A single-center retrospective review of outcomes associated with sunitinib alternative schedule compared to traditional schedule.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 381-381 ◽  
Author(s):  
Bradley J. Atkinson ◽  
Sarathi Kalra ◽  
Xuemei Wang ◽  
Nizar M. Tannir ◽  
Eric Jonasch

381 Background: Sunitinib is a front-line therapy for metastatic renal cell cancer (mRCC). Recommended dose is 50 mg daily; 28 days (d) on/14 d off (traditional schedule; TS). Sunitinib is associated with several adverse events (AEs). An ideal treatment modification algorithm is not known. We sought to identify (1) common AEs, (2) alternative schedules (AS) that maintained dose intensity while decreasing AEs, and (3) the impact of AS on outcomes. Methods: Single-center retrospective review of mRCC pts performed from January 26, 2006 to March 1, 2011. Pts > 18 years of age with mRCC who received first-line antiangiogenic therapy with sunitinib were eligible. A subset of pts were switched at first intolerable AE from TS to a 14 d/7 d, or further adjusted to 7 d /3 d, or other AS. Control group underwent standard dose reduction. Pt characteristics including demographics, disease status, laboratory data, AEs, AS, and treatment outcomes were analyzed. Results: 186 eligible pts were identified. At baseline, 87% received sunitinib 50 mg and 88% were on TS. 99 pts (53%) continued TS and 87 pts (47%) were switched to AS. Baseline characteristics were similar. Median age was 61 yrs; by MSKCC criteria 5% were good, 50% intermediate, and 45% poor prognosis. Pts had median 2 visceral mets and 42% had primary tumor in place. AEs included fatigue (47%), diarrhea (24%), and hand-foot syndrome (26%). Median time to AS was 126 d with 14 d/7 d the most common (82%). Median time on treatment was 14.9 months (mo) (95% CI:10.2 – 17.0 mo) in AS pts vs. 4.2 mo (95% CI: 3.6 – 5.7 mo), respectively (p < 0.0001). Median OS was 32.9 mo (95% CI:28.3-54.1 mo) vs. 18.5 mo (95% CI: 10.3-21.5 mo), respectively (p = 0.0001). ECOG PS > 2 (HR 3.9), elevated LDH (HR 2.04), and > 2 mets (HR 1.79) were associated with decreased OS. MSKCC intermediate vs. poor (HR 0.57) and AS (HR 0.54) were associated with improved OS by multivariate regression analysis (p < 0.05). Conclusions: In our cohort study, AS sunitinib significantly prolonged outcomes and was predictive of OS. Prospective investigations of alternate dosing schemas are warranted.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15611-e15611
Author(s):  
Bradley J. Atkinson ◽  
Sarathi Kalra ◽  
Xuemei Wang ◽  
Tharakeswara Bathala ◽  
John Perpich ◽  
...  

e15611 Background: Sunitinib is a front-line therapy for metastatic renal cell cancer (mRCC). Recommended dose is 50 mg daily; 28 days (d) on/14 d off (traditional schedule; TS). Sunitinib is associated with several adverse events (AEs). An ideal treatment modification algorithm is not known. We sought to identify 1) common AEs, 2) alternative schedules (AS) that maintained dose intensity while decreasing AEs, and 3) the impact of AS on outcomes. Methods: Single-center retrospective review of mRCC pts performed from 1/26/06 to 3/1/11. Pts > 18 years of age with mRCC who received first-line antiangiogenic therapy with sunitinib were eligible. A subset of pts were switched at first intolerable AE from TS to a 14 d/7 d, or further adjusted to 7 d /3 d, or other AS. Control group underwent standard dose reduction. Pt characteristics including demographics, disease status, laboratory data, AEs, AS, and treatment outcomes were analyzed. Results: 186 eligible pts were identified. At baseline, 87% received sunitinib 50 mg and 88% were on TS. 99 pts (53%) continued TS and 87 pts (47%) were switched to AS. Baseline characteristics were similar. Median age was 61 yrs; by MSKCC criteria 5% were good, 50% intermediate, and 45% poor prognosis. Pts had median 2 visceral mets and 42% had primary tumor in place. AEs included fatigue (47%), diarrhea (24%), and hand-foot syndrome (26%). Median time to AS was 126 d with 14 d/7 d the most common (82%). Median time on treatment was 14.9 months (mo) (95% CI:10.2 – 17.0 mo) in AS pts vs 4.2 mo (95% CI: 3.6 – 5.7 mo), respectively (p < 0.0001). Median OS was 32.9 mo (95% CI:28.3-54.1 mo) vs 18.5 mo (95% CI: 10.3-21.5 mo), respectively (p = 0.0001). ECOG PS > 2 (HR 3.9), elevated LDH (HR 2.04), and > 2 mets (HR 1.79) were associated with decreased OS. MSKCC intermediate vs poor (HR 0.57) and AS (HR 0.54) were associated with improved OS by multivariate regression analysis (p < 0.05). Conclusions: In our cohort study, AS sunitinib significantly prolonged time on treatment and was predictive of OS. Prospective investigations of alternate dosing schemas are warranted.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.A.B Boros ◽  
V.S.C Bellini ◽  
D Fatori ◽  
C Bernoche ◽  
M.F Macatrao-Costa ◽  
...  

Abstract Background The role of intra-aortic balloon pump (IABP) in advanced heart failure (HF) treatment is still under debate. Some heart transplant (HTx) candidates on the waiting list require mechanical support, and IABP may be the simple and most available device. Purpose Describe the impact of IABP treatment in advanced HF patients who underwent HTx. Methods We retrospectively analysis patients who underwent HTx from a single center intensive care unit (ICU), between 2009 and 2018, to evaluate the use of IABP as bridge therapy. Selection included decompensated chronic HF patients that required intensive care with optimized intravenous drugs before IABP placement. Exclusion criteria were acute myocardial infarction or cardiac surgery 90 days prior to admission, and implant of ventricular assist device before HTx. Results We included 134 HF patients with IABP therapy before HTx. Insertion site was exclusively femoral. Mean time of IABP onset to HTx were 26±21 days, and hospital admission to HTx 65±45 days. The main cardiomyopathy etiology was Chagas Disease (46%) and mean LVEF was 23±6% (TABLE 1). Clinical and laboratory data were compared before and 96 hours after IABP therapy. Mean central venous oxygen saturation (SvO2) increased from 49.7±14.6% to 67.4±11.3% (p&lt;0.001), creatinine decreased from 1.77±0.9 mg/dL to 1.40±0.6 mg/dL (p&lt;0.001), and urine output increased from 1552±886 mL/24h to 2189±1029 mL/24h (p&lt;0.001). These differences were sustained or improved until the day before HTx (FIGURE 1). After 96 hours dobutamine was maintained in 98% of patients, nitroprusside increased from 56% to 67%, milrinone decreased from 26% to 20%, and norepinephrine decreased from 18% to 3%. Significant IABP complications were few (5.2%; n=7: 3 infections, 2 major bleeding, 2 arterial injury). Conclusion In this single center ICU sample, IABP improved hemodynamic status and renal function in refractory HF patients waiting for HTx. IABP can be a reasonable, available and effective bridging therapy. Figure 1 Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Marina Reis ◽  
Catarina Ribeiro ◽  
Ana Marta Gomes ◽  
Clara Santos ◽  
Daniela Lopes ◽  
...  

Peritonitis is a major peritoneal dialysis complication. Despite a high cure rate, relapsing and repeat peritonitis is associated with Tenckhoff catheter biofilm and multiple episodes of peritoneal damage. In relapsing peritonitis, prompt catheter removal is mandatory; otherwise, in repeat peritonitis, there is not a clear indication for catheter removal. It is questionable if the approach to removal should be different. There are few recent data on repeat and relapsing peritonitis microbiology and clinical outcomes since most studies are from the past decade. This study evaluates the microbiology, clinical outcomes, and impact of relapsing and repeat peritonitis on technique survival and the impact of catheter removal in development of further peritonitis episodes by the same microorganism. We developed a single-center retrospective study from 1998 to 2019 that compared repeat and relapsing peritonitis with a control group in terms of causative microorganisms, cure rate, catheter removal, and permanent and temporary transfer to hemodialysis. We also compared repeat and relapsing peritonitis clinical outcomes when Tenckhoff catheter was not removed. Comparing to the control group, the repeat/relapsing group had a higher cure rate (80.4% versus 74.5%, p = 0.01 ) and lower rate of hospitalization (10.9% versus 27.7%, p = 0.01 ). Technique survival was superior in the repeat/relapsing group (log rank = 4.5, p = 0.03 ). Gram-positive peritonitis was more common in the repeat/relapsing group especially Streptococci viridans (43.5% versus 21.3%, p = 0.01 ) and Gram-negatives in the control group (26.6% vs 9.0%, p = 0.02 ). When the Tenckhoff catheter was not removed after a repeat episode, 58.6% developed a new repeat/relapsing episode versus 60.0% in the relapsing group. Although repeat and relapsing peritonitis have a higher cure rate, it leads to further episodes of peritonitis and consequent morbidity. When Tenckhoff catheter was not removed, the probability of another peritonitis episode by the same microorganism is similar in repeat and relapsing peritonitis.


2021 ◽  
Author(s):  
Meng-Meng An ◽  
Chenxi Liu ◽  
Yi Jiang ◽  
Bei-Bei Jin ◽  
Da Cao ◽  
...  

Abstract Background: Iron metabolism disorder is commonly seen in patients with sepsis. This study aimed to evaluate whether continuous veno-venous hemofiltration (CVVH) improved the iron metabolism disorders in sepsis. Methods: In a single-center, retrospective cohort study, totally 89 sepsis patients were prospectively enrolled and divided into the CVVH group (n=39) and the control group (n=50). Clinical and laboratory data were collected and compared between the groups on days 1, 3 and 7 of ICU admission. Plasma interleukin (IL)-6, hepcidin, erythropoietin (EPO), ferritin and soluble transferrin receptor (sTfR) were determined by enzyme linked immunosorbent assay (ELISA). Sequential organ failure scores (SOFA) on days 1 and 7, and 28-day survival between groups were compared. Results: Plasma IL-6, hepcidin, ferritin and RDW on days 3 and 7 were significantly reduced in the CVVH group compared with those in the control group (all P<0.05). The CVVH group had a significantly lower SOFA score on day 7 compared with the control group (P<0.05). Hemoglobin and EPO were gradually decreased within the first week of ICU admission in both groups although no significant differences between the groups were observed. There was no significant difference in sTfR between the two groups along with the time (all P > 0.05). In addition, there were no significant differences in 28-day survival rate and median survival time between the two groups. Conclusions: CVVH improves iron metabolism disorders and the disease severity in sepsis. However, it does not alleviate anemia and fails to improve the survival.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 332-332 ◽  
Author(s):  
D. H. Cauley ◽  
B. J. Atkinson ◽  
P. G. Corn ◽  
E. Jonasch ◽  
N. M. Tannir

332 Background: Pneumonitis is a known adverse effect (AE) of mammalian target of rapamycin-inhibitors, with a literature reported incidence for everolimus ranging from 4 to 45%. The goal of this review was to characterize the incidence, timing, management, and outcomes related to everolimus-associated pneumonitis (EAP). Methods: Retrospective review of 86 mRCC patients (pts) with complete, evaluable records, given everolimus (E) between 4/2009 and 3/2010. We assessed baseline patient (pt) characteristics, previous therapies, time on E therapy, pt symptoms, physician management of AE, NCI-CTC pneumonitis grading, and survival outcomes. Radiologic CT indicated ground glass, inflammatory, and/or parenchymal opacities. Results: (See table.) EAP occurred in 28% of pts on E therapy, confirmed radiologically. 8% of EAP patients reported no symptoms. In EAP pts, 58% reported cough, 75% dyspnea and/or SOB, 17% fever, 71% fatigue. The median number of symptoms/patient was 3. 46% of pts received steroids (median 21 days (3-120)), 38% received antibiotics, 25% received pulmonary consultation, and 8% required oxygen. In pts who developed EAP, providers discontinued E in 75%, held and dose reduced E in 8%, and continued E in 17%. The median NCI-CTC pneumonitis grade was 2 (1-3); there were no treatment-related deaths. The median time to EAP onset was 67 days (8-442). There was no statistically significant difference in outcomes between EAP pts and non-EAP pts. Conclusions: EAP occurs often in mRCC pts treated with E. It is an important AE that can negatively affect pt symptoms, but did not adversely impact pt outcomes in our single-center experience. [Table: see text] [Table: see text]


2020 ◽  
Vol 30 (10) ◽  
pp. 3753-3760
Author(s):  
Hannes Beiglböck ◽  
Alexander Kautzky ◽  
Paul Fellinger ◽  
Tamara Ranzenberger-Haider ◽  
Bianca Itariu ◽  
...  

Abstract Context A substantial number of patients undergoing bariatric surgery are prescribed psychopharmacological medication. However, the impact of concomitant psychopharmacological medication on the frequency of relevant vitamin deficiencies in postoperative follow-up is not known. Methods Five hundred twenty-four patients with obesity who underwent bariatric surgery (January 2004 to September 2018) with follow-up of at least 12 months, were included in retrospective analysis. Postoperative follow-up visits between January 2015 and September 2019 were analyzed. Anthropometric and laboratory data were analyzed at the first documented follow-up visit after on average 39.5 ± 37.3 months and at every following visit during the observation period. Patients with prescribed psychopharmacological drugs (PD) were compared with patients without (control group, CON). Results Psychopharmacological medication was documented in 25% (132) of patients. In 59 patients documented prescription of more than one psychiatric drug was found, whereas psychopharmacological monotherapy was found in 73 patients. Frequencies of vitamin deficiencies were comparable between PD and CON (vitamin A: p = 0.852; vitamin D: p = 0.622; vitamin E: p = 0.901; folic acid: p = 0.941). Prevalence of vitamin B12 deficiency was rare (6% CON, 1% PD) but was significantly higher in CON (p = 0.023). A comparison of CON and POLY also showed no significant differences between the groups concerning prevalence of vitamin deficiencies. Conclusions Intake of psychopharmacological medication is highly prevalent in patients after bariatric surgery. Patients with psychopharmacological medication, who participate in structured follow-up care after bariatric surgery, are not at higher risk for vitamin deficiencies compared with controls.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1073-1073
Author(s):  
Mamie Myo Thant ◽  
Alesia Kaplan

Abstract Background: The direct antiglobulin test (DAT) identifies the presence of immunoglobulins and complement on the surface of red blood cells and is used to differentiate immune from non-immune hemolysis. Standard DATs done by conventional methods, using anti-IgG or anti-C3 antihuman globulin (AHG) in tube or gel, are performed routinely by laboratories associated with hospital transfusion services. However, if the standard DAT is negative but a strong clinical suspicion for immune-mediated hemolysis remains, serologic testing at an immunohematology reference lab (IRL) can be performed. Subtle differences in reagents and technique in the IRL may identify red cell-bound antibodies missed at the local hospital-based laboratory. In addition, the clinician can request an enhanced DAT, colloquially referred to as a Super Coombs, as a send-out test. This test can detect antibodies that are not detected by standard methods and that have been reported to cause autoimmune hemolysis, namely IgG bound at low levels, low affinity IgG, and IgA. We conducted a retrospective review of enhanced DATs sent by hematologists at the University of Pittsburgh Medical Center and the Allegheny Health Network to an outside IRL to determine the incidence of new autoantibodies detected by the enhanced DAT and assessed the impact of these results on patient management. Methods: We retrospectively identified patients at our center on whom enhanced DATs were sent from January 2019 to January 2021. Demographic, laboratory, and clinical data were collected and analyzed. Results: Twenty one patients were identified as having enhanced DATs sent to one outside IRL during the two year period. The majority of patients had abnormal clinical laboratory markers of hemolysis (81% with an elevated lactate dehydrogenase, 90% with an undetectable haptoglobin) and a history of immune dysregulation (79%). About 2/3 of the patients had a hemoglobin nadir above 6 g/dL. The median number of DATs performed locally prior to requesting the enhanced DAT evaluation was 2 (5 th to 95 th percentile: 1 - 3). Four out of 21 patients (19%) had previously tested positive at the local IRL by conventional serologic methods and 17 (81%) had tested negative. Among the 21 patients, 7 (33%) had at least one positive test on the enhanced DAT battery, including 5 out of the 17 (29%) who had previously tested negative locally. In 5 out of those 7 patients who tested positive by enhanced methods, the positive tests included standard serologic test done by conventional means. The only specialty serologic tests that yielded positive results was testing done at 4 °C, meant to detect low affinity IgG. The mean (±SD) overall turnaround time from sample collection to receipt of the enhanced DAT results was 3.8 (±1.5) days, the bulk of which was transit time from the local hospital to the outside IRL (2.5 (±1.5) days). Empiric high-dose steroid therapy was started in 68% of the patients prior to receipt of the enhanced DAT results. The median time between the first DAT result at the local IRL and the initiation of high dose steroid therapy was 1.5 (5 th to 95 th percentile: 0 - 12.5) days, while the median time from steroid initiation to the time the enhanced DAT was ordered was 5 (5 th to 95 th percentile: 1-256) days. Four patients were diagnosed with DAT-negative autoimmune hemolytic anemia based on response to steroids, whether complete (Hb ≥ 12 g/dL and normalization of LDH and haptoglobin) or partial (Hb improvement by 2 g/dL and no transfusion requirement), despite negative local and enhanced DAT results (table 1). Patients who had self-limited (2 patients) or subacute, non-severe anemia (5 patients) did not undergo a steroid trial and were diagnosed by non-serologic testing, specifically peripheral blood flow cytometry or bone marrow biopsy. Conclusions: The tests that most often yielded positive results on the enhanced DAT were standard serologic tests, suggesting that differences in timing of sample collection or technique may have explained result disparity between the local and outside IRL. Specialty testing done at 4 °C detects low affinity IgG antibodies bound to red cells, but the clinical significance of these antibodies is unclear. The majority of patients in our cohort underwent an empiric trial of high dose steroids prior to receipt of the enhanced DAT results. For these patients, the response to steroids was the deciding factor in AIHA diagnosis rather than the enhanced DAT results. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Author(s):  
Meng-Meng An ◽  
Yi Jiang ◽  
Bei-Bei Jin ◽  
Da Cao ◽  
Ping Gong

Abstract Background: Iron metabolism disorder is commonly seen in patients with sepsis. This study aimed to evaluate whether continuous veno-venous hemofiltration (CVVH) improved the iron metabolism disorders in sepsis. Methods: In a single-center, retrospective cohort study, totally 89 sepsis patients were prospectively enrolled and divided into the CVVH group (n=39) and the control group (n=50). Clinical and laboratory data were collected and compared between the groups on days 1, 3 and 7 of ICU admission. Plasma interleukin (IL)-6, hepcidin, erythropoietin (EPO), ferritin and soluble transferrin receptor (sTfR) were determined by enzyme linked immunosorbent assay (ELISA). Sequential organ failure scores (SOFA) on days 1 and 7, and 28-day survival between groups were compared.Results: Plasma IL-6, hepcidin, ferritin and RDW on days 3 and 7 were significantly reduced in the CVVH group compared with those in the control group (all P<0.05). The CVVH group had a significantly lower SOFA score on day 7 compared with the control group (P<0.05). Hemoglobin and EPO were gradually decreased within the first week of ICU admission in both groups although no significant differences between the groups were observed. There was no significant difference in sTfR between the two groups along with the time (all P > 0.05). In addition, there were no significant differences in 28-day survival rate and median survival time between the two groups. Conclusion: CVVH improves iron metabolism disorders and the disease severity in sepsis. However, it does not alleviate anemia and fails to improve the survival.


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