Prevention of chemotherapy-induced delayed nausea and vomiting with aprepitant in patients recieving highly emetogenic-five day cisplatin regimens

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14125-14125 ◽  
Author(s):  
A. J. Joshi ◽  
H. Singh ◽  
S. Chawla
Keyword(s):  
Small Sample Size ◽  
Rescue Therapy ◽  
Small Sample ◽  
P Value ◽  
High Dose ◽  
Delayed Emesis ◽  
End Point ◽  
Group I ◽  
Delayed Nausea ◽  
Group Ii

14125 Background: It has been shown that addition of the NK1 receptor antagonist aprepitant to 5HT3 antagonist plus dexamethasone is more effective than just the 5HT3 antagonist plus dexamethasone for prevention of acute and delayed emesis due to high dose cisplatin and also that this effect lasts for multiple cycles. This study evaluated whether the antiemetic efficacy of aprepitant could be sustained for 5 day cisplatin regimens. Methods: Patients receiving cisplatin 20mg/m2/day for 5 days (PEB and TCF regimens ) were randomized to one of the following two regimens: (1) aprepitant 125 mg 1 hour before cisplatin on day 1 and aprepitant 80 mg on days 2 and 3 (n = 17); (2) placebo before cisplatin on days 2 to 7 (n = 19). All groups received ondansetron 32 mg and dexamethasone 20 mg before cisplatin, and dexamethasone 8 mg on days 2 to 7. The primary end point was complete response (no emesis and no rescue therapy) over 7 days following cisplatin in up to six cycles analyzed by a modified intent-to-treat approach. Secondary end point was evaluated using Functional Living Index-Emesis questionnaire. Treatment comparisons were made using logistic regression models and P value calculated using the chi square test due to small sample size. Results: In the acute period, 83% and 56% of patients were without emesis in groups I and II, respectively (P < .01 for group I v group II). In the delayed period upto day 5, the proportion of patients without emesis in groups I and II, was 59% and 32%, respectively (P < .01 for groups I v group II). In the extended period day 6 and 7 the proportion of patients without emesis in groups I and II was 50% and 38% respectively (P< .01 for groups I v II). The distribution of nausea scores in the delayed period beyond day 5 was lower when comparing group I with group II (P < .05 for days 6 and 7). Two serious adverse events of diarrhea were probably attributed to aprepitant. Conclusions: Once daily oral administration of aprepitant was effective and superior in reducing delayed emesis and nausea after 5 days cisplatinum regimen when added to 5HT3 antagonist plus dexamethasone. This benefit persists upto day 7. Confirming and extending previous results aprepitant should be used in triple combination in patients receiving 5 day cisplatin regimens. No significant financial relationships to disclose.

Periodic Evaluation Of The Clone Size Is Mandatory In PNH: Study Of The Spanish Cohort Of The International PNH Registry

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3715-3715
Author(s):  
Ana Villegas ◽  
Ana Gaya ◽  
Emilio Ojeda ◽  
Ataulfo Gonzalez ◽  
Alvaro Urbano ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Small Sample Size ◽  
Small Sample ◽  
Additional Patient ◽  
Clone Size ◽  
Hematopoietic Stem ◽  
Future Analysis ◽  
Group I ◽  
Group Ii ◽  
Pnh Clone

Abstract Background Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, life threatening hematopoietic stem cell disorder with chronic hemolytic anemia, peripheral blood cytopenias and thrombosis Aims To observe the PNH clone and LDH evolution of the Spanish patients enrolled in the International PNH Registry, the thrombotic events and the role of eculizumab Methods We analyzed the 117 patients enrolled in the Registry until Dec. 31st 2012, classified in 3 groups: Classic/ hemolytic (group I, n 59), PNH with another bone marrow disorder (group II, n 42) and Subclinical (group III, n 14). The variables analyzed were PNH clone size, LDH levels, and incidence of thrombosis. Medians and percentages should be taken with caution due to the relatively small sample size. In addition to data collected in the Registry, additional patient information was obtained from local physicians. Results The median (range) age at presentation was 36.6 yrs. (16-83); 48 patients (41.0%) were women. Median (range) time from disease start to enrollment was 11.3 years in group I (0.1-41.2), 3.5 in II (0.1-33.8) and 3.4 (0.3-20.8) in III. A total of 49 patients (39 in group I) were started on eculizumab, 38 prior to enrollment (31 in group I) and 11 on or after enrollment; 3 were treated prior to enrollment but discontinued for different reasons (pregnancy, ending trial, access problems). Clone evolution (Table 1). In group I the median clone size remained stable during the follow-up period in the Registry; however, 4 patients in group II evolved to group I, with granulocyte clones > 50% and LDH levels >2000 U/L, while 3 initially in group I evolved to group II at 6, 12 and 18 months respectively. At enrollment 64 patients had a clone ≥30% and 31<30%; 7 patients in group II had a clone ≥30% despite hypoplasia, and they were treated with eculizumab. In groups I and II median clone size increased from Diagnosis to Enrollment in line with the physiopathology of the disease. LDH evolution (Table 2). Median LDH levels at diagnosis were higher in group I. In this group the decrease in LDH level between Diagnosis and Enrollment could be attributed to the start of treatment in 31 patients before the enrollment visit, but that hypothesis will need confirmation in future analysis. Thrombotic episodes (Table 3). Twenty six patients (22.6%) presented 52 TEs along the study period, 41 in group I and 11 in group II. Of the 26, fourteen presented 1 TE, six 2, one 3, four 2 and one 5. Twenty five patients presented 51 TEs since the moment of diagnosis while they were not being treated with eculizumab. Only one patient in the treated group presented a TE (CVA), of which he recovered well; after 30 months of the episode continues with the treatment and scores 90 in the Karnofsky index. Fifty eight percent of the patients presenting TEs were male, showing they may be more prone to TE than women. Conclusions These data show the dynamic features of the disease in some patients, which justifies the necessity of regularly monitoring the clone size LDH levels are higher in patients with classical PNH at diagnostic; the effect of the treatment in the whole cohort will require future analysis Thrombosis is highly prevalent in PNH; 22.6% of the patients in this sample had at least 1 episode along their time in the study. Disclosures: No relevant conflicts of interest to declare.

Prevention of Cisplatin-Induced Emesis by the Oral Neurokinin-1 Antagonist, MK-869, in Combination With Granisetron and Dexamethasone or With Dexamethasone Alone

2001 ◽  
Vol 19 (6) ◽  
pp. 1759-1767 ◽  
Author(s):  
Daniel Campos ◽  
Jose Rodrigues Pereira ◽  
Rick R. Reinhardt ◽  
Carlos Carracedo ◽  
Sergio Poli ◽  
...  
Keyword(s):  
High Dose ◽  
Delayed Emesis ◽  
Double Blind ◽  
Acute Emesis ◽  
Group Iii ◽  
Group I ◽  
Efficacy Parameter ◽  
Group Ii ◽  
Neurokinin 1 ◽  
Present Trial

PURPOSE: The NK1-receptor antagonist MK-869 (L-754,030) has demonstrated antiemetic activity in humans receiving chemotherapy. Objectives of the present trial included the first assessment of oral MK-869 plus dexamethasone compared with a 5HT3 antagonist plus dexamethasone for prevention of acute and delayed emesis after high-dose cisplatin. Furthermore, the study sought to confirm that addition of MK-869 to a 5HT3 antagonist plus dexamethasone was more effective than just the 5HT3 antagonist plus dexamethasone for prevention of acute and delayed emesis. METHODS: This multicenter, double-blind, parallel-group trial in 351 cisplatin-naïve patients evaluated prevention of acute (0 to 24 hours) and delayed emesis (primary efficacy parameter; days 2 to 5) after cisplatin (≥70 mg/m2). Patients were randomized to four groups (I to IV) (n = number randomized; number evaluable): granisetron (10 μg/kg intravenously) pre-cisplatin followed by placebo on days 2 to 5 (group I) (n = 90; 90); granisetron and MK-869 (400 mg PO [by mouth]) pre-cisplatin, followed by MK-869 (300 mg PO) on days 2 to 5 (group II) (n = 86; 84); MK-869 (400 mg PO) the evening before and pre-cisplatin, followed by MK-869 (300 mg PO) on days 2 to 5 (group III) (n = 89; 88); or MK-869 (400 mg PO) pre-cisplatin, followed by MK-869 (300 mg PO) on days 2 to 5 (group IV) (n = 86; 84). All patients also received dexamethasone (20 mg PO) before cisplatin. Additional medication was available to treat emesis or nausea at any time. RESULTS: In the acute period, 57%, 80%, 46%, and 43% of patients were without emesis in groups I, II, III, and IV, respectively (P < .01 for group II v group I). In the delayed period, the proportion of patients without emesis in groups I, II, III, and IV was 29%, 63%, 51%, and 57%, respectively (P < .01 for groups II, III, and IV v group I). The distribution of nausea scores in the delayed period was lower when comparing group II with group I (P < .05 for days 1 to 5 and days 2 to 5). One serious adverse event (dizziness) was rated as possibly related to MK-869. CONCLUSION: Once daily oral administration of MK-869 was effective in reducing delayed emesis and nausea after high-dose cisplatin. However, the combination of the 5HT3 antagonist plus dexamethasone was numerically superior to MK-869 plus dexamethasone in reducing acute emesis. Confirming and extending previous findings, the triple combination of a 5HT3 antagonist, MK-869, and dexamethasone provided the best control of acute emesis.

Neoadjuvant chemoradiation (NACRT) and the prognostic effect of surgical margin (SM) status in pancreatic adenocarcinoma (PAC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 407-407
Author(s):  
Lora S Wang ◽  
John Parker Hoffman ◽  
Elizabeth Handorf ◽  
Colin T. Murphy ◽  
Harry S. Cooper ◽  
...  
Keyword(s):  
Negative Impact ◽  
Small Sample Size ◽  
Surgical Margin ◽  
Neoadjuvant Chemoradiation ◽  
Small Sample ◽  
R0 Resection ◽  
Palliative Intent ◽  
Prognostic Effect ◽  
Group I ◽  
Group Ii

407 Background: Many studies have associated a R0 resection to have significantly improved survival compared with a R1 resection in PAC. Patients (pts) who undergo NACRT often go to surgery 4-8 weeks after the end of therapy, before the effects of NACRT can be fully manifested. The goal of this study is to evaluate if a positive SM (+SM) after NACRT has the same poor prognosis as a +SM after upfront surgery. Methods: After IRB approval, we retrospectively reviewed all cases of surgically resected PAC at a single institution from Dec 1996 to Jan 2014. Pts were stratified by receipt of NACRT as well as by SM status. We excluded pts treated with palliative intent, metastatic disease at presentation, death within 90 days of surgery, and biliary or ampullary tumors. The primary endpoint was overall survival (OS). We assessed the relationship between pt and tumor variables with treatment/margin combination using Chi-squared tests. OS was examined using Kaplan-Meier curves, and we tested association with treatment/margin using log-rank tests. Results: A total of 213 pts met inclusion criteria; 111 received upfront surgery (group I) with 94 (85%) receiving adjuvant chemotherapy or CRT and 102 received NACRT (group II) with either concurrent 5-fluorouracil (n=18) or gemcitabine (n=84). There were 31 pts with +SM in group I and 29 pts in group II. Pt demographics were balanced. There was more vessel involvement in group II (81%) at diagnosis than group I (11%) (p<0.01) with a trend towards improved OS in group II vs group I (p=0.09). Pathological evaluation revealed more PNI (61% vs 42%, p<0.01) and more lymph node positivity (71% vs 33%, p<0.01) in group I vs group II, respectively. Median OS for group I SM+/SM- and group II SM+/SM- were 15/25 months and 26/32 months respectively. OS is significantly improved with a negative SM (-SM) compared with a +SM (p<0.01). If the SM is positive, pts in group II had improved OS compared with group I (p=0.02). OS was not significantly different for group II +SM vs group I –SM (p=0.34). Conclusions: The negative impact of a +SM on survival is partially mitigated by NACRT. This data further supports the use of NACRT, although it is limited by its retrospective nature and small sample size.

Comparison of Outcome of Lateral Pinning Versus Medial and Lateral Cross Pinning in Childhood Supracondylar Fractures of Humerus

2021 ◽  
Vol 15 (9) ◽  
pp. 2873-2875
Author(s):  
Mudassar Nazzar ◽  
Muhammad Adeel-Ur- Rehman ◽  
Rizwan Anwar ◽  
Omer Farooq Tanveer ◽  
Muhammad Abdul Hanan ◽  
...  
Keyword(s):  
Nerve Injury ◽  
Ulnar Nerve ◽  
Functional Outcomes ◽  
P Value ◽  
Supracondylar Fractures ◽  
Group I ◽  
Pin Fixation ◽  
Group Ii ◽  
Carrying Angle ◽  
Ulnar Nerve Injury

Objectives: To compare the complications and outcomes of lateral entry pin fixation with medial and lateral pin fixation for Gartland type III supracondylar fractures of humerus. Methodology: This prospective comparative study involving 190 patients of Gartland type III close supracondylar fractures were included. from March-2019 to Dec-2020. In all patients, initially the elbow was mobilized using the splint placed above the elbow joint at 30 to 45 degrees’ flexion. After closed reduction, lateral pinning was applied in group I and in group II lateral and medial cross pinning was applied using the standard protocol. Patients were followed for iatrogenic ulnar nerve injury, radiologic and function outcomes in-terms of loss of reduction, elbow range of motion, loss in carrying angle and functional outcomes. Results: The two groups were comparable for loss of elbow range of motion, loss of carrying angle and loss of Bauman's angle. On clinical examination, immediate post-operative ulnar nerve injury was diagnosed in 4 (4.2%) cases in group II and in no patient in group I (p-value 0.12). Satisfactory functional outcomes were achieved in 85 (89.5%) patients in group I and in 88 (92.6%) patients in group II (p-value 0.44). Conclusion: Lateral pinning provided stable fixation clinically and radiologically as compared to lateral and medial cross pinning. Keywords: Supracondylar fracture of Humerus, Iatrogenic ulnar nerve injury, Lateral pin entry, lateral and medial cross pin entry.

Comparison of Adverse Outcomes in Cirrhotic and Non-Cirrhotic Patients with Covid-19 Disease

2021 ◽  
Vol 15 (7) ◽  
pp. 2289-2291
Author(s):  
Jahangir Anjum ◽  
Talal Safdar ◽  
Muhammad Imran ◽  
Muazzam Fuaad ◽  
Waheed Iqbal ◽  
...  
Keyword(s):  
Liver Disease ◽  
Chronic Liver Disease ◽  
Teaching Hospital ◽  
Adverse Outcomes ◽  
Chronic Liver ◽  
P Value ◽  
Group I ◽  
Cirrhotic Patients ◽  
Group Ii ◽  
Disease Study

Objective: The aim of this study is to determine the comparison of adverse outcomes in cirrhotic and non-cirrhotic patients presented with coronavirus disease. Study Design: Place and Duration: The department of Medicine of Divisional Headquarters Teaching Hospital Mirpur Azad Kashmir and Mohiuddin Teaching Hospital, Mirpur AJK for six months during the period from October 2020 to March 2021. Methodology: Total 80covid-19 patients of both genders with or without chronic liver disease were enrolled in this study. Patients were aged between 20-55 years. Patients were divided in to two groups. Group I (with cirrhosis 40 patients) and group II (without cirrhosis 40 patients). Outcomes in term of mortality between both groups were examined. All the data was analyzed by SPSS 26.0 version. Results: There were 24 (60%) males and 16 (40%) were females with mean age 44.19±7.65 years in group I while in group II 27 (67.5%) and 13 (32.5%) patients were males and females with mean age 43.62±5.34 years. We found that mortality rate among patients of group I (cirrhotic) had high mortality rate13 (32.5%) as compared to patients without cirrhosis 5 (12.5%) in group II with p-value 0.0003. Conclusion: We concluded in this that frequency of adverse outcomes was significantly high among cirrhotic patients with coronavirus disease as compared to non-cirrhotic patients. Keywords: Corvid-19, Mortality, Chronic Liver Disease

scholarly journals Transport Factors Affecting the Outcome of Referred Neonates Admitted in A Tertiary Care Hospital

2018 ◽  
Vol 41 (3) ◽  
pp. 159-164 ◽  
Author(s):  
Madhabi Baidya ◽  
Mahfuza Shirin ◽  
Liton Chandra Saha
Keyword(s):  
Perinatal Asphyxia ◽  
Care Center ◽  
Tertiary Care ◽  
Preterm Neonates ◽  
P Value ◽  
Care Hospital ◽  
Cross Sectional ◽  
Neonatal Transport ◽  
Group I ◽  
Group Ii

Background: Adequate neonatal transport is a key component of care of the sick newborns who require referral to tertiary care center. Poor transportation is one of the iatrogenic factors associated with greater neonatal mortality. Neonatal transport is the greatest challenge faced today in our country. The purpose of this study was to find out characteristics of transport of referred neonates and to idention the factors that contribute to mortality.Methodology: This cross sectional study was conducted in Dhaka Shishu (Children) Hospital from June 2013 to November 2013. Both term and preterm neonates who were referred within first seven days of life were included and those with gross congenital abnormalities and left against medical advice were excluded from the study. After enrollment, data were collected using a structured questionnaire including birth details, interventions before transportation, reasons for referral, and details of transportation. Outcome & duration of hospital stay were also recorded. Neonates who were expired considered as group I and who were survived considered as group II. The study variables were analyzed for their association with immediate outcome by applying chi square test and t test. P value <0.05 was considered significant.Results: This study found that out of 332 neonates 181 were expired with 54.5% mortality rate. One eighty one neonates who were expired, considered as group I and one fifty one neonate were survived, considered as group II. The mortality was significantly high in male neonates [RR 0.80 (0.66-0.97)] and neonates those delivered at home [RR 1.34(1.10-1.64)] (p<0.05). Perinatal asphyxia, pre-term low birth weight, neonatal sepsis were the main causes of referral. It was found that transportation without any referral note [RR 1.40 (1.14- 1.71)], no advice regarding maintenance of airway[RR 1.50(1.17- 1.92)]and keeping warm [RR 1.51(1.17-1.950], resuscitation on admission [RR 1.63(1.23-2.17)] and transportation required > 3hours [RR 1.36(1.09-1.69)] were associated with significantly higher mortality among referred transported neonates(p<0.05).Conclusions: This study found that male neonates, home delivery, transportation without any referral note, no advice regarding maintenance of airway and keeping warm, resuscitation needed on admission and prolonged transportation time were significantly associated with mortality of referred transported neonates.Bangladesh J Child Health 2017; VOL 41 (3) :159-164

scholarly journals The prognostic role of inflammatory markers in COVID 19 patients – A retrospective analysis.

2021 ◽  
Author(s):  
Shivkumar Gopalakrishnan ◽  
sangeetha kandasamy ◽  
S.Malini ◽  
S.Peer Mohamed ◽  
k.velmurugan
Keyword(s):  
Inflammatory Markers ◽  
Severe Disease ◽  
Radiation Hazard ◽  
P Value ◽  
Binary Logistic Regression Analysis ◽  
Group Iii ◽  
Group I ◽  
Group Ii ◽  
D Dimer

Abstract Background. Approximately 5% of COVID-19 patients suffer near fatal disease. Clinical and radiologic features may predict severe disease albeit with limited specificity and radiation hazard. Laboratory biomarkers are eyed as simple, specific and point of care triage tools to optimize management decisions.This study aimed to study the role of inflammatory markers in prognosticating COVID-19 patients.Methodology. A hospital based retrospective study was conducted on COVID-19 adult inpatients classified into three groups as mild disease-recovered [Group I], severe disease-recovered [Group II] and dead [Group III]. Categorical outcomes were compared using Chi square test. Univariate binary logistic regression analysis was performed to test the association between the explanatory and outcome variables. Unadjusted OR along with 95% CI was calculated. The utility of lab parameters (Ferritin, LDH, D dimer, N/L ratio and PLT/L ratio) in predicting severity of COVID-19 was assessed by Receiver Operative Curve (ROC) analysis. P value < 0.05 was considered statistically significant.Results. The mean age was 49.32 +/- 17.1 years. Among study population, 378 were Group I, 66 Group II, and 56 Group III. Median levels of Ferritin among the 3 groups were 62ng/mL, 388.50 ng/mL and 1199.50 ng/mL. Median value of LDH were 95U/L, 720 and 982.50(p <0.001). D-dimer values of 3 groups were 23.20ng/mL, 104.30 ng/mL and 197.10 ng/mL (p <0.001). CRP done qualitatively was positive in 2 (0.53%), 30 (45.45%) and 53 (94.64%) of patients. The odds of patients suffering severe COVID-19 rose with rising values of ferritin, LDH and D-dimer [unadjusted OR 1.007, 1.004 &1.020]Conclusion. One time measurement of serum ferritin, LDH, D-dimer and CRP is promising to predict outcomes for COVID 19 inpatients. Single qualitative CRP was equally good but more cost effective than quantitative CRP. The most specific combination was NLR, Lymphocyte percentage and D-dimer levels done between 7th – 10th day of symptoms.

scholarly journals Results of modern tuboperitoneal infertility treatment

2009 ◽  
Vol 66 (1) ◽  
pp. 57-62 ◽  
Author(s):  
Drenka Turjacanin-Pantelic ◽  
Dragana Bojovic-Jovic ◽  
Biljana Arsic ◽  
Eliana Garalejic
Keyword(s):  
Statistical Analysis ◽  
Surgical Treatment ◽  
Infertility Treatment ◽  
P Value ◽  
Modern Approach ◽  
Vitro Fertilization ◽  
Group I ◽  
Significant Difference ◽  
Group Ii

Background/Aim. A modern approach to surgical treatment of tuboperitoneal infertility is based on laporascopic techniques. The aim of this study was to compare results of tuboperitoneal infertility treatment by the use of laparoscopy and classical laparotomy. Methods. A retrospectiveprospective study on 66 women treated operatively form tuboperitoneal infertility was performed. Data from patient's anamnesis and those related to the surgical treatment results, obtained by the use of an inquiry, were used in retrospective and prospective analysis, respectively. Chi-square test was used in statistical analysis. P value < 0.05 was considered significant. Results. Classical laparotomy was used on 34 women in a period from 1996 to 1997, while 32 women were operated laparoscopically in a period from 1999 to 2000. The results were as follows: a total number of conceived women was 16 (24%), seven in the group I (20.6%) and nine in the group II (28.1%); 13 women were with one pregnancy, six in the group I (17.6%) and seven in the group II (22%). Twice pregnant were three women, one in the group I (2.9%) and two in the group II (6.2%). The resulting pregnancies were: five women with abortion spontaneous, two in the group I (5.9%) and three in the group II (9.4%); two women with extrauterine pregnancy in the group I (5.9%); three with pretemporal birth, one in the group I (2.9%) and two in the group II (6.2%), while six women were with the temporal birth, two in the group I (5.9%) and four in the group II (12.5%). Statistical analysis showed that there was no significant difference in the results between these two groups. Conclusion. Surgical treatment of tubeperitoneal infertility, regardless of the used methods (classical laparotomy or laparoscopy) was successful in a great number of women. These methods have a great advantage over in vitro fertilization, and they should not be ignored.

scholarly journals Retrospective, observational study on usage of evogliptin in T2DM patients: A real-World experience in Indian patients

2021 ◽  
Vol 8 (3) ◽  
pp. 205-207
Author(s):  
Abhijit Trailokya ◽  
Amol Aiwale ◽  
Roshan Pawar ◽  
Suhas Erande
Keyword(s):  
Real World ◽  
Small Sample Size ◽  
Small Sample ◽  
Hypoglycemic Agents ◽  
P Value ◽  
Base Line ◽  
Oral Hypoglycemic Agents ◽  
Naive Patient ◽  
Indian Patients ◽  
Treatment Naïve

This study aimed to assess effectiveness and safety of Evogliptin 5 mg in patients with T2DM who were prescribed Evogliptin alone or with other oral hypoglycemic agents in real world scenario. Overall 20 patients who received Evogliptin as routine clinical practice in management of T2DM were analyzed retrospectively from single center. Data collected from past medical records. Primary endpoint was mean changes in HbA1c from baseline to weeks 24 and secondary endpoints were Change in HbA1c from baseline to weeks 12 Change from baseline in FPG & PPG at weeks 12 & 24.Significant reduction in HbA1c at the end of 12 and 24 weeks of Evogliptin therapy was - 0.9% and -1.45% respectively from the baseline of HbA1c 8.6% (p value &#60;0.001). At the end of 12 and 24 weeks of addition of Evogliptin, significant reduction in FBG were seen i.e -49.5 mg/dl and -90.7mg/dl respectively from base line of 182 mg/dl and reduction in PPG was -79.4mg/dl and -116.6mg/dl respectively from base line 277 mg/dl (p value &#60;0.001). Evogliptin was found to be effective when added to the patients who were uncontrolled on dual / triple oral anti-diabetic medications and even in treatment naïve patient. It effectively showed reduction in HbA1c, FBG and PPG and the end of 12 and 24 weeks when added to existing anti-diabetic medications & well tolerated in type 2 diabetes Indian patients.Small sample size and retrospective study

scholarly journals Discrepancy of Blast Percentage between the Bone Marrow Aspirate and Flow Cytometry and Its Impact on Survival Outcomes in Patients with Myelodysplastic Syndromes Excess Blast (MDS-EB)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5441-5441
Author(s):  
Meera Yogarajah ◽  
Phuong L. Nguyen ◽  
Rong He ◽  
Hassan B. Alkhateeb ◽  
Mithun Vinod Shah ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Flow Cytometry ◽  
Small Sample Size ◽  
Scoring Systems ◽  
Standard Of Care ◽  
Risk Groups ◽  
Small Sample ◽  
International Prognostic Scoring System ◽  
P Value ◽  
Number Of Patients

Background MDS is a heterogeneous disease and the revised International Prognostic Scoring System (IPSS-R) is utilized in prognostication. The percentage (%) of blasts in the bone marrow is determined in the aspirate morphologically. Though the former is the standard of care the blast percentage is also reported by flow cytometry and biopsy which can many times be inconsistent. We previously presented the utilization of biopsy based blast percentage which showed meaningful prognostic groups compared to aspirate. In this study we compare the blasts as reported by the aspirate and flow cytometry in MDS-EB in calculating IPSS-R. Methods The MDS database was reviewed for cases of MDS-EB after due IRB approval at the Mayo clinic. We calculated IPSS-R scores based on the aspirate blast % (IPSS-RAsp) and flow blast% (IPSS-Rfl). The aspirate blast percentage was reported morphologically. Suboptimal aspirates were excluded from the study. The flow blast percentage was determined by immunophenotyping. The overall survival (OS) was determined by IPSS-RAsp and IPSS-RFl. OS estimates were calculated by Kaplan-Meier curves and log-rank testing using JMP v.13. Uno's concordance statistic was used to compare the 2 risk scoring systems. Results Of 1322 patients, 431 (33%) cases were identified with MDS-EB out of which 120 (29%) cases had blasts reported in the aspirate and flow. Based on aspirate MDS EB1: 54% (n=65), MDS EB2 46% (n=55). The hematological, cytogenetic and R-IPSS categories were compared between MDS-EB1 and MDS- EB 2. The blast percentage and hemoglobin levels was significantly different between MDS-EB1 and EB2 as seen in table 1, however the IPSS-R risk groups were not significantly different. The flow cytometry was concordant with aspirate in 66/120 (55%) cases. Out of the dis-concordant cases only 20% (11/54) was upstaged by flow cytometry with most of the patients being down staged as expected by the techniques used in processing the blood and hence not reliable when reported low (Figure 1). The OS outcomes based on the IPSS- R asp, IPSS-Rfl areshown in figure 2A,2B .The p value with aspirate based R-IPSS was more significant than flow cytometry based R-IPSS (p= 0.0007 vs 0.0174). We compared the two models for observed OS differences using the Uno model which was not statistically significant. (p= 0.6) Conclusions Both models did not show a difference which is likely due to the very small sample size. However flow cytometry did down stage more patients when disconcordant and may have less value in that setting. It would be ideal to compare all 3 models aspirate, biopsy and flow cytometry however we did not have enough number of patients to do the comparison. Disclosures Patnaik: Stem Line Pharmaceuticals.: Membership on an entity's Board of Directors or advisory committees. Al-Kali:Astex Pharmaceuticals, Inc.: Research Funding.

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