at all (57.6%). The follow-up patterns did not change significantly (Kruskal Wallis; P=0.6759) over time (Figure 1) and were similar when age groups were compared (Figure 2; P=0.1328). However, males were followed more frequently than females (P=0.0365). Among patients 80 years and older, 32.1% continued to be followed at least once every 2 years (Figure 2). Hematologists were more likely than non-hematologists to follow MGUS patients regardless of the risk category (Figures 3-4). Among low risk patients, 31.1%, 22.2%, 20.7%, and 19.1% had at least one follow-up during years 2, 3, 4, and 5, after MGUS diagnosis (Figure 3).Conclusions: Approximately 1/3 of MGUS diagnoses were made during the evaluation of signs and symptoms not related to lymphoplasmacytic malignancies. The subsequent diagnoses found were a wide variety of common diseases. Most MGUS diagnoses were made by general internists, neurologists, and nephrologists. Follow-up practices varied between hematologists and non-hematologists. Nearly 1/3 of the oldest old patients continued to have follow-up, despite limited life expectancy. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Safely Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge.

The HEART Pathway (history, ECG, age, risk factors, and initial troponin) is an accelerated diagnostic protocol designed to identify low-risk emergency department patients with chest pain for early discharge without stress testing or angiography. The objective of this study was to determine whether implementation of the HEART Pathway is safe (30-day death and myocardial infarction rate <1% in low-risk patients) and effective (reduces 30-day hospitalizations) in emergency department patients with possible acute coronary syndrome. A prospective pre-post study was conducted at 3 US sites among 8474 adult emergency department patients with possible acute coronary syndrome. Patients included were ≥21 years old, investigated for possible acute coronary syndrome, and had no evidence of ST-segment-elevation myocardial infarction on ECG. Accrual occurred for 12 months before and after HEART Pathway implementation from November 2013 to January 2016. The HEART Pathway accelerated diagnostic protocol was integrated into the electronic health record at each site as an interactive clinical decision support tool. After accelerated diagnostic protocol integration, ED providers prospectively used the HEART Pathway to identify patients with possible acute coronary syndrome as low risk (appropriate for early discharge without stress testing or angiography) or non-low risk (appropriate for further in-hospital evaluation). The primary safety and effectiveness outcomes, death, and myocardial infarction (MI) and hospitalization rates at 30 days were determined from health records, insurance claims, and death index data. Preimplementation and postimplementation cohorts included 3713 and 4761 patients, respectively. The HEART Pathway identified 30.7% as low risk; 0.4% of these patients experienced death or MI within 30 days. Hospitalization at 30 days was reduced by 6% in the postimplementation versus preimplementation cohort (55.6% versus 61.6%; adjusted odds ratio, 0.79; 95% CI, 0.71-0.87). During the index visit, more MIs were detected in the postimplementation cohort (6.6% versus 5.7%; adjusted odds ratio, 1.36; 95% CI, 1.12-1.65). Rates of death or MI during follow-up were similar (1.1% versus 1.3%; adjusted odds ratio, 0.88; 95% CI, 0.58-1.33). HEART Pathway implementation was associated with decreased hospitalizations, increased identification of index visit MIs, and a very low death and MI rate among low-risk patients. These findings support use of the HEART Pathway to identify low-risk patients who can be safely discharged without stress testing or angiography. URL: http://www.clinicaltrials.gov . Unique identifier: NCT02056964.

Measured Implementation of an Accelerated Chest Pain Diagnostic Pathway in Primary Care

Aim: To assess the efficacy, safety and feasibility of implementing an Emergency Department Assessment of Chest Pain Accelerated Diagnostic Pathway (EDACS-ADP) using a current generation point-of-care cardiac troponin (POC cTn) assay for rule-out of acute myocardial infarction in patients presenting to rural General Practices in the Midland region of New Zealand with suspected cardiac chest pain. Method: The EDACS-ADP was implemented and evaluated in twelve rural Midland general practices. The primary outcomes assessed were the number of patients identified as low risk managed without transfer to hospital following presentation and major adverse cardiac events (MACE) (myocardial infarction, death, cardiac arrest, revascularization, shock, arrhythmia,) at 30 days. Results: Between October 2016 and March 2018, 142 patients with chest pain of suspected cardiac origin entered the pathway. 69 (49%) were male, mean age of 56. Over half were considered low risk, managed and discharged home by primary care. Low risk were more likely to be younger (mean age 53 yrs. v 63yrs). No MACE was noted in the low risk group. 1 in 3 patients were assessed as non-low risk and referred to hospital with MACE rate of 15%.Tabled 1Number30 days MACELow Risk80 (56%)0Non Low Risk46(44%)7(15%) Open table in a new tab Conclusion: This rural chest pain pathway has the potential to identify a low risk population who may be safely managed locally thereby reducing transfer to hospital and allowing more rural autonomy, benefiting both patients, and secondary and tertiary health care services.

Addition of rituximab to CHOP-like chemotherapy in first line treatment of primary mediastinal B-cell lymphoma

BackgroundThe addition of rituximab (R) to CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) -like therapy has improved survival in primary mediastinal B-cell lymphoma (PMBCL) patients. However, these results were obtained in young low risk patients and a reevaluation in an unselected patient cohort is warranted.MethodsIn this study, we analyzed 80 PMBCL patients treated with a CHOP-based regimen with and without rituximab.ResultsIn the non-rituximab cohort 10-year progression free survival (PFS) was 67% and 10-year overall survival (OS) was 72% versus a PFS of 95% and a OS of 92% in the rituximab group, PFS P = 0.001, OS P = 0.023. A subgroup PFS analysis by international prognostic index (IPI) risk revealed that all risk groups benefit from addition of rituximab to induction chemotherapy. In addition, OS probability was higher in the group of non-low risk patients who were treated with rituximab compared to those patients who did not receive rituximab (P = 0.035). In multivariate analysis, only addition of rituximab to induction chemotherapy and reaching complete remission (CR) after first line therapy had a beneficial effect on both PFS and OS, whereas IPI, age, upfront high dose (HD) chemotherapy/autologous blood stem cell transplantation (ABSCT) and rituximab maintenance had no impact on survival.ConclusionsOur data demonstrate a survival benefit in unselected PMBCL patients treated with CHOP-like induction regimen and additional rituximab independently of the IPI risk score.

Adjuvant treatment recommendations for patients with ER-positive/HER2-negative early breast cancer by Swiss tumor boards using the 21-gene recurrence score (SAKK 26/10)

BackgroundTo evaluate the effect of Recurrence Score® results (RS; Oncotype DX® multigene assay ODX) on treatment recommendations by Swiss multidisciplinary tumor boards (TB).MethodsSAKK 26/10 is a multicenter, prospective cohort study of early breast cancer patients: Eligibility: R0-resection, ≥10% ER+ malignant cells, HER2–, pN0/pN1a. Patients were stratified into low-risk (LR) and non-low-risk (NLR) groups based on involved nodes (0 vs 1–3) and five additional predefined risk factors. Recommendations were classified as hormonal therapy (HT) or chemotherapy plus HT (CT + HT). Investigators were blinded to the statistical analysis plan. A 5%/10% rate of recommendation change in LR/NLR groups, respectively, was assumed independently of RS (null hypotheses).ResultsTwo hundred twenty two evaluable patients from 18 centers had TB recommendations before and after consideration of the RS result. A recommendation change occurred in 45 patients (23/154 (15%, 95% CI 10–22%) in the LR group and 22/68 (32%, 95% CI 22–45%) in the NLR group). In both groups the null hypothesis could be rejected (both p < 0.001). Specifically, in the LR group, only 5/113 (4%, 95% CI 1–10%) with HT had a recommendation change to CT + HT after consideration of the RS, while 18/41 (44%, 95% CI 28–60%) of patients initially recommended CT + HT were subsequently recommended only HT. In the NLR group, 3/19 (16%, 95% CI 3–40%) patients were changed from HT to CT + HT, while 19/48 (40%, 95% CI 26–55%) were changed from CT + HT to HT.ConclusionThere was a significant impact of using the RS in the LR and the NLR group but only 4% of LR patients initially considered for HT had a recommendation change (RC); therefore these patients could forgo ODX testing. A RC was more likely for NLR patients considered for HT. Patients considered for HT + CT have the highest likelihood of a RC based on RS.

Management of Suspected Acute Coronary Syndromes in a Regional Australian Hospital: An Audit of Adherence with Guidelines.

Background: Despite well-established management guidelines for acute coronary syndromes (ACS), including unstable angina (UA) and non-ST elevation myocardial infarction (NSTEMI), there are deficiencies in application of evidence based care. Contemporary Australian data has highlighted the discrepancy between metropolitan and rural ACS management and poorer rural outcomes.1 We examined adherence to evidence based guideline recommendations for ACS at the Albany Health Campus (AHC), a rural hospital in southern Western Australia that services an area of 39,000 km2. Methods: A retrospective review of hospital notes for patients with suspected ACS between July and September 2016 at AHC. For those with suspected ACS, we assessed acute medical care according to Australian guideline recommendations. Results: Eighty-two patients met inclusion criteria, including 30 (37%) NSTEMI and 52 (63%) UA. Mean adherence to the guideline recommendations was 75% overall, 80% for NSTEMI and 72% for UA. All patients had a 12-lead ECG performed and baseline troponin, which was repeated for all non-low risk patients if the initial troponin was normal. Management risk stratification was undertaken routinely but bleeding risk was not formally documented prior to therapy. Only 63 patients received aspirin as recommended. 19 (68%) NSTEMI patients received recommended angiographic investigation. 19 (35%) UA patients were referred for outpatient investigation, including 10 (19%) who were referred to an outpatient cardiology clinic. Conclusion: While some aspects of risk assessment were universally practised we observed significant deficiencies relative to guideline recommendations for ACS in this regional hospital. Rates of early invasive management were below optimal for NSTEMI patients.

Rebounds after discharge from the emergency department for community-acquired pneumonia: focus on the usefulness of severity scoring systems.

Background:Community-acquired pneumonia (CAP) is common cause of hospital admission and leading cause of morbidity and mortality. Severity scoring systems are used to predict risk profile, outcome and mortality, and to help decisions about management strategies.Aim of the work and Methods:To critically analyze pneumonia “rebound” cases, once discharged from the emergency department (ED) and afterwards admitted. We conducted an observational clinical study in the acute setting of a university teaching hospital, prospectively analyzing, in a 1 year period, demographic, medical, clinical and laboratory data, and the outcome.Results:249 patients were discharged home with diagnosis of CAP; 80 cases (32.1%) resulted in the high-intermediate risk class according to CURB-65 or CRB-65. Twelve patients (4.8%) presented to the ED twice and were then admitted. At their first visit 5 were in the high-intermediate risk group; just 4 of them were in the non-low risk group at the time of their admission. The rebound cohort showed some peculiar abnormalities in laboratory parameters (coagulation and renal function) and severe chest X-rays characteristics. None died in 30 days.Conclusions:The power of CURB-65 to correctly predict mortality for CAP patients discharged home from the ED is not confirmed by our results; careful clinical judgement seems to be irreplaceable in the management process. Many patients with a high-intermediate risk according to CURB-65 can be safely treated as outpatients, according to adequate welfare conditions; we identified a subgroup of cases that should worth a special attention and, therefore, a brief observation period in the ED before the final decision to safely discharge or admit. (www.actabiomedica.it)

Small Bowel Gastrointestinal Stromal Tumors: Multidetector Computed Tomography Enhancement Pattern and Risk of Progression.

Small bowel gastrointestinal stromal tumors (SB-GISTs) are rare lesions with a variable appearance on computed tomography (CT). This case series analyzes the CT enhancement pattern with the histologic risk assessment of tumor progression. Local institutional pathology database was searched for SB-GISTs from 2000 to 2015. Pathology reports and clinical notes were reviewed. Imaging was qualitatively reviewed for pattern of enhancement categorized into homogeneous or heterogeneous groups. Nonparametric statistical analysis was performed comparing enhancement to segment of bowel involved, presence of necrosis, tumor size, histologic grade (ie, G1 or G2), and histologic risk of progression (ie low, moderate, high). For simplicity, risk of progression was binned into low-risk or non-low-risk groups. Twenty-six pathology-proven, first presentation, nonmetastatic SB-GISTs were included into study. Seventeen were located in duodenum, 7 in jejunum, and 2 within the ileum. Dual phase (arterial and venous) CT imaging was available for 22 cases. Four cases did not have dual phase (three venous phase and one arterial phase only). Seventeen cases demonstrated heterogeneous enhancement and 9 cases homogeneous enhancement. Statistically significant difference was found between size versus enhancement groups (3.1 cm for homogeneous versus 6.8 cm for heterogeneous) (Mann-Whitney U test, n = 26, P = 0.002). Presence of necrosis versus enhancement group was statistically significant (Pearson χ, P = 0.001). Low-risk and non-low-risk groups versus enhancement groups was very significant (P = 0.001). Bowel segment involvement and histologic grading versus enhancement group did not reach statistical significance (P = 0.174 and P = 0.07, respectively). This case series reveals an important significant association between heterogeneous enhancement and non-low risk (ie, moderate/high) SB-GISTs. Beyond just describing the tumor, using enhancing pattern, the interpreting radiologist can preoperatively suggest additional prognostic information, potentially helpful for surgical planning.

MP53-01 DEFINING DELIVERABLES OF MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING (MPMRI)/ULTRASOUND (US) FUSION-GUIDED TARGETED PROSTATE BIOPSY: ACTIONABLE INTELLIGENCE METRIC (AIM) AND REDUCTION METRIC (RM)

You have accessJournal of UrologyProstate Cancer: Detection & Screening VII1 Apr 2016MP53-01 DEFINING DELIVERABLES OF MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING (MPMRI)/ULTRASOUND (US) FUSION-GUIDED TARGETED PROSTATE BIOPSY: ACTIONABLE INTELLIGENCE METRIC (AIM) AND REDUCTION METRIC (RM) Benjamin Ristau, Aseem Malhotra, Serge Ginzburg, David Chen, Rosaleen Parsons, Barton Milestone, Marion Brody, Michael Haifler, Mohammed Haseebuddin, Nikhil Waingankar, Rosalia Viterbo, Richard Greenberg, Marc Smaldone, Robert Uzzo, and Alexander Kutikov Benjamin RistauBenjamin Ristau More articles by this author , Aseem MalhotraAseem Malhotra More articles by this author , Serge GinzburgSerge Ginzburg More articles by this author , David ChenDavid Chen More articles by this author , Rosaleen ParsonsRosaleen Parsons More articles by this author , Barton MilestoneBarton Milestone More articles by this author , Marion BrodyMarion Brody More articles by this author , Michael HaiflerMichael Haifler More articles by this author , Mohammed HaseebuddinMohammed Haseebuddin More articles by this author , Nikhil WaingankarNikhil Waingankar More articles by this author , Rosalia ViterboRosalia Viterbo More articles by this author , Richard GreenbergRichard Greenberg More articles by this author , Marc SmaldoneMarc Smaldone More articles by this author , Robert UzzoRobert Uzzo More articles by this author , and Alexander KutikovAlexander Kutikov More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.498AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Transrectal ultrasound-guided prostate biopsy (TRUS-B) is the gold standard for prostate cancer (CaP) diagnosis. mpMRI/US fusion targeted biopsy (TB) has emerged as a technique to optimize the procedure. The ideal prostate biopsy would: (1) identify all non-low risk CaP with greater sensitivity than TRUS-B; (2) eliminate the need for unnecessary sampling. Using our institutional dataset and the available literature, the objective of the present study was to define metrics that more accurately demonstrate the deliverables of TB and facilitate meaningful data comparisons. METHODS Patients (pts) with indications for TRUS-B having identified prostate lesions (PIRADS 3-5) on mpMRI were included. The UroNav System (Invivo) was used to obtain 1-4 TBs of each targeted lesion. All men underwent concurrent 12-core TRUS-B. Actionable intelligence metric (AIM) was defined as all pts with higher Gleason score (GS) on TB (minimum GS≥3+4=7) relative to TRUS-B ÷ total pts with GS≥3+4=7 CaP (i.e. % for whom TB offered actionable data over TRUS-B). Reduction metric (RM) was defined as 1 - [all pts with higher GS on TRUS-B (minimum GS≥3+4=7) relative to TB ÷ total pts undergoing biopsy] (i.e. % who could have foregone TRUS-B). Cohort metrics were compared to previously published data. RESULTS 149 pts (mean age 64±7.4y, PSA 9.1±8.6 ng/ml, and prostate volume 53.6±34.2 cc) were examined: 21 (14.1%) biopsy naive men (G1), 74 (49.7%) men with prior negative TRUS-B (G2), and 54 (36.2%) men with prior positive TRUS-B on an active surveillance (AS) protocol (G3). Overall cancer detection rate was 90/149 (60.4%): 12/21 (57%) for G1, 33/74 (44.6%) for G2, and 45/54 (83.3%) for G3. AIM and RM for the entire cohort was 22.6% and 78.5%; 25% and 81.0% for G1, 28.6% and 81.1% for G2, and 12.0% and 72.2% for G3. These findings are similar to previously published cohorts in which the AIM and RM are 13.6% and 95.5% and 23.6% and 93.6% for G1 and G2, respectively. AIM and RM for men on AS is not calculable from the currently published literature. CONCLUSIONS TB harbors potential for improvement over TRUS-B; however, deliverables of this costly technology must be outlined. We define two metrics, AIM and RM, for use in future reports to help quantify, communicate, and compare the added value of TB technology. At present, 12-core TRUS-B remains a necessary adjunct to TB, particularly in the AS setting. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e697 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Benjamin Ristau More articles by this author Aseem Malhotra More articles by this author Serge Ginzburg More articles by this author David Chen More articles by this author Rosaleen Parsons More articles by this author Barton Milestone More articles by this author Marion Brody More articles by this author Michael Haifler More articles by this author Mohammed Haseebuddin More articles by this author Nikhil Waingankar More articles by this author Rosalia Viterbo More articles by this author Richard Greenberg More articles by this author Marc Smaldone More articles by this author Robert Uzzo More articles by this author Alexander Kutikov More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Abstract S3-01: EndoPredict (EPclin) score for estimating residual distant recurrence (DR) risk in ER+/HER2- breast cancer (br ca) patients treated with 5 years adjuvant endocrine therapy alone: Validation and comparison with the oncotype DX recurrence score (RS)

Abstract Background: RS is widely used for estimating 10-yr risk of DR for br ca patients receiving 5yrs adjuvant endocrine treatment alone. EndoPredict is a prognostic test which unlike RS combines its eight-gene expression signature (EP score) with tumor size and nodal status to provide the EPclin score with a single low/high risk cut-off at 10% risk of DR at 10yrs similar to the low/intermediate risk cut-off with RS. Aims: To determine the prognostic value of EP/EPclin over 10yrs, 0-5yrs and 5-10yrs in ER+/HER2- br ca patients and to compare this with the RS (i) alone (primary objective) and (ii) in addition to the clinical treatment score (CTS [developed in TransATAC]: nodes (N); tumour size; grade; age; tam or AI). Methods: mRNA from 928 ER+/HER2- primary br ca from patients treated with anastrozole or tamoxifen in the ATAC trial on which RS was already available were assessed for the EP/EPclin. Primary end point was DR. Kaplan–Meier and Cox regression analyses were used to determine DR risk for 0-10, 0-5 and 5-10yrs follow-up. Likelihood ratio tests (LR-chi sq) were used to assess the prognostic information provided by EP, EPclin, and RS alone and in combination with CTS. Results: Median follow-up was 9.95 yrs. The table shows the LR-chi sq for the prognostic information provided by each marker alone (univariate) and the information on top of CTS for all patients, and N- and N+ subgroups in 0-10, 0-5 and 5-10yrs. EP and EPclin provided substantially more prognostic information than RS across all three time periods and subgroups, except for N- patients in 0-5yrs. EP and EPclin also provided more information in addition to CTS than RS in 0-10yrs due to better performance of EP and EPclin in 5-10yrs where RS added no significant information to CTS. Using predefined cut-offs, EPclin and RS identified 546 (58.8%) and 573 (61.7%) patients as low risk respectively (HR (95%CI) low vs. non-low risk: 5.9 (3.9-9.1) and 2.7 (1.9-3.8), respectively). The EP score significantly added prognostic information to the RS over 0-10yrs and 5-10yrs in the overall, N- and N+ populations. Cases classified discordantly by EPclin and RS followed the EPclin classification more closely than RS classification. Prognostic information from EP, EPClin, RSLR-chi-sqAll patientsNode-negativeNode-positiveUnivariate0-10yrs0-5; 5-10yrs0-10yrs0-5; 5-10yrs0-10yrs0-5; 5-10yrsEP49.325.7; 23.630.811.9; 15.614.57.9; 6.6EPclin139.380.0; 59.340.017.0; 22.748.332.2; 16.1RS29.126.1; 5.621.318.7; 4.88.08.0; 1.0CTS149.885.0; 64.735.619.0;16.961.635.2; 26.3added to CTS EP16.46.9; 9.815.55.2; 6.68.32.3; 3.4EPClin20.310.5; 9.917.03.6; 9.05.46.4; 2.3RS12.811.8; 2.318.78.1; 1.44.13.7; 0.7LR-chi sq &amp;gt;3.8, p&amp;lt;0.05 Conclusions: EPclin was highly prognostic for DR in all patients, N-, N+, early and late metastasis. EPclin provided more prognostic information than RS in part but not solely because of the integration of the EP score with N and tumour size parameters. The data stress the importance of including clinicopathological factors in deriving an overall estimate of risk. Citation Format: Dowsett M, Sestak I, Buus R, Kronenwett R, Denkert C, Krappmann K, Scheer M, Petry C, Dubsky P, Cuzick J. EndoPredict (EPclin) score for estimating residual distant recurrence (DR) risk in ER+/HER2- breast cancer (br ca) patients treated with 5 years adjuvant endocrine therapy alone: Validation and comparison with the oncotype DX recurrence score (RS). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr S3-01.

Earlier Discharge of Febrile Infants

Source: Biondi EA, Mischler M, Jerardi KE, et al. Blood culture time to positivity in febrile infants with bacteremia. JAMA Pediatr. 2014; 168(9): 844– 849; doi: 10.1001/jamapediatrics.2014.895Investigators at multiple medical centers affiliated with the Pediatric Research in Inpatient Settings (PRIS) network conducted a retrospective, cross-sectional evaluation of time to positivity (TTP) of blood culture results in febrile infants <91 days of age. Microbiology laboratories at each study site supplied all positive culture results obtained in a non-ICU setting; individual site investigators reviewed records for eligibility. All sites used a BACTEC automated blood culture detection system and collected at least 2 consecutive years of data ending January 1, 2013. Blood cultures were included if positive for bacteria in an infant <91 days of age with a temperature ≥38.0°C who was treated with a full course of antibiotics. With this definition, cultures that were positive for bacteria typically classified as contaminants were included if the treating clinicians treated the patient with a full course of antibiotics. Cultures from infants in an ICU, surgical patients, or patients with central lines were excluded. Clinical information, TTP in minutes (the time the machine alarmed minus the time the culture was placed in the analyzer), and bacterial species were collected. Each patient was stratified as low risk or nonlow risk based on the Rochester criteria.1 The primary aim of the study was to determine the proportion of positive cultures that become positive >24 hours after collection.A total of 392 blood cultures that were positive for a bacterial pathogen were analyzed. The mean TTP was 15.4 hours and the median TTP was 13.0 hours. TTP did not vary by gender or Rochester risk stratification. TTP did not change significantly when 39 cultures that were positive only for common contaminants were removed from the analysis. By 24, 36, and 48 hours, 91%, 96%, and 99% of cultures were positive, respectively. Escherichia coli was the most prevalent species (41%), followed by Group B Streptococcus (22%), Staphylococcus aureus (5%), and Streptococcus pneumoniae (5%).The authors conclude that most pathogens in febrile bacteremic infants <91 days old will be identified within 24 hours of collection, and that 24 hours is an adequate observation period to detect most clinically significant bacteremia.Dr Garber has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.Pediatric hospitalists frequently care for young well-appearing infants with fever. Traditional practice is to risk stratify and perform cultures of blood, urine, and cerebrospinal fluid (CSF). While urinalysis and CSF indices can rule out urinary tract infection and meningitis, infants often remain hospitalized for 48 hours awaiting blood culture results.2 Automated continuously monitored blood culture systems which identify bacteria more quickly than manual methods, the changing epidemiology of bacteremia in infants, and decreases in bacteremia due to vaccinations and maternal intrapartum Group B Streptococcus prophylaxis have altered the risk:benefit ratio of this approach.Previously, an evidenced-based process model for managing well-appearing febrile infants under 91 days old was evaluated in a large system with 21 hospitals, and the results indicated that many infants can be discharged at 24 or 36 hours without adverse consequences (see AAP Grand Rounds, November 2012;28[5]:49).3 In the current study, the authors evaluated nationally representative data on TTP in an attempt to generalize those geographically limited efforts. Using the PRIS network, they obtained data from 17 hospital systems across all major regions of the United States. Their findings have the potential to increase quality and decrease costs of care for this common condition. Using current estimates of the incidence of bacteremia in this population, 0.9% to 2%,2 the authors calculate that 556 to 1,235 infants would need to be observed beyond 24 hours to capture 1 additional case of bacteremia, and that 1 of those infants would be predicted to acquire a nosocomial infection during the extra day of hospitalization.4The authors discuss important limitations: lack of urine/CSF TTP data, unknown volume of blood cultured and length of time from blood draw to analyzer placement, lack of clinical predictors for delayed culture growth, and unknown number of negative cultures. The authors did not address whether low numbers of cultures from 8 of the sites affect the generalizability of the results. Furthermore, hospitalists will need to become familiar with their laboratory’s monitoring procedures before adopting this strategy. Despite these limitations, the data may allow pediatric hospitalists to give parents of febrile infants a great gift – fewer nights in the hospital!

Abstract P4-03-09: Time points to diagnosis and treatment of invasive breast cancer in southwestern Ontario

Abstract Background Delays in breast cancer diagnosis and treatment are associated with increased tumour size at presentation, higher incidence of lymph node metastasis, higher relapse rates and lower 5-year survival rates in some studies. Diagnosis and treatment of breast cancer is complex, involving many health care practitioners at multiple locations. New advances in diagnostic and prognostic indicators make the process ever more complex. We reviewed the timing of crucial events in breast cancer diagnosis and treatment in Southwestern Ontario. Methods: Two time periods (2001, 2011) were assessed. Patients with new early invasive breast cancer with specific TNM criteria (T1c or greater plus any N, or any T plus N1-3; M0) were included. Data collection and analysis explored significant time points from first suspicion of malignancy, to diagnosis and definitive treatment, as well as patient demographic information. Results: 300 and 451 eligible patients were identified in 2001 and 2011 cohorts. Distribution of T and N status by cohort was compared by Chi-square test and time from first suspicion to diagnosis by Wilcoxon testing. The proportion of patients in which the time from first suspicion (clinical by lay person or health professional or by imaging) to pathological diagnosis exceeded two months increased from 20.4% in 2001 to 42.1% in 2011. There were no differences in time from first suspicion to diagnosis when analyzed by age (p = 0.54) or location (p = 0.50). Pathological T2-4 status at diagnosis increased from 48.4% in 2001 to 56.8% in 2011, and N2-3 status increased from 7.3% to 12.6%. Patients who had mammograms increased from 52.7% to 59.4%. A positive or suspicious mammogram was the first sign in 36% and 39.1% of cases. There was a trend towards more pathological diagnoses and definitive surgeries at tertiary centers compared to community hospitals. Conclusions: There is a longer time interval from first suspicion of malignancy to pathological diagnosis in 2011 compared to 2001 for both urban and rural populations. The number of non-low risk, non-metastatic cancers at diagnosis increased by 50% over the time interval studied (300 v 451), but number of T2-T4 non-metastatic cancers increased by 77% (145 v 256) and N2,3 cancers by 136% (22 v 52). This is despite more patients receiving mammograms (52.7% v 59.4%). Delays in breast cancer treatment are multifactorial, including both system-, and patient-related factors. This is an under-researched area and more investigation is needed to understand the reasons for the diagnostic delays and more serious cancers at presentation in order to improve outcomes. Reasons for higher proportions of advanced cancers will be discussed. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-03-09.

Pneumococcal pneumonia – Are the new severity scores more accurate in predicting adverse outcomes?

IntroductionThe site-of-care decision is one of the most important factors in the management of patients with community-acquired pneumonia. The severity scores are validated prognostic tools for community-acquired pneumonia mortality and treatment site decision.The aim of this paper was to compare the discriminatory power of four scores – the classic PSI and CURB65 and the most recent SCAP and SMART-COP – in predicting major adverse events: death, ICU admission, need for invasive mechanical ventilation or vasopressor support in patients admitted with pneumococcal pneumonia. MethodsA five-year retrospective study of patients admitted for pneumococcal pneumonia.Patients were stratified based on admission data and assigned to low-, intermediate-, and high-risk classes for each score. Results were obtained comparing low versus non-low risk classes. ResultsWe studied 142 episodes of hospitalization with 2 deaths and 10 patients needing mechanical ventilation and vasopressor support. The majority of patients were classified as low risk by all scores – we found high negative predictive values for all adverse events studied, the most negative value corresponding to the SCAP score. The more recent scores showed better accuracy for predicting ICU admission and need for ventilation or vasopressor support (mostly for the SCAP score with higher AUC values for all adverse events). ConclusionsThe rate of all adverse outcomes increased directly with increasing risk class in all scores. The new gravity scores appear to have a higher discriminatory power in all adverse events in our study, particularly, the SCAP score.

Pneumonia pneumocócica – serão os novos scores mais precisos a prever eventos desfavoráveis?

IntroductionThe site-of-care decision is one of the most important factors in the management of patients with community-acquired pneumonia. The severity scores are validated prognostic tools for community-acquired pneumonia mortality and treatment site decision.The aim of this paper was to compare the discriminatory power of four scores – the classic PSI and CURB65 ant the most recent SCAP and SMART-COP – in predicting major adverse events: death, ICU admission, need for invasive mechanical ventilation or vasopressor support in patients admitted with pneumococcal pneumonia. MethodsA five year retrospective study of patients admitted for pneumococcal pneumonia.Patients were stratified based on admission data and assigned to low-, intermediate-, and high-risk classes for each score. Results were obtained comparing low versus non-low risk classes. ResultsWe studied 142 episodes of hospitalization with 2 deaths and 10 patients needing mechanical ventilation and vasopressor support. The majority of patients were classified as low risk by all scores – we found high negative predictive values for all adverse events studied, the most negative value corresponding to the SCAP score. The more recent scores showed better accuracy for predicting ICU admission and need for ventilation or vasopressor support (mostly for the SCAP score with higher AUC values for all adverse events). ConclusionsThe rate of all adverse outcomes increased directly with increasing risk class in all scores. The new gravity scores appear to have a higher discriminatory power in all adverse events in our study, particularly, the SCAP score.

2208 ACTIVE SURVEILLANCE FOR PROSTATE CANCER: DIAGNOSTIC ACCURACY OF MULTIPARAMETRIC MRI IN SELECTION OF PATIENTS

INTRODUCTION AND OBJECTIVES: In case of low risk prostate cancer (PCa), the question arises whether to treat or follow a program of active surveillance (AS). These programs can sometimes mistakenly select patients. Multiparametric MRI (mp-MRI) has shown promise in localizing and characterize PCa. Aim of this study was to evaluate the role of mp-MRI in improving the selection of patients eligible for AS programs. METHODS: We reviewed our prospectively maintained PCa database and extracted the data about consecutive patients treated with radical prostatectomy (RP) previously undergone mp-MRI. We compared data of patients who fulfilled the AS criteria with data of mp-MRI and the pathological analysis. Clinical AS criteria were those of PRIAS (Prostate Cancer Research International: Active Surveillance) protocol: PSA 10 ng/ml and density 0.2 ng/ml; 2 positive cores at prostate biopsy and GS 6; clinical stage T1c-T2. Radiological criteria of inclusion of AS on mp-MRI were major tumor diameter 10 mm, organ-confined PCa, ADC 0.8/1. Pathological criteria using Epstein definition of insignificant disease were: organ-confined PCa, non-evidence of Gleason 4 or 5; tumor volume 0.5 cc. The same surgeon, the same uro-pathologist and the same uro-radiologist performed all the procedures. Sensitivity, specificity, positive and negative predictive value (PPV and NPV) of PRIAS criteria, mp-MRI and PRIAS mp-MRI were calculated based on 2x2 tables, using pathological results as gold standard. RESULTS: On pathological examination, 19/180 (10.6%) patients would have been properly selected for AS. Results are summarized in Table 1. Using PRIAS criteria to select patients for AS, sensitivity, specificity, PPV and NPV were 15.8%, 75.8%, 7.1% and 88.4%, respectively. Using mp-MRI criteria only to select patients for AS, sensitivity, specificity, PPV and NPV were 100%, 87.9%, 50% and 100%, respectively. Using PRIAS mp-MRI criteria, sensitivity, specificity, PPV and NPV were 15.8%, 98.8%, 60% and 90.9%, respectively. Only 2 patients selected for AS with PRIAS and MRI criteria had a non-low risk PCa (GS 7). CONCLUSIONS: Our results suggested that actual inclusion criteria are inadequate to candidate patients with PCa for AS. In our cohort, mp-MRI seems to improve selection of patients for AS when used in combination with clinical criteria.

Prognostic value of adenosine stress perfusion cardiac MRI with late gadolinium enhancement in an intermediate cardiovascular risk population

BackgroundThe high diagnostic accuracy of adenosine stress cardiac magnetic resonance (AS-CMR) for detecting coronary artery stenoses, with high sensitivity and specificity, is well documented. Prognostic data, particularly in non-low risk study populations and for greater than 12months of follow up, is however lacking or variable in its findings. We present prognostic data, in an intermediate cardiovascular risk cohort undergoing adenosine stress perfusion CMR, over approximately 2years of follow up. MethodsThe study population comprised 362 patients referred for a clinically indicated stress CMR and included patients with proven coronary artery disease (CAD; n=157) or unknown CAD status, yet an intermediate cardiovascular risk profile (n=205). Perfusion imaging was performed at stress (adenosine 140μg/kg/min) and rest on a 1.5T system. Patient records and state-wide hospital databases were reviewed. Major adverse cardiac events — death, myocardial infarction, revascularisation or ischaemic hospitalisation — were evaluated over a median follow up of 22months. ResultsOf the 362 cases, 90 had a stress perfusion CMR positive for ischaemia and experienced a MACE rate of 24%. Of the 272 negative CMR scans, 225 were also negative for late gadolinium enhancement, and in this group MACE was encountered in only 6 (2.7%) patients. Accordingly a negative stress CMR afforded a freedom from MACE of 97.3%. Freedom from death/myocardial infarction was 99.6%. ConclusionsIn patients with confirmed coronary artery disease or at intermediate risk for cardiovascular events, a negative stress perfusion CMR is associated with an excellent prognosis over nearly 2years of follow up.

Relationship between symptom-onset-to-balloon time and long-term mortality in patients with acute myocardial infarction treated with drug-eluting stents

Time from hospital arrival to reperfusion in ST-segment elevation myocardial infarction (STEMI) has been predictive of in-hospital mortality. The purpose of this study was to evaluate the relationship between symptom-onset-to-balloon time and long-term mortality in patients with STEMI in the drug-eluting stent (DES) era. A series of 393 patients with STEMI treated with DES from 2005 to 2007 was stratified according to risk profile and preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow grade, and clinical, angiographic, and follow-up data were collected. A total of 98 (24.9%) low-risk patients and 295 (75.1%) non-low-risk patients were identified. Three-year mortality rate was 3.1% for low-risk patients and 10.2% for non-low-risk patients (p=0.034), respectively; however it did not differ according to symptom-onset-to-balloon time in either low-risk (p=0.333) or non-low-risk patients (p=0.881). Similarly, symptom-onset-to-balloon time and mortality were not related to preprocedural TIMI flow (p=0.474 for TIMI 0-1; p=0.428 for TIMI 2-3). In multivariate analysis, final TIMI flow 0-2, systolic blood pressure <100 mmHg at admission, age ≥70 years, anterior infarction, C-reactive protein level, and peak creatine kinase myocardial band isoenzyme level were identified as independent predictors of 3-year mortality while symptom-onset-to-balloon time and preprocedural TIMI flow were not. In STEMI patients treated with DES, symptom-onset-to-balloon time does not affect long-term outcomes even in individuals at non-low risk and with poor preprocedural TIMI flow grade.