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The association between alcohol consumption and kidney function is intriguing, but study results are mixed and controversial. We examined the association of alcohol consumption with the overall change in kidney function over 12 years. We analyzed data from a population-based cohort that was part of the Korean Genome and Epidemiology Study. Primary exposure was total alcohol intake (non-drinkers, 0 to

Background: The association between ultrafiltration rate (UFR) and mortality may be affected by the muscle mass or volume status in hemodialysis (HD) patients. However, there is an absence of data regarding this association. Methods: We performed an observational study on patients (≥18 years old) who had been on HD for at least 3 months. A body composition monitor (BCM) was used for baseline bioimpedance analysis measurement. The primary composite outcome was defined as the time to death or the first cardiovascular event. Results: The median (interquartile range) UFR, volume excess measured by the BCM, and lean tissue index (LTI) (calculated as lean tissue mass/height2) were 11.4 (8.0–15.0) mL/h/kg, 2.4 (1.4–4.1) L, and 12.5 (10.4–14.4) kg/m2, respectively. During 284 person-years of follow-up, the primary outcome occurred in 44 of the 167 patients (26%). Higher UFR was associated with an increased outcome of death or cardiovascular event; the adjusted hazard ratio (HR) was 1.044 (95% confidence interval [CI]: 1.006–1.083). This association remained consistent even after adjusting for volume excess. However, the association between UFR and the primary outcome was modified by LTI (pinteraction = 0.027); the association was significant in patients with LTI < 12.5 kg/m2, and the HR (95% CI) was 1.050 (1.001–1.102). Conclusion: Higher UFR was associated with an increased risk of a composite outcome of death or cardiovascular event regardless of volume status in HD patients. However, muscle mass may modify the association between higher UFR and increased risk of a composite outcome.

Background: Intradialytic hypotension (IDH) is a common serious complication in hemodialysis (HD) patients. Hyperphosphatemia is also common in HD patients and promotes vascular calcification. Given the association between vascular calcification and IDH, we investigated the association between IDH and serum phosphorus in HD patients. Methods: We enrolled 173 patients who received HD for 3 months or more. IDH was defined as a nadir systolic blood pressure (SBP) Results: IDH occurred in 40 (23.1%) of the 173 patients. The mean phosphorus level was 4.9 mg/dL. A 1 mg/dL higher serum phosphorus resulted in a 2.1-fold greater odds of IDH. The fully adjusted odds ratio (OR) and 95% confidence interval (CI) were 2.11 (1.48–3.01). High categorized phosphorus levels were also associated with IDH. The highest tertile of serum phosphorus was associated with 6.5-fold greater odds of developing IDH compared to the referent group (the middle tertile of serum phosphorus, 4.0–Conclusion: In HD patients, higher phosphorus levels were associated with an increased occurrence of IDH.

Background A loss of muscle mass may be influenced by multiple factors. Insulin sensitivity and metabolic acidosis are associated with muscle wasting and may be improved with potassium intake. This study evaluated the association between dietary potassium intake and skeletal muscle mass. Methods We performed a cross-sectional study with data obtained from the Korean National Health and Nutrition Examination Survey (KNHANES) (2008–2011). Participant’s daily food intake was assessed using a 24-h recall method. Appendicular skeletal muscle mass (ASM) was calculated as the sum of muscle mass in both arms and legs, measured using dual energy X-ray absorptiometry. The skeletal muscle index (SMI) was calculated as ASM divided by height2 (kg/m2). Low muscle mass was defined as a SMI 2 for men and 2 for women. Results Data from 16,558 participants (age ≥ 19 years) were analyzed. Participants were categorized into quintiles according to their potassium intake. Sex-specific differences were found in the association between potassium intake and muscle mass (PInteraction Conclusions Higher dietary potassium intake decreased the odds of low muscle mass in men but not in women.

Background/Aims The strategy of access care at out center involves the use of ultrasound (USG) in case of physical examination (PE) abnormality. USG determines the need of angiography. This study investigated the possible association between the need for percutaneous transluminal angioplasty (PTA) and hemodynamic parameters of USG. The study also assessed the effects of this monitoring strategy on outcomes in comparison with a historical control. Methods A retrospective study of the medical records of 127 patients (65 PTA, 62 non-PTA) was conducted. Data were analyzed using logistic regression analysis and receiver operating characteristic curve. Fistula outcomes and intervention rates were calculated and compared with 100 historic controls. Results Logistic regression analysis showed that brachial artery flow volume (FV) < 612.9 mL/min or brachial artery resistance index (RI) > 0.63 was independently associated with the need for PTA. This monitoring strategy showed an a reduction in thromboses (0.02 ± 0.11 events/arteriovenous fistula [AVF]-year vs. 0.07 ± 0.23 events/AVF-year, p = 0.046), reduction in central venous catheter placement (0.01 ± 0.05 events/AVF-year vs. 0.06 ± 0.22 events/AVF-year, p = 0.010), reduction in access loss (0.02 ± 0.13 events/AVF-year vs. 0.19 ± 0.34 events/AVF-year, p = 0.015), and increase in access selective repair (0.49 ± 0.66 events/AVF-year vs. 0.21 ± 0.69 events/AVF-year, p = 0.003), compared to historic control. Conclusions There was significant stenosis if brachial artery FV was < 612.9 mL/min or RI was > 0.63 for PE abnormality. These parameters should be used as markers for assessing PTA risk in hemodialysis patients. Addition of USG to determine the need of angiography after detection of PE abnormality leads to decreases in access thrombosis, catheter placement, and access loss despite increasing access intervention rates compared to clinical monitoring.

Background: High ultrafiltration rate (UFR) has been associated with increased mortality in hemodialysis (HD) patients. However, the impact of UFR on decline of residual kidney function (RKF) has not been elucidated among patients receiving conventional HD. Methods: We performed a retrospective cohort study of 7,753 patients who initiated conventional HD from 2007 to 2011 and survived the first year of dialysis with baseline UFR and renal urea clearance (KRU) data at baseline and 1 year (5th patient-quarter). The primary exposure was average UFR at the 1st patient-quarter from dialysis initiation (Results: In our HD cohort, mean baseline UFR was 7.0 ± 3.1 mL/h/kg, and median (interquartile range) baseline KRU was 3.5 (2.1–5.3) mL/min/1.73 m2. There was a graded association between UFR and a rapid decline in RKF; the expanded case mix-adjusted ORs and 95% CIs were 1.21 (1.04–1.40), 1.34 (1.16–1.55), 1.73 (1.46–2.04), and 1.93 (1.48–2.52) for baseline UFR 4 to Conclusion: Higher UFR was associated with a rapid decline in RKF among conventional HD patients. Further clinical trials are needed to elucidate a causal effect of UFR on RKF among HD patients.

To investigate the development of nephrotoxicity associated with colistin dose, and whether this relationship differs depending on renal function.A retrospective cohort study of patients who received intravenous colistin to treat infections caused by extensively drug-resistant Gram-negative microorganisms. Adult patients receiving colistin for 72 hours or longer were included in this study. Patients who received renal replacement therapy at baseline or were administered colistin for less than 3 days were excluded. Colistin-induced nephrotoxicity was defined as a doubling of baseline serum creatinine. Colistin dosing was evaluated based on both actual body weight and ideal body weight.Single general hospital between 2010 and 2013.A total number of 475 patients received colistin therapy. Of these patients, 329 met the inclusion criteria and were included in the analysis.None.One hundred forty-three patients (43.5%) experienced nephrotoxicity during colistin treatment. The median onset time of nephrotoxicity was 6 days (interquartile range, 4-8 days). The patients with nephrotoxicity were older. Hematocrit and serum albumin levels were lower in patients with nephrotoxicity. Median daily dosing of colistin based on ideal body weight was significantly higher in patients with nephrotoxicity than in those without nephrotoxicity (4.55 vs 4.43 mg/kg/d, respectively; p=0.021). The cumulative dose was not different between patients with and without nephrotoxicity. In multiple logistic regression analysis, daily colistin dosing based on ideal body weight was only significantly associated with the development of nephrotoxicity in patients with an estimated glomerular filtration rate60 mL/min/1.73 m2 (odds ratio, 2.34; 95% CI, 1.22-4.5). In these affected patients, based on a receiver operating characteristic plot, the optimal predictive cutoff of colistin dose for the development of nephrotoxicity was 2.87 mg/kg/d of colistin, with a sensitivity of 92.3% and a specificity of 76.7%. In patients with estimated glomerular filtration rate≥60 mL/min/1.73 m, age, serum albumin, hematocrit, and use of glycopeptide were associated with the development of nephrotoxicity.Development of nephrotoxicity was significantly more strongly associated with the dose of colistin, but only in patients with an estimated glomerular filtration rate60 mL/min/1.73 m2 and not in those with normal renal function.

Purpose Recently, there have been many reports that exact central vein catheter tip positioning was possible using intracardiac electrocardiographic (ECG) monitoring. Ultrasonic guidance in combination with intracardiac ECG monitoring may allow for a tunneled dialysis catheter to be inserted at the bedside without using fluoroscopy. Therefore we report on the intracavitary ECG method for insertion of a tunneled dialysis catheter with ultrasound guidance and the feasibility, safety, effectiveness, complications and limitations of this method. Methods From April 2012 to June 2014, we evaluated 142 hemodialysis (HD) patients who were dialyzed by a tunneled dialysis catheter that was inserted using intracardiac ECG monitoring without fluoroscopic usage. We checked the intracardiac P wave and the point at which it gradually rose to the highest P wave morphology, we stopped inserting the catheter. Results Catheter flow during dialysis was adequate in 139 cases. There were three cases where it malfunctioned. Catheter malposition occurred in 6 out of 142 cases. The correct matching rate between the intracardiac ECG and chest posteroanterior (PA) view was 98.5%. No significant complications developed. Conclusions To conclude, in this single-center study, the intracavitary ECG method for assessing the position of the tip of tunneled dialysis catheter was proven to be safe and feasible in virtually all adult patients who had an evident P wave at the basal ECG tracking.

Purpose Acute pyelonephritis (APN) generally involves a single kidney, but it can be bilateral. The aim of the present study was to evaluate differences in clinical presentation, progress and outcome for bilateral APN compared with unilateral APN. Study design The medical records of all patients over 19 years of age, hospitalised for APN and who underwent abdominal enhanced CT at Samsung Changwon Hospital between January 2009 and August 2012 were retrospectively reviewed. Patients were divided into two groups according to whether unilateral or bilateral lesions were identified on the CT scan. Results Of the 296 patients, 99 had bilateral APN. Only 64/86 (74.4%) patients with clear tenderness in the bilateral APN group had bilateral tenderness. Patients with bilateral APN had more severe abnormalities, based on the results of laboratory tests. Leukocytosis, thrombocytopenia, bacteraemia, acute kidney injury, shock and death occurred more frequently in bilateral than in unilateral APN. In the bilateral APN group, broad spectrum antibiotics were used more frequently as an initial antibiotic treatment. A history of stroke or diabetes mellitus, and duration of symptoms before admission, were independent risk factors associated with bilateral APN. Conclusions Patients with bilateral APN experienced more severe clinical and laboratory manifestations and had a poorer outcome than those with unilateral APN. Early imaging tests can be considered to discriminate unilateral from bilateral APN, especially in those with a history of stroke or diabetes and with a longer duration of symptoms. Moreover, initial use of broader spectrum antibiotics can be considered in patients with bilateral APN.

Purpose Neuropathic cancer pain (NCP) is a common and potentially debilitating symptom in cancer patients. We investigated the prevalence of NCP, as well as its management and association with QOL. Methods Cancer patients with pain ≥1 on the visual analogue scale (VAS) were surveyed with the Douleur Neuropathique (DN4) questionnaire, the Brief Pain Inventory-Short Form (BPI-SF), and the EuroQOL five dimensions (EQ-5D) questionnaire. The associations between NCP and pain severity or NCP and QOL, while controlling for variables relevant to QOL, were then analyzed. Results A total of 2003 patients were enrolled in this survey; the prevalence of NCP was 36.0% (n = 722, 95% CI, 32.5–39.5). We found that NCP in cancer patients was closely correlated to a higher pain severity (BPI-SF; 4.96 ± 1.94 versus 4.24 ± 2.02, p

Background/Aims: An association between metabolic syndrome and impaired health-related quality of life (HRQoL) is still controversial. We investigated the association between metabolic syndrome in itself and HRQoL in the Korean adult population. Methods: The study is a cross-sectional analysis of 8,941 adults ≥19 years of age who participated in the 2007 and 2008 Korean National Health and Nutrition Examination Survey. EuroQoL five-dimension (EQ-5D), the EQ-5D index and the EQ visual analogue scale (EQ VAS) were used to assess HRQoL. Results: The prevalence of metabolic syndrome was 26.2%. Compared to the participants without metabolic syndrome, those with metabolic syndrome were older and comprised a higher proportion of men. Moreover, participants with metabolic syndrome were more likely to have a lower education level, to be current smokers, to have activity limitation and to have more frequent metabolic abnormalities and comorbidities. Metabolic syndrome was associated with HRQoL based on EQ-5D and EQ VAS in simple regression analysis. However, metabolic syndrome was not significantly associated with HRQoL after adjusting for age, sex, smoking status, income, education level, marital status, obesity, diabetes mellitus, stroke, history of heart disease and chronic kidney disease for EQ-5D, and in addition history of depression for EQ VAS. Conclusion: Metabolic syndrome in itself was not associated with impaired HRQoL after adjusting for confounding variables such as socio-demographic factors, medical comorbidities and obesity.

Aims and Background Low-dose leucovorin is a well known potentiator of 5-fluorouracil activity in colorectal cancer but not in gastric cancer. To assess their efficacy on response rate and survival, 5-fluorouracil and low-dose leucovorin were combined with mitomycin C. Methods Fifty patients with gastric cancer and metastatic disease, unresectable or relapsed disease were treated with the following regimen every 28 days: mitomycin C, 7 mg/m2 IV bolus on day 1, and leucovorin, 20 mg/m2 IV, followed immediately by 5-fluorouracil, 375 mg/m2 on days 1–5. All had measurable disease and were assessable for toxicity. Prognostic factors were analyzed to examine any association with response rate or overall survival. Results Nineteen of the 48 assessable patients (39.6%; 95% confidence interval [CI], 25.8–53.4) responded, including 4 complete responses (8.3%). The median progression-free survival was 108 days (range, 18+ - 146), and the median duration of survival was 338 days (11.3 months; range, 18+ - 903 days). Response rate and overall survival were not significantly associated with CEA level, performance status, age, or primary and metastatic tumor sites. Toxicity associated with the chemotherapy was tolerable, and all patients were treated at the outpatient clinic. Leukopenia and thrombocytopenia WHO grade ≥3 occurred in 5% and 1% of the patients, respectively. Nausea and vomiting were the most frequent adverse effects (29%), all grade 1 or 2. Conclusions Combination chemotherapy of 5-fluorouracil plus leucovorin with mitomycin C is effective for the treatment of advanced gastric cancer and is well tolerated.

Purpose Activation of the rennin–angiotensin system (RAS) is thought to contribute to hypertension and proteinuria, and eventually to the progression of chronic kidney disease (CKD). Recent evidence suggests that urinary angiotensinogen (UAGT) excretion reflects activation of the intrarenal RAS. This study was performed to determine the effect of losartan on proteinuria and UAGT excretion in non-diabetic patients with CKD with non-nephrotic-range proteinuria. Study design Thirty-two patients with non-nephrotic-range proteinuria (0.045–0.23 g/mmol creatinine) and normal renal function between April 2005 and April 2006 were randomised to a losartan (n=17) or a control (n=15) group. Patients in the losartan group received losartan 50 mg/day, and the doses were titrated up to 100 mg/day after 6 weeks. Serum and urinary angiotensinogen concentrations were measured by sandwich ELISA. The primary end point was the percentage change in proteinuria. The secondary end points were changes in estimated glomerular filtration rate and UAGT excretion. The follow-up period was 24 months. Results Baseline characteristics in the two groups were similar. After 24 months, losartan had reduced urinary protein excretion by 43% (from mean±SD 0.13±0.04 to 0.073±0.03 g/mmol, p Conclusion Losartan significantly decreased proteinuria and UAGT excretion, and preserved renal function in non-diabetic patients with CKD.

A phase II study was conducted to assess the efficacy and tolerability of capecitabine in combination with irinotecan (CAPIRI) in advanced colorectal cancer. Forty-seven patients with previously untreated metastatic or unresectable colorectal adenocarcinoma received capecitabine 1000 mg/m2 twice daily on days 2-15 and intravenous irinotecan 100 mg/m2 on days 1 and 8, every 21 days. A total of 268 cycles of chemotherapy (median 6: range 1-11) were administered. According to an intent-to-treat analysis, the overall response rate was 49% (95% CI, 35-63%). Median time to progression and overall survival were 7.5 months (95% CI, 4.8-10.2) and 19.5 months (95% CI, 15.7-23.8), respectively. The most common grade 3/4 adverse events were diarrhea (24%) and neutropenia (11%). There were no treatment-related deaths. These results indicate that CAPIRI has comparable activity and tolerability to FOLFIRI as first-line treatment for advanced colorectal cancer.

Aims Metabolic acidosis is a common manifestation of chronic kidney disease (CKD) and appears to be associated with CKD progression and mortality. We evaluated whether serum bicarbonate level is associated with albuminuria in patients with stage 3 and 4 CKD. Methods This was a retrospective cross-sectional study of outpatients with CKD stages 3 - 4 (estimated glomerular filtration rate 15 - 59 mL/minutes/1.73 m2). Serum bicarbonate levels, serum creatinine levels, and random urinary albumin-to-creatinine ratios (UA/Cr) examined on the same day were required for enrollment. Significant albuminuria was defined as UA/Cr >= 300 mg/g. Serum bicarbonate was analyzed as both a continuous variable and a categorical variable after it was divided into categories of = 26 mmol/L. Results 151 patients were included in this study. Their mean age was 59.1 ± 13.9 years, and 60.9% were men. The mean serum bicarbonate level was 23.7 ± 3.3 mmol/L. In a multiple logistic regression analysis to determine the factors associated with significant albuminuria, the serum bicarbonate categories were independent factors associated with significant albuminuria after adjustments were made for relevant covariates (p = 0.028). In a subgroup analysis according to CKD stage, the association between bicarbonate categories and significant albuminuria was significant only for patients with stage 3 disease, regardless of renal function or blood pressure (p = 0.014 and 0.706 in stage 3 and 4 diseases, respectively). Conclusions Low serum bicarbonate levels were ssociated with significant albuminuria, even at levels in the normal range, in CKD patients, especially with stage 3 disease.

Aims and background For advanced cancers of the bile duct, gallbladder and ampulla of Vater, there are only a few treatment options. We explored the efficacy of the combination of gemcitabine, 5-fluorouracil and cisplatin for advanced biliary cancers. Methods From September 2003 to April 2010, 28 patients with recurrent or metastatic biliary tract cancer were enrolled. A treatment regimen consisting of gemcitabine (800 mg/m2 at a fixed dose rate on days 1 and 8), 5-fluorouracil (1 g/m2/day continuous infusion for 4 days) and cisplatin (60 mg/m2 on day 2) was repeated every 3 weeks. Results One (3.6%) patient showed complete response, 8 (28.6%) partial response, 14 (50%) stable disease and 5 (17.9%) disease progression. Overall, the objective response rate was 32.1% (95% CI, 17.9–50.6%) and the disease control rate was 82.1% (95% CI, 64.4–92.1%). Median progression-free survival and overall survival were 7.6 months (95% CI, 5.5–9.7) and 11.2 months (95% CI, 6.8–15.5), respectively. G3/4 neutropenia was observed in 44 (24.3%) of 181 cycles and G3/4 thrombocytopenia in 48 (26.5%) of 181 cycles. There was no treatment-related mortality. Conclusions The combined regimen of gemcitabine, 5-fluorouracil and cisplatin has comparable activity for patients with advanced cancer of the bile duct, gallbladder and ampulla of Vater. Toxicity was tolerable but substantial.

Objectives Many chronic kidney disease (CKD) patients have persistent overt proteinuria despite angiotensin receptor blocker (ARB) treatment. This study investigated whether the initial difference in intrarenal renin–angiotensin system activity measured with urinary angiotensinogen would affect the antiproteinuric effects of ARB. Methods Between September 2005 and September 2008, in 50 non-diabetic proteinuric CKD patients not taking renin–angiotensin system inhibitors, the urinary protein/creatinine ratio (P/Cr), angiotensinogen/creatinine ratio (AGT/Cr), plasma renin and aldosterone were measured before starting valsartan, and were followed for 18 months. Results Patients were divided into three groups according to their initial urinary AGT/Cr. The urinary P/Cr was lower in the low angiotensinogen group, but similar in the high and extremely high angiotensinogen groups (1.3±0.38 vs 2.0±0.92 vs 2.2±0.78). In all groups, the urinary P/Cr was decreased most for the first 6 months. The urinary P/Cr reduction at 6 months was greatest in the high angiotensinogen group (−24.2% vs −46.2% vs −16.4%). The urinary AGT/Cr was decreased most in the high angiotensinogen group. Renal functional deterioration was attenuated in the high angiotensinogen group compared with the extremely high angiotensinogen group. Conclusions The antiproteinuric effects of ARB were different according to the initial urinary angiotensinogen levels. These results suggest the potential value of the initial urinary AGT/Cr for predicting the therapeutic effect of ARB in proteinuric non-diabetic CKD patients.

BACKGROUND/AIMS As the population ages, endoscopic retrograde cholangiopancreaticography (ERCP) is being used increasingly as a diagnostic and therapeutic tool for elderly patients with pancreatobiliary disease. The aim of this study was to assess the outcomes, safety and complications associated with ERCP performed in the elderly patients. METHODS We retrospectively reviewed the medical record of 596 patients who were 50 years of age or older and underwent ERCP from January 2005 to September 2010. The patients were classified into two groups according to the age: non-elderly, 50-74 years old and elderly, ≥75 years old. Comparisons were made between two groups. RESULTS Five hundred and ninety-six patients (132 elderly and 464 non-elderly patients) were enrolled. The success rate of ERCP was 89.4% in the elderly and 91.9% in the non-elderly. The major complications were occurred in 11 patients of the elderly and 16 of the non-elderly, and the complication rate was significantly higher in the elderly compared to the non-elderly (8.3% vs. 3.4%, p=0.011). Pancreatitis occurred in 2 elderly patients and 10 non-elderly patients (1.5% vs. 2.1%, p=1.0). There was a higher rate of bleeding in the elderly patients (4.5% vs. 1.3%, p=0.01). CONCLUSIONS ERCP is effective and safe even in elderly patients. Outcomes of diagnostic and therapeutic ERCP in the elderly patients were similar to those in non-elderly patients. Elderly patients undergoing ERCP carried similar risk of pancreatitis but a higher risk of bleeding and perforation compared to non-elderly patients.

Adiponectin plays an important role in the regulation of body weight, insulin sensitivity, lipid metabolism, and the inflammatory response. Adiponectin is elevated in hemodialysis patients. We investigated the association between altered serum adiponectin levels and the nutritional-inflammation status of hemodialysis patients. Forty-four hemodialysis patients (21 men and 23 women; mean age 53.9 ± 9.2 years) were enrolled and 32 healthy volunteers were included as the control group. Serum adiponectin was measured using a commercial radioimmunoassay kit. Serum albumin, cholesterol, triglyceride, high-sensitivity C-reactive protein, urea, creatinine, transferrin, lean body mass, fat mass, body mass index (BMI), the subjective global assessment (SGA) score, and the malnutrition-inflammation score (MIS) were measured in all patients. Adiponectin levels were significantly elevated in the hemodialysis patients compared with the healthy subjects (24.8 ± 10.4 μg/mL and 6.8 ± 4.2 μg/mL, respectively, p < 0.0001). Serum adiponectin correlated positively with SGA (r = 0.47) and MIS (r = 0.38), and negatively with BMI (r = -0.34), triglyceride (r = -0.53), and glucose levels (r = -0.42). Serum adiponectin levels were significantly higher in malnourished patients than in well-nourished patients when assessed with SGA (20.5 ± 10.4 μg/mL and 29.0 ± 8.7 μg/mL, respectively, p = 0.005). In conclusion, serum adiponectin levels reflect the nutritional-inflammation status of hemodialysis patients. Adiponectin may also be associated with insulin resistance, dyslipidemia, and the inflammatory response in these patients.

Gemcitabine has been the standard regimen for advanced pancreatic cancer, but the effect on the response rate and survival is still disappointing, leading to many trials of combination chemotherapy. 5-FU and cisplatin were combined with gemcitabine in this trial, as they are synergistic with gemcitabine and each other as well. This study was aimed to assess the effectiveness and safety of combination chemotherapy with gemcitabine, 5-FU, and cisplatin for advanced pancreatic cancer.Patients with advanced pancreatic cancer were entered into this study. Gemcitabine at a dose of 800 mg/m2 on day 1 and 8, 5-FU 1,000 mg/m2/day from day 1 to 3 for 72 hours, and cisplatin 60 mg/m2 on day 2, 24 hours after the start of gemcitabine were administered every 3 weeks.From December 2001 to January 2004, twenty patients were enrolled in this study. Among 17 of these patients assessable, 3 patients had a partial remission with the response rate of 23.6% (95% confidence interval, 6.2-41.0%). The median time to disease progression was 230 days and median duration of survival was 322 days. Among total of 91 cycles, leukopenia, neutropenia, and thrombocytopenia of grade 3 or 4 occurred in 12 cycles (13.2%), 12 cycles (13.2%), and 23 cycles (24.4%), respectively. Grade 3 or 4 mucositis developed at 2 cycles (2.2%), and nausea and vomiting were encountered in 3 cycles (3.3%).Combination chemotherapy with gemcitabine, 5-FU, and cisplatin for advanced pancreatic cancer is active and well-tolerated, warranting a phase III study.

To compare survival rates and long-term complications after bone marrow transplantation (BMT) or treatment with immunosuppressive agents (ISA) in the management of adult aplastic anemia (AA) and to identify prognostic factors associated with improved survival, we evaluated 229 adult AA patients treated with ISA from 1990 to 2001 and compared the results with those for 64 BMT recipients. Of 156 patients with severe aplastic anemia (SAA) or very severe AA treated with ISA (antithymocyte globulin [ATG] or ATG plus cyclosporine), 46.8% showed complete or partial response and 7.1% had relapses. After long-term follow-up, 1 case each of acute leukemia, myelodysplastic syndrome, and paroxysmal nocturnal hemoglobinuria developed. The 6-year survival rate was 69%. Response to ISA, disease severity, and low absolute neutrophil count (ANC) (or = 200/mm3) were associated with poor survival. Patient age, sex, initial platelet count, etiology, or treatment regimen did not significantly affect survival. Cox regression analysis showed low ANC to be the only pretreatment variable significantly associated with poor survival (P = .000). Of 64 BMT recipients, 82.8% had sustained engraftment, and 12.5% experienced graft failure. Twenty (31.3%) of the patients developed grade II to IV acute graft-versus-host disease (GVHD), and 12 (18.8%) of the patients developed chronic GVHD. The 6-year survival rate was 79%. Patient age and sex, disease severity, etiology, ANC, initial platelet count, and treatment regimen did not affect survival. Survival of 83 AA patients, aged 14 to 40 years, treated with ISA was not statistically significant from that of 61 adult AA patients who underwent BMT (6-year survival rate, 65% and 79%, respectively). However, BMT in adult AA achieved long-term engraftment and a lower relapse rate than ISA. These results suggest that ISA can achieve a high response rate and long-term survival among patients with adult AA, regardless of disease severity. Further studies with larger numbers of patients and long-term follow-up are needed.