Impact of glycemic control on treatment efficacy and safety during nabpaclitaxel plus gemcitabine therapy in unresectable pancreatic cancer.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 337-337
Author(s):  
Junko Tauchi ◽  
Akira Shinohara ◽  
Ken Ohashi ◽  
Taro Shibuki ◽  
Gen Kimura ◽  
...  

337 Background: Diabetes mellitus (DM) and hyperglycemia have been widely considered to be associated with the risk of pancreatic cancer. However, the aim of this study was to evaluate the relationship between glycemic control and the efficacy or safety in pancreatic cancer pts receiving treatment with nab-Paclitaxel (nab-PTX) plus Gemcitabine (GEM). Methods: We retrospectively reviewed 285 pts with unresectable pancreatic cancer with nab-PTX plus GEM as the first-line chemotherapy from December 2014 to March 2017 at the National Cancer Center Hospital East, Kashiwa, Japan. The pts were divided into two groups, average blood glucose level during the period of chemotherapy was less than 160 mg/dL (Group GC: Good glycemic control group) and more than 160 mg/dL (Group PC: Poor glycemic control group). Results: A total of 285 pts were enrolled. Median age was 66 years (range: 26-84) and males/females: 180/105, PS (0-1/2-3): 272/13, stage (III/IV): 77/208. There were 226 pts in GC group and 59 pts in PC group. No significant differences were seen in the overall survival between Group GC and PC (median: 16.1 months vs. 13.8 months, p = 0.344) and in the progression free survival between the two groups (median: 7.5 months vs. 8.2 months, p = 0.862). The incidence rate of grade 2-3 chemotherapy-induced peripheral neuropathy (CIPN) was significantly higher in Group PC compared with Group GC (Group GC 28.3%, Group PC 45.8%, p = 0.010). Univariate and multivariate analyses identified glycemic control as significant independent factors associated with the incidence of grade 2-3 of CIPN (Odds ratio 2.182, 95% CI 1.20-3.96, p = 0.010). There was no significant difference in the relative dose intensity of nab-PTX between two groups (median, 56.6% in group GC, 56.5% in group PC, p = 0.952). Conclusions: Glycemic control during the chemotherapy with nab-PTX plus GEM in unresectable pancreatic cancer was not associated with OS. The incidence of severe CIPN was higher in pts with poor glycemic control compared with good glycemic control.

1999 ◽  
Vol 19 (2_suppl) ◽  
pp. 179-183 ◽  
Author(s):  
Mai-Szu Wu ◽  
Chun-Chen Yu ◽  
Ching-Herng Wu ◽  
Jeng Yi Haung ◽  
Mei-Lin Leu ◽  
...  

Objective To evaluate the impact of pre-dialysis glycemic control on clinical outcomes for type II diabetic patients on continuous ambulatory peritoneal dialysis (CAPO). Materials and Methods One hundred and one type II diabetic patients receiving CAPO for at least 3 months were enrolled in a single institute. The patients were classified into two groups according to status of glycemic control. In the good glycemic control group, more than 50% of blood glucose determinations were within 3.3 11.0 mmol/L and glycosylated hemoglobin (HbA 1 C) levels were within 5% -10% at all times. In the poor glycemic control group, less than 50% of blood glucose determinations were within 3.3 -11.0 mmol/L, or HbA1C levels were above 10% at least 6 months before peritoneal dialysis was started. In addition to glycemic control status, pre-dialysis serum albumin, cholesterol levels, residual renal function, peritoneal membrane function, and modes of glycemic control were also recorded. Results The patients with good glycemic control had significantly better survival than those with poor glycemic control (p < 0.01). There was no significant difference in pre-dialysis morbidity between two groups. No significant differences were observed in patient survival between patients with serum albumin above 30 g/L and those with serum albumin under 30 g/L; between those with cholesterol levels above or below 5.2 mmol/L; and between those with different peritoneal membrane solute transport characteristics as evaluated by a peritoneal equilibration test (PET). Furthermore, there was no significant difference in survival between patients who controlled blood sugar by diet and those who controlled it by insulin. Cardiovascular disease and infection are the major causes of death in both groups. Although good glycemic control predicts better survival, it does not change the pattern of mortality in diabetic patients maintained on CAPO. Conclusions Glycemic control before starting dialysis is a predictor of survival for type II diabetic patients on CAPO. Patients with poor glycemic control predialysis are associated with increased morbidity and shortened survival.


Author(s):  
Malayana Rahmita Nasution ◽  
Adi Koesoema Aman ◽  
Dharma Lindarto

Diabetes mellitus patients often have hypercoagulable blood, as evidenced by the increased coagulation, impaired fibrinolysis, endothelial dysfunction and platelet hyperactivity. Hyperactive platelet is the major determinant of pro thrombotic state in DM. By assessing the MPV and platelet aggregation, which is a marker of platelet activity, in patients with type 2 DM, it is expected to help the prediction of acute events. This research is aimed to know the differences of MPV and the aggregation of platelet between poor glycemic control as well as good the control group in type 2 DM patients. This study was conducted in cross sectional method using 22 people with good glycemic control and 28 people with poor one (glycemic control) from June to August 2013. Fasting blood samples were analyzed for CBC, HbA1c, TG and platelet aggregation. MPV and platelet aggregation value were compared between groups using independent t-test. Based on this study, there is no significant difference in MPV and platelet aggregation between groups (p=0.598, p=0.464 (1 μM), p=0.868 (2 μM), p=0.984 (5 μM), p=0.401 (10 μM)). Mean Platelet Volume (MPV) correlate significantly with platelet aggregation at 1 μM and 5μM ADP concentration in good glycemic control group (r=0.591; p=0.004 at 1 μM ADP and r=0.521; p=0.013 at 5 μM ADP). Mean platelet volume correlate significantly with the platelet aggregation at 2 μM ADP and the concentration in poor glycemic control group (r=0.405; p=0.033). There are no significant differences in MPV and platelet aggregation between groups, but there is a significant correlation between them (MPV and platelet aggregation) in the good glycemic control of the type 2 DM group


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 469-469 ◽  
Author(s):  
Akihiro Ohba ◽  
Hideki Ueno ◽  
Yasunari Sakamoto ◽  
Shunsuke Kondo ◽  
Chigusa Morizane ◽  
...  

469 Background: Various modified FOLFIRINOX (mFFX) regimens have been reported and widely used in clinical practice. Although there are retrospective studies and single-arm phase 2 studies comparing modified regimens to the full-dose regimen of the historical control group, head-to-head comparisons in the same population are limited. This study aimed to compare mFFX with full-dose FOLFIRINOX (fFFX) in patients with advanced pancreatic cancer (APC). Methods: We reviewed 85 patients with APC who received mFFX (no bolus fluorouracil and irinotecan 150 mg per square) or fFFX as first-line chemotherapy between January 2014 and December 2016. mFFX has been used since January 2016 on the basis of results of a Japanese phase 2 study. The efficacy, safety, and dose reduction pattern were evaluated. Results: A total of 56 eligible patients (26 treated with mFFX and 30 with fFFX) were selected. Baseline characteristics of each group were well-balanced. The median relative dose intensities of oxaliplatin, irinotecan, bolus fluorouracil, and continuous infusion fluorouracil were 68.6%, 78.5%, 0%, and 88.5% in the mFFX group, and 80.5%, 76.5%, 25.6%, and 83.6% in the fFFX group, respectively. Second cycle dose reduction occurred in 38% of the patients in the mFFX group and in 62% of those in the fFFX group. The median overall survival (OS) was 19.0 months in the mFFX group, compared to 13.2 months in the fFFX group (HR 0.60, 95% CI 0.25–1.47, P = 0.27). In a multivariate analysis to adjust for prognostic factors for OS, the hazard ratio for death with mFFX was significant (adjusted HR 0.36, 95% CI 0.14–0.93, P = 0.04). The median progression-free survival was 8.3 months in the mFFX group and 5.9 months in the fFFX group (HR 0.83, 95% CI 0.44–1.54, P = 0.55). The response rate was 35% in the mFFX group versus 30% (P = 0.78) in the fFFX group, respectively. Grade 3 or 4 leucopenia (15% versus 40%), neutropenia (42% versus 70%), febrile neutropenia (8% versus 17%), and nausea (4% versus 13%) were decreased in the mFFX group, but the differences were not statistically significant. Conclusions: mFFX had equivalent or higher efficacy and improved safety compared to fFFX in the same population.


2001 ◽  
Vol 19 (15) ◽  
pp. 3447-3455 ◽  
Author(s):  
S. R. Bramhall ◽  
A. Rosemurgy ◽  
P. D. Brown ◽  
C. Bowry ◽  
J. A.C. Buckels ◽  
...  

PURPOSE: The prognosis for unresectable pancreatic cancer remains dismal (1-year survival rate, < 10%; 5-year survival rate, < 5%). Recent advances in conventional chemotherapy and novel molecular treatment strategies warrant investigation. This, the largest randomized study in pancreatic cancer performed to date, compares marimastat, the first of a new class of agents, with gemcitabine. PATIENTS AND METHODS: Four hundred fourteen patients with unresectable pancreatic cancer were randomized to receive marimastat 5, 10, or 25 mg bid or gemcitabine 1,000 mg/m2. The primary end point was survival. Progression-free survival, patient benefit, and safety were also assessed. RESULTS: There was no significant difference in survival between 5, 10, or 25 mg of marimastat and gemcitabine (P = .19). Median survival times were 111, 105, 125, and 167 days, respectively, and 1-year survival rates were 14%, 14%, 20%, and 19%, respectively. There was a significant difference in survival rates between patients treated with gemcitabine and marimastat 5 and 10 mg (P < .003). Both agents were well tolerated, although grade 3 or 4 toxicities were reported in 22% and 12% of the gemcitabine- and marimastat-treated patients, respectively. The major toxicity of marimastat was musculoskeletal (44% of marimastat patients, compared with 12% of gemcitabine patients; musculoskeletal toxicity was severe in only 8% of marimastat patients). CONCLUSION: The results of this study provide evidence of a dose response for marimastat in patients with advanced pancreatic cancer. The 1-year survival rate for patients receiving marimastat 25 mg was similar to that of patients receiving gemcitabine. In view of the manageable tolerability of marimastat and its ease of administration, further studies are warranted.


2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 485-485
Author(s):  
Kei Saito ◽  
Yousuke Nakai ◽  
Hiroyuki Isayama ◽  
Naminatsu Takahara ◽  
Suguru Mizuno ◽  
...  

485 Background: Gemcitabine + nab-Paclitaxel (GnP) is considered as one of the standard first-line chemotherapy for advanced pancreatic cancer (PC), but its efficacy and safety of GnP in patients with refractory or recurrent (Ref/Rec) PC has not been fully reported. Therefore, we conducted this retrospective analysis of GnP in patients with Ref/Rec PC. Methods: Consecutive patients with PC who received GnP at the University of Tokyo Hospital were retrospectively studied. Clinical outcomes in patients with Ref/Rec PC were compared with those in patients with PC receiving GnP as 1st line therapy. Dose intensity was calculated as the total amout of drug given in eight weeks. Tumor response was evaluated using RECIST 1.1 and adverse event using CTCAE ver 4.0. Progression free survival (PFS) were evaluated using the Kaplan-Meier method and compared by long-rank test. Cox regression models were used to calculate hazard ratios (HRs) to evaluate the prognostic factors in patients with Ref/Rec PC and in patients receiving GnP as 1stline therapy. Results: A total of 80 patients (37 as 1st line, 18 refractory and 25 recurrent) received GnP between January 2015 and July 2016. There were no significant differences in patient characteristics between 1st line therapy group and Ref/Rec group other than sex (Male in 41 vs. 67%). In relative dose intensity (RDI), there were no significant difference (75 vs. 72%). AE rates, both hematologic and non-hematologic, did not differ significantly between two groups. RDI was 75 vs. 72% for gemcitabine and 80 vs. 79% for nab-Paclitaxel. Response rate and disease control rate were 23 and 93% vs. 11 and 86%. The median PFS were 9.0 (95%CI: 4.9-13.9) vs. 5.5 (95%CI: 3.5-8.0) months (p = 0.06) and 1-year survival rate were 42.9 vs. 14.3% (p = 0.16). In the multivariate analyses, HRs of RDI < 70 were 2.44 (95%CI: 1.07-5.49, p = 0.04) in Ref/Rec group, while the association was not significant in the 1st line group (HR 1.70 [95%CI: 0.63-4.25], p = 0.28). Conclusions: GnP was safely administered in patients with Ref/Rec PC with DI comparable to 1st line therapy. However, PFS in refractory and recurrent group tended to be short compared to those receiving GnP as 1st line therapy. DI was associated with the prognosis only in Ref/Rec PC.


1997 ◽  
Vol 17 (3) ◽  
pp. 262-268 ◽  
Author(s):  
Chun-Chen Yu ◽  
Mai-Szu Wu ◽  
Ching-Herng Wu ◽  
Chih-Wei Yang ◽  
Jeng-Yi Huang ◽  
...  

Objective To evaluate the correlation between predialysis glycemic control and clinical outcomes for type II diabetic patients on continuous ambulatory peritoneal dialysis (CAPD). Design Sixty type II diabetic patients on CAPD were classified into 2 groups according to the status of glycemic control. In group G (good glycemic control), more than 50% of blood glucose determinations were within 3.3 11 mmol/L and the glycosylated hemoglobin (HbA 1 C) level was within 5 -10% at all times. In group P (poor glycemic control), fewer than 50% of blood glucose determinations were within 3.3 -11 mmol/L or HbA 1 C level was above 10% at least once during the follow-up duration. In addition to glycemic control status, predialysis serum albumin, cholesterol levels, residual renal function, peritoneal membrane function, and the modes of glycemic control were also recorded. Setting Dialysis Unit, Department of Nephrology of a single university hospital. Patients From February 1988 to October 1995, 60 type II diabetic patients receiving CAPD for at least 3 months were enrolled. Main Outcome Measures Morbidities before and during the dialysis period, patient survival, and causes of mortality. Results The patients with good glycemic control had significantly better survival than patients with poor glycemic control (p < 0.01). There was no significant difference in predialysis morbidity between the two groups. No significant differences were observed in patient survival between the patients with serum albumin greater than 30 g/L and those with less than 30 g/L (p = 0.77), with cholesterol levels greater or less than 5.18 mmol/L (p = 0.73), and with different peritoneal membrane solutetrans port characteristics evaluated by peritoneal equilibration test (p = 0.12). Furthermore, there was no significant difference in survival whether the patients controlled blood sugar by diet or with insulin (p = 0.33). Cardiovascular disease and infection were the major causes of death in both groups. Although good glycemic control predicts better survival, it does not change the pattern of mortality in diabetics maintained on CAPD. Conclusions Glycemic control before starting dialysis is a predictor of survival for type II diabetics on CAPD. Patients with poor glycemic control predialysis are associated with increased morbidity and shortened survival.


Author(s):  
Malayana Rahmita Nasution ◽  
Adi Koesoema Aman ◽  
Dharma Lindarto

Diabetes mellitus patients often have hypercoagulable blood, as evidenced by the increased coagulation, impaired fibrinolysis,endothelial dysfunction and platelet hyperactivity. Hyperactive platelet is the major determinant of pro thrombotic state in DM. Byassessing the MPV and platelet aggregation, which is a marker of platelet activity, in patients with type 2 DM, it is expected to help theprediction of acute events. This research is aimed to know the differences of MPV and the aggregation of platelet between poor glycemiccontrol as well as good the control group in type 2 DM patients. This study was conducted in cross sectional method using 22 people withgood glycemic control and 28 people with poor one (glycemic control) from June to August 2013. Fasting blood samples were analyzedfor CBC, HbA1c, TG and platelet aggregation. MPV and platelet aggregation value were compared between groups using independentt-test. Based on this study, there is no significant difference in MPV and platelet aggregation between groups (p=0.598, p=0.464 (1 μM),p=0.868 (2 μM), p=0.984 (5 μM), p=0.401 (10 μM)). Mean Platelet Volume (MPV) correlate significantly with platelet aggregationat 1 μM and 5μM ADP concentration in good glycemic control group (r=0.591; p=0.004 at 1 μM ADP and r=0.521; p=0.013 at 5 μMADP). Mean platelet volume correlate significantly with the platelet aggregation at 2 μM ADP and the concentration in poor glycemiccontrol group (r=0.405; p=0.033). There are no significant differences in MPV and platelet aggregation between groups, but there is asignificant correlation between them (MPV and platelet aggregation) in the good glycemic control of the type 2 DM group.


Author(s):  
Supriya Singh ◽  
Arpita Suri ◽  
Maheep Sinha ◽  
Bushra Fiza

Background & Objectives:  Adenosine modulates insulin action on various tissues and its concentration in tissues is affected by Adenosine Deaminase (ADA) levels. ADA is an enzyme involved in purine metabolism and is considered to be a marker of T cell activation. Immunological disturbances in type 2 diabetic individuals have an association with cell mediated responses and inappropriate T-lymphocyte function. Hence, the study was undertaken to determine the levels of Serum ADA activity in patients of type 2 DM and its correlation with parameters of glycemic profile such as Fasting blood sugar (FBS) and Glycated Haemoglobin. Material and Methods- A total of 100 patients diagnosed for type 2 DM visiting the Outpatient Department of General Medicine and Endocrinology at Mahatma Gandhi Medical College & Hospital, Jaipur were enrolled for the study based on predefined inclusion and exclusion criteria. Blood samples were collected for all enrolled patients and analysed for the investigations like Serum BSF, HbA1c and Serum ADA. Results- In the study, BSF, mean HbA1c and serum ADA level was significantly higher in diabetic group in comparison to control group (p=0.000). The diabetic group was subdivided on the basis of HbA1c levels, HbA1c ≤ 8% as good glycemic control and HbA1c > 8% as poor glycemic control. BSF, mean HbA1c and serum ADA levels were observed to be significantly higher in poor glycemic control group as compared to that of good glycemic control. A significant positive correlation between S. ADA and HbA1c activity was also seen (r= 0.388). Conclusion- Increased ADA level can be used to determine the glycemic status in the patients of type 2 DM and serve as a marker for insulin resistance. Hence, by analysing ADA levels in diabetes, glycemic control and insulin resistance can be assessed. Raised ADA levels can be an early indicator of progressive diabetic change and help to take preventive measures for the development of diabetic complication and thereby improving the outcome of the disease. Keywords- Diabetes Mellitus, Adenosine Deaminase, Glycated haemoglobin


2017 ◽  
Vol 03 ◽  
pp. 42
Author(s):  
Ni Putu Tesi Maratni ◽  
Dwijo Anargha Sindhughosa ◽  
I Gusti Ayu Mardewi ◽  
Ida Bagus Amertha Putra Manuaba ◽  
Made Ratna Saraswati ◽  
...  

The amount of glycosylated hemoglobin (HbA1c) reflects the long-term glycemic control of patients with diabetes. HbA1c also predicts the risk for the development of diabetic complications such as cardiovascular disease (CVD). Patients with type-2 diabetes and the characteristic of dyslipidemia are frequently found. Also, dyslipidemia plays as an independent risk factor for CVD. This study was aimed to evaluate the relationship between glycemic control status with serum individual lipid profiles and lipid ratios in patients with type-2 diabetes. This cross-sectional study consisted of 80 patients. Depending on the HbA1c level, the patients were divided into two groups, good glycemic control group (HbA1c < 7.0%, n = 15) and poor glycemic control group (HbA1c ≥ 7.0%, n = 65). The association of HbA1c with individual lipids (TC, TG, HDL-C, LDL-C, Non- HDL-C) and lipid ratios (TC/HDL-C, TG/HDL-C, LDL-C/HDL-C, monocyte/HDL-C) were analyzed. The value of individual lipids and lipid ratios did not correlate with HbA1c level (p-value ≥ 0.05). Parameters of individual lipids and lipid ratios were not independently associated with poor glycemic control, which was analyzed by logistic regression. ROC analysis found both LDL-C and LDL-C/HDL-C were not accurate to be used as a prognostic indicator of poor glycemic control in patients with type-2 diabetes (p = 0.155, p = 0.297, respectively). The present study found that there was no association between individual lipids and lipid ratios with glycemic control status.


2016 ◽  
Vol 5 (05) ◽  
pp. 4563
Author(s):  
Tariq A. Zafar

Glycated haemoglobin (HbA1c) test indicates the blood glucose levels for the previous two to three months. Using HbA1c test may overcome many of the practical issues and prevent infections such as urinary tract infections (UTIs). The study aimed to evaluate the impact of glycemic control using HbA1c test to understand patient characteristics and UTIs prevalence. Glycemic control was evaluated by measuring HbA1c for a total of 208 diabetes patients who were regularly attending diabetes center in Al-Noor specialist hospital in Makkah.  The results showed that good and moderate glycemic controlled patients were 14.9% and 16.9% respectively while the poor glycemic patients were 68.3%. Among the good improved glycemic control, 83.9% were females, 48.4% were from age group (15-44y). Among the moderately improved glycemic control, 68.4% were females, 54.3% were from age group (45-64 y) with no significant difference. The total number of the patients with positive UTIs was 55 (26.4%) while the total number of patients with negative was UTIs 153 (73.6%). Among the positive UTIs, 76.3% were with poor glycemic control while only 12.3% and 11% were moderate and good improved glycemic control respectively. Among the negative UTIs, 65.3% were with poor glycemic control while only 19% and 15.7% were with moderate and good improved glycemic control respectively.  Prevalence of UTIs among diabetic patients was not significant (p > 0.05). It was concluded that HbA1c was useful monitoring tool for diabetes mellitus and may lead to improved outcomes. Using a HbA1c test may overcome many of the practical issues that affect the blood glucose tests.


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