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Background Post-gastrectomy weight loss is associated with deterioration in quality of life, and influences the long-term prognosis of gastric cancer patients. We conducted a prospective, randomized controlled, open-label study to examine whether an oral elemental diet (Elental ® , Ajinomoto Pharmaceuticals, Tokyo, Japan; hereafter referred to as ED) prevents postoperative weight loss in post-gastrectomy patients. Methods Patients were randomly divided to receive the ED or control diet. The ED group received 300 kcal of ED plus their regular diet for 6–8 weeks after surgery, starting from the day the patient started a soft rice or equivalent diet after surgery, while the control group received the regular diet alone. The primary endpoint was the percentage of body weight loss (%BWL) from the presurgical body weight to that at 6–8 weeks after surgery. Secondary endpoints were dietary adherence, nutrition-related blood parameters, and adverse events. Results This study included 112 patients in eight hospitals. The mean treatment compliance rate in the ED group was 68.7 ± 30.4 % (median 81.2 %). The %BWL was significantly different between the ED and control groups (4.86 ± 3.72 vs. 6.60 ± 4.90 %, respectively; p  = 0.047). In patients who underwent total gastrectomy, the %BWL was significantly different between the two groups (5.03 ± 3.65 vs. 9.13 ± 5.43 %, respectively; p  = 0.012). In multivariate analysis, ED treatment, surgery type, and preoperative performance status were independently associated with %BWL. No significant differences were observed in the other clinical variables. Conclusions ED supplementation reduced postoperative weight loss in gastric cancer patients undergoing gastrectomy.

Background Although perioperative treatment has been the standard of care for resectable gastric cancer in the West, postoperative adjuvant chemotherapy is still the standard in Japan. We conducted the first phase 2 trial to investigate the efficacy and safety of neoadjuvant docetaxel, oxaliplatin, and S‐1 (DOS) chemotherapy for cStage III gastric or esophagogastric junction (EGJ) adenocarcinoma in Japan. Methods Eligibility criteria included cStage III adenocarcinoma of the stomach or EGJ. Patients received docetaxel (40 mg/m2, day 1), oxaliplatin (100 mg/m2, day 1), or S‐1 (80 mg/m2, days 1–14) during a 3‐week cycle. After two or three cycles of DOS, patients underwent surgical resection. The primary endpoint was progression‐free survival (PFS). Results Between June 2015 and March 2019, 50 patients were enrolled from four institutions. Of 48 eligible patients (37 gastric and 11 EGJ adenocarcinoma), 42 (88%) completed two or three DOS cycles. Grade 3–4 neutropenia and diarrhea occurred in 69% and 19% of patients, respectively, but there were no treatment‐related deaths. R0 resection was achieved in 44 (92%) patients, and the pathological response rate (≥ grade 1b) was 63% (30/48). The 3‐year PFS, overall survival, and disease‐specific survival rates were 54.2%, 68.7%, and 75.8%, respectively. Conclusion Neoadjuvant DOS chemotherapy had a sufficient antitumor effect and tolerable safety profile in patients with gastric or EGJ adenocarcinoma. The survival benefit of a neoadjuvant strategy using our DOS regimen should be validated in phase 3 trials. In this phase 2 trial, neoadjuvant DOS chemotherapy had a sufficient antitumor effect and tolerable safety profile in patients with gastric or EGJ adenocarcinoma. The survival benefit of a neoadjuvant strategy using our DOS regimen should be validated in phase 3 trials.

Background Recent developments in the field of companion diagnosis and molecular-targeting therapeutic agents have helped in developing treatments targeting human epidermal growth factor receptor 2 (HER2) in gastric cancer (GC) and esophagogastric junction cancer (EGJC), and the importance of accurate diagnosis of HER2 expression is increasing. However, the HER2-positivity rate significantly differs among reports in GC and EGJC, and factors that affect HER2-positivity require elucidation. Methods The present study retrospectively examined factors related to HER2-positivity in a single institution, including age, sex, body mass index, the American Society of Anesthesiologists physical status, tumor information, and surgery information, including time to specimen processing. Results Our study included 165 patients tested for HER2 using GC and EGJC surgery specimens among the 1,320 patients who underwent gastrectomy from January 2007 to June 2022. In total, 35 (21.2%) and 130 (78.8%) patients were HER2-positive and -negative, respectively. Multivariate analysis revealed that intestinal type (odds ratio [OR]: 3.41, 95% confidence interval [CI]: 1.44–8.09, p  = 0.005), pM1 (OR: 3.99, 95% CI: 1.51–10.55, p  = 0.005), and time to specimen processing of < 120 min (OR: 2.65, 95% CI: 1.01–6.98, p  = 0.049) were independent factors that affected HER2-positivity. Conclusions The outcomes of the present study indicated that intestinal type, pM, and time to specimen processing are important factors affecting HER2-positive rates in GC and EGJC. Therefore, the risk of false-negative HER2 results may be reduced by decreasing the time required to process the resected specimen. Additionally, accurate diagnosis of HER2 expression may increase the opportunity to administer molecular-targeted drugs that can expect therapeutic effects to patients appropriately. Trail registration Retrospectively registered.

BackgroundWe previously showed that daily nutritional intervention with an oral elemental diet (ED) at 300 kcal/day for 6–8 weeks postoperatively decreased the percentage of body weight loss (%BWL), and that the effect was maintained for 1 year. This post hoc analysis aimed to determine whether this intervention decreased skeletal muscle mass loss 1-year post-gastrectomy.MethodsData from consecutive, untreated patients with histopathologically confirmed stage I–III gastric adenocarcinoma who planned to undergo total gastrectomy (TG) or distal gastrectomy (DG) and were enrolled in a previously published randomized trial were used. The primary endpoint was the percentage of skeletal muscle mass index (%SMI) loss from baseline at 1 year postoperatively, based on abdominal computed tomography images obtained preoperatively and at 1 year postoperatively.ResultsThe overall median %SMI loss was lower in the ED versus control group, but the difference was not significant. The difference in %SMI loss in the ED and control groups was greater in patients with TG (10.1 vs. 13.0; P = 0.12) than in those with DG (5.5 vs. 6.8; P = 0.69). A correlation was observed between %BWL and %SMI loss in both groups (ED group, coefficient 0.591; control group, coefficient 0.644; P < 0.001 for both). Type of gastrectomy (coefficient 7.38; P = 0.001) and disease stage (coefficient − 6.43; P = 0.04) were independent predictors of postoperative skeletal muscle mass loss.ConclusionED administration for 6–8 weeks following gastrectomy had no inhibitory effect on skeletal muscle loss at 1 year postoperatively.Clinical Trial RegistrationUMIN000023455.

Background Paraduodenal hernia is a rare internal hernia which accounts for only 1% of all intestinal hernias. There have been limited reported cases of paraduodenal hernia treated by laparoscopic surgery. We report a case of left paraduodenal hernia that was successfully treated by single-incision laparoscopic surgery (SILS). Case presentation A 17-year-old woman presented with left upper abdominal pain. An abdominal enhanced multi-detector computed tomography demonstrated encapsulated cluster of small bowel loops in the left upper quadrant which passed through the dorsal side of the inferior mesenteric vein, and showed that blood flow of the prolapsed small bowel was preserved. We preoperatively diagnosed left paraduodenal hernia without ischemia or necrosis. We performed elective SILS because she was a young actress training school student and cosmetic benefit was thought to be important. We pulled out the protruded small bowel and closed a defect with a running suture by SILS. The patient was discharged 3 days after the surgery with no complications. Conclusions We reported the case of left paraduodenal hernia successfully diagnosed and treated by SILS.

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.

BackgroundTo compare irinotecan-alone, paclitaxel-alone, and each combination chemotherapy with S-1 in patients with advanced gastric cancer (AGC) that is refractory to S-1 or S-1 plus cisplatin (SP).MethodsPatients with AGC after first-line chemotherapy with S-1 or SP, or patients during adjuvant chemotherapy or within 26 weeks after adjuvant chemotherapy completion with S-1 with confirmed disease progression were eligible. Patients were randomly divided into four groups based on treatment: irinotecan-alone (irinotecan; 150 mg/m2, day 1, q14 days), paclitaxel-alone (paclitaxel; 80 mg/m2, days 1, 8, 15, q28 days), S-1 plus irinotecan (irinotecan; 80 mg/m2, days 1, 15, S-1; 80 mg/m2, days 1–21, q35 days), and S-1 plus paclitaxel (paclitaxel; 50 mg/m2, day1, 8, S-1; 80 mg/m2, days 1–14, q21 days). The primary endpoint was overall survival (OS) and secondary endpoints were progression-free survival (PFS), response rate, and safety.ResultsFrom July 2008 to March 2012, 127 patients were enrolled. No difference in median OS was observed in the irinotecan vs. paclitaxel groups or in the monotherapy groups vs. the S-1 combination therapy groups. Median PFS was longer in the paclitaxel group compared with the irinotecan group (4.1 vs. 3.6 months, p = 0.035), although no difference was observed when comparing monotherapy vs. S-1 combination. The most common grade 3 to 4 hematological adverse events were neutropenia with no difference in incidence rate across the treatment groups.ConclusionsThere was no difference in OS between irinotecan and paclitaxel no in OS prolongation of S-1 combination therapy in second-line chemotherapy.

BackgroundAlthough there is insufficient evidence for the treatment of older patients with advanced gastric cancer, fluorouracil combined with platinum chemotherapy has been recognized as a standard first-line treatment for such populations in Japan despite the lack of efficacy and toxicity data.MethodsPatients aged 75 years or older with advanced gastric cancer were enrolled. S-1 plus docetaxel (docetaxel: 40 mg/m2, day 1; S-1: 80 mg/m2, days 1–14; q21 days) was repeated every 3 weeks. The primary endpoint was overall response rate. Secondary endpoints were safety, progression-free survival, time to treatment failure, and overall survival. The sample size was calculated as 30 under the hypothesis of an expected response rate of 40% and a threshold response rate of 20%, at a power of 90% and a two-sided alpha value of 5%.ResultsFrom February 2010 to January 2015, 31 patients were enrolled and assessed for efficacy and toxicity. The response rate was 45.2% (95% CI 27.3%–64.0%; p = 0.001) and it exceeded the expected response rate set at 40%. Median progression-free survival was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1 months. The major grade 3/4 adverse events were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%).ConclusionsThese findings indicate that S-1 plus docetaxel as first-line treatment for older patients is feasible and that it has promising efficacy against advanced gastric cancer.

Aim Post‐surgical weight loss influences chemotherapy compliance and may be a risk factor for survival. Intake of an oral elemental nutritional supplement (OENS) can reduce weight loss after gastric cancer (GC) surgery. We assessed whether therapy completion levels would increase in patients receiving postoperative adjuvant chemotherapy in combination with an OENS. Methods This was a multicenter, open‐label, single‐arm, phase II study in GC patients who underwent curative total or distal gastrectomy (TG/DG) and received adjuvant S‐1 chemotherapy. The primary endpoint was the S‐1 completion rate for 1 year with a relative performance (RP) value of ≥70%; secondary endpoints included factors affecting the completion rate of S‐1, RP value after eight S‐1 courses, S‐1 and OENS persistence rates, nutritional index, OENS compliance, and safety. Results In 71 efficacy‐evaluable patients, the S‐1 completion rate was 69.0% (TG, 68.0%; DG, 69.6%) and the RP value was 87.5 (TG, 89.1; DG, 87.5). Over eight treatment courses, median persistence rates were 89.0% for S‐1 and 93.8% for the OENS. The mean OENS compliance was 81.8% at the fourth S‐1 course and 52.9% at the eighth course. The incidence of Grade 3 or 4 adverse events was 27.2%, most commonly neutropenia (12.3%). Conclusions The completion rate of S‐1 for 1 year in patients who could take the OENS exceeded the pre‐defined threshold level. Randomized controlled trials are warranted to confirm the role of OENS in adjuvant chemotherapy. Post‐surgical weight loss influences chemotherapy compliance and may be a risk factor for survival. Intake of an oral elemental nutritional supplement (OENS) can reduce weight loss after gastric cancer (GC) surgery

BackgroundReal-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.MethodsIn 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).ResultsOf 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.ConclusionsThe 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.