Real-world data on efficacy/safety and economic impact of nivolumab administered every 2 and 4 weeks among Japanese patients.

AIM: A new treatment interval for nivolumab administration at 480 mg every 4 weeks, in addition to 240 mg every 2 weeks, was approved in Japan in 2020. Using model-based evaluation, it was speculated that the effects or safety of nivolumab do not differ between the two treatment intervals; however, real-world data on nivolumab efficacy, safety, and economic impact are lacking. Accordingly, we aimed to examine the effects of nivolumab treatment intervals (2 weeks vs. 4 weeks) in terms of efficacy, safety, and economic impact in Japanese patients with cancer. METHODS: We retrospectively analyzed 126 patients treated with nivolumab. The patients were divided into two groups depending on whether they received nivolumab at 240 mg every 2 weeks (2-week group) or 480 mg every 4 weeks (4-week group). RESULTS: Efficacy results found no significant difference between the 4- and 2-week groups considering median overall survival (p = 0.70) and median progression-free survival (p = 0.57). The incidence of any grade and ≥  grade 3 immune-related adverse events did not differ between the 4-week and 2-week groups (any grade, p = 0.13; ≥  grade 3, p = 0.36). Excluding drug costs, the 4-week group had significantly lower medical costs than the 2-week group (2-week vs. 4-week: mean, 94,659 JPY [679.0 USD] vs. 58,737 JPY [421.3 USD]; p < 0.05). CONCLUSION: Collectively, our findings suggest that nivolumab 480 mg every 4 weeks may be more effective than nivolumab 240 mg every 2 weeks in terms of economic impact.

A case of laparoscopic sigmoidectomy using thermography for colonic blood flow assessment.

BACKGROUND: Indocyanine green (ICG) fluorescence imaging is widely used in gastrointestinal surgery and is considered useful for reducing anastomotic leakage; however, because ICG remains in the tissue for a certain amount of time, we occasionally must re-evaluate colonic blood flow over a short time period during surgery. Herein, we verify the usefulness of thermography (TG) for evaluating colonic blood flow in a patient who underwent a laparoscopic sigmoidectomy for sigmoid colon cancer. CASE PRESENTATION: The patient is 43-year-old man who underwent laparoscopic resection of the sigmoid colon for colon cancer. After vascular treatment of the colonic mesentery, ICG/TG identified the boundary between ischemic and non-ischemic colon tissues. An additional 2 cm of colonic mesentery was resected because of the presence of a diverticulum noted at the intended site of oral anastomosis when attaching the anvil head. After additional vascular treatment of the colonic mesentery and administration of ICG, fluorescence was observed in the colon; however, TG identified the zone of the temperature transition on the surface of the colonic mesentery, even after additional colonic mesentery resection in the same region as previously observed. This zone was used as the cut-off line. There were no complications, such as anastomotic leakage, after the surgery. CONCLUSION: Although accumulation of similar cases is necessary, TG has the potential for use as an auxiliary diagnostic tool in clinical practice. TG can depict the presence or absence of blood flow based on surface temperature without the use of imaging agents, and is inexpensive and easy to perform.

Accurate intraoperative real-time blood flow assessment of the remnant stomach during robot-assisted distal pancreatectomy with celiac axis resection using indocyanine green fluorescence imaging and da Vinci Firefly technology.

INTRODUCTION: Ischemic gastropathy is one of the unique postoperative complications associated with distal pancreatectomy with celiac axis resection for locally advanced pancreatic cancer. Therefore, it is essential to evaluate blood flow to the stomach following a resection; however, no intraoperative procedures have been established to assess this issue. Herein we describe two cases in which intraoperative evaluation of real-time blood flow in the residual stomach was performed using indocyanine green fluorescence and da Vinci Firefly technology during a robot-assisted distal pancreatectomy with celiac axis resection. METHODS: Robot-assisted distal pancreatectomy with celiac axis resection was performed using a da Vinci Xi surgical system on two patients with locally advanced pancreatic cancer and suspected invasion of the celiac artery. Indocyanine green (ICG) (0.5 mg/kg) was injected intravenously after resection to evaluate real-time blood flow of the stomach using the da Vinci Firefly system. Blood flow of the stomach was evaluated 60 seconds after the intravenous injection of ICG. RESULTS: All cases were confirmed that there was sufficient blood flow in the residual stomach. Therefore, reconstruction of the left gastric artery was not performed, and the surgery was completed with preservation of the stomach. Good postoperative outcomes were achieved and there was no evidence of ischemic gastropathy or delayed gastric emptying in both cases. CONCLUSION: This method is very useful in determining whether or not to perform reconstruction of the left gastric artery and/or additional resection of the remnant stomach during a robot-assisted distal pancreatectomy with celiac axis resection.

Validation study of a skill assessment tool for education and outcome prediction of laparoscopic distal gastrectomy.

BACKGROUND: The Japanese operative-rating scale for laparoscopic distal gastrectomy (JORS-LDG) was developed through cognitive task analysis together with the Delphi method to measure intraoperative performance during laparoscopic distal gastrectomy. This study aimed to investigate the value of this rating scale as an educational tool and a surgical outcome predictor in laparoscopic distal gastrectomy. METHODS: The surgical performance of laparoscopic distal gastrectomy was assessed by the first assistant, through self-evaluation in the operating room and by video raters blind to the case. We evaluated inter-rater reliability, internal consistency, and correlations between the JORS-LDG scores and the evaluation methods, patient characteristics, and surgical outcomes. RESULTS: Fifty-four laparoscopic distal gastrectomy procedures performed by 40 surgeons at 16 institutions were evaluated in the operating room and with video recordings using the proposed rating scale. The video inter-rater reliability was > 0.8. Participating surgeons were divided into the low, intermediate, and high groups based on their total scores. The number of laparoscopic surgeries and laparoscopic gastrectomy procedures performed differed significantly among the groups according to laparoscopic distal gastrectomy skill levels. The low, intermediate, and high groups also differed in terms of median operating times (311, 266, and 229 min, respectively, P < 0.001), intraoperative complication rates (27.8, 11.8, and 0%, respectively, P = 0.01), and postoperative complication rates (22.2, 0, and 0%, respectively, P = 0.002). CONCLUSIONS: The JORS-LDG is a reliable and valid measure for laparoscopic distal gastrectomy training and could be useful in predicting surgical outcomes.

Supportive care needs and psychological distress and/or quality of life in ambulatory advanced colorectal cancer patients receiving chemotherapy: a cross-sectional study.

BACKGROUND: Although currently many advanced colorectal cancer patients continuously receive chemotherapy, there are very few findings with regard to the supportive care needs of such patients. METHODS: The purposes of this study were to investigate the patients' perceived needs and the association with psychological distress and/or quality of life, and to clarify the characteristics of patients with a high degree of unmet needs. Ambulatory colorectal cancer patients who were receiving chemotherapy were asked to complete the Short-Form Supportive Care Needs Survey questionnaire, which covers five domains of need (health system and information, psychological, physical, care and support, and sexuality needs), the Hospital Anxiety and Depression Scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. RESULTS: Complete data were available for 100 patients. Almost all of the top 10 most common unmet needs belonged to the psychological domain. The patients' total needs were significantly associated with both psychological distress (r = 0.65, P < 0.001) and quality of life (r = -0.38, P < 0.001). A multiple regression analysis revealed that the female gender was significantly associated with higher total needs. CONCLUSIONS: The moderate to strong associations that exist between patients' needs and psychological distress and/or quality of life suggest that interventions that respond to patients' needs may be one possible strategy for ameliorating psychological distress and enhancing quality of life. Female patients' needs should be evaluated more carefully.

Assessment potential of a new suture simulator in laparoscopic surgical skills training.

BACKGROUND: The skills necessary for performing effective laparoscopic suturing are difficult to acquire; as a result, simulators for learning these skills are rapidly becoming integrated into surgical training. The aim of the study was to verify whether a new hybrid simulator has the potential to measure skill improvement in young, less experienced gastroenterological surgeons. MATERIAL AND METHODS: The study included 12 surgeons (median age, 29 (27-38)] years; 11 men (91.7%), one woman (8.3%)) who participated in a two-day laparoscopic training seminar. We used the new simulator before and after the program to evaluate individual performance. Skills were evaluated using five criteria: volume of air pressure leakage, number of full-thickness sutures, suture tension, wound area, and performance time. RESULTS: Air pressure leakage was significantly higher after than before the training (p = .027). The number of full-thickness sutures was significantly higher post-training (p < .01). Suture tension was significantly less post-training (p = .011). Wound opening areas were significantly smaller post-training (p = .018). Performance time was significantly shorter post-training (p = .032). CONCLUSIONS: Our study demonstrated the assessment quality of this new laparoscopic suture simulator.

Risk Evaluation of Postoperative Delirium Using Comprehensive Geriatric Assessment in Elderly Patients with Esophageal Cancer.

BACKGROUND: The number of geriatric patients with esophageal cancer is increasing in step with the aging of the population. Geriatric patients have a higher risk of postoperative complications, including delirium that can cause a fall or impact survival. Therefore, it is very important that we evaluate risks of postoperative complications before surgery. The aim of this study was to predict postoperative delirium in elderly patients. METHODS: We retrospectively reviewed the medical records of 91 patients aged 75 years and over who underwent esophagectomy between January 2006 and December 2014. We investigated the association between postoperative delirium and clinicopathological factors, including comprehensive geriatric assessment (CGA). RESULTS: Postoperative delirium developed in 24 (26 %) patients. Postoperative delirium was significantly associated with low mini-mental state examination (MMSE) and high Geriatric Depression Scale 15 (GDS15), which are components of CGA, and psychiatric disorder (P < 0.0001, P = 0.002, and P = 0.017, respectively). With multiple logistic regression analysis, MMSE (odds ratio [OR], 1.4; 95 % confidence interval [CI], 1.2-1.6; P < 0.0001] and GDS15 (OR, 1.3; 95 % CI, 1.1-1.6; P = 0.004) were independently associated with postoperative delirium. CONCLUSIONS: Preoperative CGA, especially MMSE and GDS15, was useful for predicting postoperative delirium in elderly patients undergoing esophagectomy for esophageal cancer. Intervention by a multidisciplinary team using CGA might help prevent postoperative delirium.

Assessment of stanniocalcin-1 as a prognostic marker in human esophageal squamous cell carcinoma.

Stanniocalcin-1 (STC1) is a secreted glycoprotein hormone and highly expressed in various types of human malignancies. Although evidence points to the role of STC1 in human cancers, the clinical significance of STC1 expression in esophageal cancer has not been well established. Quantitative reverse transcriptase-polymerase chain reaction and immunohistochemistry were performed to assess the expression of STC1 in the cancer cell line TE8 and esophageal cancer tissues from 229 esophageal squamous cell carcinomas (ESCC). Surgically-resected tissue sections were immunostained for potential regulators of STC1 expression, hypoxia-inducible factor-1α (HIF-1α) and p53. Marked increase in STC1 mRNA and protein expression was noted in TE8 cells cultured under hypoxic conditions. Overexpression of STC1 mRNA was noted in ESCC tumors compared to normal counterparts. Positive immunohistochemical staining for STC1 protein was observed in 38.9% of patients, and correlated significantly with advanced pT status (p=0.019), poor prognosis [overall survival (p<0.0006) and disease-free survival (p<0.0002) of ESCC patients who had undergone curative surgery]. Positive staining for HIF-1α and p53 proteins in ESCC did not correlate with STC1 expression. The results showed marked induction of STC1 expression under hypoxia in cultured cells and in esophageal cancer cells and that overexpression of STC1 was an independent prognostic factor in patients with esophageal cancer who had undergone curative surgery. STC1 is a potentially useful biomarker for ESCC treatment.