Peritoneal Albumin Excretion is a Strong Predictor of Cardiovascular Events in Peritoneal Dialysis Patients: A Prospective Cohort Study

Background Microalbuminuria is a marker of systemic endothelial dysfunction. We hypothesize that peritoneal albumin excretion in peritoneal dialysis (PD) patients, which is conceptually analogous to microalbuminuria in nonuremic patients, can predict cardiovascular disease in new PD patients. Method We studied peritoneal albumin excretion in 43 new PD patients. They were then followed prospectively for the development of cardiovascular events. All-cause mortality and duration of hospitalization for cardiovascular diseases were also recorded. Result The average duration of follow-up was 26.5 ± 17.6 months. During the follow-up period, 15 patients developed cardiovascular events. Event-free survival at 36 months was 81.4% and 53.6% for low (<300 mg/L) and high (≥300 mg/L) peritoneal albumin excretion groups respectively (log rank test, p = 0.042). By Cox regression analysis, the only independent factors for event-free survival were diabetic status and peritoneal albumin excretion rate. For every 100 mg/L increase in peritoneal albumin excretion, the adjusted hazard ratio of developing a cardiovascular event was 1.83 [95% confidence interval (CI) 1.11 – 3.02, p = 0.018]. Actuarial patient survival at 36 months was 85.7% and 59.1% for low and high peritoneal albumin excretion groups respectively (log rank test, p = 0.10). After adjusting for the duration of follow-up for individual patients, the average duration of hospitalization was 9.1 ± 16.2 and 21.7 ± 25.7 days per year of follow-up for low and high peritoneal albumin excretion groups respectively (Mann–Whitney U test, p = 0.012). Conclusion Although the sample size of our present study is small and does not have adequate statistical power, we conclude that peritoneal albumin excretion may be an important predictor of cardiovascular disease. Further studies are needed to examine the role of dialysate albumin excretion as a means of cardiovascular risk stratification in PD patients.

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Timing of Second Autologous Transplantations in Multiple Myeloma: Results of a Multicenter Sequential Randomized Clinical Trial.

Blood ◽

10.1182/blood.v108.11.59.59 ◽

2006 ◽

Vol 108 (11) ◽

pp. 59-59 ◽

Cited By ~ 5

Author(s):

Abderrahman Abdelkefi ◽

Saloua Ladeb ◽

Tarek Ben Othman ◽

Lamia Torjman ◽

Amel Lakhal ◽

...

Keyword(s):

Overall Survival ◽

Randomized Trial ◽

Rank Test ◽

Optimal Timing ◽

High Dose ◽

Consolidation Therapy ◽

Event Free Survival ◽

Free Survival ◽

Log Rank Test

Abstract Background: Autologous stem cell transplantation (ASCT) is now considered standard therapy in young patients (<65 years) with multiple myeloma (MM). The Intergroupe Francophone du Myelome conducted a randomized trial of the treatment of MM with high-dose chemotherapy followed by either one or two successive ASCTs. The probabilities of event-free-survival and overall survival were doubled with a double transplant. However, no randomized trial has compared tandem transplant up-front with a strategy including planned second ASCT at relapse or progression. Therefore, we performed a multicenter, sequential, randomized trial designed to assess the optimal timing of a second ASCT. Methods: From May 2003 to April 2006, 140 patients with symptomatic MM (de novo) and less than 60 years of age, were randomly assigned to receive either tandem transplantation up-front (within 6 months of the first transplantation) [Arm A, n=69] or one ASCT followed by a consolidation therapy with thalidomide (day +90, 100 mg/per day during 5 months) [Arm B, n=71]. Patients included in the arm B received a second transplant in case of disease progression on consolidation therapy, or in case of relapse in responders. Clinical characteristics of each group were similar. In both arms of the study, ASCT was preceded by first-line therapy with thalidomide-dexamethasone and subsequent collection of peripheral blood stem cells with high-dose cyclophosphamide (4 g/m2) and G-CSF. Data were analyzed on an intent-to-treat basis. Results: With a median follow-up of 23 months (range: 6–34), the 2-year overall survival was 55% in the arm A and 75% in the arm B. Survival curves were not different (P=0.28, log-rank test). The 2-year event-free survival was 41% in the arm A and 60% in the arm B (P=0.4, log-rank-test). In the arm B, relapse-free survival of ≥ 16 months following the first transplantation was an important predictor of overall survival (p< 0.001). Conclusion: Data from the present study suggest that up-front single ASCT followed by a consolidation therapy with thalidomide and a second ASCT after relapse or progression is a safe and effective global strategy to treat MM patients. Longer follow-up is needed before definite conclusions can be given concerning the optimal timing of second autologous transplantations in patients with MM.

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Interferon Adjuvant to Radical Nephrectomy in Robson Stages II and III Renal Cell Carcinoma: A Multicentric Randomized Study

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.2.425 ◽

2001 ◽

Vol 19 (2) ◽

pp. 425-431 ◽

Cited By ~ 195

Author(s):

Giorgio Pizzocaro ◽

Luigi Piva ◽

Maria Colavita ◽

Sonia Ferri ◽

Raffaella Artusi ◽

...

Keyword(s):

Renal Cell Carcinoma ◽

Prognostic Factors ◽

Protective Effect ◽

Cell Carcinoma ◽

Renal Cell ◽

Radical Nephrectomy ◽

Rank Test ◽

Event Free Survival ◽

Free Survival ◽

Log Rank Test

PURPOSE: Because interferon gave promising results in the management of metastatic renal cell carcinoma in the 1980s, a multicentric randomized controlled trial was planned to compare adjuvant recombinant interferon alfa-2b (rIFNα2b) with observation after radical nephrectomy in patients with Robson stages II and III renal cell carcinoma. Overall and event-free survival were to be evaluated together with prognostic factors. PATIENTS AND METHODS: Overall and event-free survival curves for 247 patients (124 controls and 123 treated) were estimated by the Kaplan-Meier method and compared using the log-rank test. Cox’s multiple regression models were adopted to perform a joint analysis of treatment and prognostic factors. RESULTS: The 5-year overall and event-free survival probabilities were 0.665 and 0.671, respectively, for controls and 0.660 and 0.567, respectively, for the treated group; the differences were not statistically significant (2P = .861 for overall and 2P = .107 for event-free survival with the log-rank test). Regarding prognostic factors, only grade, pT, and pN demonstrated a significant prognostic role. First-order interactions of treatment with pT and pN category were investigated; a significant interaction was found between pN and treatment. A harmful effect of rIFNα2b in the 97 treated pN0 patients and a protective effect in the 13 treated pN2/pN3 patients were statistically significant. CONCLUSION: Adjuvant rIFNα2b is not indicated after radical nephrectomy for renal cell carcinoma. The protective effect in the small group of pN2/pN3 patients requires further investigation.

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Evaluation of pulse wave velocity for predicting major advanced cardiovascular events in patients with chronic myocardial infarction

European Heart Journal ◽

10.1093/eurheartj/ehab724.2533 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

Z Meiszterics ◽

T Simor ◽

R J Van Der Geest ◽

N Farkas ◽

B Gaszner

Keyword(s):

Myocardial Infarction ◽

Regression Analysis ◽

Cardiovascular Events ◽

Pulse Wave ◽

Cox Regression ◽

Event Free Survival ◽

Free Survival ◽

Cox Regression Analysis ◽

Kaplan Meier

Abstract Introduction Increased aortic pulse wave velocity (PWV) as a strong predictor of major advanced cardiovascular events (MACE) has a prognostic relevance in patients after myocardial infarction (MI). Several non-invasive methods have been proposed for the assessment of arterial stiffness, but the PWV values show significant differences according to the applied techniques. Cardiac magnetic resonance imaging (CMR) provides an accurate method to measure PWV and infarct size in patients after MI. Purpose Calculated PWV values of CMR based phase-contrast (PC) and invasively validated oscillometric methods were compared in this prospective observational study. We aimed to evaluate the cut-off PWV values for each method, while MACE predicted and validated the prognostic value of high PWV in post-infarcted patients in a 6-year follow-up. Methods 3D aortic angiography and PC velocity imaging was performed using a Siemens Avanto 1,5 T CMR device. Oscillometric based Arteriograph (AG) was used to assess PWV using direct body surface distance measurements. The comparison between the two techniques was tested. Patients received follow-up for MACE comprising all-cause death, non-fatal MI, ischemic stroke, hospitalization for heart failure and coronary revascularization. Event-free survival was analysed using Kaplan-Meier plots and log-rank tests. Univariable and multivariable Cox regression analysis was performed to identify outcome predictors. Results 75 patients (56 male, 19 female, average age: 56±13 years) referred for CMR were investigated, of whom 50 had coronary artery disease (CAD) including 35 patients with previous MI developing ischaemic late gadolinium enhancement (LGE) pattern. AG and CMR derived PWV values were significantly correlated (rho: 0,343, p<0,05), however absolute PWV values were significantly higher for AG (median (IQR): 10,4 (9,2–11,9) vs. 6,44 (5,64–7,5); p<0,001). Bland Altman analysis showed an acceptable agreement with a mean difference of 3,7 m/s between the two measures. In patients with CAD significantly (p<0,01) higher PWV values were measured by AG and CMR, respectively. During the median follow-up of 6 years, totally 69 MACE events occurred. Optimized PWV cut-off values for MACE prediction were calculated (CMR: 6,47 m/s; AG: 9,625 m/s) by receiver operating characteristic analysis. Kaplan-Meier analysis in both methods showed a significantly lower event-free survival in case of high PWV (p<0,01, respectively). Cox regression analysis revealed PWV for both methods as a predictor of MACE (PWV CMR hazard ratio (HR): 2,6 (confidence interval (CI) 1,3–5,1), PWV AG HR: 3,1 (CI: 1,3–7,1), p<0,005, respectively). Conclusions Our study showed good agreement between the AG and CMR methods for PWV calculation. Both techniques are feasible for MACE prediction in postinfarcted patients. However, different AG and CMR PWV cut-off values were calculated to improve risk stratification. FUNDunding Acknowledgement Type of funding sources: None. Agreement between the two methods Kaplan-Meier event curves for MACE

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The Impact of Lymphocyte Subset Recovery At 3 Months on Progression-Free Survival After Myeloablative Allogeneic Stem Cell Transplantation,

Blood ◽

10.1182/blood.v118.21.4065.4065 ◽

2011 ◽

Vol 118 (21) ◽

pp. 4065-4065

Author(s):

Junya Kanda ◽

David A. Rizzieri ◽

Gwynn D. Long ◽

Cristina Gasparetto ◽

John P. Chute ◽

...

Keyword(s):

T Cells ◽

T Cell ◽

Complete Remission ◽

Progression Free Survival ◽

Myelogenous Leukemia ◽

Rank Test ◽

Free Survival ◽

Log Rank Test ◽

Standard Risk

Abstract Abstract 4065 Background: Opportunistic infection and disease relapse due to a delayed or impaired cellular immune reconstitution following allogeneic stem cell transplantation (SCT) is associated with significant morbidity and mortality. Various lymphoid subsets have been suggested to play an important role in immune function. However, it remains unknown which of these subsets directly impact survival after SCT. Therefore, we prospectively quantified multiple lymphoid subsets at 3 months following myeloablative allogeneic SCT and evaluated their impact on progression-free survival (PFS). Methods: Quantitative recovery of 13 lymphoid subsets was prospectively characterized in a consecutive cohort of adult patients undergoing T-cell replete myeloablative SCT using peripheral blood stem cells (PBSCs) from a matched sibling donor (MSD) or a matched unrelated donor (MUD), or dual umbilical cord blood (DUCB) grafts. CD3+, CD4+, CD8+, regulatory (Treg) (CD4+, CD25+, CD62L+), cytotoxic (CTL) (CD8+, CD57+, CD28-), and activated T cells (CD8+, HLA-DR+), naïve CD4+ T cells with L-selectin expression (CD4+, CD45RA+/CD45RO-, CD62L+), NK (CD3-, CD16+/CD56+) and NKT cells (CD3+, CD16+/CD56+), B cells (CD19+, CD3-, CD16-, CD56-), plasmacytoid dendritic cells (DCs) (CD123+, CD11c-), and myeloid DCs (CD123-, CD11c+) were analyzed by flow cytometry on fresh peripheral blood. We included 69 patients (MSD, n = 23; MUD, n = 24; DUCB, n = 22) with standard-risk hematologic malignancies who survived at least 3 month (landmark day) following transplantation to evaluate the prognostic impact of lymphoid subset recovery at 3 months on PFS. Standard-risk diseases were defined as acute myelogenous leukemia (AML) in 1st or 2nd complete remission, acute lymphoblastic leukemia (ALL) in 1st or 2nd complete remission, myelodysplastic syndrome (MDS) with blasts <5%, malignant lymphoma (ML) in any complete remission, chronic myelogenous leukemia (CML) in 1st or 2nd chronic phase, and myelofibrosis (MF). PFS was defined as period from the 3 month after transplantation to disease progression or death, whichever occurred first and censored at time of last follow-up. The probability of PFS was estimated according to the Kaplan-Meier method, and groups were compared using the log-rank test. Cox proportional hazards multivariate regression modeling was used to predict PFS. Each lymphocyte subset was dichotomized at the median value and analyzed in a bivariate model adjusted for donor type (MSD/MUD or CBT) as well as in a univariate model in the MSD/MUD group. A parallel analysis was not performed in the CBT group due to few events. Results: Median age (range) of recipients was 40 (19–65) years. Primary diseases were AML (n = 42), ALL (n = 12), MDS (n = 8), CML (n = 4), ML (n = 2), and MF (n = 1). Tacrolimus-based GVHD prophylaxis was used in 83% of recipients. Median follow-up of survivors after transplantation was 21.1 (range, 3.9–53.6) months. PFS rate at 1 year among DUCB, MSD, and MUD recipients was 0.85 (95% confidence interval, 0.61–0.95), 0.64 (0.40–0.80), and 0.73 (0.49–0.86), respectively, without significant difference between the 3 groups (log-rank test, P = 0.164). Patient characteristics were not associated with PFS in the univariate analysis. In the bivariate analysis controlling for donor type, higher numbers of T cells (P = 0.016), Treg (P = 0.015), CTL (P = 0.041), and myeloid DC (P = 0.028) were significantly associated with improved PFS. In the MSD/MUD group, myeloid DC was the only significant variable (hazard ratio 0.25, 95% confidence interval, 0.07–0.89, P = 0.032) (Figure 1). Conclusion: Total T cell, regulatory T cell, cytotoxic T cell and myeloid DC recovery at 3 months post transplant is predictive of PFS. Given the unique properties of the DUCB graft, the predictive potential of lymphocyte subsets on PFS may differ from that of MSD/MUD transplant recipients and a larger cohort of DUCB recipients is needed to perform such an analysis. However, among recipients of MSD/MUD grafts, poor myeloid DC recovery at 3 months following transplantation predicted for worse PFS. These data allow for identification of a population at high risk for poor outcome who may be appropriate targets for intervention to augment post-transplant immune recovery using novel techniques. Disclosures: No relevant conflicts of interest to declare.

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Analysis of p16 gene mutations and deletions in childhood acute lymphoblastic leukemias

Sao Paulo Medical Journal ◽

10.1590/s1516-31802003000200005 ◽

2003 ◽

Vol 121 (2) ◽

pp. 58-62 ◽

Cited By ~ 8

Author(s):

José Alexandre Rodrigues Lemos ◽

Ricardo Defavery ◽

Carlos Alberto Scrideli ◽

Luiz Gonzaga Tone

Keyword(s):

T Cell ◽

Rank Test ◽

Event Free Survival ◽

P16 Gene ◽

Exon 2 ◽

Free Survival ◽

Direct Dna Sequencing ◽

Log Rank Test ◽

Kaplan Meier ◽

Exon 1

CONTEXT: The p16 tumor suppressor gene encodes a cyclin-dependent kinase 4 inhibitor that blocks cell division during the G1 phase of the cell cycle. Alterations in this gene have been reported for various neoplasia types, including acute lymphoblastic leukemias (ALL), especially T-cell acute lymphoblastic leukemias (ALL). OBJECTIVE: To determine probable alterations in the p16 gene in children with acute lymphoblastic leukemias using the polymerase chain reaction (PCR) and direct DNA sequencing and also to analyze event-free survival (EFS). DESIGN: Retrospective study. SETTING: Department of Child Care and Pediatrics, Faculty of Medicine of Ribeirão Preto, Universidade Federal de São Paulo. PARTICIPANTS: Fifty-six children with ALL (mean age 4 years). Forty (71.43%) had B-cell and 12 (21.43%) had T-cell ALL; 4 (7.1%) were biphenotypic. SAMPLE: DNA samples were extracted from bone marrow upon diagnosis and/or relapse. In 2 T-cell cases, DNA from cerebrospinal fluid (CSF) was analyzed. MAIN MEASUREMENTS: Deletions or nucleotide substitutions in exons 1, 2 and 3 of the p16 gene were determined by PCR and nucleotide sequencing. Event-free survival was determined by the Kaplan-Meyer and log-rank test for patients carrying normal and altered p16. RESULTS: Deletions in exon 3 were observed in five cases. Abnormal migration in PCR was observed in seven cases for exon 1, six for exon 2, and five for exon 3. Mutations in exon 1 were confirmed by direct DNA sequencing in four cases and in exon 2 in two cases. The Kaplan-Meyer survival curves and the log-rank test showed no significant differences in 5-year EFS between children with normal or altered p16, or between patients with B-ALL carrying normal or altered p16 gene. Patients with T-ALL could not be evaluated via Kaplan-Meier due to the small number of cases. CONCLUSIONS: Our results, particularly regarding deletion frequency, agree with others suggesting that deletions in the p16 are initial events in leukemia genesis. The small number of samples did not allow stablishment of correlation between childhood ALL and the p16 point mutations found in our study. Kaplan-Meier analysis revealed no significant correlation between EFS and alterations in ALL. The p16 alterations frequency observed for B and T-ALL agreed with reports from other centers.

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Handheld Capillary Blood Lactate Analyzer as an Accessible and Cost-Effective Prognostic Tool for the Assessment of Death and Heart Failure Occurrence during Long-Term Follow-Up

Disease Markers ◽

10.1155/2016/5965782 ◽

2016 ◽

Vol 2016 ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Grzegorz M. Kubiak ◽

Wojciech Jacheć ◽

Celina Wojciechowska ◽

Magdalena Traczewska ◽

Agnieszka Kolaszko ◽

...

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Survival Rate ◽

Capillary Blood ◽

Rank Test ◽

Free Survival ◽

Log Rank Test ◽

Group I ◽

Group Ii

Impact of tissue lactate accumulation on prognosis after acute myocardial infarction (AMI) is biased. The study aimed to assess the prognostic role of lactate concentration (LC) in patients with AMI during one year of follow-up. 145 consecutive patients admitted due to AMI were enrolled. The data on the frequency of endpoint occurrence (defined as I, death; II, heart failure (HF); and III, recurrent myocardial infarction (re-MI)) were collected. The patients were divided into group A (LC below the cut-off value) and group B (LC above the cut-off value) for the endpoints according to receiver operating characteristic (ROC) analysis. The cumulative survival rate was 99% in group I-A and 85% in group I-B (p = 0.0004, log-rank test). The HF-free survival rate was 95% in group II-A and 82% in group II-B (p = 0.0095, log-rank test). The re-MI-free survival rate did not differ between groups. A multivariate Cox analysis showed a statistically significant influence of LC on death [Hazard Ratio (HR): 1.41, 95% Confidence Interval (CI) (1.13–1.76), and p = 0.002] and HF [HR: 1.21, 95% CI (1.05–1.4), and p = 0.007] with no impact on re-MI occurrence. LC in capillary blood may be considered a useful prognostic marker of late-onset heart failure and death after AMI.

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Risk Factor Analysis of Intravesical Recurrence After Laparoscopic Nephroureterectomy for Upper Tract Urothelial Carcinoma

10.21203/rs.3.rs-885355/v1 ◽

2021 ◽

Author(s):

Masato Yanagi ◽

Tsutomu Hamasaki ◽

JunJun Akatsuka ◽

Yuki Endo ◽

Hayato Takeda ◽

...

Keyword(s):

Urothelial Carcinoma ◽

Survival Rates ◽

Urine Cytology ◽

Rank Test ◽

Free Survival ◽

Log Rank Test ◽

Kaplan Meier ◽

Positive Urine ◽

Laparoscopic Nephroureterectomy

Abstract Background: One of the major concerns of patients with upper tract urothelial carcinoma (UTUC) treated with nephroureterectomy is intravesical recurrence (IVR). The purpose of the present study was to investigate the predictive risk factors for IVR after laparoscopic nephroureterectomy (LNU) for UTUC.Methods: Clinicopathological and surgical information were collected from the medical records of 73 patients treated with LNU for non-metastatic UTUC, without a history of or concomitant bladder cancer. The association between IVR after LNU and clinicopathological and surgery-related factors, including preoperative urine cytology and pneumoperitoneum time, was analyzed using Cox proportional hazards regression models and the Kaplan–Meier method with log-rank test.Results: During the median follow-up time of 39.1 months, 18 (24.7%) patients had subsequent IVR after LNU. The 3- and 5-year IVR-free survival rates were 76.5% and 74.3%, respectively. In the multivariate Cox regression analysis, positive preoperative urine cytology (hazard ratio [HR]: 3.55; 95% confidence interval [CI]: 1.326–11.327; p=0.011) and prolonged pneumoperitoneum time of ≥ 210 min (HR: 3.40; 95% CI: 1.271–10.692; p=0.014) were independent prognostic factors for IVR-free survival. In patients with positive urine cytology, the Kaplan–Meier method with log-rank test revealed that the 3-year and 5-years IVR free survival rates were 46.3% and 39.7%, respectively, in patients with a prolonged pneumoperitoneum time of ≥ 210 min, which was significantly lower than that in their counterparts (76% and 76%, respectively, p=0.041).Conclusions: In UTUC patients with positive urine cytology, the occurrence of IVR is highly probable when the pneumoperitoneum time of LNU is prolonged (≥ 210 min). Strict follow-up after LNU is highly recommended for these patients.

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Impact of Thromboembolism on Overall and Event-Free Survival in Children with Acute Lymphoblastic

Blood ◽

10.1182/blood-2020-134853 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 51-52

Author(s):

Marie-Claude Pelland-Marcotte ◽

Ketan Kulkarni ◽

Uma Athale ◽

Jason Pole ◽

Leonardo R. Brandao ◽

...

Keyword(s):

High Risk ◽

Cancer Diagnosis ◽

Risk Group ◽

Low Risk ◽

Rank Test ◽

Event Free Survival ◽

Free Survival ◽

Log Rank Test ◽

Life Threatening ◽

Very High

Introduction: Thromboembolism (TE) is a well-known complication of cancer and its treatments. The impact of TE on survival outcomes remains unclear, especially in children. We assessed whether TE development was associated with overall survival (OS) and event-free survival (EFS) in children with acute lymphoblastic leukemia (ALL). Methods: We performed a population-based retrospective cohort study using the national registry Cancer in Young People Canada (CYP-C). Children 0-<15 years of age diagnosed with ALL (2000-2018) and treated at one of 12 Canadian pediatric centers outside of Ontario were included. OS was defined as the time between the date of cancer diagnosis and death and, EFS, as the time between the date of cancer diagnosis and the date of relapse, subsequent malignancy or death (whichever came first). Patients were categorized as to whether they experienced a radiologically-confirmed TE during treatment graded 3, 4 or 5 as per the Common Terminology Criteria for Adverse Events v.4 (i.e. requiring medical treatment, life-threatening or fatal). Only TEs that occurred before relapse or subsequent malignancy were considered. The Kaplan-Meier survival method estimated the 5-year OS and EFS of children with TE compared to those without TE. Univariate and multivariable Cox regression models were used to estimate the hazard ratio (HR) and 95% confidence interval (CI) of death or an event between groups, adjusted for age, sex, and leukemia risk group. A sub-analysis stratified the analysis by leukemia risk group. Results: The study included 2,208 children (median age: 4 years [interquartile range: 2-7 years], 54.9% male). Precursor B-cell ALL was the most common diagnosis (1,789, 89.1%). Patients were stratified as standard/low risk ALL in 58.0% of cases, and high/very high risk ALL in 42.0%. Of these, 121 (6.0%) developed a TE, at a median time of 100 days (interquartile range: 30-183 days) after cancer diagnosis. Eight patients (0.4%) had a life-threatening or fatal TE. Patients with TE were more likely to be aged 10 years or older, to present with T-cell ALL, and to have high risk leukemia. The 5-year OS (95% CI) of patients with and without TE was 80.2% (72.9-87.5%) and 93.7% (92.5-94.9%) respectively (log-rank test: p<0.001, Figure 1). The adjusted HR (95% CI) of death in children with TE was 2.09 (1.33-3.27, p=0.001). Similarly, as shown in Figure 2, the 5-year EFS (95% CI) of patients with and without TE was 68.7% (59.7-77.7%) and 88.6% (87.1-90.1%), respectively (log-rank test: p<0.001). The adjusted HR (95% CI) of an event was 2.01 (1.39-2.90, p<0.001). When stratified by leukemia risk group, no statistically significant difference was seen in standard/low risk ALL for both OS and EFS but TE was associated with a significantly lower OS and EFS in children with high/very high risk ALL (Table 1). In this group, the increased risk of death was attributable to both deaths following relapsed disease (HR [95% CI]: 2.37 [1.39-4.04]) and death not following relapse (HR [95% CI]: 2.93 [1.35-6.35]). Sensitivity analyses in which 1) patients with very high risk ALL were removed and 2) only grade 3 or 4 TE were considered showed similar results. Conclusions: Clinically relevant TE led to a statistically significant reduction in OS and EFS in children with high risk/very high risk leukemia. Further research is needed to assess whether TE prevention may improve anti-cancer outcomes. Disclosures Brandao: Boehringer Ingelheim: Other: Member of a paediatric expert working group.

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Re-bleeding and its predictors after capsule endoscopy in patients with obscure gastrointestinal bleeding in long-term follow-up

BMC Gastroenterology ◽

10.1186/s12876-019-1137-3 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Panu Wetwittayakhlang ◽

Jirapat Wonglhow ◽

Nisa Netinatsunton ◽

Naichaya Chamroonkul ◽

Teerha Piratvisuth

Keyword(s):

Specific Treatment ◽

Rank Test ◽

Gi Bleeding ◽

Free Survival ◽

Log Rank Test ◽

Negative Study ◽

Long Term Follow Up ◽

Bleeding Episodes

Abstract Background Capsule endoscopy (CE) is the preferred diagnostic test of choice in the investigation of obscure gastrointestinal bleeding (OGIB). Although, a conservative strategy is recommended in the short-term, for cases with a negative result from CE, the impact of CE on long-term re-bleeding still remains unclear. Hence, the aim of this study was to determine the long-term re-bleeding rate along with predictors after CE in patients with OGIB. Methods We retrospectively reviewed 216 patients with OGIB, whom had received a CE examination, so as to investigate the cause of obscure GI bleeding; between July 2008 and March 2018. The patient’s characteristics, medication use, CE finding, treatments strategy, re-bleeding episodes and follow-up information were collected from the institutional electronic medical chart and CE database. Re-bleeding free survival was evaluated using Kaplan-Meier curves with log rank test, whilst predictors associated with the re-bleeding episodes were analyzed via the use of Cox proportional hazard model. Results One hundred and thirty-three patients with OGIB, having received CE were enrolled in the analysis. The pool rate of re-bleeding was 26.3% (35/133) during a follow-up duration of 26 months after CE. Patients with positive CE study, without specific treatment, had higher rates of re-bleeding (47.6%) than those with positive study whom received specific treatment (25.7%), and negative study (20.8%) (p = 0.042). Although, the re-bleeding free survival was not significantly different among the groups (log rank test; P = 0.10). Re-bleeding events occurring within 6, 12, and 24 months after CE were 36, 64 and 92%, respectively. The high-frequency re-bleeding etiologies were the small bowel angiodysplasias and abnormal vascular lesions. Furthermore, independent predictors for re-bleeding after CE were patients with cirrhosis (hazard ratio, HR 4.06), incomplete CE visualization (HR 2.97), and a history of previous GI bleeding (HR 2.80). Conclusions The likelihood of re-bleeding after CE was higher in patients with positive CE study than those with negative study. Specific treatments, or therapeutic interventions for patients with detectable lesions reduced the probability of re-bleeding episodes in long-term follow-up. Close follow-up for recurrent bleeding is recommeded for at least 2 years after CE.

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Robot-assisted minimally invasive thoracolaparoscopic esophagectomy versus open esophagectomy: long-term follow-up of a randomized clinical trial

Diseases of the Esophagus ◽

10.1093/dote/doaa079 ◽

2020 ◽

Vol 33 (Supplement_2) ◽

Author(s):

Eline M de Groot ◽

Sylvia van der Horst ◽

B Feike Kingma ◽

Lucas Goense ◽

Pieter C van der Sluis ◽

...

Keyword(s):

Overall Survival ◽

Disease Free Survival ◽

Rank Test ◽

Robot Assisted ◽

Short Term ◽

Free Survival ◽

Log Rank Test ◽

Disease Free

ABSTRACT Initial results of the ROBOT, which randomized between robot-assisted minimally invasive esophagectomy (RAMIE) and open transthoracic esophagectomy (OTE), showed significantly better short-term postoperative outcomes in favor of RAMIE. However, it is not yet clarified if RAMIE is equivalent to OTE regarding long-term outcomes. The aim of this study was to report the long-term oncological results of the ROBOT trial in terms of survival and disease-free survival. This study is a follow-up study of the ROBOT trial, which was a randomized controlled trial comparing RAMIE to OTE in 112 patients with intrathoracic esophageal cancer. Both the trial protocol and short-term results were previously published. The primary outcome of the current study was 5-year overall survival. Secondary outcomes were disease-free survival and recurrence patterns. Analysis was by intention to treat. During the recruitment period, 109 patients were included in the survival analysis (RAMIE n = 54, OTE n = 55). Majority of patients had clinical stage III or IV (RAMIE 63%, OTE 55%) and received neoadjuvant chemoradiotherapy (80%). Median follow-up was 60 months (range 31–60). The combined 5-year overall survival rates for RAMIE and OTE were 41% (95% CI 27–55) and 40% (95% CI 26–53), respectively (log rank test P = 0.827). The 5-year disease-free survival rate was 42% (95% CI 28–55) in the RAMIE group and 43% (95% CI 29–57) in the OTE group (log rank test P = 0.749). Out of 104 patients, 57 (55%) developed recurrent disease detected at a median of 10 months (range 0–56) after surgery. No statistically difference in recurrence rate nor recurrence pattern was observed between both groups. Overall survival and disease-free survival of RAMIE are comparable to OTE. These results continue to support the use of robotic surgery for esophageal cancer.

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