Treatment Rationale and Study Design for Clinical Trial on the Efficacy of UFT/LV for Stage II Colorectal Cancer With Risk Factors for Recurrence (JFMC46-1201).

BACKGROUND: The usefulness of adjuvant chemotherapy for stage II colon cancer has not been established. Meanwhile, the presence of stage II colon cancer with high-risk factors for recurrence has been reported. To our knowledge, no prospective study of adjuvant chemotherapy for stage II colon cancer with high-risk factors has been implemented to date. PATIENTS AND METHODS: This study is a prospective nonrandomized controlled study based on patients' selection of treatment option, including randomized therapeutic decision-making, to evaluate the usefulness of adjuvant chemotherapy with tegafur-uracil (UFT) with leucovorin (LV) for stage II colon cancer with high-risk factors for recurrence, compared with surgery alone. Five courses of UFT/LV therapy will be given as follows: UFT (300 mg/m(2)/d) with LV (75 mg/d) will be orally administered in 3 doses per day. Treatment will be received daily for 28 days, followed by a 7-day rest or will be received daily for 5 days, followed by a 2-day rest. For both regimens, 1 course will last 5 weeks, and 5 courses will be given. The primary end point is disease-free survival. A propensity score matching will be conducted based on 7 variables that represent risk factors to minimize selection bias in a comparison between the nonrandomized arms. For this nonrandomized comparison, a target sample size is set at 1200 (400 and 800 patients for the surgery alone and UFT/LV groups, respectively) and 1720 patients will be enrolled. In this study we aim to evaluate the therapeutic usefulness of adjuvant chemotherapy with UFT/LV for stage II colorectal cancer with risk factors for recurrence.

Safety analysis of two different regimens of uracil-tegafur plus leucovorin as adjuvant chemotherapy for high-risk stage II and III colon cancer in a phase III trial comparing 6 with 18 months of treatment: JFMC33-0502 trial.

PURPOSE: The JFMC33-0502 trial is a phase III clinical study designed to determine the most appropriate duration of postoperative adjuvant chemotherapy with uracil-tegafur (UFT) plus leucovorin in patients with stage IIB or III colon cancer. We report the interim results of preplanned safety analyses. METHODS: Patients with stage IIB or III colon cancer who had undergone curative resection were randomly assigned to receive UFT (300 mg/m(2)) plus leucovorin (75 mg/day) for 6 months (control group, 4 weeks of treatment followed by a 1-week rest, five courses) or for 18 months (study group, 5 days of treatment followed by a 2-day rest, 15 courses). Treatment status and safety were evaluated. RESULTS: A total of 1,071 patients were enrolled, and 1,063 were included in safety analyses. Treatment completion rate at 6 months was 74.0 % in the control group and 76.7 % in the study group. Treatment completion rate in the study group at 18 months was 56.0 %. The overall incidence of adverse events (AEs) was 75.3 % in the control group and 77.6 % in the study group. The incidences of grade 3 or higher AEs were low in both groups. During the first 6 months, the incidences of the subjective AEs were significantly lower in the study group. CONCLUSIONS: Oral UFT plus leucovorin given by either dosage schedule is a very safe regimen for adjuvant chemotherapy. In particular, 5 days of treatment followed by a 2-day rest was a useful treatment option from the viewpoint of toxicity even when given for longer than 6 months.

Number of lymph nodes retrieved is an important determinant of survival of patients with stage II and stage III colorectal cancer.

OBJECTIVE: The number of lymph nodes retrieved is recognized to be a prognostic factor of Stage II colorectal cancer. However, the prognostic significance of the number of lymph nodes retrieved in Stage III colorectal cancer remains controversial. METHODS: The relationship between the number of lymph nodes retrieved and clinical and pathological factors, and significance of the number of lymph nodes retrieved for prognosis of Stage II and III colorectal cancer were investigated. A total of 16 865 patients with T3/T4 colorectal cancer who had R0 resection were analysed. RESULTS: The arithmetic mean of the number of lymph nodes retrieved of all cases was 20.0. The number of lymph nodes retrieved were varied according to several clinical and pathological variables with significant difference, and the greater difference was observed in scope of nodal dissection. Survival of Stages II and III was significantly associated with the number of lymph nodes retrieved. Five-year overall survival of the patients with ≤ 9 of the number of lymph nodes retrieved and those with >27 differed by 6.4% for Stage II colon cancer, 8.8% for Stage III colon cancer, 12.5% for Stage II rectal cancer and 10.6% for Stage III rectal cancer. With one increase in the number of lymph nodes retrieved, the mortality risk was decreased by 2.1% for Stage II and by 0.8% for Stage III, respectively. The cut-off point of the number of lymph nodes retrieved was not obtained. CONCLUSIONS: The number of lymph nodes retrieved was shown to be an important prognostic variable not only in Stage II but also in Stage III colorectal cancer, and it was most prominently determined by the scope of nodal dissection. A cut-off value for the number of lymph nodes retrieved was not found, and it is necessary to carry out appropriate nodal dissection and examine as many lymph nodes as possible.

Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC).

OBJECTIVE: In the latter 1990s, adjuvant chemotherapy for completely resected Stage III colorectal cancer remained controversial in Japan. We conducted two independent randomized controlled trials in patients with Stage III colon and rectal cancer. METHODS: Patients were randomly assigned to receive surgery alone or surgery followed by treatment with UFT (400 mg/m²/day), given for five consecutive days per week for 1 year. The primary endpoint was relapse-free survival (RFS), and the secondary endpoint was overall survival (OS). RESULTS: A total of 334 patients with colon cancer and 276 with rectal cancer were enrolled. The patients' characteristics were similar between the UFT group and the Surgery-alone group. There was no significant difference in RFS or OS in colon cancer. In rectal cancer, however, RFS and OS were significantly better in the UFT group than in the Surgery-alone group. The only grade 4 toxicity in the UFT group was diarrhea, occurring in one patient with colon cancer and one patient with rectal cancer. CONCLUSIONS: Postoperative adjuvant chemotherapy with UFT is successfully tolerated and improves RFS and OS in patients with Stage III rectal cancer. In colon cancer, the expected benefits were not obtained (hazard ratio = 0.89).

Randomized trial of the efficacy of adjuvant chemotherapy for colon cancer with combination therapy incorporating the oral pyrimidine 1-hexylcarbamoyl-5-fluorouracil.

BACKGROUND AND AIMS: The purpose of the present trial was to clarify the efficacy of postoperative adjuvant chemotherapy including an oral fluoropyrimidine anticancer drug, the 1-hexylcarbamoyl-5-fluorouracil (HCFU), for the treatment of colon cancer. METHOD: Patients with clinical stage Dukes' B and C colon cancer, who had been treated surgically, were assigned to a chemotherapy group treated with mitomycin C, 5-fluorouracil (5-FU), and HCFU and to a control group that received no postoperative adjuvant chemotherapy. RESULTS: Of the 1,001 patients registered for the study, 17 (1.7%) were ineligible. The incidence of toxicity was significantly higher in the chemotherapy group than in the control group. However, there were few severe side effects and no deaths related to the treatment. Overall survival showed no significant difference between the groups. The disease-free survival or the recurrence-free intervals was significantly higher in the chemotherapy group than in the control group. The incidence of hepatic recurrence was significantly (P=0.003) lower in the chemotherapy group than in the control group. CONCLUSION: The results of this study demonstrated the efficacy of adjuvant chemotherapy for colon cancer, i.e., combined chemotherapy that included the 5-FU oral anticancer drug HCFU.

Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial.

BACKGROUND: Although adjuvant radiotherapy was proved to be effective for local control of rectal cancer even after standardized mesorectal excision, the role of adjuvant chemotherapy after such standardized surgery remains to be clarified. We aimed to assess the efficacy of a combination of uracil and tegafur for pathological stage III rectal cancer treated by standardized mesorectal excision with selective lateral pelvic lymphadenectomy. METHODS: We randomly assigned patients with completely resected stage III rectal cancer, who underwent standardized mesorectal excision with selective lateral pelvic lymphadenectomy, to receive either oral uracil-tegafur (400 mg/m2 tegafur per day) for one year or no treatment. Standardization and quality control of the surgery and pathological techniques were ensured by use of the guidelines of the Japanese Society for Cancer of the Colon and Rectum. The primary endpoint was relapse-free survival. The secondary endpoint was overall survival. RESULTS: We enrolled and randomized 276 patients. Excluding two ineligible patients, 274 were included in the analysis. Planned interim analysis 2 years after accrual termination revealed significant prolongation of relapse-free survival (P = 0.001) and overall survival (P = 0.005) in the uracil-tegafur group. The 3-year relapse-free survival and overall survival rates were 78 and 91% in the chemotherapy group and 60 and 81% in the surgery-alone group, respectively. Local recurrence rates were low in both groups. Grade 3 events occurred in 17% of the chemotherapy patients, but no grade 4 or more events occurred. CONCLUSION: Adjuvant chemotherapy with uracil-tegafur improves survival of patients with stage III rectal cancer after standardized mesorectal excision with selective lateral pelvic lymphadenectomy.

Significance of histologic type of primary lesion and metastatic lymph nodes as a prognostic factor in stage III colon cancer.

PURPOSE: This study was designed to investigate whether the histologic types of the primary lesion and of metastatic lymph nodes in Stage III colon cancer are useful as prognostic factors. The usefulness of adjuvant chemotherapy in a randomized, controlled trial by using these prognostic factors as stratification criteria was also investigated. METHODS: Stage III colon cancer patients were enrolled and were divided into two groups: Group W, in which the histologic type of both primary tumors and metastatic lymph nodes was well-differentiated adenocarcinoma; and Group U, in which the primary tumors and the metastatic lymph nodes were of any type other than well-differentiated. Group W patients were assigned to Treatment Arm A (surgery alone) or Arm B (surgery, then 1-hexylcarbamoyl-5-fluorouracil); and Group U patients, to Treatment Arm C (same as B), and Arm D (surgery + 1-hexylcarbamoyl-5-fluorouracil + mitomycin C). RESULTS: The Group W five-year survival rate was significantly superior to that in Group U (P = 0.0035). There was a better survival rate in Treatment Arm A than Arm B (P = 0.0321), but no difference between Treatment Arms C and D. CONCLUSIONS: In Stage III colon cancer, the prognosis of cases whose primary lesion and lymph node tissues are both well differentiated is extremely good. In such cases, it is possible for adjuvant chemotherapy to have a deleterious effect, and therefore, it is not recommended.

An individual patient data meta-analysis of adjuvant therapy with carmofur in patients with curatively resected colon cancer.

BACKGROUND: Oral carmofur, either as a single or in combination with other chemotherapeutic agents, has been used as adjuvant chemotherapy for curatively resected colon cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with this cancer. The objective of this study was to perform a reappraisal of randomized clinical trials conducted in this regard. METHODS: We designed an individual patient-based meta-analysis of relevant clinical trials to examine the benefit of oral carmofur for curatively resected colon cancer in terms of overall survival (OS) and disease-free survival (DFS). RESULTS: We analyzed individual patient data of three randomized clinical trials, which met the predetermined inclusion criteria. These three trials had a combined total of 2152 patients, carmofur as adjuvant chemotherapy compared with surgery-alone, 5 years follow-up, intention-to-treat-based analytic strategy and similar end points (OS and DFS). In a pooled analysis, 5 year OS rates were 80.4 and 76.4%, and 5 year DFS rates 76.9 and 71.0%, respectively, in carmofur and surgery-alone group. Oral carmofur had significant advantage over surgery-alone in terms of both OS [pooled hazard ratio, 0.82; 95% confidence interval (CI) = 0.68-0.99; P = 0.043] and DFS (pooled hazard ratio, 0.77; 95% CI = 0.65-0.91; P = 0.003). CONCLUSIONS: This individual patient-based meta-analysis demonstrated that oral carmofur significantly improves both OS and DFS in patients with curatively resected colon cancers.

A multicenter randomized study comparing 5-fluorouracil continuous infusion (ci) plus 1-hexylcarbamoyl-5-fluorouracil and 5-FU ci alone in colorectal cancer.

To verify the effectiveness of oral 1-hexylcarbamoyl-5-fluorouracil (HCFU) in improving the surgical cure rate in advanced colorectal cancer, a multicenter randomized comparative study was conducted. A total of 429 patients who had had curative resection for stage II and III colorectal cancer were randomly assigned to a study group receiving a 14-day course of 5-FU continuous infusion (320 mg/m2/day) followed by oral HCFU for a year (300 mg/day), or to the control group receiving a 14-day course of 5-FU continuous infusion alone. In terms of background factors, no significant differences were found between the 214 patients in the study group and the 215 in the control group. Adverse reactions during the treatment were more frequently seen in the study group. But with few exceptions, the toxicities were mild and the compliance was acceptable. The 5-year overall survival rate of the study group was similar to that of the control group. The 5-year disease-free survival rate of the study group was better than that of the control group in the patients with colon cancer (hazard ratio=1.87; 95% confidence interval 1.03-3.38; p=0.037). However, this benefit was not seen in the patients with rectal cancer. A significant improvement in the disease-free survival rate was demonstrated through the addition of HCFU to 5-FU continuous infusion for the patients with colon cancer. The usefulness of oral fluoropyrimidine as an adjuvant for curative surgery for colon cancer was further warranted.

Esophageal intramural spreading from an adenocarcinoma of the esophagogastric junction.

Although intramural spreading from gastric carcinoma to the esophageal wall is occasionally reported, longitudinal intramural lesion of the esophagus is very rare. We herein report the case of a patient found to have a carcinoma of the gastric cardia with intramural spreading to the esophagus approximately 7.0 cm in length. A 65-year-old man was admitted to our department suffering from a persistent midthoracic pain and mild dysphagia during the previous 3 months. Upper gastrointestinal studies revealed an oval submucosal tumor of the lower esophagus and a flare irregular lesion on the esophagogastric junction. An endoscopic ultrasonography showed the main tumor was in the submucosal layer and invaded beyond the muscularis propria. Histopathological examination of the resected specimen confirmed a poorly differentiated adenocarcinoma, 7.0 cm in length, which penetrated through the gastric wall, and invaded the submucosal layer of the esophagus. When only a few scattered carcinoma cells infiltrate only the mucosa or submucosa, it is difficult to diagnose the extent of esophageal invasion. In treating patients with gastric cancer with esophageal invasion, it is important to determine the safety of the proximal margin for esophageal resection. Histological examination using frozen sections obtained during surgery is essential for deciding the operative safety margin.

Effective treatment with chemotherapy and surgery for advanced small cell carcinoma of the esophagus.

A 78-year-old man reported a persistent midthoracic pain, mild dysphagia, and an abdominal distention. An abdominal computed tomography scan showed massive ascites, extensive paracardial mass, a large mass which invaded the pancreas, and a mass of multiple para-aortic lymphadenopathies which involved the superior mesenteric artery. An upper gastrointestinal endoscopic study revealed an infiltrative, ulcerating tumor of the lower esophagus. Histological study of the biopsy specimens from esophageal tumor showed small cell carcinoma. After combination chemotherapy, an abdominal computed tomography scan showed a disappearance of asites, a partial response reduction of paragastric mass, peripancreatic mass and para-aortic lymphadenopathies. Histological study of the biopsy specimens from esophageal tumor showed a viable small cell carcinoma. In June 2001, the patient underwent lower esophagectomy and proximal gastrectomy combined with splenectomy and distal pancreatectomy through an abdominal approach. Histological findings of the resected specimen showed that the esophageal tumor was a small cell carcinoma which invaded into the submucosal layer, and both paracardial and peripancreatic tumors, and all lymph nodes had no cancer cells. The patient's postoperative recovery was uneventful and discharged without aggressive chemotherapy postoperatively. However, he eventually died of progression of the metastasis 21 months after first detection of the carcinoma. Patients with esophageal small cell carcinoma treated with surgery following chemotherapy and/or radiotherapy have been reported to survive longer than those treated with chemotherapy and/or radiotherapy. Therefore, surgical resection may be recommended as the second therapy that occasionally produces long-term remission and possibly long-term survival for patients with small cell carcinoma of the esophagus.

Randomized controlled trial of the efficacy of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil and uracil/tegafur.

BACKGROUND: We investigated the efficacy and safety of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil (carmofur, HCFU) and uracil/tegafur (UFT). METHODS: Patients with stage II, III, or IV (Dukes' B, C) colorectal cancer were enrolled and randomly assigned to one of three groups: an immunochemotherapy group (mitomycin C [MMC] + 5-fluorouracil [5-FU] + HCFU + OK-432), a chemotherapy group (MMC + 5-FU + HCFU), and a control group (surgery alone) for those with colon cancer (study 1); and an immunochemotherapy group (MMC + 5-FU + UFT + OK-432), a chemotherapy group (MMC + 5-FU + UFT), and a control group (surgery alone) for those with rectal cancer (study 2). RESULTS: A total of 760 patients with colon cancer and 669 patients with rectal cancer were entered into this randomized clinical trial (RCT). The incidence of side-effects was in the order of: immunochemotherapy group >> chemotherapy group >> control group in both the cohort of patients with colon cancer and the cohort with rectal cancer. In particular, the frequency of leucopenia and skin disorders was significantly higher than control groups. There were no severe adverse events such as death related to the adjuvant therapy. In both the colon cancer and rectal cancer cohorts, no significant difference in the 5-year survival rate and disease-free survival rate was noted among the three groups. CONCLUSION: The results of an RCT demonstrated that the combination of MMC + 5-FU + HCFU + OK-432 for colon cancer and that of MMC + 5-FU + UFT + OK-432 for rectal cancer could not prolong the survival of patients with surgically resected colorectal cancer, but that both combinations were well tolerated as adjuvant therapy. We investigated the efficacy and safety of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil (carmofur, HCFU) and uracil/tegafur (UFT).

Dynamic graciloplasty resulting fecal continence without electrical stimulation: report of a case.

A 32 year-old man received dynamic graciloplasty for fecal incontinence due to a pelvic fracture. The perception of stool was obtained soon after the colostomy closure. Defecography and a manometric study showed that the patient could contract the transposed gracilis muscle independently. While the resting anal canal pressure remained low (52 cmH(2)O), he maintained excellent continence without stimulation. When stimulated, the anal canal pressure rose to 112 cmH(2)O. Electrical stimulation is therefore not always necessary for a good function after dynamic graciloplasty.

The usefulness of CEA and/or CA19-9 in monitoring for recurrence in gastric cancer patients: a prospective clinical study.

BACKGROUND: Many studies on postoperative carcinoembryonic antigen (CEA) and/or carbohydrate antigen (CA)19-9 monitoring after operation for gastric cancer have been reported, but most have been retrospective. METHODS: A nationwide observational study was implemented in 135 leading institutions in Japan to evaluate the significance of CEA and/or CA19-9 in postoperative monitoring for recurrence in patients with advanced gastric cancer. Three hundred and twenty-one patients examined in this analysis underwent radical gastrectomy at one of Japan's leading institutions between November 1993 and March 1996 and had been followed up for at least 5 years. Serum levels of CEA and CA19-9 were examined preoperatively and every 3 months postoperatively, with diagnostic imagings, such as chest X-ray, computed tomography (CT), and ultrasonography also being performed every 3 months. RESULTS: Recurrence was observed in 120 patients (peritoneum, 48; liver 16; lymph node, 16; multiple sites, 25; and others, 12). Sensitivities of CEA and either CEA or CA19-9, or both, for recurrence were 65.8% and 85.0%, respectively, both of which values were significantly higher than the preoperative positivities (28.3% and 45.0%, respectively). In most patients with high preoperative levels CEA and/or CA19-9, these tumor markers increased again at recurrence. Recurrent diseases were detected between 5 months after detection by diagnostic imagings and 12 months before detection by diagnostic imagings (mean of 3.1 +/- 3.6 months before detection by diagnostic imagings) and between 10 months after detection by diagnostic imagings and 13 months before detection by diagnostic imagings (mean of 2.2 +/- 3.9 months before detection by diagnostic imagings) by CEA and CA19-9 monitorings, respectively. CONCLUSION: These results suggest that CEA and/or CA19-9 monitoring after operation was useful to predict the recurrence of gastric cancer, especially in almost all the patients with high preoperative levels of these markers.

Changes in colorectal cancer during a 20-year period: an extended report from the multi-institutional registry of large bowel cancer, Japan.

PURPOSE: This study was designed to examine trends of colorectal cancer in relation to age, gender, site, and survival during the past 20 years. METHODS: The multi-institutional registry of the Japanese Society for Cancer of the Colon and Rectum offered 87,695 surgical cases with invasive adenocarcinoma during 1978 to 1997 for analysis. We calculated survival rates and used the Cox's proportional hazard model for cases during 1978 to 1994. RESULTS: The number of cases showed a 2.5-fold increase with consistent male predominance confined to the distal colon and the rectum. Colon cancer in the last five-year period was more likely right-sided for females (odds ratio, 1.26; 95 percent confidence interval, 1.16-1.38) and males (odds ratio, 1.16; 95 percent confidence interval, 1.06-1.25) compared with the first period. Cancers in younger patients were more likely at Stage III to IV in the late 1990s if the cancers were in the distal colon, the rectum (for both genders), or the proximal colon (for females). Survival was improved except for cases with proximal colon cancer of Stage IV. In the multivariate analysis, hazard ratios for death in the postoperative five years were 0.77, 0.59, and 0.66 for proximal colon, distal colon, and rectal cancers, respectively, in the last period as compared with those in the first period [corrected]. Reduced hazard ratio for females was the largest for proximal colon cancer with Stage I to II. CONCLUSION: Although surgical outcome was largely improved, delayed presentation or diagnosis in younger patients remained a problem. Preferential localization in the proximal colon and survival benefit for females should be investigated.

Reliable cervical anastomosis through the retrosternal route with stepwise gastric tube.

OBJECTIVES: An extra-anatomic reconstruction would be beneficial in preventing recurrent malignant dysphagia. A long gastric tube that allowed a sufficient blood flow was necessary to perform the successful cervical anastomosis through the retrosternal route. METHODS: The gastric tube was created by means of separate division and closure of the seromuscular and submucosal-mucosal layers (stepwise group) in 15 consecutive patients and by means of full-thickness cutting of the stomach and closure of the seromuscular layer (standard group) in 22 patients. We compared these 2 types of gastroplasties in terms of total length of the tube, blood flow, and the incidence of anastomotic leakage. Blood flow was measured with a laser Doppler flowmeter during surgical intervention. RESULTS: The gastric tube in the stepwise group was significantly longer than that in the standard group (P <.01, unpaired t test). Tissue blood flow at the site of anastomosis in the stepwise group was significantly greater than that in the standard group (P <.01, unpaired t test), and the rate of anastomotic leakage in the stepwise group was significantly lower than that in the standard group (P <.05, chi(2) test). CONCLUSION: We consider this technique to be a useful procedure for retrosternal reconstruction after subtotal esophagectomy.

A randomized controlled trial of postoperative adjuvant immunochemotherapy for colorectal cancer with oral medicines.

Postoperative adjuvant chemotherapy reportedly improves advanced colorectal cancer patients' survival, however, it is necessary to assess what regimens are useful. Doxifluridine (5'-DFUR) is an intermediate of capecitabine approved in Europe and USA to treat metastatic colorectal cancer. 5'-DFUR is metabolized to 5-fluorouracil (5-FU) by thymidine phosphorylase existing in tumor at high concentrations, suggesting high 5-FU levels in tumor tissues and lesser complications. Present study compared usefulness of 5'-DFUR to that of oral 5-FU. Patients were enrolled at 38 centers from April 1993 to September 1996. They had diagnosed colorectal cancer of TNM stages II and III, and underwent macroscopic curative resection. Patients were prestratified into colon or rectum cancer and allocated into either 5'-DFUR (5'-DFUR 460 mg/m(2)/day + PSK 3 g/day) or 5-FU (5-FU 115 mg/m(2)/day + PSK 3 g/day) group by dynamic randomization (stratification factors such as depth of tumor, degree of lymph node metastasis, and location of tumor). Drugs were orally administered daily from postoperative week 2 to 54, with 6 mg/m(2) mitomycin C at operation and following days. Subjects for analysis were 277 in 5'-DFUR and 281 in 5-FU groups. Median follow-up was 6.5 years. Although no differences in overall survival curves were detected, multivariate analysis showed that 5'-DFUR + PSK regimen was a significantly better prognostic factor in patients with Dukes B or C (risk ratio, 1.451; p=0.048); with tumor depth of pT3 or pT4 (risk ratio, 1.568; p=0.020). For patients with advanced colorectal cancer, 5'-DFUR + PSK therapy may possibly be more useful than 5-FU + PSK, but further study is required.

Conformal radiation therapy for liver metastasis of esophageal carcinoma.

Recently, aggressive hepatectomies or hepatic arterial infusion chemotherapy for liver metastasis from gastric or colorectal carcinoma have been performed, and the number of successful studies of liver metastasis have increased. However, there have been few successful cases of liver metastasis from esophageal carcinoma by surgery or chemotherapy. Herein, we show the benefits of radiation therapy for the treatment of liver metastasis from esophageal carcinoma. A 60-year-old woman with a 5-cm solitary liver metastasis from esophageal squamous cell carcinoma was treated with radiation therapy. The treated volume was encompassed by the anteroposterior and right lateral opposing fields, shaped by a multileaf collimator. The daily fraction size was 1.8 Gy, 5 days per week, for a total dose of 54 Gy. During the course of treatment, the patient did not experience any complications. After radiotherapy, abdominal computed tomography showed that the enhanced solid tumor had changed to a very low-density mass lesion with a clear margin, and the size was decreasing gradually between the 6 months. Radiotherapy could be a treatment of choice in patients with liver metastasis from esophageal squamous cell carcinoma.