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In patients with Crohn's disease (CD) and intestinal failure, home parenteral nutrition (HPN) is a necessary lifesaving treatment. The aim of this study was to investigate the long-term outcomes of patients with CD after initiation of HPN.This study included patients with CD receiving HPN for intestinal failure. The patients were treated at Osaka University Hospital between January 2000 and December 2019. Patients' demographic characteristics, HPN dependence and complications, and mortality were analyzed. HPN dependence was estimated using the Kaplan-Meier method. Cox regression analysis was used for between-group comparisons.Twenty-one patients with CD received HPN. HPN dependence rates were 85%, 75%, 75%, and 64%, respectively, at 2, 5, 10, and 15 y after HPN initiation. Patients who weaned off HPN exhibited lower rates of immunomodulator therapy and additional intensive CD treatment (P0.05). Multivariate analysis revealed that not requiring additional intensive CD treatment was a significant factor in weaning off HPN. Two patients (9%) died, at a median of 14.9 y after HPN initiation, due to HPN-related liver disease and CD-associated carcinoma. Among all patients, 61% experienced catheter-related bloodstream infections (CRBSIs), with an incidence of 0.32/1000 catheter-days. Methicillin-resistant bacteria and Candida spp. each accounted for 27% of all pathogens detected in CRBSI.Patients with CD receiving HPN had a good prognosis, despite frequent CRBSIs in which methicillin-resistant bacteria and fungi were common pathogens. Some patients with CD can wean off HPN, even after a long period of HPN treatment. A stable disease condition during HPN might be an important factor for weaning off HPN.

Background Irinotecan have been well known to correlate between UGT1A1 polymorphisms (UGT1A1) and adverse events. Modified XELIRI (irinotecan 200 mg/m2 on day 1, capecitabine 1600 mg/m2 on days 1 to14 every 3 weeks) has shown non inferiority of overall survival compared with FOLFIRI based on "Asian XELIRI ProjecT" (AXEPT) as second line chemotherapy for patients with mCRC. In this preplanned analysis of the AXEPT trial, we evaluated the relationship between UGT1A1 and the efficacy and safety of irinotecan-based chemotherapy. Methods Patients were randomized FOLFIRI ± bevacizumab (BV) or modified XELIRI ± BV based on UGT1A1 results (wild type, heterozygosity, and homozygosity). With regard to irinotecan dosage in both treatment arms, the reduced dosage (150mg/m2) were administered in case of homozygosity. Assessed endpoints were overall survival (OS), progression free survival (PFS), overall response rate (ORR), relative dose intensity (RDI) and safety. Result UGT1A1 was available for all 650 randomized patients (wild type, 309 (47.5%) heterozygosity, 291 (44.8%) and homozygosity, 50 (7.7%)). Median OS was of patients with a wild/hetero/homo was 14.3, 18.3 and 9.1 months in FOLFIRI arm and 18.1, 16.3 and 13.0 months in mXELIRI arm, respectively. Median PFS of patients with a wild/hetero/homo was 6.8, 8.8 and 4.8 months in FOLFIRI arm and was 8.3, 8.7 and 6.5 months in mXELIRI arm, respectively. Grade 3, 4 toxicities of special interests (wild/hetero/homo) were neutropenia (35.9%/50.4%/45.8% in FOLFIRI arm and 17.0%/15.7%/21.7% in mXELIRI arm), febrile neutropenia (5.9%/2.3%/4.2% in FOLFIRI arm and 1.4%/4.3%/8.7% in XELIRI arm), and diarrhea (1.3%/6.0%/0% in FOLFIRI arm and 4.8%/10.7%/0% in mXELIRI arm). Conclusions mXELIRI±BV was showed the good efficacy and well tolerated in patients with all UGT1A1 polymorphisms. mXELIRI+BV could be an alternative to FOLFIRI as a standard second line backbone treatment for mCRC.

Background and aims Although chemotherapy-induced oral mucositis (COM) is a common side effect of many anticancer therapies, the optimal treatment for this condition is not well established. Recent studies showed that one of the traditional Japanese herbal medicines (Kampo) called TJ-14 (hangeshashinto) may be useful for COM via downregulating pro-inflammatory prostaglandins in the cyclooxygenase pathway (ASCO-GI2011, AGA2012). The efficacy of TJ-14 for the prevention and/or treatment of COM was exploratively tested in a randomized, double-blind, placebo-controlled trial in colorectal cancer patients. Methods Ninety-three patients who developed COM during FOLFOX, FOLFIRI or XELOX treatment for advanced colorectal cancer were centrally randomized to receive either a topical application of TJ-14 or placebo. Patients were advised to dissolve 2.5 g of TJ-14 or placebo in 50 mL of tap water and rinse their oral cavity three times daily for 10 seconds with the solution before expectorating it. Patients followed this oral care throughout the treatment before the next course of chemotherapy began. The COM grade was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 and a self-administered questionnaire before and after the 2-week treatment with the TJ-14 or placebo solution. The study endpoints included the incidence of worst grade COM, the incidence of grade 2 or higher COM, the duration of grade 2 or higher COM, and the healing time of COM. Results Ninety patients (43 in the TJ-14 group, 47 in the placebo group) were included in the statistical analysis. The incidence of grade 3 COM was 9.5% vs. 17%, while no significant difference in the incidence of grade 2 or higher COM was found between the two groups. The median duration of grade 2 or higher COM was 5.5 days vs. 10.5 days (p = 0.018). No significant difference was observed between the two groups with regard to the incidence of grade 2 or higher adverse events. Conclusions Topical TJ-14 rinse appears to have a significant ability to treat grade 2 or higher COM and reduce the risk of developing grade 3 COM. Our results are encouraging and warrant further phase III trials. Disclosure All authors have declared no conflicts of interest.