Validation of a prognostic score for early mortality in severe head injury cases

2014 ◽  
Vol 121 (6) ◽  
pp. 1314-1322 ◽  
Author(s):  
Pedro A. Gómez ◽  
Javier de-la-Cruz ◽  
David Lora ◽  
Luis Jiménez-Roldán ◽  
Gregorio Rodríguez-Boto ◽  
...  
Keyword(s):  
Head Injury ◽  
High Risk ◽  
Risk Score ◽  
Prognostic Score ◽  
Early Death ◽  
Early Mortality ◽  
Final Model ◽  
Sum Score ◽  
The Impact ◽  
Very High

Object Traumatic brain injury (TBI) represents a large health and economic burden. Because of the inability of previous randomized controlled trials (RCTs) on TBI to demonstrate the expected benefit of reducing unfavorable outcomes, the IMPACT (International Mission on Prognosis and Analysis of Clinical Trials in TBI) and CRASH (Corticosteroid Randomisation After Significant Head Injury) studies provided new methods for performing prognostic studies of TBI. This study aimed to develop and externally validate a prognostic model for early death (within 48 hours). The secondary aim was to identify patients who were more likely to succumb to an early death to limit their inclusion in RCTs and to improve the efficiency of RCTs. Methods The derivation cohort was recruited at 1 center, Hospital 12 de Octubre, Madrid (1990–2003, 925 patients). The validation cohort was recruited in 2004–2006 from 7 study centers (374 patients). The eligible patients had suffered closed severe TBIs. The study outcome was early death (within 48 hours post-TBI). The predictors were selected using logistic regression modeling with bootstrapping techniques, and a penalized reduction was used. A risk score was developed based on the regression coefficients of the variables included in the final model. Results In the validation set, the final model showed a predictive ability of 50% (Nagelkerke R2), with an area under the receiver operating characteristic curve of 89% and an acceptable calibration (goodness-of-fit test, p = 0.32). The final model included 7 variables, and it was used to develop a risk score with a range from 0 to 20 points. Age provided 0, 1, 2, or 3 points depending on the age group; motor score provided 0 points, 2 (untestable), or 3 (no response); pupillary reactivity, 0, 2 (1 pupil reacted), or 6 (no pupil reacted); shock, 0 (no) or 2 (yes); subarachnoid hemorrhage, 0 or 1 (severe deposit); cisternal status, 0 or 3 (compressed/absent); and epidural hematoma, 0 (yes) or 2 (no). Based on the risk of early death estimated with the model, 4 risk of early death groups were established: low risk, sum score 0–3 (< 1% predicted mortality); moderate risk, sum score 4–8 (predicted mortality between 1% and 10%); high risk, sum score 9–12 (probability of early death between 10% and 50%); and very high risk, sum score 13–20 (early mortality probability > 50%). This score could be used for selecting patients for clinical studies. For example, if patients with very high risk scores were excluded from our study sample, the patients included (eligibility score < 13) would represent 80% of the original sample and only 23% of the patients who died early. Conclusions The combination of Glasgow Coma Scale score, CT scanning results, and secondary insult data into a prognostic score improved the prediction of early death and the classification of TBI patients.

Proposal of A Prognostic Score for Previously Untreated Patients with Chronic Lymphocytic Leukemia Based on An Overall Survival Analysis of Three German CLL Study Group Phase III Trials

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2831-2831
Author(s):  
Jasmin Bahlo ◽  
Natali Pflug ◽  
Thomas Elter ◽  
Kathrin Bauer ◽  
Barbara Eichhorst ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Risk Score ◽  
Research Funding ◽  
Prognostic Score ◽  
Phase Iii ◽  
Mutational Status ◽  
Phase Iii Trials ◽  
Binet Stage ◽  
Very High

Abstract Abstract 2831 Introduction Prognosis and need of treatment in CLL is currently determined by clinical staging systems of Binet and Rai. Recent research has focused on prognostic factors that may predict a poor prognosis independent of the clinical stage. Markers which have shown independent prognostic information are serum parameters and genetic factors (genomic aberrations, IgHV and p53 mutational status). To investigate the relevance of these different factors, we performed a pooled analysis using the data of three multicenter German CLL Study Group phase III trials (CLL1, CLL4 and CLL8). Based on this analysis we propose a prognostic score for previously untreated patients with early and advanced CLL. Material and Methods Patients were recruited between 1997 and 2006 into three phase III trials: 715 in CLL1 (“watch and wait” versus fludarabine (F)), 362 in CLL4 (F versus F and cyclophosphamide (FC)) and 817 patients in the CLL8 trial (FC versus FC and rituximab (FCR)). Serum parameters and genetic factors were centrally analyzed prior to treatment. The main end point of all statistical analyses was overall survival. First, univariate analyses were performed including variables of different groups such as baseline characteristics, stage of disease, laboratory results, molecular cytogenetics, mutational status and serum parameters. Next, multivariate Cox regressions were applied including all parameters that showed a significant association with overall survival in univariate analyses. To create a prognostic score we developed a weighted grading algorithm for independent factors based on ranges of hazard ratios. Finally, a prognostic score was defined as the sum of single ratings of adverse factors. According to this score, four different risk groups for overall survival could be identified. Results In total 1948 patients were eligible for the pooled analysis with a median age of 60 years (range, 30 to 81 years). After a median observation time of 63.4 months 485 deaths were reported. At study entry, 799 patients (42.4%) were at Binet stage A, 717 (38.0%) at Binet stage B and 370 (19.6%) at Binet stage C. Almost all considered variables were significantly associated with outcome and therefore included in the multivariate analysis. Based on the data of 1223 patients for whom all parameters were available, multivariate Cox regressions were performed and identified gender, age, ECOG score, del(17p), del(11q), IgHV mutational status, serum β2-microglobulin and serum thymidine kinase as independent factors for overall survival. Deletion 17p was the strongest adverse factor. Neither the clinical staging (Rai, Binet) nor the treatment modality were independent prognostic factors for overall survival. Similarly, the time interval between first diagnosis and study entry was not an independent prognostic factor. Due to the great differences between hazard ratios of independent factors, we developed a weighted grading system based on a simple algorithm to assign an individual grade to each adverse factor. By using this weighted grading, four different prognostic groups could be separated: low risk (score 0 – 2), intermediate risk (score 3 – 5), high risk (score 6 – 10) and very high risk (score 11 – 14) (figure 1). Overall survival rates were significantly different for these four groups with 95.2%, 86.9%, 67.7% and 18.7% survival after 5 years for the low, intermediate, high and very high risk group, respectively (p<0.0001). Moreover, within the group of patients showing a deletion 17p the score could distinguish patients of a high risk and a very high risk group (p<0.0001). Finally, the score could predict the individual risk for short overall survival independent of and within the different Binet or Rai stages (p<0.0001) (figure 2). Conclusion While Binet and Rai staging systems may remain important for the initial clinical assessment due to their simplicity, our prognostic score using a weighted combination of genetic and serum markers is superior to predict the overall survival of CLL patients. Disclosures: Pflug: Hoffmann-la Roche: Travel grant; Mundipharma: Travel grant. Eichhorst:Hoffmann La Roche: Honoraria, Research Funding, Travel Grants; Mundipharma: Research Funding, Travel Grants; Gilead: Consultancy. Bergmann:Celgene: Honoraria. Döhner:Hoffmann-la Roche: Research Funding. Stilgenbauer:Hoffmann La Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Travel Grants. Fischer:Hoffmann La Roche: Travel Grants. Hallek:Hoffmann-la Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.

scholarly journals A Peri-Implant Disease Risk Score for Patients with Dental Implants: Validation and the Influence of the Interval between Maintenance Appointments

2019 ◽  
Vol 8 (2) ◽  
pp. 252 ◽  
Author(s):  
Miguel de Araújo Nobre ◽  
Francisco Salvado ◽  
Paulo Nogueira ◽  
Evangelista Rocha ◽  
Peter Ilg ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Score ◽  
Disease Risk ◽  
Disease Incidence ◽  
Risk Groups ◽  
Risk Profile ◽  
Moderate Risk ◽  
C Statistic ◽  
Disease Risk Score ◽  
Very High

Background: There is a need for tools that provide prediction of peri-implant disease. The purpose of this study was to validate a risk score for peri-implant disease and to assess the influence of the recall regimen in disease incidence based on a five-year retrospective cohort. Methods: Three hundred and fifty-three patients with 1238 implants were observed. A risk score was calculated from eight predictors and risk groups were established. Relative risk (RR) was estimated using logistic regression, and the c-statistic was calculated. The effect/impact of the recall regimen (≤ six months; > six months) on the incidence of peri-implant disease was evaluated for a subset of cases and matched controls. The RR and the proportional attributable risk (PAR) were estimated. Results: At baseline, patients fell into the following risk profiles: low-risk (n = 102, 28.9%), moderate-risk (n = 68, 19.3%), high-risk (n = 77, 21.8%), and very high-risk (n = 106, 30%). The incidence of peri-implant disease over five years was 24.1% (n = 85 patients). The RR for the risk groups was 5.52 (c-statistic = 0.858). The RR for a longer recall regimen was 1.06, corresponding to a PAR of 5.87%. Conclusions: The risk score for estimating peri-implant disease was validated and showed very good performance. Maintenance appointments of < six months or > six months did not influence the incidence of peri-implant disease when considering the matching of cases and controls by risk profile.

scholarly journals Pemetaan Area Berisiko Persampahan di Kota Cimahi Berdasarkan Pedoman Strategi Sanitasi Kabupaten/ Kota 2018

2019 ◽  
Vol 3 (2) ◽  
Author(s):  
Indah Fionita ◽  
Iwan Juwana
Keyword(s):  
High Risk ◽  
Solid Waste ◽  
Waste Disposal ◽  
Waste Reduction ◽  
Open Burning ◽  
Risk Areas ◽  
Strategic Policy ◽  
Waste Solid ◽  
The Impact ◽  
Very High

ABSTRAKKota Cimahi merupakan salah satu kota di Jawa Barat yang masih menghadapi permasalahan persampahan, seperti terbatasnya penerapan kegiatan pemilahan sampah, terbatasnya jumlah Tempat Penampungan Sementara (TPS), terjadi pembuangan sampah secara sembarangan ke sungai, terdapat penanganan sampah dengan cara dibakar dan ditimbun, dan lain-lain. Dalam menindaklanjuti berbagai permasalahan sampah tersebut serta mencapai target 30% pengurangan sampah yang ditentukan oleh Kebijakan Strategis Nasional (Jakstranas), maka diperlukan suatu instrumen yang mampu menganalisis area berisiko berdasarkan tingkat risiko persampahan per kelurahan di Kota Cimahi. Area berisiko tersebut digambarkan dalam bentuk peta dengan mengacu pada pedoman Strategi Sanitasi Kabupanen/Kota (SSK) 2018. Area berisiko dinilai melalui skor 1 s.d. 4 secara berturut-turut untuk risiko sangat rendah, rendah, tinggi, dan sangat tinggi. Skor tersebut diperoleh dengan mengalikan parameter Impact dan parameter Exposure. Hasil penelitian ini menunjukkan terdapat tiga kelurahan dengan risiko persampahan sangat tinggi, yaitu Kelurahan Cibeureum, Setiamanah, dan Padasuka serta satu kelurahan dengan risiko persampahan tinggi, yaitu Kelurahan Melong. Penambahan jumlah unit pengolahan direkomendasikan di beberapa kelurahan sehingga terjadi perubahan skor area berisiko.Kata Kunci: Kota Cimahi, Peta Area Berisiko, Persampahan ABSTRACTCimahi City is one of the cities in West Java that still faces solid waste problems, such as the limited implementation of waste sorting activities, the limited number of temporary shelter sites, the indiscriminate waste disposal on river, open burning of solid waste, etc. In following up on these various waste problems and achieving the target of 30% waste reduction determined by the National Strategic Policy, an instrument is needed to analyze risk areas based on the level of risk of solid waste per village in Cimahi City. These risk areas are depicted in the form of maps by referring to the 2018 District/City Sanitation Strategy Guidelines. Risk areas are assessed through a score of 1 s.d. 4 for very low, low, high and very high risks. The score is obtained by multiplying the Impact parameters and Exposure parameters. The results of this study indicate that there are three villages with very high risk of solid waste, namely Kelurahan Cibeureum, Setiamanah, and Padasuka and one village with high risk of solid waste, namely Kelurahan Melong. The addition of the number of processing units was recommended in several villages so that changes in the score of risk areas occurred. Keyword: Cimahi City, Map of Risk Areas, Waste Solid

scholarly journals Preoperative Score to Stratify Recurrence Risk After Curative Resection of Resectable Pancreatic Ductal Adenocarcinoma: A Retrospective Cohort Study

2021 ◽  
Author(s):  
Yu Jiang ◽  
SIYI Zou ◽  
Weishen Wang ◽  
Haoda Chen ◽  
Qian Zhan ◽  
...  
Keyword(s):  
High Risk ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Prognostic Score ◽  
Multidisciplinary Treatment ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Ductal Adenocarcinoma ◽  
Final Model ◽  
Significant Difference ◽  
Risk Patients

Abstract Background: Oncological survival after operation of resectable pancreatic ductal adenocarcinoma (R-PDAC) is variable depending on various factors. Preoperative risk stratification could guide decision-making in multidisciplinary treatment concepts. We develop and validate a prognostic score for disease-free survival (DFS) in R-PDAC to solve this issue.Methods: 421 R-PDAC patients between January 2012 and December 2015 were enrolled. Performance of the final model was evaluated with respect to discrimination, calibration and clinical usefulness. A prognostic score based on the final model was developed, and external validated in 290 patients.Results: On multivariable analysis, age, tumor size, carbohydrate antigen (CA)19-9, CA125, lymphocyte-monocyte ratio, and systemic-immune-inflammation index were independently associated with DFS. Final model had acceptable calibration, discrimination and internal validity. The prognostic score could delineate low- and high-risk groups with median DFS of 19.6 and 10.1 months (P<0.0001). Tumors in high-risk group exhibited more aggressive pathobiological behaviors. Additionally, at 1-year follow-up, the restricted mean survival time was longer with adjuvant chemotherapy than those without in low-risk patients. However, no significant difference was detected in high-risk patients.Discussion: The prognostic score could accurately predict DFS preoperatively in R-PDAC patients and provide reference for risk-adapted strategies formulation for R-PDAC management in the future.

A practical composite risk score for the development of Haemolytic Uraemic Syndrome from Shiga toxin-producing Escherichia coli

2019 ◽  
Vol 29 (5) ◽  
pp. 861-868 ◽  
Author(s):  
Douglas Hamilton ◽  
John Cullinan
Keyword(s):  
Escherichia Coli ◽  
High Risk ◽  
Risk Score ◽  
Shiga Toxin ◽  
Haemolytic Uraemic Syndrome ◽  
Low Risk ◽  
Medium Risk ◽  
Composite Risk ◽  
Very High ◽  
Estimation Of Risk

Abstract Background Haemolytic Uraemic Syndrome (HUS) is a serious complication of Shiga toxin-producing Escherichia coli (STEC) infection and the key reason why intensive health protection against STEC is required. However, although many potential risk factors have been identified, accurate estimation of risk of HUS from STEC remains challenging. Therefore, we aimed to develop a practical composite score to promptly estimate the risk of developing HUS from STEC. Methods This was a retrospective cohort study where data for all confirmed STEC infections in Ireland during 2013–15 were subjected to statistical analysis with respect to predicting HUS. Multivariable logistic regression was used to develop a composite risk score, segregating risk of HUS into ‘very low risk’ (0–0.4%), ‘low risk’ (0.5–0.9%), ‘medium risk’ (1.0–4.4%), ‘high risk’ (4.5–9.9%) and ‘very high risk’ (10.0% and over). Results There were 1397 STEC notifications with complete information regarding HUS, of whom 5.1% developed HUS. Young age, vomiting, bloody diarrhoea, Shiga toxin 2, infection during April to November, and infection in Eastern and North-Eastern regions of Ireland, were all statistically significant independent predictors of HUS. Demonstration of a risk gradient provided internal validity to the risk score: 0.2% in the cohort with ‘very low risk’ (1/430), 1.1% with ‘low risk’ (2/182), 2.3% with ‘medium risk’ (8/345), 3.1% with ‘high risk’ (3/98) and 22.2% with ‘very high risk’ (43/194) scores, respectively, developed HUS. Conclusion We have developed a composite risk score which may be of practical value, once externally validated, in prompt estimation of risk of HUS from STEC infection.

The Combination of ISS 3, High LDH and t(4;14) and/or Del(17p) Identify a Simple Prognostic Index for Overall Survival in Patients Treated with Novel Agents-Based Induction Therapy and Front-Line Autologous Stem Cell Transplantation, and Allow the Definition of a Subgroup of Patients At High-Risk of Early Death From Progressive Disease

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 598-598 ◽  
Author(s):  
Philippe Moreau ◽  
Lucie Planche ◽  
Michel Attal ◽  
Cyrille Hulin ◽  
Thierry Facon ◽  
...  
Keyword(s):  
High Risk ◽  
Board Of Directors ◽  
Progressive Disease ◽  
Prognostic Index ◽  
Early Death ◽  
Novel Agents ◽  
Advisory Committees ◽  
High Risk Disease ◽  
Definition Of ◽  
Very High

Abstract Abstract 598 Background: Several biological parameters have been described, which define patients with multiple myeloma with a high-risk of progression. Nevertheless, apart from the International Staging System (ISS), no clear, simple and reliable prognostic index has yet been identified, especially for the classification of patients with very high-risk disease. We aimed to characterize the group of patients who have a high risk of early death from progression in the context of frontline therapy using novel agents-based induction therapy and autologous stem cell transplantation. Methods: We investigated prognostic parameters of patients enrolled in the IFM2005-01 trial, which compared bortezomib-dexamethasone versus VAD induction followed by ASCT (Harousseau et al, J Clin Oncol 2010;28:4621–4629). Results: In a multivariate logistic regression analysis, the risk of death from progressive disease (and not toxicity) (42 cases out of 482 patients) within the first 2 years from the start of therapy was related to 3 independent adverse baseline characteristics: high LDH > normal value (p = 0.0014), ISS 3 (p = 0.0097) and cytogenetic abnormalities defined by the presence of either t(4;14) or 17p deletion (p = 0.0002). These 3 variables enabled the definition of a simple scoring system consisting of 4 categories (scores 0–3) that predicts for overall survival (OS). Score 0 was defined by the absence of adverse factors (neither high LDH, nor ISS 3, nor t(4;14) and/or del(17p)); in this group of patients, representing 57% of the overall population, the 4-year OS rate was 84%. A score of 1 was defined by the presence of only 1 adverse factor (either high LDH or ISS 3 or t(4;14) and/or del(17p)). The 4-year OS rate in this group of patients (32% of the overall population) was 73%. A score of 2 defined by the presence of high LDH plus ISS 3 in the absence of t(4;14) and/or del(17p), was found in 6% of the overall population. The 4-year OS rate in this group was 68%. Score 3 was defined by the presence of t(4;14) and/or del(17p) in addition to either ISS 3 or high LDH. In this group of patients, representing 5% of the overall population, the median OS was only 19 months (Figure). Conclusion: We have defined a new and simple scoring system that allows the identification of a small group of patients with very high-risk disease and a shortened survival despite the use of intensive novel agents-based therapy. These preliminary findings require confirmation using data from a large number of patients enrolled in the most recent prospective clinical trials investigating triplet induction regimens prior to ASCT. The subgroup of patients with a score of 3, which is associated with a detrimental outcome, might benefit from innovative therapeutic approaches. Disclosures: Moreau: janssen: Membership on an entity's Board of Directors or advisory committees; millenium: Membership on an entity's Board of Directors or advisory committees; celgene: Membership on an entity's Board of Directors or advisory committees. Attal:janssen: Membership on an entity's Board of Directors or advisory committees; celgene: Membership on an entity's Board of Directors or advisory committees. Hulin:janssen: Membership on an entity's Board of Directors or advisory committees; celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Facon:millenium: Membership on an entity's Board of Directors or advisory committees; janssen: Membership on an entity's Board of Directors or advisory committees; celgene: Membership on an entity's Board of Directors or advisory committees; onyx: Membership on an entity's Board of Directors or advisory committees. Kolb:celgene: Honoraria; janssen: Honoraria. Roussel:janssen: Honoraria; celgene: Honoraria. Leleu:celgene: Honoraria; janssen: Honoraria. Avet-Loiseau:janssen: Membership on an entity's Board of Directors or advisory committees; celgene: Membership on an entity's Board of Directors or advisory committees.

Age Does Not Predict Outcomes For Elderly Patients With Myelodysplastic Syndromes Undergoing Hematopoietic Stem Cell Transplantation With Reduced-Intensity Conditioning

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2147-2147
Author(s):  
Gregory A. Abel ◽  
Haesook T. Kim ◽  
Philippe Armand ◽  
Corey S. Cutler ◽  
Joseph H. Antin ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Hematopoietic Stem Cell Transplantation ◽  
Older Patients ◽  
Prognostic Score ◽  
Reduced Intensity Conditioning ◽  
Hematopoietic Stem ◽  
Gvhd Prophylaxis ◽  
Very High ◽  
Reduced Intensity

Background The National Care Determination for allogeneic hematopoietic stem cell transplantation (allo HSCT) for the treatment of myelodysplastic syndromes (MDS) stated that there is an absence of convincing evidence that allo HSCT improves health outcomes. A prospective data-gathering trial sponsored by the CIBMTR is ongoing; however, until such results are available, retrospective methods specifically comparing older populations are illustrative. Methods We analyzed outcomes for older patients with MDS undergoing HSCT with reduced intensity conditioning (RIC) at the Dana-Farber/BWH with uniform conditioning and graft versus host disease (GVHD) prophylaxis regimens from 2001 to 2011. Patients with CMML were excluded. Those aged 60-65, and those ≥ 66 were compared to assess overall survival (OS), progression free survival (PFS), and other HSCT-related outcomes. Aiming to build a better prognostic score using its significant components, we also assessed the association of the IPSS-R at transplantation as well as each of its components with OS, and fit multivariable Cox regression models with the new prognostic score as well as age. Results We identified 67 patients aged 60 or older who underwent RIC HSCT for MDS. All patients received fludarabine and intravenous busulfan as conditioning, and peripheral blood stem cells. GVHD prophylaxis included tacrolimus/rapamycin +/- MTX. The median age was 64 (60-74) years, and the majority (64%) had unrelated donors. 60% had advanced MDS (IPSS-R high risk or very high risk), 46% had poor risk cytogenetics, and 67% had high or very high disease risk index (DRI). The median age for the 60-65 group was 63; the median age for the ≥ 66 group was 69. We found no significant differences in PFS or OS by age category, as shown below (also see figure): In addition, rates of 6-month grade III-IV GVHD (p=.45) and 2-year incidence of cGVHD (p=0.78) did not significantly differ. The IPSS-R performed only modestly in predicting 4-year OS for this older cohort (p=.20); however, a new 3-level score (including collapsed cytogenetic categories, dichotomous platelet count [ ≥ 50 or < 50], percent blasts in marrow and dichotomous ANC) performed better (p=.008; see figure). In two multivariable models, one that included the IPSS-R and another that included the new score, age was not a significant predictor of OS (p=.78 and .77 respectively). Conclusions Our data suggest that age alone should not limit availability of RIC HSCT for patients with MDS, as older patients in our elderly cohort faired similarly to younger ones with respect to important HSCT-related outcomes. Our new prognostic score, if validated, may be able to help risk-stratify patients. Finally, continued efforts are needed to reduce relapse in high-risk elderly MDS patients. Disclosures: No relevant conflicts of interest to declare.

A Risk Score to Predict CMV Viremia within the First 100 Days after Allogeneic Stem Cell Transplantation Based on Pre-Transplant Parameters

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3877-3877
Author(s):  
Feras Alfraih ◽  
John Kuruvilla ◽  
Naheed Alam ◽  
Anna Lambie ◽  
Vikas Gupta ◽  
...  
Keyword(s):  
Risk Factors ◽  
Stem Cell ◽  
High Risk ◽  
Risk Score ◽  
Risk Group ◽  
Risk Groups ◽  
Low Risk ◽  
Cmv Infection ◽  
Allogeneic Hsct ◽  
Very High

Abstract Introduction: Cytomegalovirus (CMV) is a major infectious complication following allogeneic hematopoietic stem cell transplantation (HSCT). Risk of CMV infection varies between patients and individualized strategies for monitoring and therapy for CMV are needed. In this study, we attempted to establish a clinical score based on patient and transplant characteristics in order to predict the probability for early CMV viremia (CMV-V) within the first 100 days after HSCT. Methods: A total of 548 patients were evaluated after receiving HSCT between 2005 and 2012 at Princess Margaret Cancer Centre. CMV sero-negative recipients with CMV sero-negative donors (R-D-) were excluded. CMV-V was diagnosed in peripheral blood samples obtained on two occasions either by PCR (>200 IU/ml) or antigenemia testing (>2 positive cells/100000). A total of 378 patients were included into the study. Uni- and multivariable analyses were performed to identify risk factors for CMV-V. A weighted score was assigned to each factor based on the odds ratios determined by the multivariable analysis. A total score was calculated for each patient and used for assignment into one of 4 risk categories, the low risk (score 0-1), the intermediate (score 2-3), the high (score 4-5) and the very high (score 6-8). Median age for all patients was 51 years (range 17-71) and 173 (46%) were female. Matched related donors were used for two hundred fifteen patients (57%). Two hundred forty-three patients (64%) were transplanted for myeloid and 108 (29%) for lymphoid malignancies. One hundred thirteen patients (30%) were CMV sero-positive with a negative donor (R+D-) while 191 (51%) were recipient and donor CMV sero-positivity (R+D+). Graft versus host disease (GVHD) prophylaxis included CSA/MMF (n=200, 52%), and CSA/MTX (n=178, 48%). Myeloablative conditioning regimens were administered to 220 patients (58%), 158 patients (42%) were treated with a reduced intensity regimen. Three hundred-thirty seven patients (89%) received peripheral blood stem cells as a stem cell source. In vivo T cell depletion (TCD) with alemtuzumab was used in 138 (37%). Results: CMV-V occurred in 246 (64%) patients by day 100 post HSCT. The impact of patient and HSCT characteristics on the risk of CMV-V was assessed by multivariable analysis. The significant factors were CMV sero-status R+D- and R+D+, TCD, GVHD prophylaxis with MMF administration of myeloablative preparative regimens (Table 1). Table 1. Multivariate analysis for risk factors of CMV infection following allogeneic HSCT Table 1. Multivariate analysis for risk factors of CMV infection following allogeneic HSCT CMV-V rates on the 4 new risk categories amounted to 93% in the very high-risk, 78% in high-risk, 41% in intermediate-risk and 11% in low-risk group (Fig 1). The risk score was also predictive for the occurrence of multiple CMV-V reactivations with rates of 71%, 45%, 19% and 4% for the very high, high, intermediate and low-risk groups, respectively. The overall survival (OS) rate at 2 years was 33%(n=56) in the very high-risk group compared to 50% in other-risk groups (n=147) (P=0.01) (Fig 2). Non-relapse mortality (NRM) was 53% in the very high-risk versus 33% in other-risk groups (P<0.001). However, there was no difference on cumulative incidence of relapse between the groups (P=0.3). The cumulative incidence of grades 1-4 acute GVHD, grades 2-4, grades 3-4 at day 120 and overall chronic GVHD at 2 years was 68%, 47%, 25% and 39% in very high-risk group versus 65%, 52%, 21% and 52% in other-risk groups, suggesting slightly lower incidence of chronic GVHD in very high-risk vs other-risk groups. Conclusion: We present a new clinical scoring system to stratify the risk of early CMV viremia after allogeneic HSCT based on patients and HSCT characteristics. Identifying the risk for each patient would facilitate decision making with respect to strategies including CMV prophylaxis, pre-emptive treatment or inclusion into clinical trials, as well directing the CMV monitoring policy post-transplant. In addition, the risk score was associated with higher risk of overall mortality and NRM in the very high-risk versus other-risk groups. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures No relevant conflicts of interest to declare.

HCT.CI in Autologous Stem Cell Transplantation. Predicting Early and Late Transplant Related Mortality

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3449-3449 ◽  
Author(s):  
Mariano Berro ◽  
Maria M Rivas ◽  
Jorge Alberto Arbelbide ◽  
Ana Lisa Basquiera ◽  
Adriana Vitriu ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Stem Cell ◽  
High Risk ◽  
Hodgkin Lymphoma ◽  
Early Mortality ◽  
Cell Transplant ◽  
End Point ◽  
The Impact ◽  
Autologous Hsct ◽  
Related Mortality

Abstract Background. Hematopoietic Stem Cell Transplant Comorbidity Index (HCT.CI) score, described by Sorror, is a useful tool to assess the risk for Non Relapse Mortality (NRM) after Allogeneic HSCT. The impact of this score in Autologous HSCT is still to be confirmed. Aims. To determine the impact of HCT.Ci score in the morbidity and mortality after autologous HSCT, assessing the 100 day morbidity defined as orothraqueal intubation (OTI), dialysis or shock (defined as vasopressors need), 100 day mortality, early morbi-mortality (combined end-point by any of the previous end-point) and long term NRM. Materials and Methods. We retrospectively reviewed 1478 medical records of adult patients who received an autologous HSCT in our centre between October 2002 and April 2016. Median age was 49 years (range 16-74 years), 58% were male, prevalent diseases were Multiple Myeloma (48%), Non Hodgkin Lymphoma (27%) and Hodgkin Lymphoma (18%), 49% were in complete remission, 46% received one chemotherapy scheme before transplant, 41% two schemes and 12% three or more (heavily pre-treated). In respect to conditionings, melphalan was used in 48% of the cases, CBV in 25%, BEAM in 8% as well as BendaEAM. Seventy five percent received an infusion of stem cells CD34+≥3x10.6/kg. Regarding comorbidities, 58% had low risk (LR) HCT.CI (score 0), 32% intermediate risk (IR) (1-2) and 11% high risk (HR) (≥3). For univariate analysis we use Chi2 for dichotomic variables, Kaplan-Meier for Overall Survival (OS) and cumulative incidence for NRM; for multivariate analysis we used logistic regression for dichotomic and Cox regression for time dependant variables. Results. Median follow up was 1.9 years. Early mortality (day 100) was 2.8%, 5.6% required OTI, 4.8% required vassopresors and 2.2% dialysis, 1-3 years NRM and OS were 4.3-5.2% and 89-77% respectively. High risk HCT.Ci patients had a significant increase in 100 day mortality compared to IR and LR (7% vs.3% vs. 2% respectively, p=0.002), OTI (12% vs. 7% vs. 4%, p<0.001), dialysis (4.5% vs.2.6% vs. 1.5%, p=0.04), shock (10% vs.6.4% vs. 3%, p<0.001), early morbi-mortality (15% vs.9 % vs. 4.6%, p<0.001) and NRM (1-3 years 9.2-13% vs. 3.8-3.8% vs. 3.5-4.5%, p<0.001) (figure 1). After multivariate analysis these outcomes remain significant (showed as OR with 95% CI, IR and HR compared to LR): early mortality (1.8, 0.8-4.2 and 3.9, 1.6-9.7, p=0.003), OTI (2.1, 1.2-3.7, p<0.01 and 3.9, 2.0-7.5, p<0.001), dialysis (2.2, 0.8-5.5 and 4.1, 1.4-11.7, p<0.01), shock (2.7, 1.4-4.9, p=0.001 and 4.4, 2.1-8.9, p<0.001), early morbi-mortality (2.4, 1.4-4.0, p=0.001 and 4.2, 2.3-7.6, p<0.001) and NRM (1.3, 0.7-2.4 and 3.0, 1.5-5.7, p=0.001) (table 1). No significant impact was observed in OS. Other than comorbidities, significant impact was observed in early mortality (pre-transplant status, heavily pre-treated patients and BendaEAM conditioning), OTI (NHL, heavily pre-treated patients, BendaEAM conditioning), dialysis (pre-transplant status and BendaEAM conditioning), shock (NHL, heavily pre-treated patients and BendaEAM conditioning), morbi-mortality (NHL and BendaEAM conditioning) and NRM (male patients, NHL, pre-transplant status, heavily pre-treated patients and BendaEAM conditioning). Conclusions. We observed that HCT.CI had a significant impact on Autologous HSCT treatment related mortality basically due to early toxicity express as 100 day mortality and the three main morbidity outcomes as well as the combined end point. This observation should be confirmed in larger series. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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