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Background This nationwide prospective registry study investigated the real-world effectiveness, safety, and persistence of vedolizumab (VDZ) in inflammatory bowel disease (IBD) patients in Taiwan. Disease relapse rates after VDZ discontinuation due to reimbursement restriction were assessed. Methods Data were collected prospectively (January 2018 to May 2020) from the Taiwan Society of IBD registry. Results Overall, 274 patients (147 ulcerative colitis [UC] patients, 127 Crohn’s disease [CD] patients) were included. Among them, 70.7% with UC and 50.4% with CD were biologic-naïve. At 1 year, 76.0%, 58.0%, 35.0%, and 62.2% of UC patients and 57.1%, 71.4%, 33.3%, and 30.0% of CD patients achieved clinical response, clinical remission, steroid-free remission, and mucosal healing, respectively. All patients underwent hepatitis B and tuberculosis screening before initiating biologics, and prophylaxis was recommended when necessary. One hepatitis B carrier, without antiviral prophylaxis due to economic barriers, had hepatitis B reactivation during steroid tapering and increasing azathioprine dosage, which was controlled with an antiviral agent. No tuberculosis reactivation was noted. At 12 months, non–reimbursement-related treatment persistence rates were 94.0% and 82.5% in UC and CD patients, respectively. Moreover, 75.3% of IBD patients discontinued VDZ due to mandatory drug holiday. Relapse rates after VDZ discontinuation at 6 and 12 months were 36.7% and 64.3% in CD patients and 42.9% and 52.4% in UC patients, respectively. Conclusions The findings demonstrated VDZ effectiveness in IBD patients in Taiwan, with high treatment persistence rates and favorable safety profiles. A substantial IBD relapse rate was observed in patients who had mandatory drug holiday.

Background/Purpose This analysis reports safety and effectiveness data from the Taiwanese cohort of the CORRELATE study. Methods CORRELATE was a prospective, observational study to assess the safety and effectiveness of regorafenib for the treatment of metastatic colorectal cancer (CRC) in real-world clinical practice that was conducted in 13 different countries in Asia, Europe and Latin America. The primary endpoint of the study was incidence of all treatment-emergent AEs (TEAEs), and secondary endpoints included overall survival (OS), progression-free survival (PFS), and disease control rate (DCR). Results The global study population (N = 1037) included 128 Taiwanese patients with a median age of 64 years, median weight of 62.02 kg and 66.41% were male. Reduced initiating doses of regorafenib and dose interruptions were common in Taiwanese patients (71.87% and 50.00%, respectively). The safety profile of regorafenib was consistent with that seen in Asian patients in the clinical development trials, including the CORRECT and CONCUR studies, with hand–foot–skin reactions (HFSR) of any grade occurring in 33.59% of patients. Median OS was 11.64 months in the Taiwanese patients (95% confidence interval [CI], 8.36–13.82) and median PFS was 2.17 months (95% CI, 1.97–2.89). Conclusions The safety and effectiveness of regorafenib in this real-world study was generally consistent with the known efficacy and safety profile in Asian patients in clinical trials. Trial registration NCT02042144.

Background Metabolic acidosis is a major complication of critical illness. However, its current epidemiology and its treatment with sodium bicarbonate given to correct metabolic acidosis in the ICU are poorly understood. Method This was an international retrospective observational study in 18 ICUs in Australia, Japan, and Taiwan. Adult patients were consecutively screened, and those with early metabolic acidosis (pH Results We screened 9437 patients. Of these, 1292 had early metabolic acidosis (14.0%). Early sodium bicarbonate was given to 18.0% (233/1292) of these patients. Dosing, physiological, and clinical outcome data were assessed in 360 patients. The median dose of sodium bicarbonate in the first 24 h was 110 mmol, which was not correlated with bodyweight or the severity of metabolic acidosis. Patients who received early sodium bicarbonate had higher APACHE III scores, lower pH, lower base excess, lower PaCO2, and a higher lactate and received higher doses of vasopressors. After adjusting for confounders, the early administration of sodium bicarbonate was associated with an adjusted odds ratio (aOR) of 0.85 (95% CI, 0.44 to 1.62) for ICU mortality. In patients with vasopressor dependency, early sodium bicarbonate was associated with higher mean arterial pressure at 6 h and an aOR of 0.52 (95% CI, 0.22 to 1.19) for ICU mortality. Conclusions Early metabolic acidosis is common in critically ill patients. Early sodium bicarbonate is administered by clinicians to more severely ill patients but without correction for weight or acidosis severity. Bicarbonate therapy in acidotic vasopressor-dependent patients may be beneficial and warrants further investigation.

Additional file 1. Supplementary materials include detailed methods and supplementary results as referenced inthe article.

The role of adjuvant chemotherapy (ACT) in treating patients who have colorectal liver metastases (CLM) and undergo liver metastasectomy (LMS) is unclear in this patient population. We aimed to compare the mortality of patients receiving different ACT (i.e., oxaliplatin-based, irinotecan-based, and 5-fluorouracil-only (5FU)) and different treatment frequencies. We included 2583 patients with CLM who underwent LMS (including synchronous LMS [SLMS] and metachronous LMS [MLMS]) in this retrospective cohort study. We used Cox proportional hazard model to obtain hazard ratios (HRs) for mortality. The reference group was 5FU-only ACT when comparing ACT type and the reference group was treatment for ≤ 3 times when comparing ACT frequency. In SLMS patients, oxaliplatin-based ACT (HR = 0.78) and receiving ACT for ≥ 4 times (4–6 times, HR = 0.61; 7–9 times, HR = 0.69; 10–12 times, HR = 0.66) were associated with lower risk of mortality. In MLMS patients, oxaliplatin-based ACT (HR = 0.52), irinotecan-based ACT (HR = 0.64), and receiving ACT for 10–12 times (HR = 0.65) were associated with lower risk of mortality. In SLMS and MLMS patients, patients who received oxaliplatin-based ACT were more likely to survive than patients who received 5FU-only ACT. In MLMS patients, patients who received irinotecan-based ACT were also more likely to survive than those who received 5FU-only ACT. We recommend a course of at least four to six times of ACT after LMS in this patient population.

Summary Background & aims The possible dual role of serum folate in the development and progression of colorectal cancer (CRC) has not been well established in human studies. This study investigated the association between serum folate and the risk of CRC in subjects with CRC or colorectal adenomatous polyps (AP, a precursor of CRC), and healthy subjects. Methods This study has a case–control design. Two hundred and thirty-seven men and 171 women were recruited with 156 subjects in the CRC group, 70 subjects in the AP group and 182 healthy subjects in the control group. Results The risk of CRC was significantly increased in the third (OR, 3.46; 95% CI, 1.16–10.34) and fourth (OR, 4.86; 95% CI, 1.42–16.58) quartiles of serum folate concentration after adjusting for potential confounders among subjects with AP or CRC. Furthermore, serum folate concentration had no significant effect on the risk of CRC among subjects in the control and CRC groups. Conclusions Higher serum folate concentration was significantly correlated with increased CRC risk in subjects with AP, while serum folate had no effect on CRC risk in healthy controls. Serum folate might possess potential dual modulatory effects on the risk of CRC.

Summary Background & aims Increased homocysteine concentration and oxidative stress and decreased antioxidant capacities are thought to affect carcinogenesis. However, the associations of homocysteine, cysteine, pyridoxal 5′-phosphate (PLP) and folate with oxidative stress and antioxidant capacities in patients with colorectal cancer are unclear. The purpose of this study was to determine the associations of homocysteine, cysteine, PLP and folate with oxidative stress indicators and antioxidant capacities, and to further analyze their relationships with respect to risk for colorectal cancer. Methods One hundred and sixty-eight subjects with colorectal cancer (cases) and 188 healthy subjects (controls) were recruited. Results There were no significant associations of homocysteine, cysteine and folate with oxidative stress indicators and antioxidant capacities in cases; however, PLP positively correlated with glutathione S -transferase activities after adjusting for potential confounders in cases. Subjects with higher plasma homocysteine concentration exhibited significantly increased risk of colorectal cancer with or without adjustment for potential confounders. The associations of cysteine, PLP and folate with the risk of colorectal cancer were not observed when potential confounders were adjusted. Conclusions Increased homocysteine was strongly associated with the risk of colorectal cancer independently of oxidative stress indicators and antioxidant capacities. However, cysteine, PLP and folate were not found to be related to oxidative stress, antioxidant capacities and the risk of colorectal cancer.

Case Presentation: A 38-year-old Taiwanese woman had a 7 month history of abdominal pain over right lower quadrant and microcytic anemia. Upper gastrointestinal (GI) scope revealed gastric ulcer. Lower GI scope was suggested, but she hesitated to it and lost followup. This time, she visited our institution due to dyspnea for 2 days with episodic fever up to 39.4° C. Pale conjunctiva, hypoactive bowel sound, a protruding lesion with tenderness and subcutaneous crepitus over right flank and buttock were noticed on physical examination. Significant laboratory findings were white blood cell counts of 19.5 ×109 /l with segmented neutrophils of 88% and band forms of 3%, hemoglobin 3.5 g/dl, C-reactive protein 21.2 mg/l, albumin 2.3 g/l, and calcium 1.85 mmol/l. Contrast-enhanced computed tomographic scan of the abdomen demonstrated ascending colon cancer with abscess formation and subcutaneous gaseous infiltration (Figures 1A-1C). Right hemicolectomy (Figure 1D), ileostomy and debridement with rotation flap were conducted. This patient was admitted to surgical intensive care unit for postoperative critical care. Cultureof abscess grew Escherichia coli and Streptococci viridans. Surgical pathological findings showed advanced adenocarcinoma of cecum, moderately differentiated, with invasion to mesocolic soft tissue, ileocecal valve and metastasized to mesocolic lymph nodes. She was discharged on the 25th postoperative day under uneventful condition. Discussion: Necrotizing fasciitis (NF) is a fulminant and life-threatening gangrenous soft-tissue infection with mortality rate of 20-40% [1-4]. NF is usually caused by trauma to the skin or surgical wounds and less common due to underlying intestinal diseases such as perforated colonic diverticulitis or cancer [2-4]. 3.3% of patients with colon cancer had localized perforation and 0.3-0.4% of these patients had abscess formation [3,4]. Fewer cases of retroperitoneal abscess and NF caused by perforated colonic cancer have been reported and potentially fatal in immunocompromised patients with mortality rate of 50% [3]. It most commonly occurs in the abdominal wall, extremities and perineum. Clinical features of NF include fever, chills, tenderness and crepitus on the involved region with skin discoloration [1-4]. Early diagnosis by US or CT and treatment with broad-spectrum antibiotics and surgical debridement can reduce the mortality rate associated with abscess and NF [1-5]. We highlighted that colon cancer could be a cause of unexpected retroperitoneal abscess followed by NF.

Summary Background The role of pelvic exenteration in locally advanced rectal cancer (LARC) has not been clearly defined. This procedure carries a mortality rate of approximately 10%. The challenges during pelvic surgery are different between men and women. The morbidity in men with LARC who received pelvic exenteration was analyzed. Methods Medical records of men with LARC undergoing total pelvic exenteration or supralevator pelvic exenteration from January 1991 to December 2007 were retrospectively reviewed. Results A total of 23 cases were included in the analysis. Thirteen patients had primary cancer; 10 had recurrent cancer. Microscopically clear surgical margins were obtained in 14 patients (60.9%). Sixteen patients (69.6%) experienced major or minor postoperative complications. The overall in-hospital mortality rate was 8.7%. Ten patients (43.5%) died within 1 year after surgery. All 10 patients with early mortality experienced refractory complications and repeated surgeries. The longest survival of patients with margin involvement was 25 months. The correlation between involved surgical margins and 1-year mortality was statistically significant ( p = 0.001). Conclusion Resection margins with tumor involvement after pelvic exenteration is associated with poor prognosis and early mortality in men with locally advanced rectal cancer.

Background Pelvic irradiation has been a popular therapy modality for cervical cancer for many years, and its usage in rectal cancer and prostate cancer cases is on the rise. However, it is associated with significant side effects. In this study, we compared the different characteristics of surgical and nonsurgical patients who were treated for radiation enterocolitis, the treatment results, posttreatment quality of life (QOL), nutrition status, and predisposing factors for surgery. Methods From 1985 to 2009, the records of a total of 89 patients with chronic radiation enterocolitis in our hospital were retrospectively reviewed for demographic data, operative data and long-term treatment results. Posttreatment QOL and nutrition status were also recorded. Univariate and multivariate analyses were performed to identify the independent predicting factors associated with surgical intervention. Characteristics of surgical and nonsurgical patients were compared. Results Radiotherapy before 1995, concomitant radiation uropathy and smoking were independent predictive factors for surgery. Surgical and nonsurgical cases had similar Kaplan–Meier curves. Although the recurrence rate of radiation enterocolitis was much higher for the surgical group ( p = 0.031), both groups had similar QOL score (median: 8 vs .7; p = 0.709), serum albumin level (3.29 g/dL vs . 3.16 g/dL; p = 0.095), and body mass index (20.19 vs . 19.86; p = 0.603). Conclusions We confirmed that as compared with recently developed innovative techniques, early primitive radiotherapy techniques were associated with more severe radiotherapy complications that required surgery. Smoking may enhance patients' vulnerability to severe radiation injury. Surgery for radiation-induced intestinal obstruction, intestinal fistula and perforation is warranted because QOL, serum albumin level and body mass index were similar between the surgical and nonsurgical groups.

Pelvic irradiation is commonly used in the treatment of pelvic malignancies. Chronic radiation enterocolitis is the most serious complication resulting from such treatment, and it frequently requires surgery. The prognosis for patients after surgery remains ill-defined. We conducted a retrospective study to identify risk factors associated with mortality for patients who received surgery for chronic radiation enterocolitis. From 1985 to 2009, a total of 89 patients were diagnosed as having chronic radiation enterocolitis in Taichung Veterans General Hospital. The chart records of 35 surgical and 54 nonsurgical patients were reviewed. A total of 21 candidate risk factors were selected from (1) those related to rapid disease progression (recurrence within 1 year, reoperation within 1 year, short latency), (2) those mentioned in published series (diabetes mellitus, history of smoking, history of abdominopelvic surgery), and (3) other risk factors that might adversely affect outcomes (older age, higher radiation dosage, longer latency period). Factors with p

Dried flowers and buds of Sophora japonica (Huaihua) are used in China, Japan and Korea for treating haematemesis and bleeding haemorrhoids. This study compared the clinical safety and efficacy of a Sophora flower formula with a placebo for the conservative treatment of symptomatic haemorrhoids. The study was a prospective, double-blind, randomized placebo-controlled trial. The clinical effective rate, symptom score and the incidence of important clinical events were used as observation indices to evaluate the effect of the Sophora flower formula. The results showed that after 7 days of treatment, improvement was observed in 87.0% of the patients’ major symptoms in the Sophora flower formula group compared with 81.8% of those in the placebo group. After 14 days, 78.2% patients in the Sophora flower formula group were asymptomatic, whereas 40.9% of those in the placebo group exhibited residual symptoms. However, the difference between both groups was not statistically significant. As the bowel habits of the patients improved and as the patients took sitz baths, their symptoms improved drastically, regardless of the use of the Sophora flower formula. These findings indicate that the traditional Chinese Sophora flower formula is clinically safe; however, its effects on haemorrhoids need to be studied in a larger sample size and with different dosages. The present study results may be a potential clinical reference for physicians prescribing medications for patients with symptomatic haemorrhoids.

Background We conducted a Phase II study of biweekly oxaliplatin plus oral tegafur-uracil in the preoperative chemoradiotherapy (CRT) for locally advanced resectable mid-to-lower rectal cancer in our hospital, to evaluate the feasibility of this drug combination in tumor pathologic response, acute toxicity, local control, disease-free survival (DFS), overall survival (OS), and time to distant metastasis in an Asian cohort. Methods Twenty patients with histopathologically confirmed rectal cancer (Stage II–III) were enrolled in the study. Radiotherapy of 50 Gy was delivered in 25 fractions of 2 Gy, one fraction/day, five fractions/week, for 5 weeks. Oxaliplatin 55 mg/m 2 was administered intravenously for 60 minutes on Day 1 every 2 weeks, and tegafur-uracil 350 mg/m 2 was given orally everyday during the whole radiotherapy course, including holidays. Surgery was scheduled 6 weeks after completion of the preoperative chemoradiotherapy. The primary endpoint was to determine the pathologic complete response (pCR) rate after this neoadjuvant chemoradiotherapy. The secondary endpoint was to determine the treatment-related toxicity profile, local control, DFS, OS, and time to metastasis. Results All patients underwent a complete course of preoperative chemoradiotherapy. There was no local recurrence during the study period. The complete resection rate was 20/20 (100%) and the close resection margin rate was 3/20 (15%). The pCR rate was 8/20 (40%). During chemoradiotherapy, the most frequent toxicity was diarrhea 9/20 (45% of patients, grade 2 in 3/20, 15%). There were no grade 3 or higher hematologic or non-hematologic events or treatment-related deaths. The 3-year OS and DFS rates were 94.1% and 78.6%, respectively. Conclusion Preoperative chemoradiotherapy with oxaliplatin and tegafur-uracil was well-tolerated and achieved an excellent pCR in our patients with locally advanced mid-to-lower rectal cancer.