OBJECTIVE The primary outcome measure used in mechanical thrombectomy (MT) trials is the modified Rankin Scale (mRS). However, the accuracy of mRS might be limited. On the other hand, the functional independence measure (FIM) is a widely used tool to quantify the extent to which patients require assistance during their activities of daily living. The current study aimed to reveal different clinical backgrounds that affect the efficacy of MT measured either by mRS or FIM. METHODS Patients who underwent MT at our institution from January 2019 to July 2022 were included and divided into groups based on mRS scores of 0-2 and ≥ 3. Patients were also divided into two groups based on a cut-off value of FIM of ≥ 108, as patients with FIM ≥ 108 are capable of living an independent life. RESULTS The mRS score was 0-2 in 33% of the patients, while the FIM score was ≥ 108 in only 15% of the patients. In the mRS groups, there were significant differences in terms of duration of hospitalization, National Institutes of Health Stroke Scale (NIHSS) scores, achievement of thrombolysis in cerebral infarction (TICI) reperfusion grade of 2b or 3, and postoperative bleeding. Multivariate logistic regression analysis revealed that NIHSS score and achievement of TICI 2b or 3 were significant factors related to mRS 0-2 at discharge. The FIM groups differed significantly in terms of age and, duration of hospitalization, NIHSS score, although multivariate logistic regression analysis revealed that only the NIHSS score was significantly associated with an FIM score of ≥ 108. CONCLUSION The study showed that the percentage of independent patients is significantly reduced when we evaluated the patients by the FIM. In addition, there are some differences in the clinical background that led to a good outcome between that evaluated by mRS and FIM.

Background and Aim:Hepatocellular carcinoma (HCC) surveillance in low-risk patients (annual incidence <1.5%) is not recommended per the American Association for the Study of Liver Diseases guidelines. Because patients with chronic hepatitis C with non-advanced fibrosis who have achieved sustained virological response (SVR) have a low risk of HCC, HCC surveillance is not recommended for them. However, aging is a risk factor for HCC; threfore, the necessity for HCC surveillance in older patients with non-advanced fibrosis needs to be verified. Methods:This multicenter, prospective study enrolled 4993 patients with SVR (1998 patients with advanced fibrosis and 2995 patients with non-advanced fibrosis). The HCC incidence was examined with particular attention to age. Results:The 3-year incidence of HCC in patients with advanced and non-advanced fibrosis was 9.2% (95% CI: 7.8-10.9) and 2.9% (95% CI: 2.1-3.7), respectively. HCC incidence was significantly higher in patients with advanced fibrosis (P < 0.001). HCC incidence stratified by age and sex was investigated in patients with non-advanced fibrosis. The HCC incidence in the 18-49, 50s, 60s, 70s, and ≥80 age groups were 0.26, 1.3, 1.8, 1.7, and 2.9 per 100 person-years in men, and 0.00, 0.32, 0.58, 0.49, and 0.57 per 100 person-years in women, respectively. Conclusions:Male patients with non-advanced fibrosis aged ≥60 years have a higher risk of developing HCC and, thus, require HCC surveillance.

Cancer-related fatigue is often observed in cancer patients with palliative care and it includes several symptoms such as fatigue, fatigability and appetite loss. Although oral steroids are generally used for improving these symptoms, there is no established consensus for targeted patients, quantity and duration of administration. We performed the questionnaire survey with 14 questions about oral steroids usage in cancer patients with palliative care at 33 institutions in Japan. Medical doctors engaged in cancer therapy answered this questionnaire survey. We obtained 176 answers (response rate 41.3%, 176/426). 158 doctors (89.8%) used oral steroids for patients with cancer-related fatigue. Among them, most doctors used to choose agents by their familiarity and dexamethasone(D)alone/betamethasone(B)alone/both D and B/other steroids were selected in 133 (84.2%)/13 (8.2%)/9 (5.7%)/3 (1.9%) doctors, respectively. The number of initial dose of oral steroids (less than 2.0mg in terms of dexamethasone/2.0-3.9mg/4.0mg and more) were 39 (24.7%)/51 (32.3%)/65 (41.2%), respectively. 142 doctors (89.9%) had realized that oral steroids improved cancer-related symptoms in cancer patients, especially in terms of fatigue (74.1%), fatigability (33.5%) and appetite loss (23.4%). 114 doctors (72.2%) adjusted the quantity of oral steroids from initial dose during treatment according to the efficacy and 113 (71.5%) doctors continued oral steroids until patients' death. 73 doctors (46.2%) usually start oral steroids when they estimated prognosis of patient was within 3 months, and 61 doctors (38.6%) usually start it when patient has symptoms of cancer-related fatigue, regardless of prognosis. It was revealed that most doctors engaged in cancer therapy have empirically used oral steroids for cancer patients having cancer-related fatigue in palliative phase and they had realized the effectiveness of oral steroids.

BACKGROUND & AIMS: The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP. METHODS: Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement. RESULTS: PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%-23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups. CONCLUSION: ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture.

Background Olmesartan, which is an angiotensin II receptor blocker, reportedly causes spruelike enteropathy, with intestinal villous atrophy as its typical histopathological finding. Interestingly, collagenous and/or lymphocytic gastritis and colitis occur in some patients. We report the case of a 73-year-old Japanese man with a 2-month clinical history of severe diarrhea and weight loss. There were few reports in which spruelike enteropathy and collagenous colitis were both observed and could be followed up. Case presentation We report a case of a 73-year-old man with a 2-month clinical history of severe diarrhea and weight loss. He had taken olmesartan for hypertension treatment for 5 years. Endoscopic examination with biopsies revealed intestinal villous atrophy and collagenous colitis. Suspecting enteropathy caused by olmesartan, which was discontinued on admission because of hypotension, we continued to stop the drug. Within 3 weeks after olmesartan discontinuation, his clinical symptoms improved. After 3 months, follow-up endoscopy showed improvement of villous atrophy but not of the thickened collagen band of the colon. However, the mucosa normalized after 6 months, histologically confirming that the preexistent pathology was finally resolved. Conclusions This report presents a case in which spruelike enteropathy and collagenous colitis were both observed and could be followed up. In unexplained cases of diarrhea, medication history should be reconfirmed and this disease should be considered a differential diagnosis.

Aim This study aimed to determine the optimal psoas muscle mass index (PMI) cut‐off values for diagnosis of skeletal muscle mass loss. Methods We evaluated PMI in two groups of normal controls: a medical check‐up group and a liver donation candidate group. We analyzed two novel PMI cut‐off values, one based on the mean – two standard deviations (2SD) and one based on the lower 5%. Skeletal muscle mass index (SMI) evaluations using computed tomography (sliceOmatic; TomoVision) and bioelectrical impedance analysis and PMI evaluation were undertaken simultaneously. We analyzed the correlation between our PMI cut‐off values and the Japan Society of Hepatology‐defined SMI cut‐off values. The prevalence of skeletal muscle mass loss in patients with liver disease was assessed using the novel PMI cut‐off values. Results In 504 normal controls aged ≤50 years, the PMI cut‐off values based on mean –2SD and the lower 5% were set at 3.30 cm 2 /m 2 for men and 1.69 cm 2 /m 2 for women and 3.74 cm 2 /m 2 for men and 2.29 cm 2 /m 2 for women, respectively. The PMI cut‐off values based on the lower 5% alone showed that skeletal muscle mass loss increased with age. Furthermore, they correlated well with Japan Society of Hepatology‐defined SMI (sliceOmatic) cut‐off values and showed a significantly higher prevalence of skeletal muscle mass loss in patients with liver cirrhosis than those without liver cirrhosis. Conclusions We propose the following PMI cut‐off values: 3.74 cm 2 /m 2 for male individuals and 2.29 cm 2 /m 2 for female individuals. These cut‐off values can facilitate accurate diagnosis and management of sarcopenia in patients with chronic liver disease.

Abstract Background The regimens of nab-P+GEM have become available for advanced pancreatic cancer, especially metastatic disease. However, there are not enough data of nab-P+GEM for LAPC. Methods This is a retrospective multiple institutes cohort study using medical records of LAPC patients who received nab-P+GEM between January 2015 and September 2017. We have surveyed their characteristics and treatment outcomes. Results The number of relevant patients was 48 at 11 institutes. Median age was 68 years old, male/female : 22/26, ECOG PS 0/1/2 : 33/13/2, primary site; head/body/tail : 28/18/2. Relative dose intensity was nab-P; 0.588 (0.065-1.012) and GEM; 0.656 (0.368-1.012). Response rate was 27.0% and Disease control rate was 94.6% among patients who had target lesion. Median progression-free survival was 9.4 months (95% CI, 5.4 – 13.4) and median overall survival was 19.6 months (95% CI, 13.9 – 24.3). The most common adverse event of grade 3 or higher was neutropenia (61.7%). Febrile neutropenia was 8.3%. Conclusions It seemed that nab-P+GEM was effective for patients with LAPC. Prospective and further investigation in more cases is expected. Legal entity responsible for the study Hokkaido Gastrointestinal Cancer Study Group. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

BACKGROUND AND AIM:Hepatitis E virus (HEV) is mainly transmitted orally, either waterborne or zoonotic foodborne. Intestinal viruses such as rotavirus are known to induce type III interferon (IFN) in the gastrointestinal (GI) tract where type III IFN dominantly functions in comparison with type I IFN. Therefore, the aim of this study is to investigate the significance of type III IFN (IFN-λ3) in acute hepatitis E. METHODS:IFN-λ3 and HEV RNA levels in the sera of patients with acute HEV infection and in the supernatant of HEV-inoculated cells were measured, using an in-house high-sensitivity method and reverse transcription-polymerase chain reaction, respectively. RESULTS:High serum IFN-λ3 levels were found in the early phase of acute HEV infection, which normalized after resolution. Interestingly, serum IFN-λ3 levels correlated well with serum HEV RNA titers in the same sera, both of which showed the peak before the robust increase of transaminases. In vitro experiments demonstrated that HEV replicated well in the cells with little IFN-λ3 induction (Caco-2, A549) and recombinant IFN-λ3 inhibited HEV replication in a dose-dependent manner. In contrast, in HT-29 cells, a colon cancer cell line, HEV poorly replicated and induced IFN-λ3 in a titer-dependent manner. CONCLUSIONS:These clinical and experimental observations suggest that HEV induced IFN-λ3 as a host innate immune response, which may play a protective role against HEV.

AimThe safety and efficacy of sofosbuvir (SOF) and ribavirin (RBV) have not been well clarified in patients with renal dysfunction because clinical trials have not included such patients. We evaluated the safety and efficacy of SOF and RBV for genotype 2 hepatitis C virus (HCV)‐infected patients with renal dysfunction.MethodsThe study included genotype 2 HCV‐infected patients who received SOF and RBV between July 2014 and May 2017. The sustained virologic response (SVR) after the treatment and safety during the therapy were evaluated according to renal function.ResultsA total of 231 patients were included in this study. The median age was 62 years old, and 45.9% (106/231) were men. Of the 231 patients, 191 (82.8%) and 40 (17.2%) were classified as having chronic kidney disease (CKD) stages G1/2 and G3, respectively. The overall SVR rate was 97% (224/231). The SVR rates in patients with CKD stages G1, 2, G3a, and G3b were 98.1%, 98.6%, 87.9%, and 100%, respectively, and this therapy was tolerated. Multivariate analysis indicated that renal dysfunction was significantly associated with a non‐SVR (odds ratio, 6.963; 95% confidence interval, 1.494–32.41; P = 0.013). The patients with renal dysfunction were older, had advanced liver fibrosis, lower baseline platelet and hemoglobin levels, and a higher rate of RBV dose reduction.ConclusionsSofosbuvir and RBV therapy is highly effective and safe for genotype 2 HCV‐infected Japanese patients. However, attention should be paid to baseline renal function when SOF‐ and RBV‐containing regimens are used for patients with renal dysfunction.

Background/Aims Although the risk of bleeding after endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is low, the safety of EUS-FNA in patients prescribed antithrom-botic agents is unclear. Therefore, this study evaluated the incidence of bleeding after EUS-FNA in those patients. Methods : Between September 2012 and September 2015, patients who were prescribed antithrombotic agents underwent EUS-FNA at 13 institutions in Japan were prospectively enrolled in the study. The antithrombotic agents were managed according to the guidelines of the Japanese Gastrointestinal Endoscopy Society. The rate of bleeding events, thromboembolic events and other complications within 2 weeks after EUS-FNA were analyzed. Results : Of the 2,629 patients who underwent EUS-FNA during the study period, 85 (62 males; median age, 74 years) patients were included in this stduy. Two patients (2.4%; 95% confidence interval [CI], 0.6% to 8.3%) experienced bleeding events. One patient required surgical intervention for hemothorax 5 hours after EUS-FNA, and the other experienced melena 8 days after EUS-FNA and required red blood cell transfusions. No thromboembolic events occurred (0%; 95% CI, 0.0% to 4.4%). Three patients (3.5%; 95% CI, 1.2% to 10.0%) experienced peri-puncture abscess formation. Conclusion : s The rate of bleeding after EUS-FNA in patients prescribed antithrombotic agents might be considerable.

In Japan, S-1 plus cisplatin (SP) regimen has become a standard therapy for patients with advanced gastric cancer. Moreover, the S-1 plus oxaliplatin regimen is now a standard treatment.

Endoscopic biliary stenting is a useful and safe technique for malignant biliary obstructions. A plastic stent is frequently used because of its low cost and ease of deployment. However, it is occasionally difficult to remove a plastic stent because of severe stricture. We describe a rescue technique for immovable plastic stents, using a diathermic dilator in a case of perihilar biliary obstruction.

151 Background: Some phase II and III studies of second-line chemotherapy for metastatic or advanced gastric cancer have been reported in recent years. Irinotecan is one of the standard regimen for second-line therapy. On the other hand, the efficacy of continuing trastuzumab (Tmab) beyond progression in patients (pts) who had previously been treated with Tmab plus standard first line chemotherapy has not been reported. We conducted this study to assess the efficacy and safety of Tmab with irinotecan in HER2-positive gastric cancer pts previously treated with Tmab (UMIN ID: 000007636). Methods: Patients with HER2-positive metastatic or advanced gastric cancer who were previously treated with Tmab and failed were included. Pts received Tmab every 3 weeks and irinotecan every 2 weeks. Primary endpoint was response rate (RR), and secondary endpoints were progression-free survival (PFS), six-month survival rate, safety, sub-group analysis by HER2 status (IHC 3+ group, IHC 2+/FISH positive group), and so on. Results: Only 16 pts were enrolled from 9 institutions in three years during a pre-planned registration period. We stopped this study on the way, unfortunately. In a total of 16 pts, one patient was excluded and 15 were analyzed. Median age was 65, male/female; 9/6, ECOG PS 0/1; 8/7, and IHC 3+/IHC 2+ and FISH positive; 10/5, respectively. Response rate was 7% and disease control rate was 53%. Median PFS and overall survival (OS) were 2.4 (95%C.I.; 0.0-5.2 months) and 9.7 months (95%C.I.; 8.2-11.2 months), respectively. Six-month PFS rate was 13%. In sub-group analysis by HER2 status, median PFS of IHC 3+ and IHC 2+/FISH positive were 2.2 and 2.4 months, respectively. Median OS of each groups were 8.8 and 10.8 months. The most frequently reported grade 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). Conclusions: This study was closed prematurely due to poor accrual. It seemed that continued use of Tmab and irinotecan beyond disease progression has not significant clinical benefit in HER2-positive metastatic or advanced gastric cancer pts previously treated with Tmab. Clinical trial information: UMIN000007636.

Some phase II and III studies of second-line chemotherapy for metastatic or advanced gastric cancer have been reported in recent years. Irinotecan is one of the standard regimen for second-line chemotherapy. The efficacy of continuing trastuzumab(Tmab) beyond progression in patients(pts) who had previously been treated with Tmab plus standard first line chemotherapy has not been reported. We conducted this study to assess the efficacy and safety of Tmab with irinotecan in HER2-positive gastric cancer pts previously treated with Tmab (UMIN ID: 000007636). Patients with HER2-positive gastric cancer who were previously treated with Tmab and failed were included. Patients received Tmab every 3 weeks and irinotecan every 2 weeks. Primary endpoint was response rate (RR), and secondary endpoints were progression-free survival (PFS), six-month survival rate, safety, and so on. Only 16 patients were enrolled from 9 institutions in three years during a pre-planned registration period. We stopped this study on the way, unfortunately. One patient was excluded and 15 were analyzed. Median age was 65, male/female; 9/6, ECOG PS 0/1; 8/7, and IHC 3+ group/IHC 2+ and FISH positive; 10/5, respectively. RR was 7% and disease control rate was 53%. Median PFS and overall survival (OS) were 2.4 (95%C.I.; 0.0-5.2 months) and 9.7 months (95%C.I.; 8.2-11.2 months), respectively. Six-month PFS rate was 13%. In sub-group analysis by HER2 status, median PFS of IHC 3+ and IHC 2+/FISH positive were 2.2 and 2.4 months, respectively. Median OS of each groups were 8.8 and 10.8 months. The most frequently grade 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). The study was closed prematurely due to poor accrual. It seemed that continued use of Tmab and irinotecan beyond disease progression has not clinical benefit in HER2-positive metastatic or advanced gastric cancer patients previously treated with Tmab.

Background: We previously reported that S-1 chemotherapy for gastrointestinal cancer (GI cancer) induced the high incidence of eye disorders (EDs), regardless of primary cancer site, treatment regimen and administration schedule (Yagisawa M, et al. 2017 Gastrointestinal Cancers Symposium). However, because this report showed a retrospective data from single institutional small cohort by reviewing medical records, we might have underestimated the incidence of EDs. So, we have conducted this prospective cohort study to confirm the incidence of EDs induced by S-1 more precisely. Trial design: This is a multicenter prospective cohort study to evaluate the incidence of EDs and ophthalmologic changes in GI cancer patients received S-1 chemotherapy. The key eligibility criteria are as follows: 1) Histologically confirmed carcinoma in GI cancer, including esophageal, gastric, colorectal, pancreatic, and biliary tract cancer.; 2) The patient who receives chemotherapy including S-1.; 3) No prior medication of S-1.; 4) No lachrymal duct obstruction and less than three points of corner conjunctiva epithelium disorder score. All participants receive four times of ophthalmological examinations. The primary endpoint is cumulative incidence of epiphora in periods from start of S-1 chemotherapy to 12 weeks after induction S-1. The secondary endpoints are cumulative incidence of epiphora in overall S-1 chemotherapy periods, the time of onset and severity of epiphora, the situation of ophthalmological intervention, ophthalmological changes, risk factors of epiphora, and QOL. Because we supposed that incidence of epiphora at 12 weeks after induction S-1 is 10% as already reported, we calculated the sample size as 160 based on precision of the 95% confidence interval and aimed to recruit 180 patients considering the possibility of 10% dropouts. This study is sponsored by Non Profit Organization Hokkaido Gastrointestinal Cancer Study Group. Clinical trial identification: UMIN 000027192 24, June, 2017 Legal entity responsible for the study: Hokkaido Gastrointestinal Cancer Study Group Funding: None Disclosure: S. Yuki: Honoraria: Taiho Pharmaceutical Y. Sakata: Consultant fee from Taiho Pharmaceutical Co., Ltd., Y. Komatsu: Grants for research and donations: Taiho Pharmaceutical Co., Ltd., All other authors have declared no conflicts of interest.

Background The efficacy of irinotecan plus continuous trastuzumab beyond progression in patients with gastric cancer previously treated with trastuzumab plus standard first-line chemotherapy has not been reported. Methods Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer who were previously treated with trastuzumab received trastuzumab every 3 weeks and irinotecan every 2 weeks. The primary endpoint was the overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), 6-month survival rates, safety, and subgroup analysis by HER2 status. Results Sixteen patients were enrolled in a 3-year pre-planned registration period. This study was prematurely closed due to poor patient accrual. The ORR and disease control rate were 6.7% (95% CI, 0.2-32.0) and 53.3% (95% CI, 26.6-78.7). The median PFS and overall survival (OS) were 2.4 months (95% CI, 0.0-5.2) and 9.7 months (95% CI, 8.2-11.2), respectively. The most frequently reported grades 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). Conclusion With only 16 patients enrolled, the present study has very low power to detect any clinical benefit of trastuzumab plus irinotecan beyond disease progression in patients with HER2-positive advanced gastric cancer who previously received trastuzumab. Trial Identifier: UMIN000007636.

Although the risk of bleeding after endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is low, there were no data about the safety of EUS-FNA for patients taking antithrombotic agents. Therefore, we aimed to elucidate the rate of bleeding in EUS-FNA for those patients.

743 Background: The GERCOR index based on performance status and serum LDH was reported to be useful to predict survival for patients with previously untreated mCRC. However, the validity of the GERCOR index has not been reported in patients treated with bevacizumab (Bev)-based first line chemotherapy. Methods: 115 patients with mCRC treated with Bev contained first line chemotherapy were registered from 15 centers in Japan. Univariate and multivariate analysis for overall survival (OS) were performed using patient characteristics. Survival analyses were performed with the Kaplan-Meier method, log-rank test and the Cox proportional hazards model. The analysis was also designed to determine whether the GERCOR index could be extended to progression-free survival (PFS). Results: All data were available for prognostic categorization in 108 patients. Patients with the GERCOR index of low, intermediate and high risk were 45, 57, and 6, respectively. The pts characteristics between low risk (L) and intermediate/high risk (I/H) were generally balanced except for prior colorectomy (75.6% in L, 54.0% in I/H; p = 0.027), based cytotoxic agent (oxaliplatin) (80.0% in L, 93.7% in I/H; p = 0.039), liver metastasis (53.3% in L, 79.4% in I/H; p = 0.006) and median number of metastatic organ (1 in L, 2 in I/H; p = 0.024). The distribution and median OS / PFS for the GERCOR index were as follows: L (n = 45; 29.9/10.0 months), I/H (n = 63; 17.0/8.5 months). For OS, there was significant difference between L and I/H (p = 0.003). For PFS, there was not significant difference between L and I/H (p = 0.522). In the Cox multivariate analysis, GI did not show an independent prognostic impact (L vs I/H ; HR 1.499, p = 0.120) and predictive impact (L vs I/H ; HR 0.922, p = 0.733). Conclusions: In this analysis, the GERCOR index might be neither the predictive nor prognostic factor in the bevacizumab combined first line chemotherapy for patients with mCRC.

Aim/Background: Some studies had reported that oral FU/Oxaliplatin (OX) was non-inferior to infusional FU/OX as 1st line treatment for metastatic colorectal cancer (mCRC). We conducted observational cohort study (HGCSG0802) which investigated Japanese patients (pts) treated with bevacizumab (BV) containing regimen. Therefore, we had performed analysis in order to investigate whether there was a difference in safety and efficacy of infusional FU/OX (mFOLFOX6 + BV: iFU) and oral FU/OX (CapeOX/SOX + BV: oFU) using the HGCSG0802 database.Methods: The key eligibility criteria of HGCSG0802 were with evaluable lesions, older than 20 years, ECOG PS 0-2, and this analysis used the cohort treated with OX-based regimens. In this analysis, pts characteristics, RR and safety were compared using Fisher's exact test. PFS, TTF and OS were compared using log-rank test for comparison of the iFU and oFU.Results: Of 108 pts (the full analysis set), 95 pts were evaluable for treated with OX-based regimens. Forty-eight pts (50.5%) were treated with iFU and 47 pts (49.5%) were treated with oFU (CapeOX + BV 42 pts/SOX + BV 5 pts). The pts characteristics between those were generally balanced except for PS 0-1 (72.9% in iFU/93.6% in oFU; p = 0.012) and synchronous liver metastases (93.8% in iFU/78.8% in oFU; p = 0.040). Adverse events ≥ Grade 3 were balanced except for leucopenia (25.0% in iFU versus 2.1% in oFU; p =.002) and neutropenia (43.5% in iFU and 10.9% in oFU; p =.001). Hand-foot skin reaction was not different between two cohorts. RR was 62.5% in iFU versus 71.1% in oFU (p = 0.835). The median PFS was 8.3 months in iFU versus 8.2 months in oFU (p = 0.970) and median OS was 18.3 months in iFU versus 23.5 months in oFU (p = 0.247).Conclusions: As a result of this analysis, in Japanese daily practice, efficacy was no significant difference between iFU and oFU, and the profiles of adverse events varied from each regimens. This analysis had been presented at the European Cancer Congress 2015 (Nakatsumi H, et al. Abstract number was 2 092).Disclosure: Y. Komatsu: Honoraria: Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Research fund: Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Y. Sakata: Honoraria: Daiichi Sankyo Co., Ltd., Yakult Honsha Co., Ltd. All other authors have declared no conflicts of interest. Aim/Background: Some studies had reported that oral FU/Oxaliplatin (OX) was non-inferior to infusional FU/OX as 1st line treatment for metastatic colorectal cancer (mCRC). We conducted observational cohort study (HGCSG0802) which investigated Japanese patients (pts) treated with bevacizumab (BV) containing regimen. Therefore, we had performed analysis in order to investigate whether there was a difference in safety and efficacy of infusional FU/OX (mFOLFOX6 + BV: iFU) and oral FU/OX (CapeOX/SOX + BV: oFU) using the HGCSG0802 database. Methods: The key eligibility criteria of HGCSG0802 were with evaluable lesions, older than 20 years, ECOG PS 0-2, and this analysis used the cohort treated with OX-based regimens. In this analysis, pts characteristics, RR and safety were compared using Fisher's exact test. PFS, TTF and OS were compared using log-rank test for comparison of the iFU and oFU. Results: Of 108 pts (the full analysis set), 95 pts were evaluable for treated with OX-based regimens. Forty-eight pts (50.5%) were treated with iFU and 47 pts (49.5%) were treated with oFU (CapeOX + BV 42 pts/SOX + BV 5 pts). The pts characteristics between those were generally balanced except for PS 0-1 (72.9% in iFU/93.6% in oFU; p = 0.012) and synchronous liver metastases (93.8% in iFU/78.8% in oFU; p = 0.040). Adverse events ≥ Grade 3 were balanced except for leucopenia (25.0% in iFU versus 2.1% in oFU; p =.002) and neutropenia (43.5% in iFU and 10.9% in oFU; p =.001). Hand-foot skin reaction was not different between two cohorts. RR was 62.5% in iFU versus 71.1% in oFU (p = 0.835). The median PFS was 8.3 months in iFU versus 8.2 months in oFU (p = 0.970) and median OS was 18.3 months in iFU versus 23.5 months in oFU (p = 0.247). Conclusions: As a result of this analysis, in Japanese daily practice, efficacy was no significant difference between iFU and oFU, and the profiles of adverse events varied from each regimens. This analysis had been presented at the European Cancer Congress 2015 (Nakatsumi H, et al. Abstract number was 2 092). Disclosure: Y. Komatsu: Honoraria: Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Research fund: Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Y. Sakata: Honoraria: Daiichi Sankyo Co., Ltd., Yakult Honsha Co., Ltd. All other authors have declared no conflicts of interest.