A New Cytokine-Based Stratification Is Highly Predictive of Survivals in AML Patients

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1412-1412
Author(s):  
Pierre Peterlin ◽  
Joelle Gaschet ◽  
Thierry Guillaume ◽  
Alice Garnier ◽  
Marion Eveillard ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Risk Stratification ◽  
Univariate Analysis ◽  
Standard Of Care ◽  
Healthy Controls ◽  
First Line ◽  
Serum Samples ◽  
Gm Csf ◽  
Significant Difference ◽  
The Impact

Introduction: Recently, a significant impact of the kinetics of Fms-like tyrosine kinase 3 ligand concentration (FLc) during induction (day[D]1 to D22) has been reported on survivals in first-line acute myeloid leukemia (AML) patients (pts) (Peterlin et al, 2019). Three different FLc profiles were disclosed i) sustained increase of FLc (FLI group, good-risk), ii) increase from D1 to D15, then decrease at D22 (FLD group, intermediate-risk) and iii) stagnation of low levels (<1000 pg/mL, FLL group, high-risk). An update of this prospective monocentric study (www.ClinicalTrials.gov NCT02693899) is presented here evaluating also retrospectively the impact on outcomes of 6 other cytokine level profiles during induction. Methods: Between 05/2016 and 01/2018, 62 AML pts at diagnosis (median age 59 yo [29-71], <60 yo n=33) eligible for first intensive induction were included and provided informed consent. They received standard of care first-line chemotherapy. Serum samples collected on D1, 8, 15 & 22 of induction were frozen-stored until performing ELISA for FL, TNFa, SCF, IL-1b, IL-6, IL-10, GM-CSF. Normal values were assessed in 5 healthy controls. Pts outcomes considered were relapse/leukemia-free (LFS) and overall (OS) survivals. Results: FLI, FLD and FLL profiles were observed for 26, 22 and 14 pts respectively. A total of 372 samples were assayed for the 6 other cytokines. Median concentrations at D1, D8, D15, D22 for these 6 cytokines were as follows, considering the whole cohort (and healthy donors): TNFa: 0.53, 0, 0, 0 (0); SCF: 5.91, 0, 0, 0 (3); IL-1b : 0, 0, 0, 0 (0); IL-6: 4.85, 16.28, 10.11, 7.1 (0), IL-10: 0, 0, 0, 0 (0) and GM-CSF:1.63, 1.8, 0.67, 1.34 (9.98). Median IL-6 and GM-CSF levels, compared to healthy controls, were respectively higher and lower during induction. No significant difference was observed in terms of median cytokine concentrations at any time when comparing the three FL sub-groups or FLI vs FLD pts. With a median follow-up of 28 months (range: 17-37), FLI and FLD pts show now similar 2-y LFS (62.9% vs 59%, p=0.63) and OS (69.2% vs 63.6%, p=0.70). FLL pts have a significantly higher rate of relapse (85,7% vs FLI 19,2% vs FLD 32%, p=0,0001). Comparing FLL vs FLI+FLD pts disclosed significantly different LFS (7.1% vs 61.1%, p<0.001) but not OS (36.7% vs 66.6%, p=0.11). In univariate analysis, 2y LFS and OS were not affected by the concentration (< or > median) of the 7 cytokines studied except for LFS and GM-CSFc at D8 (p=0,04) and D15 (p=0,08), for LFS and FLc at D1 (p=0.06), D8 (p=0,03), D15 (p=0,04) and D22 (p=0,03) and for OS and GM-CSF at D15 (p=0.08). A significant association between LFS was observed with ELN 2017 risk stratification (2-y LFS: favorable: 68,1% vs intermediate: 48,1% vs unfavorable: 30,7%, p=0.03) but not OS (2 y: 77% vs 55,5% vs 46,1%, p=0.09). Multivariate analysis showed that no factor was independently associated with OS while LFS remained significantly associated with the FLc profile (FLL vs others, HR: 5.79. 95%CI: 2.48-13.53, p<0.0001) and GM-CSF at D15 (HR: 0.45; 95%CI: 0.20-0.98, p=0.04) but not with ELN 2017 risk stratification (p=0.06). Cytokine levels were then assessed to try to better discriminate FLI and FLD pts. A significant higher IL-6 level at D22 was found in relapsed or deceased FLI/FLD pts (median:15,34 vs 5,42 pg/mL, p=0,04). FLI/FLD pts with low IL-6 at D22 (< median, 15.5 pg/mL, n=35 vs n=14 with high level) had significant better 2y LFS and OS (74,2% vs 38,4%, p=0,005 and 77,1% vs 38,4%, p=0,009, respectively). A new prognostic risk-stratification could thus be proposed, i.e. FLI/FLD with IL-6 <15.5 pg/mL (favorable), FLI/FLD with IL-6 >15.5 pg/mL (intermediate) and FLL (unfavorable). This new classification was considered for a second multivariate analysis, showing that it is the strongest factor associated with OS (p=0.006, ELN p=0.03, FL profile p=0.04) and LFS (p<0.0001, ELN p=0.005, GM-CSFc D15 p=0.03) (figure 1). Conclusion: This study confirms stagnation of low FLc during AML induction as a strong poor prognosis factor. Moreover, IL-6 levels at D22 further discriminate FLI/FLD pts. Thus, a new cytokine-based risk-stratification integrating FL kinetics and IL-6 levels during induction may help to better predict outcomes in first-line AML patients. These results need to be validated on a larger cohort of AML patients while anti-IL-6 therapy should be tested in combination with standard 3+7 chemotherapy. Figure 1 Disclosures Peterlin: AbbVie Inc: Consultancy; Jazz Pharma: Consultancy; Daiichi-Sankyo: Consultancy; Astellas: Consultancy. Moreau:Janssen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Celgene: Consultancy, Honoraria. Chevallier:Jazz Pharmaceuticals: Honoraria; Incyte: Consultancy, Honoraria; Daiichi Sankyo: Honoraria.

Factors Predicting Intentional Non-Adherence In Chronic Myeloid Leukemia: A Multivariate Analysis On 2546 Patients By The CML Advocates Network

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4023-4023 ◽  
Author(s):  
Jan Geissler ◽  
Fabio Efficace ◽  
Felice Bombaci ◽  
Jan de Jong ◽  
Anthony Michael Gavin ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Chronic Myeloid Leukemia ◽  
Board Of Directors ◽  
Myeloid Leukemia ◽  
Univariate Analysis ◽  
Significant Proportion ◽  
First Line ◽  
Advisory Committees ◽  
Significant Difference ◽  
The Impact

Abstract Background Adherence to the prescribed dose of tyrosine kinase inhibitors (TKIs) is critical to maximize treatment effectiveness in chronic myeloid leukemia (CML). While patient-centered outcome studies are lacking in this area, literature has shown that a significant proportion of patients report both intentional and unintentional non-adherence. Objective The main objective of this multivariate analysis was to identify risk factors that might predict intentional non-adherence to TKIs in CML. Methods The CML Advocates Network, connecting 79 CML patient groups from 63 countries, conducted an international project investigating patterns of medication-taking behaviors of CML patients, supported by CML investigator groups in Germany, Italy and France. We sought to demonstrate the relationship between 16 factors and adherence in this multinational cohort. A web-based survey was launched in 12 languages, enrolling CML patients from Sept 2012 to Jan 2013. The identical questionnaire was provided to a cohort of patients recruited in clinics in France, Germany and Italy, returned by patients in a pre-stamped envelope to an independent data center. Questions included potential factors associated with non-adherence as well as on patients' perception of disease and treatment burden. Based on previous literature and on clinical relevance, a pool of 16 candidate factors, potentially predicting intentional non-adherence, was selected for analysis. These included: frequency of CML medication, co-payment for CML treatment, and current TKI therapy. Patients who reported having skipped intentionally one or more doses over the last year were considered as “intentional non-adherers”. Univariate logistic regression analysis was performed to examine the impact of pre-selected candidate factors on the probability of intentional non-adherence. Two multivariate models were fitted based on line of therapy received by patients (i.e. first line and second or greater lines of therapy). Results This patient-led study is the largest study conducted to date on the influencers of non-adherence in CML. Overall, 2546 adult CML patients (47.6% female) under TKI treatment from 79 countries responded to the survey. 2151 patients responded online, 395 questionnaires were returned on paper. No significant difference on intentional non-adherence was observed between paper or online responses. Median age of patients was 51 years (range 18-96) and median time from diagnosis was 4 years (0-27). Overall, 51.6% of all respondents reported having missed at least one dose unintentionally over the last year, and 19.5% did so intentionally. This analysis regards the intentional non-adherent population (n=490). Of those, 60% were on imatinib, 20% on nilotinib, 14% on dasatinib, 6% on other TKIs. Several factors predicted intentional non-adherence in univariate analysis, including education level (P=0.016) and co-payment for TKIs (P=0.005). For patients on first line TKI (n=1551), the following factors independently predicted a higher likelihood of being intentional non-adherers: younger age (P=0.015), longer time since diagnosis (P<0.001), lower satisfaction with information received from healthcare providers (P=0.002), higher burden on social life (P<0.001) and not being fully informed on the importance of adherence (P=0.042). Non-adherence was lower when patients were told every dose was important to make the treatment work (P=0.042). Overall, intentional non-adherers intended to avoid fatigue (13%), diarrhea and GI issues (11%), nausea (10%) and muscle pain (9%). For patients in second or greater lines of therapy (n=985) all of the above factors were still statistically significant except for satisfaction with information received. Being female (P<0.001) also increased the likelihood of intentional non-adherence in this group. Discussion Despite there is clear evidence that survival is close to that of the general population when CML is treated effectively in chronic phase with current therapies, every fifth CML patient deliberately skips doses. Key factors predicting intentional non-adherence can potentially help physicians and patient organisations to identify patients early who should be monitored more closely and informed about the importance of adherence. Managing side effects proactively also reduces reasons for intentional non-adherence. Disclosures: Geissler: Novartis: Membership on an entity’s Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity’s Board of Directors or advisory committees; Pfizer: Membership on an entity’s Board of Directors or advisory committees; Ariad: Membership on an entity’s Board of Directors or advisory committees. Efficace:Novartis: Consultancy; Bristol-Myers Squibb: Consultancy. Bombaci:Ariad: Consultancy; Bristol-Myers Squibb: Consultancy; Novartis: Consultancy. de Jong:Novartis: Membership on an entity’s Board of Directors or advisory committees. Gavin:Celgene: Membership on an entity’s Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity’s Board of Directors or advisory committees; Ariad: Membership on an entity’s Board of Directors or advisory committees; Novartis: Membership on an entity’s Board of Directors or advisory committees. Daban:Ariad: Membership on an entity’s Board of Directors or advisory committees; Pfizer: Membership on an entity’s Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity’s Board of Directors or advisory committees; Novartis: Membership on an entity’s Board of Directors or advisory committees. Pelouchová:Bristol-Myers Squibb: Membership on an entity’s Board of Directors or advisory committees; Ariad: Membership on an entity’s Board of Directors or advisory committees; Novartis: Membership on an entity’s Board of Directors or advisory committees. Sharf:Pfizer: Membership on an entity’s Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity’s Board of Directors or advisory committees; Ariad: Membership on an entity’s Board of Directors or advisory committees; Novartis: Membership on an entity’s Board of Directors or advisory committees.

scholarly journals Immunophenotypic Response After Allografting In Multiple Myeloma

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3371-3371 ◽  
Author(s):  
Luisa Giaccone ◽  
Lucia Brunello ◽  
Roberto Passera ◽  
Moreno Festuccia ◽  
Milena Gilestro ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Bone Marrow ◽  
Flow Cytometry ◽  
Conflicts Of Interest ◽  
Univariate Analysis ◽  
Conditioning Regimen ◽  
First Line ◽  
Significant Difference ◽  
The Impact

Abstract Background Minimal residual disease (MRD) by multiparameter flow-cytometry recently showed a promising role in predicting outcomes in patients with multiple myeloma. However, data on immunophenotypic response (IR) after allografting are lacking. Aim To evaluate the impact of IR and compare it to conventional complete remission (CR) following allografting in myeloma patients. Methods Sixty-six consecutive patients, median age 54 years (35-66), who underwent an allograft between January 2000 and December 2011 with a follow-up of at least 3 months were included. Disease response was evaluated by serum and urine electrophoresis, and bone marrow aspirate at baseline, 3, 6, 12, 18, 24 months after transplant and yearly thereafter. Skeletal survey or MRI were performed yearly or as clinically indicated (overt relapse or complaints of bone pain). Bone marrow aspirates had to contain at least 13000 cells/µL for flow-cytometry studies and IR was defined as absence of monoclonal plasma-cells detected by 4 or 6-colour staining with the following antibodies: CD38, CD138, CD56, CD19, CD45, cyKappa, cyLambda. CR was defined according to standard criteria (Durie et al, Leukemia 2006; 20:1467-73). Results Conditioning regimen was non-myeloablative 2Gy TBI-based in 55 patients, reduced intensity (fludarabine-melphalan-based) in 10 and myeloablative in 1 patient. Post-grafting immunosuppression consisted of cyclosporine with mycophenolate mofetil or methotrexate. Donors were HLA identical siblings in 58 patients and unrelated in 8. Only 1 patient received bone marrow as source of stem cells. Thirty-five/66 (53%) received the allograft as part of the first line treatment, whereas the remaining 31/66, (47%) were transplanted at relapse. At the time of transplant, 5/66 were both in IR and CR, 16 were only in IR and 4 patients were only in clinical CR. All 21 patients in IR at the time of transplant maintained it, while 26/45 (58%) entered IR after the allograft. Among patients surviving at least 3 months, overall treatment related mortality was 10.6% at 3 years. After a median follow-up of 69 months (range 19-147), the incidence of acute and chronic graft-versus-host disease was 45.6% and 49.3% without significant difference between responsive and non-responsive patients. At follow-up, overall, 24 patients achieved CR and IR (CR/IR group), 21 achieved IR but not CR because of persistence of urine/serum M-component (noCR/IR group), and 21 did not achieve either CR or IR (noCR/noIR group). Interestingly, none achieved CR without IR. Median overall survival (OS) and event-free survival (EFS) in patients who achieved IR were 96 and 55 months versus 36 and 7 months in those who did not (p<0.001). Median OS and EFS were not reached and 59 months in the CR/IR group, 77 and 15 months in the noCR/IR, and 30 and 5 months in the noCR/noIR respectively (p<0.001 for both EFS and OS-fig.1). In univariate analysis, being in the CR/IR group was the only significant predictor for prolonged OS and EFS (p<0.001). Of note, cumulative incidence of extra-medullary disease at first relapse after the allograft was 4% in the CR/IR, 32% in the noCR/IR and 15% in the noCR/noIR groups respectively (p<0.001). Receiving the allograft as first line therapy or later during the disease course did not significantly impact on OS and EFS. Conclusion The achievement of IR confers a favorable impact on OS and EFS after allografting. A higher incidence of extra-medullary in the noCR/IR group (some 30% of our patient cohort) may suggest that myeloma cells escape immune control outside the bone marrow. In this group, imaging studies such as positron emission tomography may clinically be indicated during follow-up to detect early relapse. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Tinzaparin Provides Lower Lipid Profiles in Maintenance Hemodialysis Patients: A Cross-Sectional Observational Study

2014 ◽  
Vol 2014 ◽  
pp. 1-9
Author(s):  
Ming-Hsien Tsai ◽  
Yu-Wei Fang ◽  
Jyh-Gang Leu
Keyword(s):  
Multivariate Analysis ◽  
Total Cholesterol ◽  
Univariate Analysis ◽  
Serum Triglyceride ◽  
Hemodialysis Patients ◽  
Chronic Hemodialysis ◽  
Maintenance Hemodialysis ◽  
Diabetic Patients ◽  
Significant Difference ◽  
The Impact

As a low-molecular-weight heparin, tinzaparin has effectively been used as an anticoagulant during hemodialysis sessions. However, the impact of different heparin types on dyslipidemia is still controversial. In our study, 434 chronic hemodialysis patients were evaluated. The mean age was 65 ± 13. Forty-eight patients (11%) and 386 patients (89%) were in the tinzaparin and unfractionated heparin (UFH) groups, respectively. Triglyceride had significant difference between the two groups (P=0.001) but total cholesterol, HDL, or LDL did not. In the univariate analysis, the triglyceride level was significantly associated with tinzaparin use [β: −39.9, 95% confidence interval (CI): −76.7 to −3.0], and this association remained following the multivariate analysis (β: −40.8, 95% CI: −75.1 to −6.5). The difference in serum total cholesterol level between tinzaparin and UFH became significant (β: −13, 95% CI: −24.5 to −1.56) after adjustment in the multivariate analysis. Moreover, in a subgroup analysis, male diabetic patients showed lower serum triglyceride levels with the use of tinzaparin, while older, nondiabetic, male patients showed significant advantages in total cholesterol levels with the use of tinzaparin. Based on our findings, tinzaparin shows a significant association with a lower lipid profile in patients with chronic hemodialysis when compared to UFH.

scholarly journals 922. The Impact of Clinically Significant CMV Infections on Other Viral Infections in the Era of Letermovir Primary Prophylaxis

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S552-S553
Author(s):  
Amy Spallone ◽  
Krithika Srinivasan ◽  
Joseph Sassine ◽  
Terri Lynn Shigle ◽  
Victoria Handy ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Viral Infections ◽  
Univariate Analysis ◽  
Primary Prophylaxis ◽  
Cell Transplant ◽  
Matched Cohort ◽  
Research Support ◽  
Significant Difference ◽  
Clinically Significant ◽  
The Impact

Abstract Background Cytomegalovirus (CMV) is a frequent complication after hematopoietic cell transplant (HCT) and may increase the risk of other viral infections through its immunomodulatory effects. Letermovir, a novel antiviral targeting the viral terminase complex, was approved for primary prophylaxis in CMV-seropositive adult recipients after allogeneic HCT (allo-HCT). Because of its efficacy and safety, letermovir has become the standard of care for primary prophylaxis against CMV during the first 100 days post-transplant. However, its impact on the frequency of other viral infections and non-relapse mortality (NRM), through its reduction in clinically significant CMV infections (CS-CMVi), is not known. Methods This is a single-center, retrospective cohort study of 150 allo-HCT recipients, including controls that were matched by the transplant type (match-unrelated, matched-related, cord, and haploidentical), cared for at our institution between March 2016 and December 2018. Baseline demographics, transplant characteristics, prophylaxis, CMV and other viral infections, and outcomes were collected (Table 1) and analyzed on IBM® SPSS version 26 using a binary logistic regression model for multivariate analysis. For univariate analysis, we used Chi-square and Fischer’s Exact Test. Results In our 2:1 matched cohort analysis, 50 patients received letermovir for primary prophylaxis during the first 100 days post-HCT, and 100 did not. In a univariate analysis with CS-CMVi as the outcome, there was a statistically significant difference in NRM at 24 and 48 weeks. Our data indicated a trend towards a decrease in other viral infections for those without CS-CMVi (Table 2). However, in a multivariate analysis accounting for primary prophylaxis with letermovir as an effect modulator, CS-CMVi did not demonstrate a significant impact on the frequency of other viral infections but was associated with NRM at week 24 and 48 (Table 3). Interestingly, having ALL and donor CMV seropositivity were protective factors against other viral infections (Herpesviridae). Conclusion Our study showed that CS-CMVi is associated with higher 24- and 48-week non-relapse mortality but with no increase in the incidence of other non-respiratory viral infections in this matched cohort of allo-HCT recipients. Disclosures Fareed Khawaja, MBBS, Eurofins Viracor (Research Grant or Support) Ella Ariza Heredia, MD, Merck (Grant/Research Support) Roy F. Chemaly, MD, MPH, FACP, FIDSA, AiCuris (Grant/Research Support)Ansun Biopharma (Consultant, Grant/Research Support)Chimerix (Consultant, Grant/Research Support)Clinigen (Consultant)Genentech (Consultant, Grant/Research Support)Janssen (Consultant, Grant/Research Support)Karius (Grant/Research Support)Merck (Consultant, Grant/Research Support)Molecular Partners (Consultant, Advisor or Review Panel member)Novartis (Grant/Research Support)Oxford Immunotec (Consultant, Grant/Research Support)Partner Therapeutics (Consultant)Pulmotec (Consultant, Grant/Research Support)Shire/Takeda (Consultant, Grant/Research Support)Viracor (Grant/Research Support)Xenex (Grant/Research Support)

Anaemia in patients with transitional cell carcinoma (TCC) of the bladder treated with radiotherapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14569-14569
Author(s):  
C. Joynson ◽  
P. Symonds ◽  
S. Sundar
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Local Recurrence ◽  
Haemoglobin Level ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Transitional Cell ◽  
Prognostic Indicators ◽  
Significant Difference ◽  
The Impact

14569 Background: Treatment of muscle invasive TCC of the bladder with radiotherapy allows organ preservation and is frequently used in the UK especially in patients not medically fit for cystectomy. Anaemia is known to be an indicator of poor response to radiotherapy in head and neck and cervical carcinomas. This study describes the prevalence and type of anaemia in patients with TCC of the bladder and looks at the impact anaemia has on treatment outcome. Methods: Retrospective review of notes was performed on patients treated radically between 1992 and1997. Potential patient, tumour and treatment prognostic indicators were reported. Patients were labelled as being anaemic if their pre treatment haemoglobin level was below the normal range (below 13.5g/dl for men and below 11.5g/dl for women). Time to local recurrence, metastases and overall survival was recorded. Recurrence free survival and overall survival actuarial estimations were done using the Kaplan Meier method and compared by log rank testing. Multivariate analysis was carried out using Cox Regression method, correcting for potential confounding factors. Results: Data on 100 patients were available for analysis. 52 patients were anaemic with 75% of these having a normochromic, normocytic anaemia. Univariate analysis showed no significant difference in time to local recurrence, a trend to shorter time to metastases, and a significant reduction in overall survival in anaemic patients (p = 0.04). Two year survival was 43% and 22% for non anaemic and anaemic patients respectively. Multivariate analysis using covariates tumour stage, grade, and serum creatinine found anaemia to be poor prognostic indicator for overall survival (p = 0.005) and time to metastases (p = 0.003). Conclusions: Anaemia is highly prevalent in patients with bladder cancer. This retrospective study shows anaemic patients to have a worse outcome with radiotherapy treatment than patients with a normal haemoglobin level. This is not accounted for by a difference in local control which may be expected from hypoxic radiobiological principles. Anaemia may be indicative of more aggressive malignancy or sub clinical metastases. No significant financial relationships to disclose.

Observational cohort study of first-line bevacizumab with oxaliplatin or irinotecan and fluoropyrimidines in metastatic colorectal cancer: HGCSG0802—Analysis of early tumor shrinkage (ETS).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 753-753 ◽  
Author(s):  
Satoshi Yuki ◽  
Hiroshi Nakatsumi ◽  
Kentaro Sawada ◽  
Takashi Kato ◽  
Takashi Meguro ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Multivariate Analysis ◽  
Metastatic Colorectal Cancer ◽  
Univariate Analysis ◽  
First Line ◽  
Factors Associated ◽  
Early Tumor Shrinkage ◽  
Significant Difference ◽  
Early Tumor ◽  
Line Chemotherapy

753 Background: It was reported that early tumor shrinkage (ETS) was associated with better overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC) receiving first line chemotherapy. We investigated association of ETS with progression-free survival (PFS) and OS in pts with mCRC treated with first-line bevacizumab (BV)-based chemotherapy (HGCSG0802). Methods: The objective of HGCSG0802 was to evaluate PFS, OS, response rate (RR), safety and so on. The key eligibility criteria were evaluable lesions, older than 20 years old, ECOG PS 0-2. This analysis evaluated the association of ETS at 8 weeks from the start of chemotherapy with pts characteristics, PFS and OS. To identify factors associated with ETS, if there were clinical variables with p < 0.2 in univariate analysis, we planned a multivariate analysis using the logistic regression model. To identify predictive and prognostic factors, a multivariate analysis was performed using Cox proportional hazard model with backward elimination for variables with p < 0.2 in univariate analysis. Results: Of 108 pts (the full analysis set), 99 pts were evaluable for ETS. Sixty-eight pts (68.7%) had ETS ≥20%. The pts characteristics between ETS ≥20% (ETS) and <20% (Non-ETS) were well balanced. In univariate analysis to identify factors associated with ETS, there were no clinical variables with p < 0.2. The median PFS and OS were 7.3/18.3 months in Non-ETS versus 10.0/25.2 months in ETS (HR 0.529; p=0.006 and HR 0.627; p=0.107). In multivariate analysis for PFS and OS, although there was no significant difference between ETS and Non-ETS for OS (HR 0.709; p=0.186), there was significant difference for PFS (HR 0.524; p=0.006). Conclusions: ETS was observed in 68.7% (68/99) and non-ETS in 31.3% (31/99) of patients with metastatic colorectal cancer received bevacizumab combined first line chemotherapy. In univariate analysis, it could not identify any factors associated with ETS. In the results of multivariate analysis, ETS showed an independent predictive impact, but not prognostic impact. Clinical trial information: UMIN000018935.

scholarly journals A Survey of Marine Coastal Litters around Zhoushan Island, China and Their Impacts

2021 ◽  
Vol 9 (2) ◽  
pp. 183
Author(s):  
Xuehua Ma ◽  
Yi Zhou ◽  
Luyi Yang ◽  
Jianfeng Tong
Keyword(s):  
Rapid Development ◽  
Univariate Analysis ◽  
Local Environment ◽  
Marine Litter ◽  
Social Ecological ◽  
The Social ◽  
Significant Difference ◽  
Valuable Method ◽  
Beach Litter ◽  
The Impact

Rapid development of the economy increased marine litter around Zhoushan Island. Social-ecological scenario studies can help to develop strategies to adapt to such change. To investigate the present situation of marine litter pollution, a stratified random sampling (StRS) method was applied to survey the distribution of marine coastal litters around Zhoushan Island. A univariate analysis of variance was conducted to access the amount of litter in different landforms that include mudflats, artificial and rocky beaches. In addition, two questionnaires were designed for local fishermen and tourists to provide social scenarios. The results showed that the distribution of litter in different landforms was significantly different, while the distribution of litter in different sampling points had no significant difference. The StRS survey showed to be a valuable method for giving a relative overview of beach litter around Zhoushan Island with less effort in a future survey. The questionnaire feedbacks helped to understand the source of marine litter and showed the impact on the local environment and economy. Based on the social-ecological scenarios, governance recommendations were provided in this paper.

scholarly journals POS1189 THE IMPACT OF TELEMEDICINE AND COVID-19 ON A TERTIARY RHEUMATOLOGY SERVICE: A RETROSPECTIVE AUDIT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 876-877
Author(s):  
W. Zhu ◽  
T. De Silva ◽  
L. Eades ◽  
S. Morton ◽  
S. Ayoub ◽  
...  
Keyword(s):  
Immunosuppressive Therapy ◽  
Univariate Analysis ◽  
Diagnostic Delay ◽  
Cohort Differences ◽  
Phone Calls ◽  
Retrospective Audit ◽  
Common Diagnosis ◽  
Significant Difference ◽  
The Impact

Background:Telemedicine was widely utilised to complement face-to-face (F2F) care in 2020 during the COVID-19 pandemic, but the impact of this on patient care is poorly understood.Objectives:To investigate the impact of telemedicine during COVID-19 on outpatient rheumatology services.Methods:We retrospectively audited patient electronic medical records from rheumatology outpatient clinics in an urban tertiary rheumatology centre between April-May 2020 (telemedicine cohort) and April-May 2019 (comparator cohort). Differences in age, sex, primary diagnosis, medications, and proportion of new/review appointments were assessed using Mann-Whitney U and Chi-square tests. Univariate analysis was used to estimate associations between telemedicine usage and the ability to assign a diagnosis in patients without a prior rheumatological diagnosis, the frequency of changes to immunosuppression, subsequent F2F review, planned admissions or procedures, follow-up phone calls, and time to next appointment.Results:3,040 outpatient appointments were audited: 1,443 from 2019 and 1,597 from 2020. There was no statistically significant difference in the age, sex, proportion of new/review appointments, or frequency of immunosuppression use between the cohorts. Inflammatory arthritis (IA) was a more common diagnosis in the 2020 cohort (35.1% vs 31%, p=0.024). 96.7% (n=1,444) of patients seen in the 2020 cohort were reviewed via telemedicine. In patients without an existing rheumatological diagnosis, the odds of making a diagnosis at the appointment were significantly lower in 2020 (28.6% vs 57.4%; OR 0.30 [95% CI 0.16-0.53]; p<0.001). Clinicians were also less likely to change immunosuppressive therapy in 2020 (22.6% vs 27.4%; OR 0.78 [95% CI 0.65-0.92]; p=0.004). This was mostly driven by less de-escalation in therapy (10% vs 12.6%; OR 0.75 [95% CI 0.59-0.95]; p=0.019) as there was no statistically significant difference in the escalation or switching of immunosuppressive therapies. There was no significant difference in frequency of follow-up phone calls, however, patients seen in 2020 required earlier follow-up appointments (p<0.001). There was also no difference in unplanned rheumatological presentations but significantly fewer planned admissions and procedures in 2020 (1% vs 2.6%, p=0.002). Appointment non-attendance reduced in 2020 to 6.5% from 10.9% in 2019 (OR 0.57 [95% CI 0.44-0.74]; p<0.001), however the odds of discharging a patient from care were significantly lower in 2020 (3.9% vs 6%; OR 0.64 [95% CI 0.46-0.89]; p=0.008), although there was no significance when patients who failed to attend were excluded. Amongst patients seen via telemedicine in 2020, a subsequent F2F appointment was required in 9.4%. The predictors of needing a F2F review were being a new patient (OR 6.28 [95% CI 4.10-9.64]; p<0.001), not having a prior rheumatological diagnosis (OR 18.43 [95% CI: 2.35-144.63]; p=0.006), or having a diagnosis of IA (OR 2.85 [95% CI: 1.40-5.80]; p=0.004) or connective tissue disease (OR 3.22 [95% CI: 1.11-9.32]; p=0.031).Conclusion:Most patients in the 2020 cohort were seen via telemedicine. Telemedicine use during the COVID-19 pandemic was associated with reduced clinic non-attendance, but with diagnostic delay, reduced likelihood of changing existing immunosuppressive therapy, earlier requirement for review, and lower likelihood of discharge. While the effects of telemedicine cannot be differentiated from changes in practice related to other aspects of the pandemic, they suggest that telemedicine may have a negative impact on the timeliness of management of rheumatology patients.Disclosure of Interests:None declared.

scholarly journals Absence of Association between Preoperative Estimated Glomerular Filtration Rates and Postoperative Outcomes following Elective Gastrointestinal Surgeries: A Prospective Cohort Study

2018 ◽  
Vol 2018 ◽  
pp. 1-7
Author(s):  
Sivesh K. Kamarajah ◽  
Behrad Barmayehvar ◽  
Mustafa Sowida ◽  
Amirul Adlan ◽  
Christina Reihill ◽  
...  
Keyword(s):  
Risk Stratification ◽  
Glomerular Filtration ◽  
Elective Surgery ◽  
Gastrointestinal Surgery ◽  
Major Complication ◽  
Postoperative Outcomes ◽  
Queen Elizabeth Hospital ◽  
Complication Rates ◽  
Significant Difference ◽  
The Impact

Background. Preoperative risk stratification and optimising care of patients undergoing elective surgery are important to reduce the risk of postoperative outcomes. Renal dysfunction is becoming increasingly prevalent, but its impact on patients undergoing elective gastrointestinal surgery is unknown although much evidence is available for cardiac surgery. This study aimed to investigate the impact of preoperative estimated glomerular filtration rate (eGFR) and postoperative outcomes in patients undergoing elective gastrointestinal surgeries. Methods. This prospective study included consecutive adult patients undergoing elective gastrointestinal surgeries attending preassessment screening (PAS) clinics at the Queen Elizabeth Hospital Birmingham (QEHB) between July and August 2016. Primary outcome measure was 30-day overall complication rates and secondary outcomes were grade of complications, 30-day readmission rates, and postoperative care setting. Results. This study included 370 patients, of which 11% (41/370) had eGFR of <60 ml/min/1.73 m2. Patients with eGFR < 60 ml/min/1.73 m2 were more likely to have ASA grade 3/4 (p<0.001) and >2 comorbidities (p<0.001). Overall complication rates were 15% (54/370), with no significant difference in overall (p=0.644) and major complication rates (p=0.831) between both groups. In adjusted models, only surgery grade was predictive of overall complications. Preoperative eGFR did not impact on overall complications (HR: 0.89, 95% CI: 0.45–1.54; p=0.2). Conclusions. Preoperative eGFR does not appear to impact on postoperative complications in patients undergoing elective gastrointestinal surgeries, even when stratified by surgery grade. These findings will help preassessment clinics in risk stratification and optimisation of perioperative care of patients.

scholarly journals Percutaneous ultrasound guided radiofrequency and microwave ablation in the treatment of hepatic metastases. A monocentric initial experience.

2019 ◽  
Vol 21 (3) ◽  
pp. 217 ◽  
Author(s):  
Zeno Sparchez ◽  
Tudor Mocan ◽  
Nadim All Hajjar ◽  
Adrian Bartos ◽  
Claudia Hagiu ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Microwave Ablation ◽  
Univariate Analysis ◽  
Hepatic Metastases ◽  
Tumor Ablation ◽  
Tumor Control ◽  
Local Tumor ◽  
Long Term Outcome ◽  
Significant Difference ◽  
Multiple Metastases

Aim: Percutaneous radiofrequency (RFA) and microwave ablation (MWA) are currently the best treatment options forpatients with liver metastases (LM) who cannot undergo a liver resection procedure. Presently, few studies have evaluated theefficacy of tumor ablation in beginner’s hands but none at all in hepatic metastasis. Our aim was to report the initial experiencewith ultrasound as a tool to guide tumor ablation in a low volume center with no experience in tumor ablation.Material and methods: We conducted a retrospective cohort study, on a series of 61 patients who had undergone percutaneous US-guided ablations for 82 LM between 2010 and 2015. Long term outcome predictors were assessed using univariate and multivariate analysis.Results: Complete ablation was achieved in 86.9% of cases (53/61). All MWA sessions (20/20) attained ablation margins >5mm, compared to 79% (49/62) for RFA sessions (p=0.031). Ablation time was significantly shorter for MWA, with a median duration of 10 minutes (range: 6-12) vs. 14 minutes (range: 10-19.5, p=0.003). There was no statistically significant difference in local tumor progression (LTP)-free survival rates between MWA and RFA (p=0.154). On univariate analysis, significant predictors for local recurrence were multiple metastases (p=0.013) and ablation margins <5 mm (p<.001), both retaining significance on multivariate analysis. Significant predictors for distant recurrence on both univariate and multivariate analysis were multiple metastases (p<0.001) and non-colorectal cancer metastases (p<0.05).Conclusion: A larger than 5 mm ablation size is critical for local tumor control. We favor the use of MWA due to its ability to achieve ablation in significantlyshorter times with less incomplete ablations.

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