Serum NY-ESO-1 antibody as a predictive biomarker for postoperative recurrence of gastric cancer: a multicenter prospective observational study.

BACKGROUND: No reliable marker has been identified to predict postoperative recurrence of gastric cancer. We designed a clinical trial to investigate the utility of serum NY-ESO-1 antibody responses as a predictive marker for postoperative recurrence in gastric cancer. METHODS: A multicenter prospective study was conducted between 2012 and 2021. Patients with resectable cT3-4 gastric cancer were included. Postoperative NY-ESO-1 and p53 antibody responses were serially evaluated every 3 months for 1 year in patients with positive preoperative antibody responses. The recurrence rate was assessed by the positivity of antibody responses at 3 and 12 months postoperatively. RESULTS: Among 1001 patients, preoperative NY-ESO-1 and p53 antibody responses were positive in 12.6% and 18.1% of patients, respectively. NY-ESO-1 antibody responses became negative postoperatively in non-recurrent patients (negativity rates; 45% and 78% at 3 and 12 months, respectively), but remained positive in recurrent patients (negativity rates; 9% and 8%, respectively). p53 antibody responses remained positive in non-recurrent patients. In multivariate analysis, NY-ESO-1 antibody positivity at 3 months (P < 0.03) and 12 months (P < 0.001) were independent prognostic factors for a shorter recurrence-free interval. CONCLUSIONS: Serum NY-ESO-1 antibodies may be a useful predictive marker for postoperative recurrence in gastric cancer. CLINICAL TRIAL REGISTRATION: UMIN000007925.

Long-Term Outcomes of Pylorus-Preserving Gastrectomy for Early Gastric Cancer.

BACKGROUND: In the short term, pylorus-preserving gastrectomy (PPG) has been reported to have advantages over distal gastrectomy (DG) with regard to postprandial symptoms and dumping syndrome. We aimed to evaluate the quality of life after PPG for early gastric cancer in the long term in comparison to that after DG. METHODS: Twenty-six patients who underwent gastrectomy (11 PPG, 15 DG) for early gastric cancer at Osaka University Hospital participated and were followed for more than 4 years. Body weight changes, nutritional status, dual-phase scintigraphy findings, endoscopic survey results, and questionnaire responses after gastrectomy were examined. RESULTS: There were significantly lower ratios of weight changes in PPG than in DG, 5 years after surgery. There were no differences in the clinicopathological characteristics, nutritional parameters, questionnaire responses, and endoscopic findings between the two groups. Based on gastric scintigraphy, although the gastric emptying of liquids showed similar curves in the two groups, gastric emptying of solids was significantly slower in the PPG group than in the DG group (P = .039). DISCUSSION: PPG had advantages with regard to long-term outcomes over DG in terms of weight maintenance and the prevention of rapid gastric emptying. PPG might be efficient in patients with early gastric cancer.

[A Case of Stage â £c dMMR Transverse Colon Cancer with Complete Response to Combination Therapy with Immune Checkpoint Inhibitor in Stage â £B Lung Adenocarcinoma].

The patient is a 72-year-old man. He was diagnosed as a duplication of left upper lobe lung adenocarcinoma cStage ⅣB and transverse colon cancer cStage Ⅳc. Because he had symptoms of atelectasis and esophageal stricture due to the progression of lung cancer, we decided to precede immunochemotherapy(CBDCA plus PEM plus pembrolizumab)for lung cancer. After the start of treatment, both lung and colorectal cancer were shrinking, but after the 3 courses of treatment, he developed intestinal obstruction due to transverse colon cancer. Because generalized peritonitis due to perforation of the colon by endoscopic stenting for the obstruction and then emergency surgery was performed. The resected transverse colon lesion was diagnosed as pathologically complete response. Lung cancer was also diagnosed as clinically complete response. Since his ADL decreased postoperatively, he is under observation without reintroduction of immunochemotherapy. Fourteen months have passed since the last administration, and no progression has been observed in either lung nor colon cancers. Pembrolizumab is considered to be successful in the patient with dMMR colorectal cancer lacking MLH1 and PMS2.

Optimization of decellularization methods using human small intestinal submucosa for scaffold generation in regenerative medicine.

Porcine small intestinal submucosa, despite its successful use as a scaffold in regenerative medicine, has innate biomechanical heterogeneity. In this study, we hypothesized that human small intestinal submucosa could be a viable alternative bio-scaffold. For the first time, we characterize submucosal extraction from human small intestine and examine appropriate decellularization methods. In total, 16 human small intestinal submucosal samples were obtained and decellularized using three reported methods of porcine decellularization: Abraham, Badylak, and Luo. For each method, four specimens were decellularized. The remaining four specimens were designated as non-decellularized. We measured the amount of residual DNA and growth factors in decellularized human intestinal samples. Additionally, decellularized human small intestinal submucosa was co-cultured with mouse bone marrow-derived mesenchymal stem cells to examine mesenchymal stem cell survival and proliferation. The reference value for the amount of residual DNA deemed appropriate in decellularized tissue was established as 50 ng/mg of extracellular matrix dry weight or less. Abraham's method most successfully met this criterion. Measurement of residual growth factors revealed low levels observed in samples decellularized using the Abraham and Badylak methods. Co-culture of each small intestinal submucosal sample with mouse bone marrow-derived mesenchymal stem cells confirmed viable cell survival and proliferation in samples derived using protocols by Abraham and Badylak. Abraham's method most successfully met the criteria for efficient tissue decellularization and cell viability and proliferation. Thus, we consider this method most suitable for decellularization of human small intestinal submucosa.

Multicenter phase II study of capecitabine plus oxaliplatin in older patients with advanced gastric cancer: the Tokyo Cooperative Oncology Group (TCOG) GI-1601 study.

BACKGROUND: Capecitabine plus oxaliplatin (CapeOX) is a standard treatment option for advanced gastric cancer (AGC). We conducted a prospective multicenter phase II study to evaluate the efficacy and safety of CapeOX as a first-line therapy for AGC in older patients. METHODS: Chemotherapy-naive patients aged ≥ 70 years with AGC were eligible. Initial treatment comprised capecitabine (2000 mg/m2 on days 1-14) and oxaliplatin (130 mg/m2 on day 1) every 3 weeks. After the initial feasibility assessment, the dose was reduced considering toxicity (capecitabine, 1500 mg/m2 on days 1-14; and oxaliplatin, 100 mg/m2 on day 1 every 3 weeks). The primary endpoint was overall survival (OS). RESULTS: In total, 108 patients were enrolled, of whom 104 were evaluated. Thirty-nine patients received the original-dose treatment, whereas 65 received the reduced-dose treatment. The median OS, progression-free survival (PFS), and time to treatment failure (TTF) were 12.9 (95% CI 11.6-14.8), 5.7 (95% CI 5.0-7.0), and 4.3 (95% CI 3.9-5.7) months, respectively, for all patients; 13.4 (95% CI 9.5-16.0), 5.8 (95% CI 4.1-7.8), and 5.3 (95% CI 3.5-7.2) months in the original-dose group; and 12.8 (95% CI 11.3-15.3), 5.7 (95% CI 4.4-7.0), and 4.1 (95% CI 3.7-5.7) months in the reduced-dose group. The most common grade 3/4 toxicities were neutropenia (17.9%), anemia (12.8%), and thrombocytopenia (12.8%) in the original-dose group and neutropenia (13.8%) and anorexia (12.3%) in the reduced-dose group. CONCLUSIONS: These findings demonstrate CapeOX's efficacy and safety in older AGC patients.

Meta-analysis of three randomized trials of capecitabine plus cisplatin (XP) versus S-1 plus cisplatin (SP) as first-line treatment for advanced gastric cancer.

BACKGROUND: S-1 plus cisplatin (SP) and capecitabine plus cisplatin (XP) are standard first-line regimens for advanced gastric cancer (AGC) worldwide. We conducted a meta-analysis using individual participant data (IPD) to investigate which is more suitable. METHODS: IPD from three randomized trials were collected. In these trials, patients with AGC were randomly allocated to SP (S-1 80-120 mg for 21 days plus cisplatin 60 mg/m2 (q5w)) or XP (capecitabine 2000 mg/m2 for 14 days plus cisplatin 80 mg/m2 (q3w)). RESULTS: In 211 eligible patients, median overall survival (OS) for SP versus XP was 13.5 and 11.7 months (hazard ratio [HR], 0.787; p = 0.114), progression-free survival (PFS) was 6.2 and 5.1 months (HR, 0.767; P = 0.076), and TTF was 5.1 and 4.0 months (HR, 0.611; P = 0.001). The most common grade ≥ 3 adverse events with SP or XP were neutropenia (18% vs. 29%) and anorexia (16% vs.18%). Subgroup analysis demonstrated significant interaction between treatment effect and performance status > 1 (HR, 0.685; P = 0.036), measurable lesion (HR, 0.709; P = 0.049), primary upper third tumor (HR, 0.539; P = 0.040), and differentiated type (HR, 0.549; interaction, 0.236; P = 0.019). For the differentiated type, OS was significantly longer in the SP group (13.2 months) than in the XP group (11.1 months) (HR, 0.549; P = 0.019). For the undifferentiated type, OS was similar in the SP group (14.2 months) and in the XP group (12.4 months) (HR, 0.868; P = 0.476). CONCLUSIONS: SP and XP were both effective and well tolerated. SP might be suitable for the pathological differentiated subtype of AGC. CLINICAL TRIAL REGISTRATION: The HERBIS-2, HERBIS-4A, and XParTS II trials were registered with UMIN-CTR as UMIN000006105, UMIN000006755, and UMIN000006045, respectively.

Proximal Resection Line Determination Using Intraoperative Radiography in Laparoscopic Distal Gastrectomy for Gastric Cancer.

BACKGROUND/AIM: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

[A Curatively Resected Case of Recto-Sigmoidal Cancer with Massive Bladder Invasion after Multimodal Therapy Including Chemotherapy].

A 68-year-old male patient was referred to our hospital because of unfit to treat his recto-sigmoidal cancer massively invaded to bladder at the former hospital. During drug administration to treat heart failure, we could perform a transverse colostomy and initiated mFOLFOX plus Pmab. During chemotherapy, he improved malnutrition. After 7 courses, CT scan showed a marked reduction in tumor diameter, which was PR. Since his nutritional and heart status were improved, he underwent a high anterior resection with partial bladder resection. Pathological findings showed that a few cancer cells were remained at bladder and bowel wall. He was diagnosed as Stage Ⅱc. His postoperative course was almost uneventful. No symptom of recurrence has been observed at 9 months after surgery without adjuvant chemotherapy.

The Suppressive Effect of NF-kB Activation After Eicosapentaenoic Acid Intake Before Surgery.

BACKGROUND/AIM: To ascertain whether preoperative neo-adjuvant nutritional therapy (NANT) using eicosapentaenoic acid (EPA) supplementation can provoke a rise in blood levels of EPA capable of restricting NF-B nuclear translocation in resected specimens. PATIENTS AND METHODS: Patients were allocated to two groups depending on individual preference: Patients in the treatment group received 2 g of EPA daily for two weeks prior to surgery (NANT group, n=18). Patients in the control group had a normal diet (CONT group, n=26). NF-B translocation rate, in specimens collected, was investigated by histopathology. Five hundred malignant cells were counted, and tissues with 10% or higher NF-B nuclear translocation were determined to be positive. RESULTS: The EPA blood concentration rose significantly in the NANT group (p<0.01). The positive rate of NF-B nuclear translocation in cancer cells was 11.1% in the NANT group compared with 50% in the CONT group. This difference was statistically significant (p<0.01). CONCLUSION: Increased blood concentrations of EPA after preoperative supplementation was associated with suppression of NF-B nuclear translocation in malignant cells. These results suggest that intake of EPA-containing supplements before surgery can control NF-B activation and by extension, cancer aggressiveness.

The prognostic significance of preoperative nutritional/inflammatory markers and clinicopathological features in resectable esophagectomy patients: possibility of nutritional intervention.

BACKGROUND: Preoperative inflammatory or nutritional biomarkers and clinicopathological features may be survival predictors in resectable esophageal squamous cell carcinoma. METHODS: We included 118 patients with resectable squamous esophageal carcinoma (stages I-IV), assessing preoperative CRP- and albumin-based modified Glasgow prognostic score, the modified controlling nutritional status score, C-reactive protein, neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, pathologic stage, and tumor location(s), looking for correlation with overall survival and relapse-free survival. Using univariate and Cox analysis, we selected the most reliable prognostic factors. RESULTS: Five-year overall survival and recurrence-free survival were 54.9% and 48.5%, respectively. C-reactive protein values correlated negatively with hypoalbuminemia (P = 0.0036). On univariate analysis, tumor stage, invasion depth, location, nodal involvement, albumin, and modified Glasgow prognostic score were significant prognostic factors for overall and recurrence-free survival. Preoperative C-reactive protein was prognostic factor for overall survival, but not for relapse-free survival (P = 0.017, 0.063, respectively). The Cox proportional hazards model showed the modified Glasgow prognostic score to be an independent prognostic factor for relapse-free survival and overall survival after using the stepwise variable selection procedure. Cox analysis including clinicopathological factors and modified Glasgow prognostic scores showed that only tumor location(s) and pathologic stage were independent prognostic factors for overall survival and recurrence-free survival. CONCLUSION: Although the modified Glasgow prognostic score is not superior to pathologic stage and tumor location as a biomarker of preoperative nutrition/inflammation and clinicopathological factors, it remains an important prognostic marker in resectable esophageal cancers. Preoperative decreased inflammatory response and improved nutritional status may contribute to prognosis in patients with esophageal cancer.

The comparison of prognoses between total and distal gastrectomy for gastric cancer in elderly patients ≥ 80 years old.

PURPOSE: In Japan, the number of distal gastrectomy for patients ≥ 80 years old is increasing, whereas that of total gastrectomy is decreasing. Surgeons seem to avoid total gastrectomy for elderly patients. Total gastrectomy is reported to have a poorer prognosis than distal gastrectomy, and postoperative pneumonia may be involved in the cause. METHODS: The medical records of 39 and 108 patients ≥ 80 years old who underwent total and distal gastrectomy, respectively, at 2 affiliated institutions between 2010 and 2019 were retrospectively reviewed. Prognoses were compared between the two groups, focusing on death from pneumonia. RESULTS: The median overall survival time after total and distal gastrectomy was 21.3 and 74.1 months, respectively, with a significantly poorer prognosis after total gastrectomy than after distal gastrectomy (p < 0.01, hazard ratio [HR] 2.20, 95% confidence interval [CI] 1.37-3.53). The gastric cancer-specific survival time was significantly worse after total gastrectomy than after distal gastrectomy (p < 0.01, HR 2.73, 95% CI 1.29-5.79). The pneumonia-specific survival time was also significantly worse after total gastrectomy than after distal gastrectomy (p = 0.01, HR 3.44, 95% CI 1.25-9.48). CONCLUSIONS: Patients who underwent total gastrectomy had a poorer prognosis than those who underwent distal gastrectomy, because many patients died of pneumonia early after total gastrectomy.

[A Case of Liver Metastasis of Gastric Cancer Successfully Treated with SOX plus Nivolumab].

An 82-year-old, male. He visited his local doctor with a chief complaint of dyspnea on exertion. Anemia was noted, and upper gastrointestinal endoscopy was performed, which revealed an ulcerative lesion in the gastric antrum. A biopsy revealed Group 5, tub2, and HER2 negative, with PD-L1≥5%. cT3N1H1(M1 HEP), cStage ⅣB was diagnosed based on CT scan showing enlarged #8 lymph node and a single liver metastasis in the 2 cm range in S6 of the liver. The patient was deemed unresectable and was started on SOX plus nivolumab therapy. On day 11 after initiation, the patient had Grade 3 diarrhea by CTCAE v5.0, and S-1 was withdrawn for 3 days, but was administered for 2 courses. CT and MRI after chemotherapy showed shrinkage of both the primary tumor and liver metastases; R0 resection was deemed possible, and pyloric gastrectomy, D2 lymph node dissection, and partial hepatic S6 resection were performed. The histological evaluation of response to treatment was Grade 1b, and the patient was in ypStage ⅠA. The patient has been alive without recurrence for 6 months postoperatively while receiving S-1 monotherapy on an outpatient basis.

Histology Classification Highlights Differences in Efficacy of S-1 versus Capecitabine, in Combination with Cisplatin, for HER2-Negative Unresectable Advanced or Recurrent Gastric Cancer with Measurable Disease.

It has been suggested that the therapeutic efficacy of S-1 + cisplatin (SP) and capecitabine + cisplatin (XP) may differ depending on the histology of the tumor, but no clear evidence exists. Individual participant data were obtained from three randomized phase II trials in which such patients received either SP (S-1 [40-60 mg twice daily for 21 days] plus cisplatin [60 mg/m2 on day 8], every 5 weeks) or XP (capecitabine [1000 mg/m2 twice daily for 14 days] plus cisplatin [80 mg/m2 on day 1], every 3 weeks). A total of 162 patients were included, with 79 patients in the SP arm and 83 patients in the XP arm. Although there was also no difference between arms in ORR according to histological classification, differentiated tumors showed a significantly better OS (but not PFS) for SP versus XP that was associated with a deeper tumor shrinkage. Undifferentiated tumors showed a consistently better OS, and PFS for SP versus XP, likely because cases without tumor shrinkage tended to be fewer for SP. Our data thus showed that SP was superior to XP in this setting, but there were qualitative differences in therapeutic efficacy dependent on tumor histology.

Neoadjuvant docetaxel, oxaliplatin and S-1 therapy for the patients with large type 3 or type 4 gastric cancer (OGSG1902): protocol of a multi-center, phase II study.

BACKGROUND: Large type 3 and type 4 gastric cancers have extremely poor prognoses. To address this, neoadjuvant chemotherapy may be a promising approach. The phase III JCOG0501 study, conducted to confirm the superiority of neoadjuvant S-1 plus cisplatin followed by D2 gastrectomy over upfront surgery, showed no survival benefit for neoadjuvant S-1 plus cisplatin. In Korea, the PRODIGY study, which was a phase III study of neoadjuvant docetaxel plus oxaliplatin plus S-1 (DOS) followed by surgery and adjuvant S-1 versus surgery and adjuvant S-1 for gastric cancer of T2-3N+ or T4Nany, showed that progression-free survival (PFS) was significantly superior in the neoadjuvant DOS arm. Therefore, DOS therapy may be a promising candidate for preoperative chemotherapy for large type 3 or type 4 gastric cancer. METHODS: Preoperative docetaxel 40 mg/m2 and oxaliplatin 100 mg/m2 will be intravenously administered on day1 every three weeks. S-1 will be orally administered 80 mg/m2 on days 1-14 of a 21-day cycle. Patients will receive three courses of treatment and gastrectomy with ≥D2 lymph node dissection. Postoperative S-1 plus docetaxel therapy (DS) will be administered according to the JACCRO GC-07 (START-2) study. The primary endpoint is the 3-year PFS rate. Secondary endpoints include PFS time, overall survival time, pathological response rate, response rate according to RECIST version1.1, proportion of completion of neoadjuvant chemotherapy, R0 resection rate, proportion of completion of surgery, proportion of completion of protocol treatment, proportion of negative conversion of CY, adverse event occurrence rate, and nutritional evaluation. The null hypothesis for the 3-year PFS rate is 45% and the expected value is 60%. The total sample size is 46 considering that the registration period and follow-up period are two and three years, respectively. DISCUSSION: This is a prospective, multicenter, single-arm, open-label, phase II trial assessing the efficacy and safety of preoperative DOS and postoperative DS for large type 3 or type 4 gastric cancer. The results will inform future phase III trials and are expected to lead to new treatment strategies for large type 3 or type 4 gastric cancer. TRIAL REGISTRATION: Registered with Japan Registry of Clinical Trials on October 11, 2019 ( jRCTs051190060 ).

Three-Year Outcomes of a Phase II Study of Perioperative Capecitabine Plus Oxaliplatin Therapy for Clinical SS/SE N1-3 M0 Gastric Cancer (OGSG 1601).

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).

Prognostic factors for elderly gastric cancer patients who underwent gastrectomy.

BACKGROUND: Patients with gastric cancer are aging in Japan. It is not clear which patients and which surgical procedures have survival benefits after gastrectomy. A multivariate analysis was performed. METHODS: The medical records of 166 patients aged ≥ 80 years who underwent gastrectomy without macroscopic residual tumors were retrospectively reviewed. Univariate and multivariate analyses using Cox proportional hazard models were performed to detect prognostic factors for overall survival. RESULTS: In univariate analyses, age (≥ 90 vs. ≥ 80, < 85), performance status (3 vs. 0), American Society of Anesthesiologists physical status (ASA-PS) (3, 4 vs. 1, 2), Onodera's prognostic nutritional index (< 40 vs. ≥ 45), the physiological score of the Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) (≥ 40 vs. ≥ 20, ≤ 29), surgical approach (laparoscopic vs. open), extent of gastrectomy (total, proximal vs. distal), extent of lymphadenectomy (D1 vs. ≥ D2), pathological stage (II-IV vs. I), and residual tumor (R1 vs. R0) were significantly correlated with worse overall survival. Multivariate analysis revealed that ASA-PS [3, 4 vs. 1, 2, hazard ratio (HR) 2.30, 95% confidence interval (CI) 1.24-4.24], extent of gastrectomy (total vs. distal, HR 2.17, 95% CI 1.10-4.31) (proximal vs. distal, HR 4.05, 95% CI 1.45-11.3), extent of lymphadenectomy (D0 vs. ≥ D2, HR 12.4, 95% CI 1.58-97.7), and pathological stage were independent risk factors for mortality. CONCLUSIONS: ASA-PS was a useful predictor for postoperative mortality. Gastrectomy including cardia is best avoided.

Survival analyses of elderly gastric cancer patients with or without surgery.

PURPOSE: Deciding whether or not surgery should be performed for elderly patients is sometimes difficult. This study examined the prognosis of patients ≥ 80 years old with gastric cancer who underwent surgery or not. METHODS: The medical records of 111 patients who underwent surgery (surgery group) and 35 who received best supportive care (BSC group) were retrospectively reviewed, excluding those with clinical stage IVB disease, those with a performance status of 4, and those who underwent endoscopic submucosal dissection. The overall survival was compared between the two groups. RESULTS: The patients in the BSC group were significantly older and had worse performance status scores, worse physiological scores, and lower prognostic nutritional indexes than those in the surgery group. The patients in the surgery group showed a significantly better survival than those in the BSC group (median survival time, 38.9 vs. 11.4 months; p = 0.01) even after propensity score matching. In the subgroups of patients ≥ 90 years old and those with a performance status of 3, no marked difference in the survival between the 2 groups was observed. CONCLUSIONS: Surgery imbued a survival benefit to elderly gastric cancer patients, except for those ≥ 90 years old and those with a performance status of ≥ 3. The surgical indication of patients ≥ 90 years old and those with a performance status of ≥ 3 requires careful deliberation.

Prospective Multicenter Interventional Study of Surgical Resection for Liver Metastasis from Gastric Cancer: R0 Resection Rate, and Operative Morbidity and Mortality.

BACKGROUND: 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 AND METHODS: 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. RESULTS: 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. CONCLUSIONS: R0 resection for LMGC could be performed in approximately two-thirds of all eligible patients, with acceptable surgical morbidity and mortality.

[Long-Term Survival following Multidisciplinary Therapy for Unresectable Pancreatic Body Cancer].

A 57-year-old man was diagnosed with a tumor in the pancreatic body at a nearby hospital and consulted our hospital. Examinations revealed that carbohydrate antigen 19-9(CA19-9)levels were 1,765.0 U/mL. We confirmed metastatic liver tumors in S4 and S8 of the liver by EOB-MRI. We diagnosed unresectable pancreatic cancer(T3N0M1, cStage Ⅳ)and administered 10 courses of gemcitabine(GEM)plus nab-paclitaxel(nab-PTX)therapy. The main lesion and the lesion in S4 subsequently disappeared, and the lesion in S8 degenerated into a cyst. CA19-9 levels were 113 U/mL. Surgery was determined as the best course of action after normalizing CA19-9 levels. Therefore, we further administered 6 courses of FOLFIRINOX therapy and 4 courses of GEM plus nab-PTX therapy, but CA19-9 was not normalized. We decided that it would be difficult to normalize CA19-9, and thus proceeded with surgery. During the operation, cystic degenerative lesions were found in S8 and peritoneal dissemination was found in the transverse mesentery. Because the ascites cytopathology was negative, it was judged that the peritoneal dissemination was localized. We performed distal pancreatectomy(D2)plus partial hepatectomy(S8)plus peritoneal dissemination resection. On day 52 after surgery, we resumed GEM plus nab-PTX. The patient has survived without any recurrence for 3 years after the initial surgery.

Effects of an oral elemental nutritional supplement in gastric cancer patients with adjuvant S-1 chemotherapy after gastrectomy: A multicenter, open-label, single-arm, prospective phase II study (OGSG1108).

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.