Comparison of hand-assisted laparoscopic surgery (HALS) and conventional laparotomy in patients with colorectal cancer: Final results from a single center.

In recent years, the use of laparoscopic surgery has been expanded to include radical curative resection. In a previous study, 212 patients with primary colorectal cancer (stages I-III) underwent radical curative resection by hand-assisted laparoscopic surgery (HALS) (n=98) or conventional laparotomy (CL) (n=114) and were compared with respect to 3-year relapse-free survival (3Y-RFS) and 3-year overall survival (3Y-OS). The study included 210/212 patients who were followed up to 5 years, including 96 patients who underwent HALS and 114 treated with CL. The two groups were matched for stage, clinical background, and postoperative management. Patient characteristics were compared and the 5Y-RFS and 5Y-OS were determined. The 5-year follow-up rate was 97.6%. In stage I-III patients, 5Y-RFS and 5Y-OS showed no significant differences between HALS and CL. The patients with stage I disease accounted for 41.7% (40/96) of the patients undergoing HALS, while stage I patients only accounted for 23.7% (27/114) of the patients undergoing CL, and the difference was significant (P=0.005). Stage II patients undergoing CL were older than those treated with HALS (P=0.017). However, there were no differences in the characteristics of stage III patients undergoing HALS or CL. In conclusion, HALS achieved a similar survival to CL in patients with stage I to III colorectal cancer. Compared with CL, HALS was performed more safely and achieved superior cosmetic results.

Repeated Hepatectomy for Recurrent Intrahepatic Cholangiolocellular Carcinoma: Report of a Case.

The patient was a 59-year-old female. A liver tumor measuring 10 cm was found in the right hepatic lobe by medical examination of August, 2008 and she underwent extended right hepatectomy in September. Microscopically, the tumor was composed of small cuboidal cells possessing oval nuclei and resembling cholangiole. These formed small tubular structures with fibrous stroma. From a result of histopathological features, a diagnosis of a cholangiolocellular carcinoma was made. She received postoperative adjuvant chemotherapy with gemcitabine and S-1. After that, the patient underwent six partial hepatectomies by August, 2013 for recurrent intrahepatic cholangiolocellular carcinoma. The patient is doing well 7 years after the first hepatectomy. Cholangiolocellular carcinoma is a rare tumor accounting for less than 1% of primary liver cancer, and the clinicopathologic features are not fully understood. Aggressive surgical resection may be one of the choices to assure a good outcome.

Early rectal cancer accompanied by multiple systemic abscesses: A case report.

A 70-year-old man undergoing treatment for diabetes presented with a cough and pyrexia that has lasted one week. Laboratory tests demonstrated evidence of inflammation. The patient was hospitalized and antibiotic treatment was initiated, but the condition of the patient did not improve. After 2 weeks, computerized tomography scanning demonstrated the presence of multiple small nodules in the lungs and a liver abscess. The patient also developed neck pain and numbness of the upper extremities and was then transferred to Tokai University Hachioji Hospital (Tokyo, Japan). Percutaneous transhepatic drainage (PTD) of the liver abscess was performed and antibiotic treatment was initiated. Detailed examination revealed there was pyogenic spondylitis of the cervical spine, therefore abscess drainage and an anterior cervical spinal fusion were performed. Culture of each lesion resulted in Klebsiella pneumoniae growth. While continuing antibiotic treatment and rehabilitation, the gastrointestinal tract was investigated and evidence of early rectal cancer was observed. The pulmonary nodules disappeared during treatment, indicating that these were multiple lung abscesses. Four weeks following abscess drainage and anterior cervical spinal fusion, lower anterior resection was performed. The present case report describes a patient who developed multiple abscesses associated with early rectal cancer and discusses the case with reference to the literature.

A Long Surviving Case of Multiple Early Stage Primary Malignant Melanoma of the Esophagus and a Review of the Literature.

We report a 75 year old man in whom primary malignant melanoma of the esophagus (PMME) was detected on an upper gastrointestinal radiographic contrast study and upper gastrointestinal endoscopy during a regular medical checkup. An extensive black lesion with a 1.5 x 1.0 cm protrusion and diffuse 1 cm flat lesions were recognized. The results of radical surgery were PMME pT1a-MM ly1 v0 pN0 (0/86) multiple lesions (+). Adjuvant chemotherapy was not employed and he has survived almost 7 years with no evidence of recurrence. PMME is a very rare lesion and in the PubMed database only 85 cases in 73 reports accumulated in a 10 year period from 2005 to 2014. Until 2014 a total of 369 cases were reported. In the ICHUSHI database (a domestic medical literature database service provided by the NPO Japan Medical Abstracts Society), 65 lesions in 62 cases were reported in the same period. Also until 2014, 301 cases were reported. At present, surgery is the first choice of treatment for PMME extending to the submucosa or deeper, but with developments in molecular targeting agents, PMME is thought to likely become an expanded indication of this technique.

Resection of a Submucosal Tumor-Like Superficial Carcinoma in Middle Thoracic Esophagus Concomitant with Mucosal Adenocarcinoma and Submucosal Squamous Cell Carcinoma: A Case Report and Review of Literature.

A 67-year-old man was pointed out mucosal irregularity on health check-up and was referred to our institution. Diagnostic examinations were performed and an aggregated type 0-IIa lesion having 3 small protrusions was recognized in the middle thoracic esophagus. Endoscopic biopsy led to diagnosis of esophageal cancer concomitant with adenocarcinoma and squamous cell carcinoma. Thoracic esophagectomy with 3-fields lymph node dissection was performed via a right thoracoabdominal approach and reconstructed with stomach roll. Three submucosal tumors like small protrusions were recognized in resected specimen. One of them was well differentiated tubular adenocarcinoma which occupied in mucosal layer. The other two were moderately differentiated squamous cell carcinoma. They existed very near but no connection was recognized by serial section. The adenocarcinoma existing in middle esophagus is very rare. Almost all of them were submucosal or advanced cancers. When we searched with the ICHUSHI database (a domestic medical literature database service provided by the NPO Japan Medical Abstracts Society) and the PubMed database, there was no report of mucosal adenocarcinoma occurred in middle thoracic esophagus in the past 10 years. Then this report was thought to be the first report of mucosal adenocarcinoma in middle thoracic esophagus in the world.

Solitary Fibrous Tumor of the Stomach Treated with Laparoscopic and Endoscopic Cooperative Surgery.

A 43-year-old Japanese woman with melena underwent an upper gastrointestinal endoscopy and was preoperatively diagnosed with sarcoma of the stomach. Physical examination revealed no abnormalities. Findings on the upper gastrointestinal endoscopy showed a pedunculated submucosal tumor measuring 17 mm in the antrum. An enhanced computed tomography showed wall thickening in the gastric antrum. The patient underwent a laparoscopic and endoscopic cooperative surgery (LECS) for wedge resection of the stomach. The excised tumor measured 27 × 20 × 15 mm in size. Histopathology showed spindle-shaped cells in the submucosal layer. Immunohistochemistry showed that the tumor was positive for CD34, bcl-2, and MIC-2. The final diagnosis was solitary fibrous tumor (SFT) of the stomach. The postoperative course was uneventful, and no evidence of recurrence was observed at the 8-month follow-up. We report a case of SFT arising from the stomach that was treated with wedge resection by LECS.

Combination of Laparoscopic and Endoscopic Approaches to Neoplasia with Non-exposure Technique (CLEAN-NET) for GIST with Ulceration.

Combination of laparoscopic and endoscopic approaches to neoplasia with non-exposure technique (CLEAN-NET) was developed to avoid intraoperative tumor dissemination. We report two cases of gastric gastrointestinal stromal tumor (GIST) with ulceration surgically treated with CLEAN-NET at our institution. The first case was a 55-year-old male with hematemesis. Gastric endoscopy revealed a gastric GIST with ulceration of the fornix. CLEAN-NET was performed with the insertion of five trocars and a liver retractor. The operative time was 202 min (including cholecystectomy), with a perioperative blood loss volume of 29 ml; the postoperative hospital stay duration was 8 days. The second case was a 66-year-old male with a gastric submucosal tumor (SMT) with ulceration. CLEAN-NET was performed in a similar fashion to the first case. The operative time was 128 min, with a preoperative blood loss volume of 16 ml; the postoperative hospital stay duration was 9 days. In conclusion, CLEAN-NET was found to be safe and useful in the treatment of gastric GIST with ulceration.

Comparison of hand-assisted laparoscopic surgery and conventional laparotomy for rectal cancer: Interim results from a single center.

Minimally invasive laparoscopic surgery has become widespread and the indications for such surgery have recently been extended to various conditions, including rectal cancer. The objective of this study was to compare the clinical outcome of hand-assisted laparoscopic surgery (HALS) and conventional laparotomy (CL) in patients with rectal cancer. Patients who underwent radical resection of stage I-III primary rectal cancer (n=111) were classified into those receiving HALS (n=57) and those receiving CL (n=54); the two groups were matched for stage and postoperative treatment. The 3-year relapse-free survival (3Y-RFS) and 3-year overall survival (3Y-OS) were calculated and compared between the two groups. Intraoperative blood loss, operating time, postoperative hospital stay and complications were also compared between the two groups. There were no significant differenceS in 3Y-RFS or 3Y-OS between the HALS and CL groups for patients with all-stage (I, II and III) rectal cancer. The mean (median) intraoperative blood loss was 344.0 (247.0) ML in the HALS group vs. 807.5 (555.5) ML in the CL group (P<0.001). The mean (median) postoperative hospital stay was 19.8 (17) and 25.5 (18.3) days, respectively (P=0.039). There were no significant differences in the operating time or the incidence of complications between the two groups. Based on these results, HALS was found to be comparable to CL regarding survival, while achieving less blood loss and a superior cosmetic outcome. However, longer follow-up is required to confirm these findings.

Clinicopathologic features and clinical outcomes of gastric cancer patients with bone metastasis.

OBJECTIVE: We conducted a retrospective analysis to evaluate the clinical manifestations and outcomes of a population of gastric cancer patients with bone metastasis. METHODS: The subjects were 31 gastric cancer patients who were diagnosed with bone metastasis between January 2000 and December 2010. RESULTS: The overall median survival time (MST) was 100 days. The results of a multivariate analysis in relation to overall survival showed that the absence of extraosseous metastasis and having received chemotherapy were favorable prognostic factors. MST was 269 days in the bone metastasis alone group (n = 6) and 65 days in the extraosseous metastasis group (n = 25). We divided the extraosseous metastasis group into two subgroups according to whether the patient had received chemotherapy. Evaluation of the response in the chemotherapy group showed that the subgroup of patients with progressive disease had a significantly longer MST than the no-chemotherapy group (63 days vs. 21 days, p = 0.012). CONCLUSIONS: We concluded that it is useful to divide gastric cancer patients with bone metastasis into two groups according to whether they have extraosseous metastasis. Aggressive chemotherapy should be considered as a means of improving the prognosis of gastric cancer patients with extraosseous metastasis.

Classification of Physiological 18F-fluorodeoxyglucose Uptake in the Large Intestine: a Preliminary Study.

Varying degrees of physiological uptake of 18F-fluorodeoxyglucose (FDG) are often noted in the large intestine and can be problematic when interpreting positron emission tomography (PET) images. In relation to colorectal tumor detection with FDG PET, we tentatively classified physiological FDG uptake in the large intestine according to its patterns and intensity. Subjects were 144 asymptomatic individuals (109 men, 35 women; mean age 57.5 ± 10.1 years) in our cancer screening program who underwent total colonoscopy within 24 days of FDG PET study and showed no evidence of colonic lesions on colonoscopy. Distinct FDG uptake on FDG PET images was classified into four types: focal, defined as distinctly nodular and visible on at least 4 axial; localized, 2 to 8 cm with SUVmean ≥ 4; diffuse, > 8 cm with SUVmean ≥ 4; and mixed, of more than one type. SUVmeans were examined by placing multiple circular regions of interest of 1 cm in diameter on the axial images. We found 21 distinct FDG uptakes matching our criteria in 20 of 144 subjects (13.9%): focal (n = 4), localized (n = 1), diffuse (n = 14), and mixed (n = 1; focal and diffuse). With regard to colorectal tumor detection, 6 subjects (4.2%) with focal or localized type of uptake were considered at risk of false-positive tumor identification, and 15 subjects (10.4%) with diffuse type of uptake were considered at risk of their tumors being missed at the site of FDG uptake. To confirm the feasibility of our criteria, this classification should be tested with a larger number of subjects.

Zinc finger protein 185 is a liver metastasis-associated factor in colon cancer patients.

LIM domain proteins are involved in several fundamental biological processes, including cell lineage specification, cytoskeleton organization and organ development. Zinc finger protein 185 (ZNF185) is one of the LIM domain proteins considered to be involved in the regulation of cellular differentiation and/or proliferation. However, the detailed functions and properties of ZNF185 in the multistep process of cancer biology have not yet been elucidated. In this study, we analyzed the association between ZNF185 and the clinicopathological characteristics of colon cancer, such as patient age and gender, histological type, lymphatic and venous involvement, T and N status, liver metastasis and stage. ZNF185 protein expression was immunohistochemically analyzed and ZNF185 was detected in the cancer cells of 78 of the 87 colon cancer patients. The correlation between ZNF185 and histological type was significant (P=0.010, G-test). ZNF185 expression was also significantly correlated with liver metastasis (P=0.030, G-test). A multivariate analysis using the Cox proportional hazards model was performed among cause-specific survival rate, ZNF185 expression and clinicopathological characteristics. Histological type, liver metastasis and ZNF185 expression were found to be independent prognostic indicators (P=0.028, P<0.0001 and P=0.036, respectively). Therefore, ZNF185 expression was found to be an independent indicator of liver metastasis and prognosis in patients with colon cancer.

Comparison of hand-assisted laparoscopic surgery and conventional laparotomy for colorectal cancer: Interim results from a single institution.

The present study aimed to compare the results of hand-assisted laparoscopic surgery (HALS) and conventional laparotomy (CL) at a single institution in Japan. Of the 212 patients with stage I/II/III colorectal cancer who received a curative resection, 98 patients underwent HALS and 114 patients underwent CL. The clinical background and post-operative management did not differ between the two groups. There were no significant differences in the 3-year relapse-free and 3-year overall survival rates between the HALS and CL groups for the patients in any stage. Blood loss during surgery was 250.1 and 135.5 ml (mean and median; the same hereafter) in stage I patients receiving HALS versus 608.2 and 315.5 ml in stage I CL patients (P=0.006), while it was 277.6 and 146 ml in stage II patients receiving HALS versus 548.6 and 347 ml in stage II CL patients (P=0.004). Post-operative hospital stay was recorded at 16.8 and 15 days in stage III patients receiving HALS versus 23.1 and 21 days in stage III CL patients (P=0.001). There were no significant differences in the operating time or complications between the two groups. These results indicate that the survival rate was comparable for HALS and CL, while HALS caused less surgical stress and achieved a better cosmetic outcome. The results of the final analysis of this cohort are awaited.

A case of isolated paraaortic lymph node recurrence from colon cancer successfully treated with chemoradiotherapy.

Isolated paraaortic lymph node (PALN) recurrence from colorectal cancer is rare and has no established treatment. A 56-year-old woman was referred to our hospital for the treatment of PALN recurrence in June 2005. She had undergone right hemicolectomy for ascending colon cancer two years earlier. The pathological diagnosis in 2003 was a well-differentiated adenocarcinoma with positive PALN metastasis in 3 of 4 dissected nodes (T3, N1b, M1a, stage IVa). At our hospital, chemoradiotherapy was started, with the radiation field determined from positron emission tomography (PET) images. Oral tegafur/uracil (600 mg/day) plus leucovorin (75 mg/day) therapy was also started. Radiotherapy (1.5 Gy/ fraction, total of 45 Gy) was completed in August 2005, while oral chemotherapy was discontinued 3 weeks after it was started due to diarrhea and epigastric discomfort. The serum carcinoembryonic antigen level was 193 ng/ml (N < 5) before treatment and decreased to within normal limits 3 months after initiation of chemoradiotherapy. Complete remission was confirmed by computed tomography (CT) and PET in December 2005 and has continued for more than 6 years. This case shows that chemoradiotherapy is potentially curative for PALN recurrence from colorectal cancer. To our knowledge, this is the first report of more than 5 years disease-free survival in a patient with PALN recurrence from colon cancer treated with chemoradiotherapy.

Significant clinical response of advanced colon cancer to peptide vaccine therapy: a case report.

Partial response (PR) was obtained in a patient with advanced colon cancer following peptide vaccine therapy. A 61-year-old woman was referred to our hospital for peptide vaccine therapy. She had undergone sigmoidectomy at a nearby hospital and eventually developed multiple metastases to the lung and pelvic lymph nodes with left hydronephrosis. A ureteral stenting catheter had been inserted for left hydronephrosis, and oral opioids had been administered for relief of pain in the left pelvic region. Three tumor-antigen-derived peptides (RNF43, TOMM34, and KOC1) and two human VEGFR-derived peptides (VEGFR1 and VEGFR2) were used as a cocktail. The peptide cocktail was subcutaneously inoculated on days 1, 8, 15, and 22 and repeated at 14-day intervals. The patient's serum level of carcinoembryonic antigen was 28.9 ng/mL (N<5 ng/mL) before treatment, and it decreased promptly after the initiation of therapy to within a normal range. Evaluation of computed tomography images at week 5 revealed PR as determined by the Response Evaluation Criteria in Solid Tumor criteria. After month 3, the oral opioid was discontinued. The PR lasted for 4 months and was followed by stable disease for another 4 months. No particular adverse effects were observed. A cytotoxic T lymphocyte (CTL) response was evaluated by immunosorbent spot assay, and a positive CTL response was recognized against at least one of five peptides at each end of the six courses. Immunotherapy has been proven to slow tumor growth by inducing an active antitumor immune response; and therefore, significant tumor shrinkage is rarely observed. To our knowledge, this is the first case report of PR presented in a patient with advanced colon cancer.

The effect of glucagon on FDG uptake in skeletal muscle.

Glucagon is used as an anti-motility agent during gastrointestinal tract examinations. We experienced subjects with enhanced 18F-fluorodeoxyglucose (FDG) uptake in whole-body skeletal muscle when conducting positron emission tomography (PET). The subjects had been administered glucagon during gastroscopy just prior to PET. This observation prompted us to perform the present retrospective study to determine whether or not glucagon enhances FDG uptake in skeletal muscle. We randomly selected 30 cases, including subjects who had undergone PET and gastroscopy on the same day as cancer screening procedures, and classified them into three groups. In the NO group (n = 10), no medications were used prior to PET. In the SC group (n = 10), scopolamine butylbromide (10 mg) was intravenously administered during endoscopy. In the GL group (n = 10), glucagon (0.5 mg) was intravenously administered during endoscopy. Both drugs were administered 45-60 min prior to FDG administration. The mean standardized uptake value (SUV) for gluteal muscle was 0.7 ± 0.14, 0.69 ± 0.15, and 0.99 ± 0.7 in the NO, SC, and GL groups, respectively. The SUV in the GL group was highest, but the difference was not statistically significant. In the subject with the highest SUV (3.04; GL group), the quality of the oncologic PET image was impaired, perhaps because of a relative decrease of FDG distribution in the chest and abdomen. Because previous literature showed that via hyperglycemia and hyperinsulinemia glucagon has the effect of increasing FDG uptake in skeletal muscle, the use of glucagon should be avoided just prior to FDG PET, although in our subjects, no statistical proof that glucagon enhances FDG uptake in skeletal muscle was obtained.

Stage II/III cancer of the rectosigmoid junction: an independent tumor type?

The 5-year relapse-free survival rate (5Y-RFS) and 5-year overall survival rate (5Y-OS) were investigated in 766 patients with stage II/III colorectal cancer (CRC). The Stage II group included 283 patients with colon cancer (CC), 40 patients with rectosigmoid junction cancer (RSC), and 74 patients with rectal cancer (RC), while the Stage III group comprised 226 patients with CC, 52 patients with RSC, and 91 patients with RC. Stage III patients with RC were further divided into 68 patients with Ra cancer (Ra, rectum/above the peritoneal reflection) and 23 patients with Rb cancer (Rb, rectum/below the peritoneal reflection). Then the 5Y-RFS and 5Y-OS were calculated for each category or subcategory. The 5Y-RFS/5Y-OS was 80.3/80.6% for Stage II patients and 63.7% (p<0.001)/66.2% (p<0.001) for Stage III patients. In the Stage II group, the survival rates were 82.9/81.2% for CC, 77.6/74.8% for RSC, and 72.9/80.5% for RC, with no significant differences between each category. In the Stage III group, the survival rates were 69.3/72.8% for CC, 71.6/77.7% for RSC, and 46.5/46.2% for RC. There was no significant difference of survival for CC vs. RSC, but significant differences were noted for CC vs. RC (p<0.001/p<0.001) and RSC vs. RC (p=0.008/p=0.007). In the Stage III group, survival rates were 71.6/77.7% for RSC, 47.6/44.8% for Ra, and 45.7/51.3% for Rb, with significant differences for RSC vs. Ra (p=0.013/p=0.005) and RSC vs. Rb (p=0.026/p=0.180), but not for Ra vs. Rb. These results suggest that Stage II/III RS cancer should be classified as colon cancer and should not be considered an independent tumor type.

Is the T1/2N1 (≤3 nodes) category actually stage IIIA (TNM)/IIIa (Japanese classification) in patients with primary colorectal cancer?

The 5-year relapse-free survival rate (5Y-RFS) and the 5-year overall survival rate (5Y-OS) were calculated for 972 patients (stage I, 206 patients; stage II, 396 patients; stage III, 370 patients). We divided the stage III group into 259 patients with IIIa/N1 disease (≤3 positive nodes) and 111 patients with IIIb/N2 disease (≥4 positive nodes) according to the Japanese classification. The IIIa/N1 and IIIb/N2 categories were each subdivided into T1/2 (stage IIIa, 45 cases; IIIb, 9 cases) and ≥T3 (stage IIIa, 214 cases; IIIb, 102 cases) according to the TNM classification, and 5Y-RFS and 5Y-OS were compared between each subcategory and each group. The 5Y-RFS/5Y-OS values calculated for each stage were as follows: stage I, 94.0/90.7%; stage II, 80.5/81.1%; stage III, 63.5/65.7%. When stage IIIa was compared with IIIb, we obtained 67.9/72.0% for stage IIIa and 53.6% (p=0.001)/50.4% (p<0.001) for stage IIIb. For stage IIIa vs. IIIb in the ≥T3 category, we obtained 63.1/68.5% for stage IIIa and 51.9% (p=0.010)/49.0% (p=0.008) for stage IIIb. For stage IIIa vs. IIIb in the T1/2 category, we obtained 92.1/92.0% for stage IIIa and 72.9% (p=0.040)/63.5% (p=0.003) for stage IIIb. There were significant differences between T1/2 and ≥T3 within stage IIIa (p=0.001/p=0.009), but not within stage IIIb. These results suggest that the T1/2N1 category of colorectal cancer should be classified as a subcategory of stage IB/Ib rather than stage IIIA (TNM)/IIIa (Japanese classification).

Anal function-preserving subtotal intersphincteric resection/partial external sphincteric resection with hybrid 2-port hand-assisted laparoscopic surgery (Mukai's operation) for very low stage I rectal cancer: A case report.

A 62-year-old male patient underwent endoscopic mucosal resection (EMR). Additional hybrid 2-port hand-assisted laparoscopic surgery (HALS) (Mukai's operation) was performed for early rectal cancer located at the distal border of the rectum/below the peritoneal reflection (Rb) region [SM massive invasion/ly+/vertical margin (VM)X] via a small transverse incision, approximately 55 mm long, at the superior border of the pubic bone. After the pelvic floor muscles were dissected by laparoscopy-assisted manipulation, transanal subtotal intersphincteric resection (ISR) was performed under direct vision, securing a margin of more than 15 mm distal to the EMR scar. Partial external sphincteric resection (ESR) was also performed to obtain an adequate VM at the posterior region of the EMR scar. After bowel reconstruction, the layers were sutured transanally and a temporary covering colostomy was created. The resected specimen contained no residual tumor cells without lymph node metastasis. At 3 months after the operation, digital examination revealed good tonus of the anal muscles without stricture. The patient is currently undergoing rehabilitation of his anal sphincter muscles in preparation for the colostomy closure. In conclusion, subtotal ISR combined with partial ESR may decrease the need to perform Miles' operation for T1/2 stage I rectal cancer located at the distal border of the Rb region.

18F-fluorodeoxyglucose uptake in uterine leiomyomas in healthy women.

The purpose of this study was to evaluate the incidence and features of increased FDG uptake in uterine leiomyomas in apparently healthy women. The incidence of increased FDG uptake is 0.1% in all 2193 women, 0.5% in women with uterine leiomyoma, and 3.4% in women with degenerated leiomyoma. There was no relationship between the intensity of FDG uptake and the size/site of leiomyoma or the tendency of degeneration in leiomyoma. The women with the increased uptake were not limited at premenopause.

Phase I/II study of 24-hour infusion of irinotecan combined with oral UFT for metastatic colorectal cancer.

BACKGROUND: To evaluate the efficacy and safety of irinotecan combined with UFT for untreated and pretreated metastatic colorectal cancer. METHODS: Escalating doses of irinotecan (80-110 mg/m(2)) were administered by 24-hour infusion on day 1. UFT was administered orally at 400 mg/m(2)/day on days 3-7 and 10-14. The treatment cycles were repeated every 2 weeks. RESULTS: In the phase I study, the maximum tolerated dose of irinotecan was 110 mg/m(2) and the recommended dose for the phase II study was determined to be 100 mg/m(2). Thirty-five patients including 3 patients at the recommended dose in the phase I study were evaluated in the phase II study. The grade 3/4 toxicities observed were leukopenia, neutropenia, thrombocytopenia and anemia. No grade 3 or more severe nonhematological toxicities were noted. The response rate was 62.9% and the median overall survival 16.7 months. CONCLUSIONS: A 24-hour infusion of irinotecan combined with UFT is feasible and active for metastatic colorectal cancer.