Showing papers by "Tadahiro Takada published in 2002"

Is Postoperative Adjuvant Chemotherapy Useful for Gallbladder Carcinoma? A Phase III Multicenter Prospective Randomized Controlled Trial in Patients with Resected Pancreaticobiliary Carcinoma

Abstract: BACKGROUND To the authors' knowledge, the significance of postoperative adjuvant chemotherapy in pancreaticobiliary carcinoma has not yet been clarified. A randomized controlled study evaluated the effect of postoperative adjuvant therapy with mitomycin C (MMC) and 5-fluorouracil (5-FU) (MF arm) versus surgery alone (control arm) on survival and disease-free survival (DFS) for each specific disease comprising resected pancreaticobiliary carcinoma (pancreatic, gallbladder, bile duct, or ampulla of Vater carcinoma) separately. METHODS Between April 1986 and June 1992, a total of 508 patients with resected pancreatic (n = 173), bile duct (n = 139), gallbladder (n = 140), or ampulla of Vater (n = 56) carcinomas were allocated randomly to either the MF group or the control group. The MF group received MMC (6 mg/m2 intravenously [i.v.]) at the time of surgery and 5-FU (310 mg/m2 i.v.) in 2 courses of treatment for 5 consecutive days during postoperative Weeks 1 and 3, followed by 5-FU (100 mg/m2orally) daily from postoperative Week 5 until disease recurrence. All patients were followed for 5 years. RESULTS After ineligible patients were excluded, 158 patients with pancreatic carcinoma (81 in the MF group and 77 in the control group), 118 patients with bile duct carcinoma (58 in the MF group and 60 in the control group), 112 patients with gallbladder carcinoma (69 in the MF group and 43 in the control group), and 48 patients with carcinoma of the ampulla of Vater (24 in the MF group and 24 in the control group) were evaluated. Good compliance (> 80%) was achieved with MF treatment. The 5-year survival rate in gallbladder carcinoma patients was significantly better in the MF group (26.0%) compared with the control group (14.4%) (P = 0.0367). Similarly, the 5-year DFS rate of patients with gallbladder carcinoma was 20.3% in the MF group, which was significantly higher than the 11.6% DFS rate reported in the control group (P = 0.0210). Significant improvement in body weight compared with the control was observed only in patients with gallbladder carcinoma. There were no apparent differences in 5-year survival and 5-year DFS rates between patients with pancreatic, bile duct, or ampulla of Vater carcinomas. Multivariate analyses demonstrated a tendency for the MF group to have a lower risk of mortality (risk ratio of 0.654; P = 0.0825) and recurrence (risk ratio of 0.626; P = 0.0589). The most commonly reported adverse drug reactions were anorexia, nausea/emesis, stomatitis, and leukopenia, none of which were noted to be serious. CONCLUSIONS The results of the current study indicate that gallbladder carcinoma patients who undergo noncurative resections may derive some benefit from systemic chemotherapy. However, alternative modalities must be developed for patients with carcinomas of the pancreas, bile duct, or ampulla of Vater. Cancer 2002;95:1685–95. © 2002 American Cancer Society. DOI 10.1002/cncr.10831

Biliary tract cancer treatment: results from the Biliary Tract Cancer Statistics Registry in Japan.

Abstract: Background/Purpose: A registry project for cancers of the biliary tract accumulated a total of 11 030 cases for 10 years. In the present study, registered cases were analyzed for information bearing on problems with the treatment of cancer of the biliary tract. The Japanese classification of lymph nodes was also considered on the basis of the results of this study. Methods: In 11 030 cases, the site of cancer was the gallbladder in 4774, the bile duct in 4833, and the papilla of Vater in 1423. Those cases were analyzed with regard to patient survival according to the stage of disease and the extent of lymph node metastasis. Results: More than 11 000 cases of cancer of the biliary tract have been registered to date from 158 member institutions of the Japanese Society of Biliary Surgery. While the 5-year survival rates for stage I gallbladder cancer and cancer of the papilla were 77% and 75%, respectively, those for stage I hilar or upper bile duct cancer and middle or lower bile duct cancer were 47% and 54%. For stage II and stage III disease, the 5-year survival rates were about 50% for gallbladder cancer and 30% or higher for cancer of the papilla, while survival was only 20% to 30% for bile duct cancer, regardless of specific site. For stage IV, the 5-year survival rate was unexpectedly high, being about 10% or higher for cancers at all sites, with 19% for cancer of the papillary region being the highest. Thus, there still seem to remain surgical indications for stage IV cancers. The lymph node metastasis rate was about 40% for cancers at all sites. Changes in surgical procedures to improve the 5-year survival rate in patients with n2 metastasis or less will be needed. Noncurative resection occurred frequently for cancers at all sites, particularly in cancers of the hilar or upper bile duct, accounting for 60% of cases or more. We have to recognize that measures to reduce inadvertent noncurative resection are fundamental to the treatment of cancer. Conclusions: Considering the survival results according to specific lymph nodes involved, we concluded that the Japanese classification of lymph nodes, particularly hepatoduodenal ligament lymph nodes, should be reexamined, while another procedure to remove such lymph nodes completely should be developed.

Evidence-based clinical practice guidelines for acute pancreatitis : proposals

Abstract: Background/Purpose: To provide a framework for clinicians to manage acute pancreatitis, evidence-based guidelines have been developed by the Japanese Society of Abdominal Emergency Medicine. Methods: Evidence was collected by a systematic search of MEDLINE and Japana Centra Revuo Medicina. A total of 1348 papers were reviewed and levels of evidence were assessed. Practical recommendations were also graded. Results: The present guidelines consist of introductions, a summary of recommendations, practice algorithms, definitions, epidemiology, diagnosis, severity assessment, and therapy. The main points of recommendation in these guidelines are: (1) measuring lipase for the diagnosis of acute pancreatitis (recommendation grade [RG], A). (2) The Severity of acute pancreatitis should be assessed using a scoring system, such as that of the Japanese Ministry of Health and Welfare or Acute Physiology and Chronic Health Evaluation (APACHE) II (RG, A). (3) Enhanced computed tomography (CT) should be used for assessment of degree of pancreatic necrosis and inflammation (RG, B). (4) Prophylactic antibiotic administration should be used for severe pancreatitis (RG, A), but not for mild to moderate pancreatitis (RG, D). (5) Gabexate mesilate should be used for severe pancreatitis (RG, B). (6) Enteral feeding should be used for all pancreatitis (RG, B). (7) Continuous hemodiafiltration and continuous arterial infusion of proteinase inhibitor and antibiotics may be of benefit (RG, C). (8) Fine-needle aspiration should be done for the diagnosis of infectious pancreatic necrosis, and if positive, necrosectomy is indicated (RG, A). Conclusions: These guidelines provide useful information for physicians to manage this troublesome disease.