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BackgroundThe 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 and MethodsPatients 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.ResultsSeventy 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.ConclusionsR0 resection for LMGC could be performed in approximately two-thirds of all eligible patients, with acceptable surgical morbidity and mortality.

Laparoscopic distal gastrectomy for gastric cancer has become a common procedure in many institutions. As manual palpation is impossible, various methods have been developed to identify the location of the tumor and determine the proximal resection line. Intraoperative endoscopy requires manpower and is time-consuming. The authors take an intraoperative X-ray. Here, we demonstrate our methods and outcomes. We preoperatively applied metal clips just proximal to the tumor through esophagogastroduodenoscopy. During surgery, we applied metal vessel clips to the greater and lesser curvatures of the planned resection line of the stomach and took an intraoperative X-ray to examine the distance between the planned resection line and the tumor. If the distance was appropriate, the stomach was resected on the planned line, and if the distance was judged to be insufficient, the stomach was resected on the more proximal line, as appropriate. An intraoperative frozen section of the proximal resection margin was examined, as appropriate. We performed this method for 71 patients. Tumors were successfully resected together with preoperative endoscopic clips in all patients. In five patients, intraoperative frozen section of the proximal resection margins was positive; however, additional resection confirmed negative margins. One patient underwent total gastrectomy, and the remaining 70 patients underwent distal gastrectomy. An intraoperative X-ray seems to be a simple and useful method for identifying the location of the tumor and determining the proximal resection line.

BackgroundThe prognosis of patients with gastric cancer and positive peritoneal lavage cytology is poor, even after gastrectomy. Though the standard therapy for this population is radical gastrectomy followed by S-1 chemotherapy, treatments vary among institutions and eras. We conducted a multicenter retrospective study to investigate the prognostic factors for cytology-positive gastric cancer.MethodsWe reviewed the medical records obtained from 6 institutions, covering 2000–2019. There were 128 patients with positive cytology and no other distant metastases that underwent R1 gastrectomy. Univariate and multivariate analyses to identify prognostic factors for overall survival were conducted using Cox’s proportional hazards models.ResultsThe median overall survival time was 18.6 months. In univariate analyses, age (≥ 80 years vs. < 70 years), performance status (2, 3 vs. 0), prognostic nutritional index (< 35 vs. ≥ 40), the extent of lymphadenectomy (D1 vs. ≥ D2), macroscopic type (type 4 vs. non-type 4), and postoperative chemotherapy (none vs. S-1) were significantly correlated with worse survival. Multivariate analysis revealed that lymph node metastasis (pN3b vs. pN0, hazard ratio 4.46, 95% confidence interval 1.17–16.9, p = 0.03) and postoperative chemotherapy (none vs. S-1, hazard ratio 2.28, 95% confidence interval 1.16–4.45, p = 0.02) were independent risk factors for death. No postoperative chemotherapy regimen showed a survival benefit over S-1 monotherapy.ConclusionsMassive lymph node metastasis was an independent risk factor in cytology-positive gastric cancer. Postoperative chemotherapy was also an independent prognostic factor, though the most beneficial regimen was still uncertain.

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.

Purpose The NY‐ESO‐1 antigen is highly immunogenic and often spontaneously induces an immune response in patients with cancer. We conducted a large‐scale multicenter cohort study to investigate the utility of serum NY‐ESO‐1 and p53 antibodies as predictive markers for the postoperative recurrence of gastric cancer. Here, we examined the usefulness of pre‐treatment NY‐ESO‐1 and p53 antibodies as tumor markers for the diagnosis of gastric cancer in combination with carcinoembryonic antigen (CEA) and carbohydrate antigen 19‐9 (CA19‐9). Methods A total of 1031 patients with cT3‐4 gastric cancer were enrolled in the study. NY‐ESO‐1 and p53 antibodies were assessed prior to treatment. The positivity of NY‐ESO‐1 and p53 antibodies, CEA, and CA19‐9 was evaluated before treatment. Results Serum NY‐ESO‐1 and p53 antibodies were positive in 12.6% and 18.1% of the patients, respectively. Positive NY‐ESO‐1 antibody response was correlated with male gender, higher cStage, and upper tumor location. However, a positive p53 antibody response was not associated with tumor factors. The combination of NY‐ESO‐1 or p53 antibody response with CEA and CA19‐9, or the 4‐factors, was positive in 45.1%, 49.6%, and 53.8% of patients, respectively. Moreover, the 4‐factor combination was able to detect >60% of cStage III‐IV diseases, which was 14% higher than that with the combination of CEA and CA19‐9. Conclusion The combination of NY‐ESO‐1 and p53 antibody responses to CEA and CA19‐9 increases the diagnostic accuracy of gastric cancer. Serum NY‐ESO‐1 and p53 antibodies may be useful tumor markers for gastric cancer. Serum NY‐ESO‐1 and p53 antibodies were evaluated in 1,000 patients with gastric cancer before treatment. The combination of NY‐ESO‐1 and p53 antibody responses to CEA and CA19‐9 enhanced the diagnostic accuracy of gastric cancer. Serum NY‐ESO‐1 and p53 antibodies may be useful as tumor markers for gastric cancer.

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.

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.

BackgroundFor unresectable or recurrent advanced gastric adenocarcinoma (AGC), tri-weekly administration of nanoparticle albumin-bound paclitaxel (nab-PTX) at 260 mg/m2 achieved a response rate of 27.8% in a phase II trial in Japan. However, frequent neutropenia and peripheral neuropathy limit its use in clinical settings. We, thus, conducted a single-arm phase II trial to investigate the efficacy and safety of a reduced dose (220 mg/m2) of tri-weekly nab-PTX.MethodsEligible patients included those with AGC and ECOG performance status of 0–2 who had received one or more prior chemotherapy containing fluoropyrimidine regimens. A reduced dose of nab-PTX (220 mg/m2) was administered tri-weekly. The primary endpoint was response rate (RR). Secondary endpoints were overall survival (OS), progression-free survival (PFS), disease-control rate (DCR), incidence of adverse events, relative dose intensity (RDI) and proportion of patients receiving subsequent chemotherapy.ResultsAmong 33 patients enrolled, 32 were treated with protocol therapy. RR was 3.1% [95% confidence interval (CI), 0–16.2%], which did not reach the protocol-specified threshold (p = 0.966). DCR was 37.5% (95% CI, 21.1–56.3%). Median OS and PFS were 6.3 (95% CI, 4.4–14.2) and 2.2 (95% CI, 1.8–3.1) months, respectively. RDI was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy. Toxicity was relatively mild with the most common grade ≥ 3 adverse events being neutropenia (38%), anemia (13%), fatigue (19%), anorexia (16%), and peripheral neuropathy (13%).ConclusionTri-weekly nab-PTX with a reduced dose (220 mg/m2) is not recommended for AGC in a second-line or later setting, despite demonstrating less toxicity than at 260 mg/m2.Clinical trial registrationThe OGSG1302 trial was registered with UMIN-CTR as UMIN000000714.

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.