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Background Real-world evidence on the preference for and effectiveness of third- or later-line (3L +) monotherapy for HER2-positive gastric cancer is limited in Japan. This study evaluated the utility of nivolumab, irinotecan, and trifluridine/tipiracil (FTD/TPI) monotherapy as 3L + treatment in Japanese patients with HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer who were previously treated with trastuzumab. Methods In this multicenter, retrospective, observational study (20 centers), data of eligible patients were extracted from medical records (September 22, 2017–March 31, 2020), with follow-up until June 30, 2020. Outcomes included overall survival (OS), real-world progression-free survival (rwPFS), time to treatment failure (TTF), objective response rate (ORR; complete response [CR] + partial response [PR]), and disease control rate (DCR). Results Of 127 enrolled patients, the overall analysis population comprised 117 patients (median [range] age, 71 [38–89] years). The most commonly prescribed 3L + monotherapy was nivolumab (n = 100), followed by irinotecan (n = 12) and FTD/TPI (n = 5). The median (95% confidence interval [CI]) OS, rwPFS, and TTF were 6.2 (4.5–8.0), 1.9 (1.5–2.3), and 1.8 (1.5–2.2) months, respectively, at median (range) 150 (25–1007) days of follow-up. The ORR (CR + PR) and DCR were 9.0% (1% + 8%) and 32.0%, respectively. Factors such as higher neutrophil–lymphocyte ratio (≥ 2.54), Glasgow prognostic score (≥ 1), Eastern Cooperative Oncology Group performance status (ECOG PS; ≥ 2), and hepatic metastasis significantly impacted OS. Conclusions The observed OS in this study for HER2-positive G/GEJ cancer was shorter than that reported previously, suggesting that the effectiveness of nivolumab, irinotecan, or FTD/TPI as 3L + therapy may be limited.

Background The Cancer-VTE Registry was a large-scale, multicenter, prospective registry designed to investigate real-world data on venous thromboembolism (VTE) incidence and risk factors in adult Japanese patients with solid tumors. This pre-specified subgroup analysis aimed to estimate the incidence of VTE, including VTE types other than symptomatic VTE, and identify risk factors of VTE in stomach cancer from the Cancer-VTE Registry. Methods Stage II–IV stomach cancer patients who planned to initiate cancer therapy and underwent VTE screening within 2 months before registration were enrolled. Results Of 1,896 patients enrolled, 131 (6.9%) had VTE at baseline, but 96.2% were asymptomatic. Female sex, age ≥ 65 years, VTE history, and D-dimer > 1.2 μg/mL were independent risk factors of VTE at baseline. Notably, patients with D-dimer > 1.2 µg/mL at the time of cancer diagnosis had an approximately 20-fold risk of VTE. During follow-up, event incidences were symptomatic VTE, 0.3%; incidental VTE requiring treatment, 1.1%; composite VTE, 1.4%; bleeding, 1.6%; cerebral infarction/transient ischemic attack/systemic embolic events, 0.7%; and all-cause death, 15.0%. The incidence of all-cause death was higher in patients with VTE vs without VTE at baseline (adjusted hazard ratio 1.67; 95% confidence interval 1.21–2.32; p = 0.002). Conclusions VTE prevalence at the time of cancer diagnosis was not negligible and was extremely high when the patients had high D-dimer. VTE screening by D-dimer before starting cancer treatment is advisable, even for asymptomatic patients, regardless of whether the patient is undergoing surgery or chemotherapy. Trial registration UMIN000024942.

Aim Osteoporosis in patients after gastrectomy is increasing with the aging of gastric cancer patients. Bisphosphonates are effective treatments for osteoporosis; however, their safety or efficacy in postgastrectomy patients has not been established. The purpose of this multicenter prospective intervention study was to investigate the impact of monthly minodronate on osteoporosis after gastrectomy. Methods Of the 261 enrolled gastric cancer patients, 164 patients were diagnosed with osteoporosis based on criteria of the Japan Society of Osteoporosis. They were randomly assigned 1:1 to groups treated with active vitamin D (VD group) or monthly minodronate (MIN group). The primary endpoint was changes in lumbar bone mineral density (L‐BMD) 12 mo after the start of administration. The secondary endpoints were changes in bone metabolism markers, adverse events (AEs), or treatment completion rates. Results There was no significant difference in patient background between the VD (n = 82) and MIN (n = 82) groups. In the MIN group, the increase in L‐BMD was significantly higher than that in the VD group (4.52% vs 1.72%, P = .001), with a significant reduction in bone metabolism markers; blood NTX (−25.6% vs −1.6%, P, Monthly minodronate is safe and effective for osteoporosis after gastrectomy.

We herein reported a case of advanced gastric cancer (GC) with para-aortic lymph node (PALN) metastases who successful achieved downstaging following systemic chemotherapy and underwent curative laparoscopic conversion surgery. A 74-year-old male patient diagnosed with advanced GC and PALN metastases [cT4N3M1(LYM), stage IVA] was administered chemotherapy and immunotherapy for 28 months. After 27 courses of nivolumab as third-line chemotherapy, PALN enlargement was resolved, for which conversion surgery was planned. Subsequently, laparoscopic distal D2 gastrectomy with sampling para-aortic lymphadenectomy was performed, after which a pathological diagnosis of type V moderately differentiated tubular adenocarcinoma with mucinous adenocarcinoma, stage ypT3 (SS), ly1c, and v0, was established. The pathological proximal and distal tumor margins were negative. One lymph node metastasis was observed (No. 6; 1/25). The sampled lymph nodes were negative (No. 16a1: 0/2). The therapeutic effect was categorized as Grade 1a. The postoperative course was uneventful, with the patient receiving nivolumab to control for potential PALN metastases. Postoperatively, no recurrence was observed over 11 months. Laparoscopic conversion gastrectomy was successfully performed in a patient with advanced GC that was originally unresectable, suggesting that minimally invasive surgery may be a good option for originally unresectable advanced GC that becomes resectable.

Background Surgeons are often faced with optimal resection extent and reconstructive method problems in laparoscopic gastrectomy for gastric cancer in the upper and middle body of the stomach. Indocyanine green (ICG) marking and Billroth I (B-I) reconstruction was used to solve these problems with the organ retraction technique. Case Presentation A 51-year-old man with upper gastrointestinal endoscopy revealed a 0-Ⅱc lesion in the posterior wall of the upper and middle gastric body 4 cm from the esophagogastric junction. CT1bN0M0 (cStage IA) was the preoperative diagnosis. Laparoscopic distal gastrectomy (LDG) and D1 + lymphadenectomy was decided to be performed considering postoperative gastric function preservation. The ICG fluorescence method was used to determine the accurate tumor location since the determination was expected to be difficult to the extent of optimal resection with intraoperative findings. By mobilizing and rotating the stomach, the tumor in the posterior wall was fixed in the lesser curvature, and as large a residual stomach as possible was secured in gastrectomy. Finally, delta anastomosis was performed after increasing gastric and duodenal mobility sufficiently. Operation time was 234 min and intraoperative blood loss was 5 ml. The patient was discharged 10 days postoperatively without complications. Conclusion The indication for LDG and B-I reconstruction can be expanded to cases where laparoscopic total gastrectomy or LDG and Roux-en-Y reconstruction has been selected for early-stage gastric cancer in the upper gastric body by combining preoperative ICG markings and gastric rotation method dissection.

There is no standard chemotherapy for esophageal squamous cell carcinoma (ESCC) refractory to first-line fluoropyrimidine- and platinum-based chemotherapy. We therefore performed a randomized, selection-design phase II trial to compare docetaxel (DTX) and paclitaxel (PTX) in this setting. Eligible patients were randomly assigned to receive either DTX (70 mg/m2 on day 1 of each 21-day cycle) or PTX (100 mg/m2 on days 1, 8, 15, 22, 29, and 36 of each 49-day cycle). The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), time to treatment failure (TTF), response rate (RR), and safety. Seventy-eight eligible patients (N = 39 in each group) were included for efficacy analysis. The median OS was significantly longer in the PTX group (8.8 vs. 7.3 months; hazard ratio [HR], 0.62; P = 0.047). A significant benefit of PTX over DTX was also apparent in the median PFS (4.4 vs. 2.1 months; HR, 0.49; P = 0.002) and median TTF (3.8 vs. 2.1 months; HR, 0.45; P PTX showed a significantly better efficacy as well as a more manageable toxicity compared with DTX.

Patients with peritoneal dissemination of gastric cancer have poor oral intake caused by malignant bowel obstruction (MBO). Palliative surgery has often been undertaken to improve quality of life (QOL), but few prospective studies on palliative surgery in this patient population have been published. We prospectively investigated the significance of palliative surgery using patient-reported QOL measures. Patients underwent palliative surgery by small intestine/colon resection or small intestine/colon bypass or ileostomy/colostomy for MBO. The primary endpoint was change in QOL assessed at baseline, 14 days, 1 month, and 3 months following palliative surgery using the Euro QoL Five Dimensions (EQ-5D™) questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire gastric cancer module (QLQ-STO22). Secondary endpoints were postoperative improvement in oral intake and surgical complications. Between April 2013 and March 2018, 63 patients were enrolled from 14 institutions. The mean EQ-5D™ utility index baseline score of 0.6 remained consistent. Gastric-specific symptoms mostly showed statistically significant improvement from baseline. Forty-two patients (67%) were able to eat solid food 2 weeks after palliative surgery and 36 patients (57%) tolerated it for 3 months. The rate of overall morbidity of ≥ grade III according to the Clavien–Dindo classification was 16% (10 patients) and the 30-day postoperative mortality rate was 3.2% (2 patients). In patients with MBO caused by peritoneal dissemination of gastric cancer, palliative surgery did not improve QOL while improving solid food intake, with an acceptable postoperative morbidity and mortality rate.

Background This study evaluated the association between early tumor response at 8 weeks, previously reported as a positive outcome prognosticator, and health-related quality of life (HRQOL) in advanced gastric cancer (AGC) patients enrolled in the ABSOLUTE trial. Methods HRQOL was assessed using the EuroQol-5 Dimension (EQ-5D) utility index score in patients with complete response (CR) + partial response (PR) and progressive disease (PD) at 8 weeks, and time-to-deterioration (TtD) of the EQ-5D score, with the preset minimally important difference (MID) of 0.05, was compared between these populations. Among the enrolled patients, 143 and 160 patients were assessable in weekly solvent-based paclitaxel (Sb-PTX) arm and weekly nanoparticle albumin-bound paclitaxel (nab-PTX) arm, respectively. Results Changes of the EQ-5D score from baseline to 8 weeks in the nab-PTX arm were 0.0009 and − 0.1229 in CR + PR and PD patients, respectively; the corresponding values for the Sb-PTX arm were − 0.0019 and − 0.1549. For both treatments, changes of the EQ-5D score from baseline at 8 weeks were significantly larger in patients with PD than in those with CR + PR. The median TtD was 3.9 and 2.2 months in patients with CR + PR and PD, respectively, for nab-PTX [hazard ratio (HR) = 0.595, 95% confidence interval (CI) 0.358–0.989]. For Sb-PTX, the corresponding values were 4.7 and 2.0 months (HR = 0.494, 95% CI 0.291–0.841). Conclusions Early tumor shrinkage was associated with maintained HRQOL in AGC patients on the second-line chemotherapy with taxanes.

It remains controversial whether the advantages of laparoscopic surgery for colorectal cancer (CRC) are beneficial in elderly patients (EP, age ≥ 80 years). The present study aimed to evaluate whether age itself is an independent risk factor for laparoscopic surgery by comparing short- and long-term outcomes between non-EP and EP groups. We retrospectively analyzed 730 consecutive patients with stage I–III CRC who had undergone elective surgery between 2010 and 2017, using propensity score–matched analysis. Median follow-up was 49 months. After matching, we enrolled 228 patients. In the matched cohort, estimated operative time, estimated blood loss, lymph node dissection ≥ D3, number of lymph nodes harvested

Background Predictive factors of nivolumab treatment response in patients with gastric cancer (GC) remain unclear. Methods In this retrospective cohort study, tissue specimens of patients with unresectable or recurrent GC and prior or scheduled treatment with nivolumab as third-line or higher therapy between September 2017 and February 2019 were collected from 23 institutions. The tumour-positive score (TPS) and combined positive score (CPS) of PD-L1 expression and mismatch repair (MMR) were analysed by immunohistochemistry. Associations between clinicopathological factors and tumour-response rate, hyperprogressive disease (HPD) rate and survival were assessed. Results Of 200 eligible patients, 143 had measurable lesions. The response and HPD rates were 17.5% and 22.1%, respectively. The response rate was significantly higher in patients with performance status (PS) 0–1 (P = 0.026), non-peritoneal metastasis (P = 0.021), PD-L1 TPS ≥ 1 (P = 0.012), CPS ≥ 5 (P = 0.007) or ≥ 10 (P P P = 0.026), liver metastasis (P P = 0.048). Multivariate analysis revealed that CPS (P = 0.001) and MMR (P = 0.002) were independent prognostic factors of progression-free survival, as well as liver metastasis (P P = 0.004) and CRP (P Conclusions PD-L1 CPS and MMR could be useful biomarkers for nivolumab treatment efficacy in GC. Clinical trial registration UMIN000032164.

A Morgagni hernia is a rare type of congenital diaphragmatic hernia. Here, a case of a Morgagni hernia repaired by SILS is presented. A 78-year-old woman was admitted to our hospital with nausea and vomiting. On CT, the transverse colon and antrum of the stomach were prolapsed into the right thoracic cavity. The herniated stomach was repositioned by emergency endoscopy, and SILS repair was performed electively. Laparoscopy showed the hernial orifice, which was 75 × 50 mm in diameter, on the right side and behind the sternum. Although the transverse colon had herniated through the defect into the right diaphragm, it was easily reduced into the abdominal cavity. Composite mesh was sutured to cover the hernial orifice. No perioperative complications or hernia recurrence have been observed in the 8 months since the surgery.

Introduction Whether prophylactic abdominal drainage after laparoscopic liver resection (LLR) is necessary remains unclear. This study aimed to evaluate the safety of omitting prophylactic abdominal drainage after LLR. Methods A retrospective analysis of 100 consecutive patients who underwent LLR at Osaka Rosai Hospital from April 2011 to November 2018 was performed. During this period, prophylactic abdominal drainage was routinely omitted during LLR without biliary anastomosis. The primary endpoint was the frequency of additional abdominal drainage. The secondary endpoint was the rate of postoperative complications. Results Ninety-six patients (96%) underwent partial resection or lateral segmentectomy, and 89 patients (89%) were Child-Pugh grade A. The median operative time was 102 (range, 31–274) minutes. The median blood loss was minimal (range, 0–280 ml), and blood transfusion was performed for one patient (1%). One case (1%) was converted to open surgery. Additional abdominal drainage was required for one patient (1%) with an intraabdominal abscess. Postoperative complications were seen in 5 patients (5%). High-grade complications (≥grade III according to the Clavien-Dindo classification) were seen in two patients (2%). There were no cases of reoperation or perioperative death. The median postoperative hospital stay was 8 (range, 4–65) days. Conclusions Prophylactic abdominal drainage could be safely omitted for selected patients and operative procedures., Highlights • Prophylactic abdominal drainage for laparoscopic liver resection could be safely omitted for selected patients and operative procedures. • Laparoscopic liver resection without prophylactic abdominal drainage might shorten patients' postoperative hospital stay.

Safety of combination chemotherapy using platinum and fluorouracil has not been evaluated adequately for advanced gastric cancer (AGC) in elderly patients.We initiated a phase II study to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapeOX) as first-line therapy for patients with AGC aged ≥70 years. Planned assessment of toxicity was made upon recruitment of the first 20 patients.In five out of 20 patients, unacceptable toxicity was observed, including three patients who were unable to complete the initial two courses due to adverse events. Among the other 15 patients, dose reduction due to toxicity were needed in 10 and treatment delay for adverse events also occurred in 12 patients during the first two courses.Early analyses of safety suggest that the CapeOX regimen was not tolerated without dose reduction for elderly patients with AGC in this study.

Osteoporosis leads to fragility fractures and is a major public health problem. We conducted this study to analyze the prevalence of and risk factors for osteoporosis after gastrectomy in older patients.This multicenter prospective trial comprised older patients without recurrence of gastric cancer for 3 years after curative surgery. The prevalence of osteoporosis was identified using the World Health Organization bone mineral density (BMD)-based definition. Univariate and multivariate analyses were performed to identify the risk factors for osteoporosis.BMD values were measured in 267 of the 271 enrolled patients. The prevalence of osteoporosis was 38.2% (men 24.0%; women 60%). Analysis using FRAXThe prevalence of osteoporosis in older patients after gastrectomy was 38.2%. Moreover, female sex, age, low body mass index after gastrectomy, and a history of fracture were risk factors significantly associated with osteoporosis. Thus, older patients undergoing gastrectomy should have proactive surveillance and receive treatment for osteoporosis.

A 70-year-old man showing positive results for a fecal occult blood test was admitted to a local hospital. He was suspected of double cancer in the cecum and duodenum. While performing ileocolic and segmental duodenal resections, he was diagnosed with cecal cancer invading the duodenum, following which he underwent surgical intervention. The tumor directly invaded the duodenum because of the mobile cecum. This case of duodenal invasion by cecal cancer is atypical.

We introduced the medication support and adverse events monitoring system using medical social networking service (SNS).Thirty-two gastric cancer patients who were treated with oral anticancer drugs were included in this study. Patients or their families input the status of medication and adverse events using the ICT terminal every day, and the pharmacist confirmed the input contents on the PC. If there was a serious adverse events, the nurse confirmed the status of patient by telephone.Of the 32 registered cases, 3 cases (9.3%) discontinued input within less than 2 months during treatment. We experienced a case whose adverse events could be dealt with during long vacations and a case whose treatment could be continued by sharing information with home-visit nursing stations. In the questionnaire survey, there were many opinions that it would lead to anxiety reduction.Medication support system using medical SNS can be a safe and useful tool.

392 Background: Recently, neoadjuvant chemotherapy has been recognized as a promising strategy to improve the survival of patients with advanced gastric cancer. On the other hand, given the adverse events and treatment cost of chemotherapy, the candidate for NAC should be limited to patients who can benefit from NAC. In fact, as previously reported, the proportion of pathological stage I tumors was 50.4% in cT2N0, 38.7% in cT2N(+), 26.7% in cT3N0, 10.6% in cT3N(+), 9.0% in cT4aN0, and 3.0% in cT4aN(+). Therefore, clinical staging before initiation of treatment is increasingly important for determining therapeutic strategy. However, the long-term survival stratified by the prospectively-determined clinical stage has not been fully investigated. Methods: Between July 2013 and November 2014, the JCOG1302A examined 1260 patients with a clinical diagnosis of cT2/T3/T4, cN0/N1/N2/N3, M0, except for diffuse large tumors like linitis plastica and extensive bulky nodal diseases according to the Japanese Classification of Gastric Carcinoma (3rd English edition). The cT diagnosis was made by upper gastrointestinal endoscopy and comprehensive findings on upper abdominal contrast CT scan with 1 or 5 mm slice thickness. Lymph nodes with a shortest dimension greater than 8 mm or a longest dimension greater than 10 mm were defined as positive for metastasis. In this follow-up study, the survival data by stratifying the clinical staging were evaluated. Results: Among 1260 patients, survival data of 1177 were analyzed. With a median follow-up for 821 surviving patients of 6.0 years, the 5y-OS was 82.1% (95% CI, 77.3-85.9) in cT2 (n=319), 72.7% (68.2-76.6) in cT3 (n=450), 60.0% (54.9-64.7) in cT4a (n=401), and 40.0% (5.2-75.3) in cT4b (n=6), while that was 78.0% (74.2-81.2) in cN0 (n=560), 70.6% (65.4-75.2) in cN1 (n=350), 59.1% (52.5-65.1) in cN2 (n=241), and 28.4% (12.7-46.5) in cN3 (n=26), respectively. When combined with cT and cN, 5y-OS was 83.5% (77.8-87.8) in cT2N0 (n=226), 77.2% (71.0-82.2) in cT3N0 (n=232), 66.8% (56.3-75.2) in cT4aN0 (n=100), 100% in cT4bN0 (n=1), 78.7% (68.6-85.8) in cT2N(+)(n=93), 68.0% (61.1-73.8) in cT3N(+)(n=218), 57.7% (51.7-63.2) in cT4aN(+)(n=301), and 25.0% (0.9-66.5) in cT4bN(+)(n=5). Conclusions: Both the survival and the proportion of overdiagnosis of stage I patients in patients with cT4aN0, categorized as cstage IIB, was almost same as in those cT3N(+) categorized as cstage III. In considering the candidate for further treatment development of NAC with high toxic regime in future, cT3N(+) and cT4aN0 should be considered as equivalent category.

348 Background: CapeOX is a standard regimen for treating advanced gastric cancer (AGC). However, limited data are available for its use in the elderly patients. Geriatric assessment (GA) assessment is also considered important other than the age. Therefore, we conducted a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CapeOX as a first-line therapy for AGC in elderly patients. We performed GA assessments using the G8, and the MINI-COG. Methods: The inclusion criteria were: HER2-negative or unknown status, age 70 years or older, PS 0 or 1, no history of chemotherapy or radiotherapy, and an evaluable lesion based on the RECIST v1.1 guidelines. The initial treatment plan consisted of capecitabine (1,000 mg/m2, b.i.d., on days 1–14), and oxaliplatin (130 mg/m2, on day 1) every three weeks. After the initial feasibility assessment, the treatment plan was modified and consisted of capecitabine (750 mg/m2, b.i.d., on days 1–14) and oxaliplatin (100 mg/m2, on day 1) every three weeks. The primary endpoint was overall survival (OS). G8 assessments were performed before the beginning of the treatment, every three months after the start of the treatment, and at the end of the treatment. MINI-COG assessments were performed before the beginning of the treatment, and at the end of the treatment. Results: Between November 2016 and June 2020, 108 patients were enrolled, out of which 104 were evaluated. Thirty-nine patients received the initial treatment whereas sixty-five patients received the modified treatment. The primary endpoint was met. The median OS, progression-free survival (PFS), and time-to-treatment failure (TTF) were 12.9 (95% CI: 11.7–14.8), 5.8 (95% CI: 5.1–7.1), and 4.3 (95% CI: 3.9–5.7) months, respectively, for all patients. The median OS, PFS, and TTF for the initial treatment plan were 13.4 (95% CI: 9.6–16.0), 5.8 (95% CI: 4.1–7.9), and 5.3 (95% CI: 3.5–7.3) months, respectively, and for the modified treatment plan were 12.8 (95% CI: 11.3–15.3), 5.7 (95% CI: 4.4–7.0), and 4.2 (95% CI: 3.7–5.7) months, respectively. The most common grade 3/4 toxicities in the initial treatment plan patients were neutropenia (17.9%), anemia (12.8%), thrombocytopenia (12.8%), anorexia (10.3%), and nausea (10.3%) and in the modified treatment plan patients were (13.8%) and anorexia (12.3%). Mean G8 score was 11.4 before the treatment, 13.4 during the treatment and 11.6 at the end of the treatment. Mean MINI-COG score was 4.0 before the treatment, and 4.1 at the end of the treatment and the positive screen for dementia was 13.5% before the treatment and 11.4% at the end of the treatment. Conclusions: Our results show that the modified treatment plan is favorable for the elderly patients with gastric cancer based on the OS and the toxicities. Clinical trial information: 000022450 .

Complete surgical resection is the only treatment for resectable gastrointestinal stromal tumors (GISTs). Three-year adjuvant chemotherapy (AC) is recommended for patients with high-risk GISTs. However, there are scarce data on this topic in Japan. We aimed to study the efficacy and safety of AC in Japanese patients with high-risk GISTs.Patients with high-risk GISTs who received complete resections during 1992-2019 in our hospitals were included in this retrospective study. We evaluated patients' treatments with or without AC, completion rates, adverse events (AEs), recurrence-free survival (RFS), and overall survival (OS).Overall, 89 patients categorized as high risk were enrolled in this study. Fifty-five patients received AC (AC group), and 34 patients did not receive AC (control group). Twenty-three (41.8%) patients experienced Common Terminology Criteria for Adverse Events Grade 2 or higher AEs. At a median follow-up of 61.6 months, 41 (74.5%) patients completed the planned treatment (including six patients with ongoing treatment), whereas 14 (25.4%) patients did not complete the treatment owing to the development of AEs (nine patients), patients' request (three patients), recurrence (one patient), and mutational analysis (one patient). Comparing the data between the treatment and control groups, the RFS rate was significantly better for the AC group (P 0.001). However, there was no significant difference in the OS rate between the two groups.Postoperative AC was well tolerated by Japanese patients at an acceptable rate, and its use may reduce the risk of recurrence in patients with high-risk GISTs.

Background The varices after proximal or total gastrectomy are uncommon because the supplying vessels are all divided. Emergent upper gastrointestinal endoscopy is the cornerstone of first-line management for the diagnosis and treatment of esophageal varices. However, there is no widely accepted standard strategy for esophagojejunal varices. We report a patient with esophagojejunal varices rupture 3 months after proximal gastrectomy treated with percutaneous transhepatic obliteration. Case presentation A 50-year-old man who had undergone proximal gastrectomy with double-tract reconstruction for esophagogastric junctional cancer 3 months before was admitted to the hospital due to gastrointestinal perforation. We performed emergency surgery and abdominal symptoms and inflammatory response improved postoperative. However, on POD3, he had eruptive bleeding at the just anal side of esophagojejunal anastomosis. Endoscopic clipping was unsuccessful because the mucosa was fragile and easily lacerated. Contrast-enhanced CT scan revealed the dilatation of the jejunal vein flowing into the ascending jejunal limb. Therefore, he was diagnosed as esophagojejunal varices rupture and percutaneous transhepatic obliteration (PTO) was tried for hemostasis. The portal and superior mesenteric veins were catheterized with the percutaneous transhepatic approach. Contrast agent injection into the jejunal branch demonstrated retrograde flow to the azygos vein through esophagojejunal varices. The microcatheter was inserted into the variceal blood supply branch and 10 mL of 5% ethanolamine oleate with iopamidol was injected. After obliteration therapy, the superior mesenteric venogram showed complete occlusion of the variceal supply branch. The patient was discharged from the hospital without any complications after 14 days. Conclusion PTO can be effective for gastroesophageal varices rupture with a dilated jejunal vein of the ascending limb, few supplying vessels, and little ascites.

Highlights • Jejunal varices should be included in the differential diagnosis of melena in patients with a bilioenteric anastomosis and portal vein hypertension. • Laparotomy-assisted transcatheter variceal embolization is one of the options for the treatment of jejunal varices. • A multidisciplinary approach is critical for timely management of the unstable patient with bleeding from jejunal varices., Introduction Bleeding from jejunal varices formed at the site of a bilioenteric anastomosis due to portal vein hypertension is relatively rare and difficult to treat. Presentation of case An 80-year-old man with melena, slight fever, and abdominal pain was referred to our hospital. He had undergone subtotal stomach-preserving pancreaticoduodenectomy for cancer of the ampulla of Vater six years earlier. Follow-up computed tomography (CT) three years earlier showed occlusion of the extrahepatic portal vein and the growth of collateral flow into the lateral segment of the liver, but there were no signs of recurrence of the cancer of the ampulla of Vater. The patient underwent prophylactic endoscopic variceal ligation for esophageal varices one year earlier. On admission, blood tests showed anemia and elevated liver enzyme and bilirubin levels. Esophagogastroduodenoscopy and colonoscopy failed to identify the site of bleeding. Double-balloon endoscopy showed the dilated blood vessels around the stenotic anastomosis of the choledochojejunostomy. A CT scan was consistent with total occlusion of the portal vein and varices around the choledochojejunostomy site. With a diagnosis of jejunal varices, laparotomy-assisted transcatheter variceal embolization was performed. Double-balloon endoscopy performed one month after laparotomy-assisted transcatheter variceal embolization showed no varices, and dilation of the stenotic anastomosis of the choledochojejunostomy was performed safely. Conclusion Jejunal varices should be included in the differential diagnosis of melena in patients with a previous history of surgery with a bilioenteric anastomosis and portal vein hypertension. Laparotomy-assisted transcatheter variceal embolization is one of the options for the treatment of jejunal varices.

Aim The present study aimed to evaluate the efficacy of short‐term nutritional intervention with an oral elemental diet (ED; Elental; EA Pharma Co., Ltd, Tokyo, Japan) at 300 kcal/day for 6‐8 weeks in the early post‐gastrectomy period on postoperative long‐term body weight loss (BWL). Methods We analyzed consecutive patients who were randomly divided to receive the regular diet with or without ED. The control group received regular diet alone post‐gastrectomy, whereas the ED group received 300 kcal ED plus regular diet for 6‐8 weeks. Primary endpoint was percentage (%) BWL (body weight loss; body weight before surgery minus that at postoperative 1 year) by surgical type. Secondary endpoints included changes in nutrition‐related blood parameters. Results Of the patients in the original trial, 106 were eligible for efficacy analyses. %BWL at postoperative 1 year was significantly lower in the ED group than in the control group among patients who underwent total gastrectomy (TG) (n = 19 and n = 17, respectively; 9.66 ± 5.98% [95% confidence interval, CI: 6.77‐12.54] vs 15.11 ± 6.78% [95% CI: 11.63‐18.60], P = .015), but not in patients who underwent distal gastrectomy (n = 38 and n = 32, respectively; 5.81 ± 7.91% [95% CI: 3.21‐8.41] vs 5.96 ± 6.20% [95% CI: 3.72‐8.19], P = .933). In multivariate analysis, ED was the only factor affecting %BWL at postoperative 1 year among patients who underwent TG. Conclusions Daily nutritional intervention (300 kcal/day ED) for 6‐8 weeks reduced %BWL not only at postoperative 6‐8 weeks but also at 1 year in patients who underwent TG., Daily nutritional intervention (300 kcal/day elemental diet) for 6‐8 weeks reduced %body weight loss not only at postoperative 6‐8 weeks but also at 1 year in patients who underwent total gastrectomy.

A 77-year-old man visited our hospital due to bilateral painful inguinal swellings. He had a history of femoral-femoral artery bypass surgery for peripheral artery disease and took ethyl icosapentate. Additionally, he had a previous history of open left colectomy for descending colon cancer and had a median incision reaching the lower abdomen. With a diagnosis of bilateral direct inguinal hernias after femoral-femoral artery bypass surgery, he underwent single-incision laparoscopic surgery for totally extraperitoneal repair, continuing on ethyl icosapentate. During surgery, the preperitoneal space was safely and easily dissected, avoiding a subcutaneous vascular graft. No perioperative complications or hernia recurrence have been observed at 3 months follow-up.

The optimal treatment for liver metastasis from gastric cancer (LMGC) remains uncertain. The relevance of surgical resection is controversial. We conducted a prospective multicenter interventional study of surgical resection for LMGC. Patients with synchronous or metachronous LMGC who were surgically fit were registered. The primary endpoint was 3-year overall survival (OS) of patients who underwent R0 resection. Secondary endpoints were R0 resection rate, operative morbidity and mortality, 3-year recurrence-free survival (RFS) of R0 patients, and OS in all registered patients. Seventy patients were registered from 24 institutions between December 2011 and November 2019 and received preoperative chemotherapy. Three patients were ineligible, and 19 patients discontinued treatment, with disease progression in 12, adverse events in 4, and consent withdrawal in 3 before surgery. Of the 48 patients eventually undergoing surgery, R0 resection of the primary and/or metastatic GC was accomplished in 43 patients, while 1 patient discontinued treatment for positive peritoneal lavage cytology and 4 patients were considered ineligible based on postoperative pathological findings other than GC. The R0 resection rate of all eligible patients was 68.3% [95% confidence interval (CI) 55.3–79.4%, 43/63 patients], while that of all resected patients was 89.6% (95% CI 77.3–96.5%, 43/48 patients). Postoperative complications were identified in 12 out of 43 patients (27.9%), and Clavien–Dindo grade III or higher complications occurred in seven patients (16.3%). No hospital mortality was observed. R0 resection for LMGC could be performed in approximately two-thirds of all eligible patients, with acceptable surgical morbidity and mortality.

Background We previously reported the good feasibility and favorable efficacy of perioperative capecitabine plus oxaliplatin (CapeOx) in patients (pts) with clinical T3(SS)/T4a(SE) N1-3 M0 gastric cancer (GC) in a phase II study in which the pathological response rate, the primary endpoint, of 54.1% was demonstrated. Here, we report 3-year follow-up data. Methods The eligibility criteria included clinical T3(SS)/T4a(SE) N1-3 M0 GC according to the Japanese Classification of Gastric Carcinoma-3rd English Edition (JCGC). Three cycles of neoadjuvant CapeOx (capecitabine, 2000mg/m2 for 14 days; oxaliplatin, 130mg/m2 on day 1, every 3 weeks) were administered, followed by 5 cycles of adjuvant CapeOx after D2 gastrectomy. Three-year overall survival and relapse-free survival are presented here, and analyzed by cohorts based on pathologic response rate (pRR). Results Thirty-seven pts were enrolled from July 2016 to May 2017, and fully evaluated for efficacy and toxicity. Thirty-three pts (89.2%) completed the planned three cycles of neoadjuvant CapeOx and underwent gastrectomy, with an R0 resection rate of 78.4% (n = 29). The overall survival (OS) rate and relapse-free survival (RFS) rate at 3 years was 83.8% (95% CI, 72.7-96.5%) and 73.0% (95% CI, 60.0-88.8%), respectively. Further, the 3-year OS rate in pts with pathological response of grade 1a (n = 13) and grade 1b or higher (n = 20) was 69.2% (95% CI: 48.2-99.5%) and 100.0%, respectively, based on JCGC. Pathological response rate was classified according to JCGC as follows: grade 0, the tumor was not affected; grade 1a, less than one-third of the tumor was affected; grade 1b, one to two thirds of the tumor was affected; grade 2, greater than or equal to two thirds was affected; and grade 3, no residual tumor. A pathological response was defined as grade 1b or greater. Conclusion Perioperative CapeOx showed good feasibility and favorable prognosis, especially in pts with pathological response of grade 1b or higher and was found to be useful in predicting prognosis. The data obtained using this novel approach warrant further investigation (Trial ID: UMIN000021641, jRCTs051180109).

There is no large real-world data regarding efficacy and safety of immunotherapy in gastric cancer (GC). Although some tumors can grow rapidly after immunotherapy, the patient proportions and survival outcomes are unclear in GC. A multicenter, prospective observational study was performed to evaluate clinical outcomes including survival time, safety, and tumor behavior of nivolumab treatment for patients with advanced GC. Primary endpoint was overall survival (OS), and secondary endpoints included response rate (RR), disease control rate (DCR), progression-free survival (PFS), tumor growth rate (TGR) at first evaluation, and safety. Of 501 enrolled patients, 487 were evaluable (median age 70 years, 71% male, performance status 0/1/2 [42%/44%/14%], 21% HER2-pos, 42% patients with ascites). Median OS was 5.82 months (95% CI 5.29–7.00) with a 1-year survival rate of 30% and median PFS of 1.84 months (95% CI 1.71–1.97). The DCR was 39.4% and the RR was 14.2% (95% CI 10.3–18.8) in 282 patients with measurable lesions. In 219 patients evaluable for TGR, 20.5% were identified as hyperprogressive disease (HPD). OS from the first evaluation of patients with HPD was shorter compared with non-HPD (HR 1.77, 95% CI 1.25–2.51, P = 0.001), but it was not worse than that of patients with progression and non-HPD (HR 1.05, 95% CI 0.72–1.53, P = 0.8). A multivariate analysis revealed the presence of peritoneal metastasis was a prognostic factor for OS and PFS. Our real-world data demonstrated the comparable survival time to a previous clinical trial and revealed the frequency and prognosis of patients with HPD in advanced GC treated with nivolumab.

Background There is no standard chemotherapy for esophageal squamous cell carcinoma (ESCC) refractory to first-line fluoropyrimidine- and platinum-based chemotherapy. We therefore performed a randomized, selection-design phase II trial to compare docetaxel (DTX) and paclitaxel (PTX) in this setting. Patients and methods Eligible patients were randomly assigned to receive either DTX (70 mg/m2 on day 1 of each 21-day cycle) or PTX (100 mg/m2 on days 1, 8, 15, 22, 29 and 36 of each 49-day cycle). The primary end-point was overall survival (OS), and secondary end-points included progression-free survival (PFS), time to treatment failure (TTF), response rate (RR) and safety. Results Seventy-eight eligible patients (N = 39 in each group) were included for efficacy analysis. OS was significantly longer in the PTX group than in the DTX group (median, 8.8 versus 7.3 months; hazard ratio [HR], 0.62; P = 0.047). A significant benefit of PTX over DTX was also apparent in PFS (median, 4.4 versus 2.1 months; HR, 0.49; P = 0.002) and TTF (median, 3.8 versus 2.1 months; HR, 0.45; P Conclusion PTX showed a significantly better efficacy as well as a more manageable toxicity compared with DTX. Clinical trial registration UMIN000007940.

It remains controversial whether the advantages of robotic-assisted surgery are beneficial for rectal cancer (RC). The study aimed to evaluate the short-term outcomes of robotic-assisted rectal surgery (RARS) compared with those of conventional laparoscopic-assisted rectal surgery. We retrospectively analyzed 539 consecutive patients with stage I–IV RC who had undergone elective surgery between January 2010 and December 2020, using propensity score-matched analysis. After propensity score matching, we enrolled 200 patients (n = 100 in each groups). Before matching, significant group-dependent differences were observed in terms of age (p = 0.04) and body mass index (p

Limited data are available regarding the efficacy of nutrition support in advanced gastric cancer (AGC) patients receiving a standard second-line combination chemotherapy. The BALAST study is conducted as a prospective, multicenter observational study to evaluate the efficacy of nutrition support for patients with AGC treated with ramucirumab plus taxane as second-line treatment. As part of the routine care, patients who are malnourished or at risk of malnutrition will receive nutrition support from dietitians. We will enroll a total of 26 patients to estimate weight control rate at 12 weeks as primary end point. This study will generate valuable data reinforcing the role of nutrition support therapy for AGC patients receiving second-line chemotherapy.Lay abstract Various guidelines recommend that nutrition support therapy should be considered if cancer patients are malnourished or at risk of malnutrition. Several studies have revealed that body weight loss, which is an important factor in determining the nutrition status, may predict survival during second-line standard chemotherapy with ramucirumab and a taxane for advanced gastric cancer (AGC) patients. However, limited data are available regarding the efficacy of nutrition support in AGC patients receiving ramucirumab and a taxane. This study is conducted as a prospective, multicenter observational study to evaluate the efficacy of nutrition support for Japanese patients with AGC treated with ramucirumab and a taxane. This study will generate valuable data reinforcing the role of nutrition support therapy for AGC patients in second-line treatment.

Microbiome analysis has attracted attention in recent years as a tool to monitor individual health status. In particular, gut microbiota is closely related to autoimmunity, and detailed study of gut microbiota may enable prediction of the health status of individuals.Here, we aimed to conduct a detailed study to identify gastric cancer-specific gut microbiota and compare the data between patients with gastric cancer and healthy individuals. Toward this, we extracted DNA from feces of patients with advanced gastric cancer enrolled in the observational/translational study, the DELIVER trial (JACCRO GC-08: UMIN000030850) which evaluated clinical outcomes of nivolumab and developed host-related biomarkers for nivolumab in 500 patients with advanced gastric cancer, and obtained their sequence data at an average of 5 Gbps using whole-genome shotgun sequencing. We then performed genus classification and functional pathway analysis using Kyoto Encyclopedia of Genes and Genomes (KEGG).We analyzed differences in bacterial composition using the data of 476 Japanese patients with advanced gastric cancer (median age 70y, median BMI 20.0, 71% male, 37.0% of patients with relapse, 55.5% with previous gastrectomy) and public database of 106 healthy cases. Bifidobacterium, Anaerostipes, and Parabacteroides were predominant in the healthy individuals, whereas Streptococcus, Lactobacillus, and Odoribacter were predominant in patients with advanced gastric cancer. Furthermore, the KEGG pathway analysis showed that butanoate and pyruvate metabolism were enriched in the healthy individuals, whereas factors such as ABC transporters and ribosomes were enriched in the patients with advanced gastric cancer. Clustering analysis broadly classified the patients with advanced gastric cancer and healthy individuals into two clusters, and the clustering using pathway data enabled clearer classification of the patients with advanced gastric cancer and healthy individuals than the clustering using flora analysis. Additionally, the healthy individuals had higher bacterial flora diversity compared to the patients with advanced gastric cancer.We thus successfully identified the molecular characteristic of microbial genera and functional pathways in the gut in patients with advanced gastric cancer. We conclude that fecal metagenomic shotgun sequencing analysis might be used to detect gastric cancer. Citation Format: Ryo Matoba, Hiroshi Iijima, Yasuhiro Sakamoto, Ryohei Kawabata, Atsushi Ishiguro, Yusuke Akamaru, Yosuke Kito, Hiroshi Yabusaki, Jin Matsuyama, Masazumi Takahashi, Akitaka Makiyama, Takahisa Suzuki, Masahiro Tsuda, Hisateru Yasui, Jun Hihara, Toru Masuzawa, Hiroyuki Okuda, Junji Kawada, Shuhei Suzuki, Hisato Kawakami, Takako Eguchi Nakajima, Kei Muro, Wataru Ichikawa, Masashi Fujii, Yu Sunakawa. Molecular characteristics of gut microbiota in patients with gastric cancer: The DELIVER trial (JACCRO GC-08) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5957.

A 77-year-old man has undergone 5 times of transcatheter arterial chemoembolization(TACE)and 5 times of radiofrequency ablation(RFA)for hepatocellular carcinoma(HCC)since 2015. In February 2019, serum tumor marker levels extremely increased and CT scan showed a 40 mm mass in hepatoduodenal ligament. Imaging study revealed that intrahepatic lesions of HCC were well controlled and the mass was diagnosed as solitary lymph node metastasis of HCC. We performed surgical resection of the lymph node. The patient discharged 8 days after the surgery. Histopathologicaly, the tumor was diagnosed as lymph node metastasis of HCC. The patient remains free from recurrence 14 months after surgery.