First prospective multicenter Italian study on the impact of the 21-Gene Recurrence Score (RS) in adjuvant clinical decisions for ER+/HER2- early breast cancer (BC) patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12038-e12038
Author(s):  
Maria Vittoria Dieci ◽  
Valentina Guarneri ◽  
Tommaso Giarratano ◽  
Marta Mion ◽  
Giampaolo Tortora ◽  
...  
Keyword(s):  
Recurrence Score ◽  
Absolute Difference ◽  
Intermediate Risk ◽  
Veneto Region ◽  
Hub And Spoke ◽  
Italian Study ◽  
Factors Associated ◽  
Number Of Patients ◽  
Main Factors ◽  
The Impact

e12038 Background: The Breast-DX Italy prospective study evaluated the impact of the 21-gene RS on adjuvant treatment decisions for early BC patients. Methods: The study was conducted in 9 centers of the Veneto Region (2 hub and 7 spoke). All consecutive patients with ER+/HER2-, T1 to T3, N0 to N1 early BC who met protocol-defined clinicopathological criteria for “intermediate risk” were included. Pre-RS and post-RS physicians’ treatment recommendations and treatment actually received were collected. Results: From November 2014 to August 2016, n=124 N0 and n=126 N1 patients were enrolled (65% at hub and 35% at spoke centers). The majority had PgR+ (86%), G2 (71%) and pT1c (63%) BC. Median age was 55 yrs, median Ki67 was 20% (range 2-70%). The distribution of RS was: <18 (61%), 18-30 (32%) and >30 (7%). Main factors associated with higher RS were G3 and higher ki67. The addition of chemotherapy (CT) to hormonal therapy (HT) was initially recommended for 48% of the patients (38% of N0 and 57% of N1 patients; 54% and 37% of patients enrolled at hub and spoke centers, respectively). The post-RS recommendation changed from the pre-RS recommendation for 40 patients, mostly from CT+HT to HT (n=30; n=25 with low and n=5 with intermediate RS). Change was more frequent for N1 patients (Table). Of the 72 N1 patients initially recommended to CT+HT, 28% had a post-RS indication to HT alone. The crude number of patients with pre-RS recommendation to CT significantly exceeded the number of patients who finally received it (absolute difference =31; p<0.001). The majority of CT treatments were spared at hub vs spoke centers (n=24 and n=7, respectively). Conclusions: Pre-RS indication to HT alone was frequent, in particular for N0 patients and at spoke centers. The use of the 21-gene RS further contributed in sparing CT administration, more so for N1 patients and at hub centers. The impact of the RS when used at discretion of the clinicians is currently under investigation in the prospective ROXANE study. [Table: see text]

Outcome Following Hematopoietic Cell Transplantation for Patients with AML-CR1: Comparison between Matched-Sibling and Unrelated Allografts.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 330-330 ◽  
Author(s):  
John M. Pagel ◽  
Ted Gooley ◽  
Effie W. Petersdorf ◽  
Mari Malkki ◽  
Lacey Drouet ◽  
...  
Keyword(s):  
Cell Transplantation ◽  
Acute Gvhd ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Intermediate Risk ◽  
Sibling Donor ◽  
Number Of Patients ◽  
Matched Sibling ◽  
The Impact ◽  
Related Mortality

Abstract Although allogeneic hematopoietic cell transplantation (HCT) often offers the best, and sometimes only chance for cure for AML patients, the procedure too often fails to eradicate the patient’s malignancy or is associated with fatal toxicities. Graft-vs-leukemia effects are felt to be associated with improved survival in the HCT setting, and recipients of unrelated allografts generally experience higher rates of graft-vs-host disease (GvHD) as compared to patients transplanted from a matched-sibling donor. With these observations in mind, we have evaluated outcome among patients transplanted for acute myeloid leukemia (AML) in first complete remission (CR1), assessing the differences between recipients of a matched unrelated donor allograft (MUD) who were matched for 10 of 10 alleles at HLA-A, -B, -C, -DRB1, and -DQB1 and allografts from an HLA-identical sibling donor (MRD). Between 1992 and 2004, 183 patients greater than 18 years of age with AML-CR1 and a donor as described above (n = 47 MUD; n = 136 MRD) received an ablative HCT at our Center. Median age was 41 (range, 19–67) years. Conditioning included use of total body irradiation (TBI) (38% MUD; 29% MRD), busulfan and cyclophosphamide (45% MUD; 39% MRD), an anti-CD45 radiolabeled antibody (9% MUD; 29% MRD), or other regimens (11% MUD; 4% MRD). Most received cyclosporine and methotrexate for GvHD prophylaxis (81% in MUD; 92% in MRD). Source of stem cells was bone marrow in 30% MUD, 63% MRD. Patients were further classified by cytogenetic risk as favorable (2% MUD; 8% MRD), intermediate (81% MUD; 70% MRD), or unfavorable (17% MUD; 22% MRD). Multivariable Cox regression models were fit for the endpoints mortality, relapse, and transplant-related mortality (TRM) and logistic regression was used for acute GvHD. Eighty percent of MUD patients developed grades 2–4 acute GVHD compared to 68% of MRD patients (adjusted odds ratio (OR) = 2.9; 95% CI 1.2–7.1; p = 0.02). Surprisingly however, the probability of grades 3–4 was not higher (11% in MUD group, 20% in MRD group; adjusted OR = 0.6; 95% CI 0.2–1.7; p = 0.31). Nineteen percent of MUD patients relapsed compared to 22% of MRD patients, leading to a 5-year estimated probability of relapse of 17% and 22%, respectively (adjusted hazard ratio (HR) = 0.9; 95% CI 0.4–2.0; p = 0.82). The estimated 5-year overall survival was 56% in the MUD group and 64% in the MRD group (adjusted mortality HR = 1.4; 95% CI 0.8–2.5; p = 0.21). Twenty-one percent of patients in the MUD group experienced transplant-related mortality (TRM) compared to 18% in the MRD group (HR = 2.0; 95% CI 0.9–4.2; p = 0.09). While the number of patients with unfavorable cytogenetics was relatively low (n = 38), there is some suggestion that the donor effect on TRM exists primarily among patients with intermediate-risk cytogenetics and not so in the group with unfavorable cytogenetics (HR = 2.9 in intermediate-risk and HR = 0.9 in unfavorable group). While larger numbers of patients are required to confirm these findings, these data suggest that in AML-CR1 patients, MUD HCT increases the risk of grades 2–4 acute GvHD relative to MRD. The impact of donor source on relapse is minimal, but the risk of mortality, mainly transplant-related, may be increased, particularly among patients with intermediate-risk cytogenetics.

scholarly journals The main factors, associated with incomplete vaccination againts measels, parotitis, rubella, and diphtheria in 170 juvenile idiopathic arthritis patients: the results of prospective pilot study

2021 ◽  
Vol 59 (3) ◽  
pp. 335-343
Author(s):  
N. A. Lybimova ◽  
I. V. Fridman ◽  
O. V. Goleva ◽  
S. M. Kharit ◽  
M. M. Kostik
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Odds Ratio ◽  
Onset Age ◽  
Biologic Treatment ◽  
Factors Associated ◽  
Prospective Pilot Study ◽  
Number Of Patients ◽  
Main Factors ◽  
Antibody Levels ◽  
Elisa Data

Background. Patients with juvenile idiopathic arthritis (JIA) may have incomplete vaccination againts different vaccines leads to lower protective levels of anti-vaccine antibodies.The aim of the study – to evaluate the rate and the main factors of incomplete vaccination against measels, parotitis, rubella (MMR), and diphtheria in JIA patients.Methods. In the present study were included data 170 JIA (55 boys and 115 girls) aged from 2 to 17 years, who received scheduled vaccination before the age of 2 years and before JIA onset against measles, parotitis, diphtheria and rubella. Incomplete vaccination means the reduced number of vaccine to age. In all patients the IgG anti-vaccine antibodies levels were detected with ELISA. Data presented with odds ratio ()OR) with 95 confidence interval (CI).Results. Incomplete vaccination against MMR was in 50 (32.5%) of children less than 6 years. Incomplete vaccination against diphtheria was in 6/16 (37.5%) of children less than 6 year, in 53/110 (48.2%) of children aged 6–14 years and in 26/44 (59.1%) of the JIA patients more than 14 years. The main predictors in logistic regression for incomplete vaccination for MMR were: onset age <4 years (OR=12.2 [95% CI: 5.0–28.9]; p=0.0000001), JIA duration >3.1 years (OR=4.4 [95% CI: 2.0–9.9]; p=0.0002), methotrexate duration >3 years (OR=5.7 [95% CI 2.7–12.0]; p=0.0000012); biologic treatment (OR=2.5 [95% CI: 1.3–4.9]; p=0.008) and treatment >1 biologic (OR=3.3 [95% CI: 1.1–10.4]; p=0.002); for diphtheria were: JIA duration >3.1 years (OR=3.4 [95% CI: 1.8–6.5]; p=0.0002), methotrexate duration >2.8 years (OR=4.1 [95% CI: 2.1–8.1]; p=0.00004), biologic treatment (OR=2.4 [95% CI: 1.3–4.4]; p=0.006). In the multiple regression only JIA onset age (p=0.00001) and duration of methotrexate (p=0.003) were predictors of incomplete vaccination against MMR. Methotrexate duration (p=0.005) and biologics treatment (p=0.05) were predictors of incomplete vaccination against diphtheria.Conclusion. The main predictor of incomplete vaccination was younger onset age of JIA. Children received more intensive immunosupression usually have scheduled vaccination rarely which leads to increased number of patients without protective antibody levels. These facts indicate the attitude of physicians parents to vaccination in immunocompromised children. Further investigations required for assessment of safety of vaccinations in children with rheumatic diseases may be a factor for changing this prejudice.

The International Prognostic Scoring System for Waldestrom’s Macroglobulinemia (ISSWM) Is Applicable in Patients Treated with Rituximab-Based Regimens.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3615-3615
Author(s):  
Meletios Athanasios Dimopoulos ◽  
Efstathios Kastritis ◽  
Dimitra Gika ◽  
Sossana Delimpassi ◽  
Konstantinos Zervas ◽  
...  
Keyword(s):  
High Risk ◽  
Alkylating Agents ◽  
Single Agent ◽  
Primary Treatment ◽  
High Risk Group ◽  
Low Risk ◽  
International Prognostic Scoring System ◽  
Intermediate Risk ◽  
Number Of Patients ◽  
The Impact

Abstract Introduction: An ISSWM was recently proposed (Morel et al, ASH 2006), which was based on a large number of patients treated primarily with alkylating agents and /or nucleoside analogues. The ISSWM based on 5 adverse covariates wich defined 3 risk groups: low, intermediate and high risk with 5-years survival rates of 87%, 68% and 36% respectively. In our current analysis, we assessed the impact of this system in patients with WM who received primary treatment with rituximab-based regimens. Patients and methods: Ninety-three previously untreated, symptomatic patients who received treatment either with single agent rituximab (21 patients) or with the combination of dexamethasone, rituximab, and cyclophosphamide (72 patients) were classified according to the ISSWM, which is based on 5 adverse covariates: age&gt; 65 years, hemoglobin ≤11.5 g/dl, platelet count ≤ 100 x 109/L, β2- microglobulin &lt;3mg/L, serum monoclonal protein concentration &gt;70g/L. Low risk is defined by the presence of ≤ 1 adverse characteristics except age, high risk by the presence of &gt;2 adverse characteristics and intermediate risk by the presence of 2 adverse characteristics or age &gt;65 years. Results: The disease features of the 93 patients were typical of symptomatic WM: age &gt; 65 years in 63%, males 65%, B-symptoms in 22%, splenomegaly in 29%, lymphadenopathy in 34%. 15% of patients were rated as low risk, 65% as intermediate risk and 20% as high risk. Criteria for initiation of therapy included cytopenia, hyperviscosity, constitutional symptoms, organomegaly or IgM-related disorders. Overall, 62% of patients were alive at 6 years. Median survival was not reached for low and intermediate risk and was 38 months for high risk patients (p=0.006). There was a clear separation of the survival curves in the three groups. At the time of last follow-up the percentage of patients alive was 100%, 82% and 58% for patients classified as low, intermediate and high-risk group respectively. Conclusions: The recently proposed ISSWM is applicable in patients with WM who receive primary treatment with rituximab-based regimens and may serve as a basis to compare outcomes in different studies.

Frequency and Impact Of Allogeneic Hematopoetic Stem Cell Transplantation and Preparative Regimen In Patients With High and Intermediate Risk Acute Myeloid Leukemia: A Single Small Center Experience

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5550-5550
Author(s):  
Shatha Farhan ◽  
Catherine Carroll ◽  
Danielle Pelland ◽  
Jose Carlos Velasco ◽  
Edward Peres ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Acute Myeloid Leukemia ◽  
Cell Transplantation ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Intermediate Risk ◽  
Number Of Patients ◽  
Preparative Regimen ◽  
The Impact ◽  
Acute Myeloid

Abstract Background Allogeneic hematopoietic cell transplantation (HCT) likely prolongs survival in high and intermediate risk adults with acute myeloid leukemia (AML). Prior studies, however, suggest that only about 15-20% of AML patients especially older than 50 with abnormal cytogenetics receive HCT. In this report, we evaluated the impact of transplant and preparative regimen on high- or intermediate-risk AML patients treated in our center. Methods We retrospectively reviewed all patients who were diagnosed with AML (non promyelocytic) in our center between 2002 and 2012. Primary objective was to study the impact of HCT and preparative regimen in high and intermediate risk AML patients. Demographics and disease-related variables were collected. OS was defined as the time from diagnosis to the time of death or last follow up. Results Between 2002 and 2012, 123 patients with high or intermediate risk AML patients were treated at our center. Median age at diagnosis was 60 (range 19-89). 82 patients had high-risk features while 41 had intermediate risk features. Median OS for all patients was 368 days. Of these 124 patients, fifty-one patients (41%) received allogeneic HSCT at a median of 4.6 months from diagnosis. Median age of patients who received HCT was 53 while median age of patients who did not get HCT was 68. Of the 51 patients who received HCT, 13 patients with median age of 61 received a reduced toxicity/ Intensity conditioning regimen (RIC) while 37 patients with median age of 49 received a fully myelo-ablative regimen (MA). One got transplant elsewhere with unknown regimen. Median percentage of blasts in bone marrow at time of HCT was 3 and 3.5% for the RIC and MA regimens, respectively. Number of patients who had 10% or more blasts in the bone marrow at transplant was 9 of the 37 patients (24%) who received MA regimen and 3 of the 13 patients (23%) who received RIC regimen. Median OS for patients who received HCT was 551 days while it was 200 days for patients who did not receive HCT (p=0.0013) Fig1. The median OS for patients who got RIC was 1095 days but less at 434 days for MA patients but not statistically significant (p=0.64) Fig2. The cumulative incidence of relapse was not different between the two groups. Conclusion In this small cohort of consecutive patients from a single center, the results suggest that HCT can be performed in patients with high and Intermediate-risk AML patients including older patients using RIC. RIC in older patients and MA in younger patients did not differ in term of OS. However this is limited by the small number of patients and a larger prospective evaluation is needed taking into consideration better models encompassing performance status and co-morbidities. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Factors Associated with Childhood Depression in Saskatoon Students: A Multilevel Analysis

2013 ◽  
Vol 32 (1) ◽  
pp. 29-42
Author(s):  
Shan Jin ◽  
Nazeem Muhajarine ◽  
Jennifer Cushon ◽  
Hyun J. Lim
Keyword(s):  
Logistic Regression Model ◽  
School Refusal ◽  
School Level ◽  
Student Health ◽  
Individual Level ◽  
Factors Associated ◽  
Main Factors ◽  
Bullying Experiences ◽  
Multilevel Logistic Regression Model ◽  
The Impact

This study examined links between depression and multilevel factors among children from Saskatoon elementary schools. A total of 4,200 students participated in the Saskatoon Student Health Survey conducted in 2008–9. Covariates included demographics and family structure, relationships, physical activity, bullying experiences, and school refusal behaviours. A multilevel logistic regression model was used to examine the impact of individual-level and school-level (contextual) factors. The study revealed that depression disparity existed among schools, and students’ school refusal behaviours such as skipping or being suspended from school were among the main factors contributing to the disparity between schools.

scholarly journals First Prospective Multicenter Italian Study on the Impact of the 21‐Gene Recurrence Score in Adjuvant Clinical Decisions for Patients with ER Positive/HER2 Negative Breast Cancer

2017 ◽  
Vol 23 (3) ◽  
pp. 297-305 ◽  
Author(s):  
Maria Vittoria Dieci ◽  
Valentina Guarneri ◽  
Tommaso Giarratano ◽  
Marta Mion ◽  
Giampaolo Tortora ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Recurrence Score ◽  
Clinical Decisions ◽  
Italian Study ◽  
Er Positive ◽  
The Impact

Primary liver angiosarcoma and factors associated with improved outcomes: An analysis of the National Cancer Database.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 498-498
Author(s):  
Prantesh Jain ◽  
Gino Cioffi ◽  
Nirav Patil ◽  
Aman Opneja ◽  
Asrar Alahmadi ◽  
...  
Keyword(s):  
Median Survival ◽  
Statistical Significance ◽  
Rank Test ◽  
National Cancer Database ◽  
Factors Associated ◽  
Academic Center ◽  
Risk Of Mortality ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Impact

498 Background: Primary liver angiosarcoma (LAS) is a rare and aggressive tumor of the liver. In this analysis of the national cancer database (NCDB) we sought the risk of mortality and factors associated with survival amongst patient diagnosed with LAS. Methods: Patients diagnosed with hepatocellular carcinoma (HCC) or LAS from 2004 – 2014 were identified in the NCDB. The Kaplan-Meier method with the log-rank test was used to calculate survival for HCC and LAS patients. Additional analyses were performed on the cohort with LAS to assess the impact of surgery, chemotherapy, radiation therapy (RT) and facility type on overall survival (OS). Multivariable analyses using cox proportional methods, adjusted for age, sex, Charlson/Deyo score, race, ethnicity, insurance status, facility location and type, surgery status, and chemotherapy status were performed to obtain adjusted hazard ratio (aHR). Results: Total of 118,066 patients with HCC and 346 patients with LAS were identified in the database. Median survival for HCC patients was 11.9 months (95% CI: 11.7-12.2) and 2.0 months for LAS patients (95% CI: 1.8 – 2.4). Risk of mortality was higher for patients with LAS compared to those with HCC (aHR (95% CI): 2.23 (1.97 - 2.53), p < .0001). Among the LAS patients, those who received surgery had a median survival of 8.6 months (95% CI: 5.6 - 17.3), and 1.8 months for those who did not (95% CI: 1.48 - 1.94). Risk of mortality was lower in patients who received surgery compared to those who did not (aHR (95% CI): 0.23 (0.15 - 0.37), p < .0001). Patients treated at and academic center had a higher median survival (3.3 months, 95% CI: 2.2 - 4.1) then those treated at a non-academic center (1.5 months, 95% CI: 1.2 - 1.8). Though, there was no significant difference in OS (aHR (95% CI): 0.48 (0.21 - 1.10), p = 0.082). A very small number of patients received chemotherapy or RT to conduct a meaningful analysis. Conclusions: Patients diagnosed with primary LAS have a worse OS compared to those with HCC. Amongst patients with primary LAS, surgical resection is associated with best survival outcomes. Treatment at an academic center is associated with better median survival, although OS did not reach statistical significance in our analysis.

Potential economic impact of the 21-gene expression panel according to tumor (T) size in lymph-node-negative (LNN), estrogen-receptor (ER)-positive early breast cancer (BC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11518-e11518
Author(s):  
F. E. Prisco ◽  
E. D. Saad ◽  
F. M. Carvalho ◽  
E. B. Ojopi ◽  
C. E. Bacchi
Keyword(s):  
Recurrence Score ◽  
Gene Panel ◽  
Third Party ◽  
Web Based ◽  
Medical Oncologists ◽  
Number Of Patients ◽  
Er Positive ◽  
Size Type ◽  
The Impact ◽  
Third Party Payers

e11518 Background: Use of the 21-gene panel may save costs in patients with LNN, ER-positive BC. Our previous analysis suggests that such would be the case in Brazil (SABCS 2008). However, the impact of the test may vary according to T size. Methods: Using a web-based survey with 30 (of a total of nearly 700) medical oncologists and literature data, we developed a model of direct medical expenses in two hypothetic cohorts (one without and one with access to the 21-gene panel) of Brazilian women with LNN, ER-positive BC, from the perspective of third-party payers. The questionnaire assessed patterns of care relating to chemotherapy (CT) regimens in each T size, type of premedication, use of G-CSF, and use of intravenous antibiotics for febrile neutropenia. Medication and 21-gene panel costs were the manufacturers’ recommended prices at the time of the survey. T size and recurrence score distributions followed those reported by Paik et al (NEJM 2004). CT use in the cohort with no access to the 21-gene panel was modeled according to the survey. In the cohort with access to the test, we assumed that patients with intermediate or high scores would receive CT, whereas patients with low score would not. Results: The table displays the number of patients receiving CT and the costs (CT, premedication, G-CSF, antibiotics, and the 21-gene panel) for two hypothetic cohorts of 100 patients. Conclusions: Our economic analysis suggests that the 21-gene panel overall would be cost-saving in Brazil, from the perspective of third-party payers. However, testing could actually increase direct medical costs in LNN, ER-positive T1 tumors, and decrease costs in T >2 cm. [Table: see text] [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document