We report a case of advanced gastric carcinoma treated successfully by four courses of neoadjuvant chemotherapy (NAC) with paclitaxel and cisplatin. The patient was a 43-year-old man with advanced ...gastric cancer, clinically diagnosed as P0H0M0CY0T3N2, which had invaded the upper body of the stomach and esophagus. He was entered into a clinical trial and received the following NAC regimen: paclitaxel 80 mg/m
2
, and cisplatin 25 mg/m
2
, on days 1, 8, and 15, followed by a rest on day 22, as one course. The lymph nodes had reduced in size to 59% after two courses and to 40% after four courses, with no sign of severe toxicity. Subsequently, he underwent D2 total gastrectomy with pancreatico-splenectomy. On microscopic examinations, no tumor cells were detected in the ulcer scar of the resected stomach or the regional lymph nodes. Thus, we discuss the potential of long-term NAC, especially for responders to two initial courses.
The current study evaluates the indices of glucose control for diabetics (i.e., glycated albumin (GA), hemoglobin A1c (HbA1c), plasma glucose (PG) and immuno-reactive insulin (IRI)) in non-diabetic ...children from a population-based cohort, and compares those values according to the presence of obesity to examine any differences in these indices.
GA, HbA1c, casual PG and casual IRI in obese children (
n
=
209) were compared to those of non-obese children (
n
=
1060) in Ina town, Saitama Prefecture, in 2002–2003.
In obese children, the levels of HbA1c, PG and IRI were statistically higher when compared to those of non-obese children. In contrast, the median and intra-quartile range (IQR) of GA of obese children (13.6%: 12.6–14.7) was statistically lower when compared to that of non-obese children (14.3%: 13.5–15.4,
p
<
0.001). The low GA (%) in obese children is mainly due to the low absolute value of GA (g/dl) rather than a higher albumin value (g/dl).
This is the first report to reveal that GA levels are low in obese, non-diabetic children. Additional data collection and an experimental approach are necessary to reveal the reasons behind lower GA levels in obese children.
This randomized Phase II trial compares neoadjuvant chemotherapy of two or four courses of S-1 (1 M tegafur–0.4 M gimestat–1 M ostat potassium) plus cisplatin or paclitaxel plus cisplatin by a ...two-by-two factorial design for patients with macroscopically resectable locally advanced gastric cancer. The primary endpoint is the 3-year overall survival. The sample size is 60–80 in a total for two hypotheses of the superiority of four courses to two courses and the superiority of paclitaxel plus cisplatin to S-1 plus cisplatin. In both arms, S-1 is strongly recommended post-operatively for at least 6 months but no adjuvant chemotherapy is permitted other than S-1 until recurrence. This trial could appraise more suitable cycles and regimen as neoadjuvant chemotherapy for gastric cancer.
Owing to its peculiar pharmacological characteristics, paclitaxel attains substantial intra-peritoneal concentration for a prolonged period when delivered intra-peritoneally, and is active against ...peritoneal metastasis of ovarian cancer. It is also considered promising against disseminated gastric cancer. However, the fact that the intra-peritoneal paclitaxel has not been approved in Japan has rendered its evaluation by a formal clinical trial impossible. The authors designed a randomized phase II trial using the Kodo Iryo Hyoka system, a new system to legally test an yet unapproved mode of treatment. It is hoped that this trial will result in a breakthrough in the treatment of peritoneal carcinomatosis from gastric cancer.
Abstract This study examined the relationships between serum adiponectin (AD) and leptin (LP) levels, and obesity using a population-based cohort consisted of 315 (9–10 year olds: G1) and 308 (12–13 ...year olds: G2) school children. Serum AD, LP and other markers were compared according to the presence of obesity. The prevalence rates of obesity were 14.9% in G1 and 9.4% in G2. The medians of serum AD (μg/dl: non-obese/obese) were statistically lower in obese children (9.6/8.3 in G1, p < 0.05; 8.9/6.6 in G2, p < 0.05), and the medians of serum LP (ng/dl) were statistically higher in obese children (3.7/12.5 in G1, p < 0.05; 2.9/8.4 in G2, p < 0.05). The serum LP levels were significantly positively correlated with percent overweight (POW) irrespective of age and sex, and the serum AD levels were significantly negatively correlated with POW except for boys in G1. Multivariate regression analyses revealed that LP, LDL-cholesterol and gender in G1, and LP, AD, blood pressure and gender in G2 were significantly correlated with POW. A large-scale, population-based study revealed that AD was lower and LP higher in obese children, and that the obese status in G2 was related to a worse metabolic profile than the case in G1.
Paclitaxel, S1 and their combined sequential administration is proposed to be examined installing UFT as an active control of adjuvant chemotherapy for curatively resected T3–4 gastric cancer in a ...multicenter Phase III trial. The primary endpoint is disease-free survival and the secondary endpoints are incidence of adverse events, overall survival and compliance. The sample size is 370 per treatment arm (1480 in total) for two hypotheses of the superiority of sequential use of paclitaxel followed by oral fluoropyrimidines to fluoropyrimidines (UFT/S1) alone and the non-inferiority of S1 to UFT to be tested by two-by-two factorial design. Abdominal CT or US is performed every 3 months in the first 2 years and every 6 months thereafter for 3 years in total to ensure recurrence data collection. This trial could appraise sequential combination therapy and efficacy of new drugs as adjuvant for gastric cancer treatment.
The large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin ...injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy.
In PROBE (Prospective, Randomized, Open, Blinded-Endpoint) design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range) age: 64.5(56.8-71.0)years) with secondary failure of sulfonylurea (SU) were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group) or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group), and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT) of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups.
After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1-11.3) --> 7.4(6.9-8.7)%, p < 0.01, vs BB;8.9(7.7-10.0) --> 6.9(6.2-7.3)%, p < 0.01), with no significant difference between the groups in percentage change in HbA1c (30 Mix; -14.7(-32.5- (-)7.5)% vs BB -17.8(-30.1- (-)11.1)%, p = 0.32). There was a significant decrease in daily glycemic profile at all points except dinner time in both groups compared to baseline. There was a significant increase in the amount of insulin used in the 30 Mix group after treatment compared to baseline (30 Mix;0.30(0.17-0.44) --> 0.39(0.31-0.42) IU/kg, p = 0.01). There was no significant difference in IMT, BMI, QOL or adiponectin levels in either group compared to baseline.
Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure.
Current Controlled Trials number, NCT00348231.
Asians are particularly susceptible to obesity-associated disorders and rapid progression of obesity from childhood to adulthood. Data on the association between adipocytokine parameters, ...particularly adipocytokine ratios, and cardiovascular risk factors in childhood remain limited. Herein, we assessed the association of resistin, adiponectin, and leptin levels and leptin/adiponectin and resistin/adiponectin ratios with selected cardiovascular risk factors and the influence of unhealthy weight on such associations in children aged 9-10 years.
We included 380 children aged 9-10 years from three public elementary schools in Japan.
The body mass index (BMI) was significantly higher in male preadolescents than in female adolescents (median 16.5 kg/m
vs. 16.2 kg/m
, p=0.032). No differences in height, weight, waist circumference (WC), waist/height ratio (W/Hr), total cholesterol and high-density lipoprotein cholesterol levels, or atherosclerosis index (AI) were observed between the sexes. Of the adipocytokine levels and ratios analyzed, only the leptin level and leptin/adiponectin ratio (L/Ar) were strongly and significantly positively correlated with the cardiovascular risk factors WC, W/Hr, and BMI (all p<0.05). The AI was not strongly correlated with any adipocytokine levels or ratios. Apart from the strong positive correlation between the L/Ar and W/Hr, no other significant associations were observed between any of the adipocytokine levels or ratios and the selected cardiovascular risk factors.
Our findings confirmed the value of adipocytokine ratios in risk assessment in pediatric populations, with leptin levels and leptin/adiponectin ratios strongly correlating with risk factors in children aged 9-10 years.
Tsunan, Niigata is a non-westernized rural Japanese town, known for heavy snowfalls and as a rice-producing area, whose inhabitants have a long life expectancy. We investigated the prevalence of ...obesity, metabolic syndrome (MetS) and its components in Tsunan. A total of 1,155 men and women, 40-69 years of age were recruited from participants in the 2005 public-health program in Tsunan. Obesity was defined as body-mass index (BMI) ≥ 25 kg/m2. MetS was defined as BMI ≥ 25 kg/m2 as well as at least two of the following three items: (1) high glycosylated hemoglobin (HbA1c ≥ 5.5%); (2) high blood pressure (HBP: systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg), and (3) low high-density lipoprotein cholesterol (HDL-C < 40 mg/dL). If an individual was diagnosed with diabetes, hypertension, or dyslipidemia, each item was recorded as a positive finding. The prevalence of MetS and its components among Tsunan inhabitants were compared to the results of the 2005 Japanese nationwide survey. The prevalence of MetS was 4.6% in males and 4.2% in females. The prevalence of obesity, high HbA1c, HBP, and low HDL-C were 22.1/22.2%, 13.4/16.4%, 46.6/40.0%, and 9.2/3.9% in males/females, respectively. All values were significantly lower than the national results, except for the rate of female obesity. The lower prevalence of MetS and its components in Tsunan may be due to the consumption of traditional Japanese food, which is still commonly eaten there, and the higher levels of regular physical activity of farmers.
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