A total of 478 resected gastric cancer cases were studied. The male-female ratio was 1.6, -294 males and 184 females. The patients were divided into two groups, namely, the elderly group (patients aged 70 and over) and the non-elderly group (patients aged 69 and below). In the elderly group males were predominant over females. The number of elderly patients accounted for 34.1% of the total number of stomach cancer cases. This percentage is higher than the national average. In the elderly group, cases detected by stomach health screening or health diagnosis tests were a few, but many cases were in stage IV. The number of inoperable cases was somewhat high, radical gastrectomy was performed on a few of the patients, and the resection rate was somewhat low. A tendency was observed for multiple cancer focuses ; in regard to the regions of occupation or spreading and tissue type, the upper region was less likely and the lower region was more likely to be affected, the anterior wall and the circle were likely to be affected. A tendency was observed for the localization of highly differentiated tissue in the patients. Although no difference was observed in the direct surgical mortality rate, the 5 year survival rate was unfavorable, suggesting the patients might have died due to other diseases. In the elderly group, those who suffered from diseases and preoperative complications comprised 92% of the total, and abnormalities during preoperative examinations were detected in 96% of these patients. Postoperative complications developed in 42%. Postoperatively, psychological problems must be taken into consideration. In elderly patients who are operable, although it is desirable to actively perform surgery aiming at radical operations, it is thought necessary to cope carefully with resection of the stomach. If a radical operation is performed after carefully evaluating preoperative risks and with adequate preparations, it is thought possible for elderly patients to achieve favorable therapeutic results and improvement in their QOL differing little from non-elderly patients.

Study was made on total of 304 cases of cancer of the large intestine resected during the period of 12 years from 1978 to 1989.
Colon cancer accounted for 56.8% of the total and rectal cancer 43.2%. There were no sexual differences. Those people aged 50 and older represented 86.0% of the total number of the cases. By age group, those in their 60s topped the list with 27.3%, followed by those in 70s with 24.4%. Almost all the cases (95.1%) were of the patients who had visited the hospital, having noticed symptoms themselves. A very few cases were detected among the people without subjective symptoms when they received group medical Checkups.
By region, 39.4% of the colon cancer cases were found in S, followed by A. In the cases of rectum cancer, Rb accounted for 50.7%. Of the total caces, 74.5% had cancer on the left side of the large intestine.
Resection rate was 91.5%. The rate of resection leading to cure was 71.8%. Broken down by histological staging, stage I came to 11.7%; stage II, 30.9%; stage III, 21.8%; stage IV, 11.7%; stage V, 23.8%.
The 5-year-survival rete averaged 57.1%. In pre-surgery tests, the positive rate of CEA was as low as 46.6%. The positive rate for early cancer was extremely low. Measurement of CEA levels as an auxiliary diagnosis, therefore, did not prove itself to be useful in searching for cancer.

Liver metastases from colorectal carcinoma commonly form nodular lesions in the liverparenchyma. We report a case of liver metastasis from rectal adenocarcinoma that extendedpredominantly into the bile duct. A 62-year-old Japanese man underwent low anteriorresection for rectal adenocarcinoma 9 years ago. Approximately 3 years later, he underwentradiofrequency ablation therapy for a metastatic liver tumor. Nine years after surgery, atumor in liver segment III exhibiting intrabiliary extension was discovered; it wasunclear if this was a metastatic liver tumor or intrahepatic cholangiocarcinoma.Accordingly, we performed a left hepatectomy with lymph node dissection. The tumor wasnegative for cytokeratins 7 and 20, and was histologically similar to the primary rectaladenocarcinoma; it was diagnosed as rectal carcinoma metastasis. The patient has survivedfor 3 years after the hepatic surgery, for 9 years after radiofrequency ablation therapy,and for 12 years after the primary surgery. This case shows that liver metastasis fromcolorectal carcinoma can present as a predominantly intrabiliary growth that mimicsintrahepatic cholangiocarcinoma on imaging. Moreover, our case provides evidence for thesuperiority of anatomical hepatectomy over partial hepatectomy for metastatic liver tumorswith intrabiliary growth arising from rectal adenocarcinomas.

MHLW released a guideline for Risk Management Plan (RMP) in April 2012, in order to manage the risk of pharmaceutical products from the development stage towards post marketing period. The guideline suggests to determine Safety Specification and to develop Pharmacovigilance Plan (PVP) and Risk Minimization Plan aligned to the ICH E2E guideline. However, in some of the RMPs, which had been published online (as of August 2014), conventional (Special) Drug Use Results Surveys are planned as a “universal” PVP regardless of the impact, severity and characteristics of the risks. Our JPMA taskforce (Data Science Expert Committee) summarized report and published in August 2014. In this report, we explained how to evaluate safety events based on evidence level for safety specification and how to develop PVP. Also, we would like to propose KAIZEN activities for RMP improvement as follows:
1. In order to clarify the research question, rationale and evidence for safety specification should be evaluated carefully.
2. It is essential to be considered in advance how to collect and analyze the safety data for detecting safety specification during clinical development.
3. Safety profiles should be discussed thoroughly on DSUR development among stakeholders in order to clarify safety specification at NDA. Research questions for each different risk and missing information should be established according to PECO, which will flow into appropriate PVP planning.
4. Continuous PDCA cycling is critical for RMP. The first survey or research will bring you next research question (s).
We expect all stakeholders, including clinical development specialists in industry, regulatory authorities, and academia, to have better understating of RMP principle and to manage and implement it more appropriately in a scientific manner.

Background/Aims: Thiopurines are key drugs for inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). Recently, NUDT15 polymorphism (R139C, c.415C > T) has been shown to be associated with thiopurineinduced adverse events in Asian populations. In patients with the C/T genotype, low-dose thiopurine treatment is recommended, but its long-term efficacy and tolerability remain unclear. This study aimed to uncover the long-term efficacy and appropriate dosage of thiopurine for IBD patients with the C/T genotype. Methods: A total of 210 patients with IBD (103 UC and 107 CD) determined to have NUDT15 R139C variants were enrolled. Clinical data were retrospectively reviewed from medical records. Results: Of 46 patients (21.9%) with the C/T genotype, 30 patients (65.2%) were treated with thiopurines. Three of whom (10.0%) discontinued thiopurine treatment due to adverse events and 27 of whom continued. The median maintenance dosage of 6-mercaptopurine was 0.25 mg/kg/day (range, 0.19–0.36 mg/kg/day), and 6-thioguanine nucleotides level was 230 (104–298) pmol/8 × 108 red blood cells. Cumulative thiopurine continuation rates for 120 months for patients with the C/C and C/T genotypes were not significantly different (P= 0.895). Cumulative non-relapse rates in the patients with UC treated with thiopurine monotherapy and surgery-free rates in CD patients treated with combination therapy (thiopurines and anti-tumor necrosis factor-α agents) for maintenance remission were not significantly different at 60 months (C/C vs. C/T, P= 0.339 and P= 0.422, respectively). Conclusions Low-dose thiopurine treatment is an effective and acceptable treatment for patients with C/T genotype.