[Regorafenib versus S-1 plus Bevacizumab for Metastatic Colorectal Cancer as Salvage Line-A Phase Ⅱ Study (OGSG1301)].

Background: Regorafenib(Rego)is the salvage line standard treatment for metastatic colorectal cancer(mCRC), which often causes severe toxicities, such as hand-foot syndrome. Previously, we reported that in phase Ⅱ study, S-1 plus bevacizumab( Bev)(SB)showed favorable anticancer activity and feasibility as a salvage line. The aim of this study was to evaluate 2 treatments for mCRC as salvage line.

Phase II study of S-1-based sequential combination chemotherapy including oxaliplatin plus bevacizumab and irinotecan with or without cetuximab for metastatic colorectal cancer: the SOBIC trial.

Background: Fluorouracil and leucovorin combined with oxaliplatin or irinotecan plus bevacizumab (Bmab) or cetuximab (Cmab) are now widely accepted treatment options as first-line or second-line chemotherapy for metastatic colorectal cancer (mCRC). Sequential chemotherapy with oral 5-FU backbone for mCRC without using central venous ports is beneficial for both patients and physicians. We designed the SOBIC trial to validate the effectiveness of the first- and second-line oral combination chemotherapy for mCRC.

A phase II study of bevacizumab and irinotecan plus alternate-day S-1 as a second-line therapy in patients with metastatic colorectal cancer: the AIRS study.

Background: The aim of this single-arm phase II clinical trial was to evaluate whether the alternate-day administration of S-1 plus irinotecan would reduce the incidence of severe diarrhea in comparison to consecutive-day S-1 administration (standard IRIS regimen) in second-line treatment for patients with metastatic colorectal cancer.

Methods: Patients with metastatic colorectal cancer after failure with first-line treatment of oxaliplatin and fluoropyrimidine were enrolled. Irinotecan (150 mg/m) and bevacizumab (5 mg/kg) were given intravenously on day 1.

Effect of pH adjustment by mixing steroid for venous pain in colorectal cancer patients receiving oxaliplatin through peripheral vein: a multicenter randomized phase II study (APOLLO).

Purpose: The aim of this phase II clinical trial was to evaluate the preventive effect of dexamethasone mixing injection for venous pain in patients with colorectal cancer during chemotherapy.

Materials And Methods: Patients were randomized to receive a 2-h intravenous infusion of oxaliplatin 130 mg/m(2) on day 1 followed by capecitabine 1000 mg/m(2) (or S-1 40-60 mg/m(2)) twice daily on days 1 through 14 of every 3 weeks with or without dexamethasone 1.65 mg at the infusion on day 1.

Multicenter randomized phase II clinical trial of oxaliplatin reintroduction as a third- or later-line therapy for metastatic colorectal cancer-biweekly versus standard triweekly XELOX (The ORION Study).

Background: The aim of this multicenter, open-label, randomized phase II trial was to evaluate the efficacy of a dose-dense capecitabine and oxaliplatin (XELOX) regimen in patients with metastatic colorectal cancer (mCRC) for whom reintroduction of oxaliplatin had been planned as a third- or later-line regimen.

Methods: The patients with mCRC who had received prior chemotherapy including oxaliplatin and were scheduled for reintroduction of oxaliplatin were randomized to capecitabine (1,000 mg/m(2)) twice daily on days 1-14 and oxaliplatin (130 mg/m(2)) on day 1 every 21 days (Q3W group) or capecitabine (2,000 mg/m(2)) twice daily on days 1-7 and oxaliplatin (85 mg/m(2)) on day 1 every 14 days (Q2W group). The primary endpoint was the time-to-treatment failure (TTF).

Clinical Role of Modified Seton Procedure and Coring Out for Treatment of Complex Anal Fistulas Associated With Hidradenitis Suppurativa.

A variety of techniques have been described to treat complex anal fistulas. When complex anal fistulas are associated with hidradenitis suppurativa, the treatment has to be appropriately tailored for the severity and distribution of the disease so as to remove the external fistula tract to prevent recurrence while ensuring fecal continence. Between 2007 and 2011, a total of 10 males (ranging in age from 32 to 54 years) complained of recurrent purulent discharge in the buttocks and thigh regions.

Impact of 5-fluorouracil metabolizing enzymes on chemotherapy in patients with resectable colorectal cancer.

Although 5-fluorouracil (5-FU) is an important drug for colorectal cancer (CRC) treatment, no useful biomarker is currently available to predict treatment response. Since 5-FU is converted into active or inactive forms by orotate phosphoribosyltransferase (OPRT) or dihydropyrimidine dehydrogenase (DPD), a correlation between these enzymes and response to 5-FU has been suggested. However, such a correlation has not been investigated prospectively.

Impact of less invasive treatments including sclerotherapy with a new agent and hemorrhoidopexy for prolapsing internal hemorrhoids.

Conventional hemorrhoidectomy is applied for the treatment of prolapsing internal hemorrhoids. Recently, less-invasive treatments such as sclerotherapy using aluminum potassium sulphate/tannic acid (ALTA) and a procedure for prolapse and hemorrhoids (PPH) have been introduced. We compared the results of sclerotherapy with ALTA and an improved type of PPH03 with those of hemorrhoidectomy.

Clinical utility of sclerotherapy with a new agent for treatment of rectal prolapse in patients with risks.

Background: Perineal approaches are widely applied for the treatment of rectal prolapse. Recently, less-invasive treatments such as sclerotherapy using aluminum potassium sulfate/tannic acid (ALTA) have been introduced for internal hemorrhoids. Herein, we report the results of ALTA injection for the treatment of rectal prolapse in high-risk patients.

A phase I study of triplet combination chemotherapy of paclitaxel, cisplatin and S-1 in patients with advanced gastric cancer.

Objective: S-1 and cisplatin combination therapy is a standard regimen for patients with advanced gastric cancer in Japan. The primary objective of this study was to determine the maximum tolerated dose and dose-limiting toxicities of a triplet regimen adding paclitaxel to S-1 and cisplatin combination therapy.

Methods: Patients with previously untreated metastatic or recurrent gastric cancer were enrolled.

Feasibility of 5-days-on/2-days-off UFT/leucovorin in post-operative long-term adjuvant chemotherapy for colorectal cancer.

Previous clinical studies have shown that the oral uracil/tegafur (UFT)/leucovorin (LV) regimen, in which the drugs are taken for 28 consecutive days every 35 days, is equivalent to an infusional 5-fluorouracil (5-FU)/LV regimen for the treatment of colorectal cancer. A 5-days-on/2-days-off schedule for UFT/LV has been proposed as the same schedule for UFT has been reported to be safe and have good compliance. However, few studies have been performed with regards to the feasibility of the UFT/LV regimen.

Clinical role of a modified seton technique for the treatment of trans-sphincteric and supra-sphincteric anal fistulas.

Purposes: We have devised a modified seton technique that resects the external fistula tract while preserving the anal sphincter muscle. This study assessed the technique when used for the management of complex anal fistulas.

Methods: Between January 2006 and December 2007, 239 patients (208 males and 31 females, median age: 41 years) underwent surgery for complex anal fistulas using the technique.

Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer: KMBOG0610B.

Background: A trial was conducted to evaluate the feasibility, efficacy, and safety of biweekly administration of irinotecan, a novel topoisomerase I inhibitor, for patients with metastatic breast cancer (MBC) previously treated with either anthracycline-based or taxane-based chemotherapy.

Methods: Eligible patients were HER2-negative, had a performance status of 0 to 2, and had been treated previously with either anthracyclines or taxanes for MBC. Patients received irinotecan intravenously at 150 mg/m(2) on days 1 and 15 every 4 weeks.

Combination chemotherapy with S-1 plus cisplatin for gastric cancer that recurs after adjuvant chemotherapy with S-1: multi-institutional retrospective analysis.

Background: It is unclear whether S-1 plus cisplatin is effective for patients with recurrent gastric cancer after adjuvant S-1 chemotherapy.

Methods: We retrospectively evaluated the efficacy of S-1 plus cisplatin in patients whose gastric cancer recurred after adjuvant S-1 chemotherapy.

Results: In the 52 patients evaluated, the median duration of adjuvant S-1 chemotherapy was 8.

[Assessment of quality of life by questionnaires between S-1/CPT-11 and mFOLFOX6 in patients with advanced colorectal cancer].

Unlabelled: Injectable combination chemotherapy with 5-fluorouracil (5-FU)/Leucovorin (LV), oxaliplatin (OHP), and irinotecan (CPT-11) has been a standard treatment for advanced colorectal cancer (CRC). An oral fluoropyrimidine, S-1 (tegafur, gimeracil, and oteracil), has been developed recently, and a combination of S-1/CPT-11 demonstrated effects comparable to FOLFIRI for the treatment of advanced CRC. Being without continuous infusion lasting for days, combination chemotherapy with oral fluoropyrimidine may limit inconvenience and improve the quality of life (QOL) of patients.

Study to predict optimal duration of chemotherapy with fluoropyrimidine by multi-point collagen gel droplet embedded drug sensitivity test.

Background/aims: In colorectal cancer (CRC), 5-fluorouracil (5-FU) has been a basic chemotherapeutic agent. Antitumor effects of 5-FU and its derivatives are likely due to inter-individual difference in the drug sensitivity.

Methodology: We evaluated the 5-FU sensitivity of cancer cells from CRC patients using the collagen gel droplet embedded culture-drug sensitivity test (CD-DST) under multiple drug concentration and contact durations.

[Investigation of chemotherapy based on enzyme expression and drug sensitivity test in colorectal cancer].

Unlabelled: In colorectal cancer (CRC), 5-fluorouracil (5-FU) has been a basic chemotherapeutic agent. Orotate phosphoribosyltransferase (OPRT) and thymidine phosphorylase (TP) are essential enzymes for activation of 5-FU. Dihydropyrimidine dehydrogenase (DPD) is an enzyme for degradation.

Evaluation of sclerotherapy with a new sclerosing agent and stapled hemorrhoidopexy for prolapsing internal hemorrhoids: retrospective comparison with hemorrhoidectomy.

Background: We retrospectively compared the results of sclerotherapy with a new sclerosing agent (aluminum potassium sulphate/tannic acid) and hemorrhoidopexy using an improved type of circular stapler with hemorrhoidectomy.

Methods: Between January 2006 and September 2008, we performed hemorrhoidectomy in 416 patients, sclerotherapy in 784 patients and hemorrhoidopexy in 118 patients with prolapsing internal hemorrhoids.

Results: The median volume of the agent injected into a hemorrhoid was 7 ml (interquartile range = 4).

Hepatic metastasis from bile duct cancer of the ampulla is effectively controlled by multidisciplinary treatment including S-1, gemcitabine and bevacizumab: A case report.

The liver is the most common site for recurrent metastases from bile duct cancer (BDC) in the ampullary area. However, the optimal chemotherapy regimen for recurrent hepatic metastases has not yet been established. An oral combined fluoropyrimidine drug, S-1 (tegafur, gimeracil and oteracil), has recently been introduced alone or in combination with gemcitabine for BDC.

[Successful management with S-1 of recurrent gastric cancer after adjuvant chemotherapy with paclitaxel/UFT].

We report here two cases of recurrent gastric cancer after post operative adjuvant chemotherapy, in which S-1 has been effective to control the recurrence and provided long-term survival. Case 1: A 75-year-old male presented with malaise. Endoscopy showed an advanced gastric cancer.

Clinical role of laparoscopic hepatectomy using vessel sealer and soft coagulation for small hepatic tumors suspected of malignancy.

Backgrounds/aims: Laparoscopic hepatectomy may provid a less invasive treatment and diagnostic modality. To date, however, few reports have been published on a clinical usefulness of laproscopic hepatectomy using vessel sealer (VS) and soft-coagulation system (SC) for small hepatic tumors suspected of malignancy.

Methodology: Case 1; A 58-year-old man presented with a small hepatic tumor, detected during a medical examination.

[A case of disease-free survival with low-dose chemotherapy after resection of hepatic and pulmonary metastases from rectal cancer].

We report a case of disease-free survival with low-dose of uracil-tegafur (UFT) after reaction of hepatic and pulmonary metastases from rectal cancer. A 58-year-old male had a medical history of low anterior resection of the rectal cancer. Hepatic and pulmonary metastases developed 3 years and 3 months after the primary operation.

[A case of gastric cancer with peritoneal dissemination responding to combination chemotherapy with oral fluoropyrimidine and weekly paclitaxel].

We report a case in which combination chemotherapy with oral fluoropyrimidine and weekly paclitaxel was effective for gastric cancer with peritoneal dissemination. A 44-year-old woman suffering from advanced gastric cancer with peritoneal dissemination underwent total gastrectomy. After surgery, combination chemotherapy with doxifluridine plus weekly paclitaxel was administered on an outpatient basis, and was effective without any sign of relapse of the disease for a year.