The cost-effectiveness of zolbetuximab in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.

Aim: To estimate the cost-effectiveness of zolbetuximab plus capecitabine/oxaliplatin (CAPOX) in CLDN18.2-positive, HER2-negative, mG/GEJ adenocarcinoma from the perspective of Chinese payers.Materials & methods: A partitioned survival model was developed to assess the costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICER) of zolbetuximab plus CAPOX versus placebo plus CAPOX. Sensitivity analyses were performed to test the robustness of model.Results: Zolbetuximab plus CAPOX gained an additional cost of $91,551 and an extra health benefit of 0.24 QALY over placebo plus CAPOX, producing an ICER of $388,186/QALY, which exceeded the willingness-to-pay threshold of $38,223/QALY. Sensitivity analysis shows that the model was generally robust.Conclusion: Zolbetuximab plus CAPOX would not be a cost-effective first-line treatment regimen in CLDN18.2-positive, HER2-negative, mG/GEJ adenocarcinoma in China.

[Box: see text].

Cost-effectiveness of tislelizumab plus chemotherapy vs chemotherapy as first-line treatment of PD-L1 positive advanced gastric or gastroesophageal junction adenocarcinoma from a Chinese perspective.

BACKGROUND: This work was designed to assess the cost-effectiveness of front-line tislelizumab plus chemotherapy (TIS+Chemo) in advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC) with positive expression of programmed cell death ligand 1 (PD-L1) from the perspective of Chinese healthcare system. RESEARCH DESIGN AND METHODS: A 10-year partitioned survival model was undertaken utilizing clinical data from RATIONALE 305. Costs and utilities were both discounted at an annual rate of 5%. The primary outcome was incremental cost-effectiveness ratios (ICERs) and calculated as the cost per quality-adjusted life years (QALYs). The willingness-to-pay (WTP) threshold was set as $18,625/QALY. Only direct medical costs were considered. Sensitivity analyses and subgroup analyses were performed to evaluate the robustness of the model. RESULTS: In the base-case analysis, the incremental cost and effectiveness associated with TIS+Chemo vs Chemo was 7,361 and 0.38 QALYs, respectively, leading to an ICER of 19,371/QALY. At the WTP threshold of $18,625/QALY, the TIS+Chemo was not a cost-effective first-line treatment option. The model outcomes were robust. CONCLUSIONS: TIS+Chemo did not provide a cost-effective approach for PD-L1 positive advanced GC/GEJC in China setting. However, TIS+Chemo might be cost-effective in provinces with higher WTP threshold. CLINICAL TRIAL REGISTRATION: RATIONALE 305, www.clinicaltrials.gov, identifier is NCT03777657.

Cost-utility of sintilimab plus chemotherapy vs chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction cancer in China.

OBJECTIVES: ORIENT-16, a phase III clinical trial conducted at 62 hospitals in China, reported that add-on sintilimab (Sin) to chemotherapy (Chemo) had favorable efficacy (p < 0.05) for patients with advanced HER2-negative gastric or gastroesophageal junction cancer (GC/GEJC). This study aimed to evaluate the cost-utility of the Sin+Chemo based on results of ORIENT-16 from the perspective of Chinese healthcare payers. METHODS: A three-state partitioned survival model was developed to simulate the 10-year life expectancy and total healthcare costs for patients with advanced HER2-negative GC/GEJC. Primary measure outcomes were: cost, quality-adjusted life-years (QALYs), and incremental cost-utility ratios (ICURs). Sensitivity/scenario analyses were conducted to assess the model robustness. RESULTS: In all patients, Sin+Chemo vs Chemo increased costs by $6,472, additionally providing 0.61 QALYs, resulting in an ICUR of $10,610/QALY. While, in PD-L1 combined positive score ≥ 5 cohort, the ICUR was $9,738/QALYs. The ICUR was most sensitive to the utility of progression-free survival. The probabilistic sensitivity analysis showed that add-on Sin had a 100% probability of being cost-effective at a willingness-to-pay threshold of $18,625/QALY gained. CONCLUSIONS: Sin+Chemo is a cost-effective first-line treatment option for advanced HER2-negative GC/GEJC in China. CLINICAL TRIAL REGISTRATION: ORIENT-16, www.clinicaltrials.gov, identifier is NCT03745170.

Assessment of risk factors of lymph node metastasis and prognosis of Siewert II/III adenocarcinoma of esophagogastric junction: A retrospective study.

Adenocarcinoma of the esophagogastric junction (AEG) has a high incidence, and the extent of lymph node dissection (LND) and its impact on prognosis remain controversial. This study aimed to explore the risk factors for lymph node metastasis (LNM) and prognosis in Siewert II/III AEG patients. A retrospective review of 239 Siewert II/III AEG patients surgically treated at Beijing Friendship Hospital from July 2013 to December 2022 was conducted. Preoperative staging was conducted via endoscopy, ultrasound gastroscopy, CT, and biopsy. Depending on the stage, patients received radical gastrectomy with LND and chemotherapy. Clinicopathological data were collected, and survival was monitored semiannually until November 2023. Utilizing logistic regression for data analysis and Cox regression for survival studies, multivariate analysis identified infiltration depth (OR = 0.038, 95% CI: 0.011-0.139, P < .001), tumor deposit (OR = 0.101, 95% CI: 0.011-0.904, P = .040), and intravascular cancer embolus (OR = 0.234, 95% CI: 0.108-0.507, P < .001) as independent predictors of LNM. Lymph nodes No. 1, 2, 3, 4, 7, 10, and 11 were more prone to metastasis in the abdominal cavity. Notably, Siewert III AEG patients showed a higher metastatic rate in nodes No. 5 and No. 6 compared to Siewert II. Mediastinal LNM was predominantly found in nodes No. 110 and No. 111 for Siewert II AEG, with rates of 5.45% and 3.64%, respectively. A 3-year survival analysis underscored LNM as a significant prognostic factor (P = .001). Siewert II AEG patients should undergo removal of both celiac and mediastinal lymph nodes, specifically nodes No. 1, 2, 3, 4, 7, 10, 11, 110, and 111. Dissection of nodes No. 5 and No. 6 is not indicated for these patients. In contrast, Siewert III AEG patients do not require mediastinal LND, but pyloric lymphadenectomy for nodes No. 5 and No. 6 is essential. The presence of LNM is associated with poorer long-term prognosis. Perioperative chemotherapy may offer a survival advantage for AEG patients.

Endoscopic Characteristics of Early Gastroesophageal Junction Adenocarcinomas and Assessment for Invasion Depth: A Case Series Study.

BACKGROUND/AIMS: Early-stage gastroesophageal junction (GEJ) adenocarcinoma can be challenging to diagnose and treat promptly using endoscopy. This study aims to summarize the endoscopic characteristics of early GEJ adenocarcinoma and investigate their correlation with pathological grade and invasion depth. MATERIALS AND METHODS: This retrospective case series study evaluated patients with early GEJ adenocarcinoma who underwent endoscopic or surgical resection at First Affiliated Hospital of Dalian Medical University between January 2016 and December 2022. RESULTS: A total of 71 patients were included in the analysis, with 59 males and a median age of 67 years. The majority of the lesions were located on the posterior side of the GEJ (40.8%) or the lesser curvature side (29.6%). Siewert II lesions accounted for 71.8% of cases, with most occurring on the posterior side (49.0%) and Siewert III lesions mostly occurring on the lesser curvature side (42.9%). Siewert I lesions accounted for only 7.0%, and all originated from Barrett mucosa. Paris classification of Is (P = .015) or IIc (P = .015), lesion size ≥12 mm (P = .017), red color with subsquamous extension (P = .038), and disordered microsurface with local fusion (P < .001) were independently and positively correlated with pathological grade and invasion depth by multivariable ordinal logistic regression. CONCLUSION: The posterior side and lesser curvature of the GEJ are the high-incidence sites of GEJ adenocarcinoma. Both forward and backward views during endoscopy should be combined to detect the lesion. Endoscopic characteristics such as Is or IIc morphology, larger size, red color with subsquamous extension, and disordered microsurface with local fusion may indicate a higher pathological grade and deeper invasion.

A proactive financial navigation intervention in patients with newly diagnosed gastric and gastroesophageal junction adenocarcinoma.

PURPOSE: Many cancer patients and caregivers experience financial hardship, leading to poor outcomes. Gastric and gastroesophageal junction (GEJ) cancer patients are particularly at risk for financial hardship given the intensity of treatment. This pilot randomized study among gastric/GEJ cancer patients and caregivers tested a proactive financial navigation (FN) intervention to obtain a signal of efficacy to inform a larger, more rigorous randomized study. METHODS: We tested a 3-month proactive FN intervention among gastric/GEJ cancer patients and caregivers compared to usual care. Caregiver participation was optional. The primary endpoint was incidence of financial hardship, defined as follows: accrual of debt, income decline of ≥ 20%, or taking loans to pay for treatment. Data from participant surveys and documentation by partner organizations delivering the FN intervention was analyzed and outcomes were compared between study arms. RESULTS: Nineteen patients and 12 caregivers consented. Primary FN resources provided included insurance navigation, budget planning, and help with out-of-pocket medical expenses. Usual care patients were more likely to experience financial hardship (50% vs 40%) and declines in quality of life (37.5% vs 0%) compared to intervention patients. Caregivers in both arms reported increased financial stress and poorer quality of life over the study period. CONCLUSIONS: Proactive financial navigation has potentially positive impacts on financial hardship and quality of life for cancer patients and more large-scale randomized interventions should be conducted to rigorously explore the impact of similar interventions. Interventions that have the potential to lessen caregiver financial stress and burden need further exploration. TRIAL REGISTRATION: TRN: NCT03986502, June 14, 2019.

Endoscopic Surveillance of Intestinal Metaplasia of the Esophagogastric Junction: A Decision Modeling Analysis.

INTRODUCTION: The incidence of esophagogastric junction adenocarcinoma (EGJAC) has been rising. Intestinal metaplasia of the esophagogastric junction (EGJIM) is a common finding in gastroesophageal reflux (irregular Z-line) and may represent an early step in the development of EGJAC in the West. Worldwide, EGJIM may represent progression along the Correa cascade triggered by Helicobacter pylori . We sought to evaluate the cost-effectiveness of endoscopic surveillance of EGJIM. METHODS: We developed a decision analytic model to compare endoscopic surveillance strategies for 50-year-old patients after diagnosis of non-dysplastic EGJIM: (i) no surveillance (standard of care), (ii) endoscopy every 3 years, (iii) endoscopy every 5 years, or (iv) 1-time endoscopy at 3 years. We modeled 4 progression scenarios to reflect uncertainty: A (0.01% annual cancer incidence), B (0.05%), C (0.12%), and D (0.22%). RESULTS: Cost-effectiveness of endoscopic surveillance depended on the progression rate of EGJIM to cancer. At the lowest progression rate (scenario A, 0.01%), no surveillance strategies were cost-effective. In moderate progression scenarios, 1-time surveillance at 3 years was cost-effective, at $30,989 and $16,526 per quality-adjusted life year for scenarios B (0.05%) and C (0.12%), respectively. For scenario D (0.22%), surveillance every 5 years was cost-effective at $77,695 per quality-adjusted life year. DISCUSSION: Endoscopic surveillance is costly and can cause harm; however, low-intensity longitudinal surveillance (every 5 years) is cost-effective in populations with higher EGJAC incidence. No surveillance or 1-time endoscopic surveillance of patients with EGJIM was cost-effective in low-incidence populations. Future studies to better understand the natural history of EGJIM, identify risk factors of progression, and inform appropriate surveillance strategies are required.

Cost-effectiveness analysis of nivolumab plus chemotherapy vs chemotherapy for patients with unresectable advanced or metastatic HER2-negative gastric or gastroesophageal junction or esophageal adenocarcinoma in Japan.

BACKGROUND: This study aimed to evaluate the cost-effectiveness of nivolumab plus chemotherapy (NIVO + Chemo) compared with chemotherapy monotherapy (Chemo) for patients with advanced or metastatic HER2-negative gastric or gastroesophageal junction or esophageal adenocarcinoma (GC/GEJC/EAC) in Japan from the perspective of healthcare payer. METHODS: A partitioned survival analysis model was developed to predict costs and quality-adjusted life years (QALYs) for NIVO + Chemo and Chemo. The time horizon of the model was set to 38 years. An annual discount rate of 2% for both costs and QALYs was applied. Data on overall survival and progression-free survival were derived from the CheckMate649 trial. Cost parameters were estimated from a Japanese medical claims database. The incremental cost-effectiveness ratio (ICER) of NIVO + Chemo compared with Chemo was estimated. A subgroup analysis on the level of PD-L1 CPS expression was conducted. In addition, sensitivity analysis was performed to assess the uncertainty in the parameter settings. RESULTS: The incremental cost and QALY of NIVO + Chemo compared with Chemo were USD99,416 and 0.30 QALY, respectively. The ICER of NIVO + Chemo was estimated to be USD327,161 per QALY gained. The results of the subgroup analysis showed that ICER was USD247,403/QALY and USD302,183/QALY for PD-L1 CPS ≧ 5 and ≧ 1, respectively. Sensitivity analyses showed a relatively robust result that the ICER remained higher than the Japanese cancer threshold of USD75,000-150,000/QALY. CONCLUSIONS: Applying the Japanese cancer threshold of USD75,000-150,000/QALY, NIVO + Chemo was not cost-effective for patients with advanced or metastatic HER2-negative GC/GEJC/EAC in Japan from the perspective of healthcare payer.

Current status and future perspectives for the treatment of resectable locally advanced esophagogastric junction cancer: A narrative review.

Incidence rates for esophagogastric junction cancer are rising rapidly worldwide possibly due to the economic development and demographic changes. Therefore, increased attention has been paid to the prevention, diagnosis, and the treatment of esophagogastric junction cancer. Although there are discrepancies in the treatment strategy between Asian and Western countries, surgery remains the mainstay of treatment for esophagogastric junction cancer. Recent developments of perioperative multidisciplinary treatment may lead to better therapeutic effect, higher complete resection rate, and better control of the residual diseases, thus result in prolonged prognosis. In this review, we will focus on the treatment of locally advanced resectable esophagogastric junction cancer, and discuss the current status and future perspectives of the perioperative treatment including chemotherapy, radiation therapy, and immunotherapy, as well as the surgical strategy. Better understanding of the latest treatment strategy and future overlook may enable to standardize and individualize the treatment for esophagogastric junction cancer, thus leading to better prognosis for those patients.

Treatment patterns, healthcare resource utilization and costs of HER2-negative gastric/gastroesophageal junction cancer.

Aim: To describe treatment patterns, healthcare resource utilization and costs in HER2-negative gastric/gastroesophageal (G/GEJ) cancer in the USA. Methods: Retrospective IQVIA Adjudicated Closed Claims database analysis; patients with HER2-negative G/GEJ cancer initiating systemic therapy between October 2016 and December 2019 were identified. Results: Among 1317 patients, platinum plus taxane regimens (54%) were common in neoadjuvant/adjuvant settings. Platinum-taxane (41%) and platinum-fluoropyrimidine (36%) regimens were common first-line therapies in the metastatic setting. Treatment regimens were heterogeneous in later lines. Hospitalization rates ranged from 39% (first-, second-line metastatic settings) to 61% (neoadjuvant/adjuvant setting). High healthcare resource utilization was driven by high outpatient costs. Mean per-patient per-month outpatient costs combining physician office and hospital visits ranged from US$10,944 to $12,582 (representing 52-70% of total costs). Conclusion: For G/GEJ cancer, systemic regimens varied across lines of therapy with variation increasing with subsequent therapy lines; high healthcare costs persist for systemic treatment, particularly outpatient services.

Interrater Reliability of Functional Lumen Imaging Probe Panometry and High-Resolution Manometry for the Assessment of Esophageal Motility Disorders.

INTRODUCTION: High-resolution manometry (HRM) and functional lumen imaging probe (FLIP) are primary and/or complementary diagnostic tools for the evaluation of esophageal motility. We aimed to assess the interrater agreement and accuracy of HRM and FLIP interpretations. METHODS: Esophageal motility specialists from multiple institutions completed the interpretation of 40 consecutive HRM and 40 FLIP studies. Interrater agreement was assessed using intraclass correlation coefficient (ICC) for continuous variables and Fleiss' κ statistics for nominal variables. Accuracies of rater interpretation were assessed using the consensus of 3 experienced raters as the reference standard. RESULTS: Fifteen raters completed the HRM and FLIP studies. An excellent interrater agreement was seen in supine median integral relaxation pressure (ICC 0.96, 95% confidence interval 0.95-0.98), and a good agreement was seen with the assessment of esophagogastric junction (EGJ) outflow, peristalsis, and assignment of a Chicago Classification version 4.0 diagnosis using HRM (κ = 0.71, 0.75, and 0.70, respectively). An excellent interrater agreement for EGJ distensibility index and maximum diameter (0.91 [0.90-0.94], 0.92 [0.89-0.95]) was seen, and a moderate-to-good agreement was seen in the assignment of EGJ opening classification, contractile response pattern, and motility classification (κ = 0.68, 0.56, and 0.59, respectively) on FLIP. Rater accuracy for Chicago Classification version 4.0 diagnosis on HRM was 82% (95% confidence interval 78%-84%) and for motility diagnosis on FLIP Panometry was 78% (95% confidence interval 72%-81%). DISCUSSION: Our study demonstrates high levels of interrater agreement and accuracy in the interpretation of HRM and FLIP metrics and moderate-to-high levels for motility classification in FLIP, supporting the use of these approaches for primary or complementary evaluation of esophageal motility disorders.

Endoscopic and histopathological assessment of individuals undergoing one anastomosis gastric bypass: a 2-year follow-up.

BACKGROUND: There is much debate over the occurrence of biliary reflux to the gastric pouch after one anastomosis gastric bypass (OAGB) and its potential risks. OBJECTIVE: To assess endoscopic and histopathological findings following a standardized protocol of biopsy collection two years after OAGB. METHODS: A historical cohort study was conducted, based on a prospectively collected database, which involved 39 participants who underwent OAGB. Participants underwent clinical evaluation and esophagogastroduodenoscopy at the time of surgery and 24 months afterward. Post-operatively, biopsy specimens in esophagogastric junction, pouch, and anastomosis were systematically collected. RESULTS: 92.3% of the participants were female and the mean age was 37 ± 8.5 years. The mean body mass index (BMI) significantly decreased from 37.6 ± 5.7 kg/m2 to 27 ± 4.1 kg/m2 after 2 years (p < 0.001). The mean %TWL was 27.2 ± 10.5%. The prevalence of non-erosive gastritis significantly increased from 25.6 to 51.3% (p = 0.02). Erosive gastritis significantly decreased from 28.2 to 10.3% (p = 0.04). Four cases of marginal ulcers were identified (10.3%). The commonest histopathological finding was mild inflammation in 74.3% (esophagogastric junction), 58.9% (pouch), and 71.8% (anastomosis). There was one case of focal intestinal metaplasia in each site of interest and no cases of dysplasia or severe inflammation. CONCLUSIONS: Using a standardized protocol of post-operative biopsy collection, low rates of severe endoscopic and histopathological abnormalities were observed two years after OAGB. Nevertheless, as most patients have histologically proven inflammation, bile in the gastric pouch, and endoscopic gastritis, long-term surveillance is essential because of the uncertain risk of these abnormalities.

Recent advances in multidisciplinary therapy for adenocarcinoma of the esophagus and esophagogastric junction.

Esophageal adenocarcinoma (EAC) and adenocarcinoma of the esophagogastric junction (EGJA) have long been associated with poor prognosis. With changes in the spectrum of the disease caused by economic development and demographic changes, the incidence of EAC and EGJA continues to increase, making them worthy of more attention from clinicians. For a long time, surgery has been the mainstay treatment for EAC and EGJA. With advanced techniques, endoscopic therapy, radiotherapy, chemotherapy, and other treatment methods have been developed, providing additional treatment options for patients with EAC and EGJA. In recent decades, the emergence of multidisciplinary therapy (MDT) has enabled the comprehensive treatment of tumors and made the treatment more flexible and diversified, which is conducive to achieving standardized and individualized treatment of EAC and EGJA to obtain a better prognosis. This review discusses recent advances in EAC and EGJA treatment in the surgical-centered MDT mode in recent years.

The Dynamic Changing Incidence of Gastric Cancer in Israel: Time for a National Surgical Management Committee?

BACKGROUND: There has been a general reduction over the last 20 years in the incidence within Israel of gastric cancer (GC). This has particularly been noted in the Jewish population with a slight increase in the incidence of cancer of the gastroesophageal junction among Jews of Sephardi origin. Given the diversity of individual ethnic subpopulations, the effects of GC incidence in second-generation immigrant Jews, particularly from high prevalence regions (e.g., the former Soviet Union, Iraq, and Iran), awaits determination. There are currently no national data on GC-specific mortality. The most recent available cross-correlated Israeli National Cancer Registry (INCR) and International Association for Cancer Research (IARC) incidence data for GC of the body and antrum in Israel are presented. Some of the challenges associated with GC monitoring in the changing Israeli population are discussed. We propose the establishment of a national GC management committee designed to collect demographic and oncological data in operable cases with the aim of recording and improving GC-specific outcomes. We believe that there is value in the development of a national surgical planning program, which oversees training and accreditation in a dynamic environment that favors the wider use of neoadjuvant therapies, minimally invasive surgery and routine extended (D2) lymphadenectomy. These changes should be supported by assessable enhanced recovery programs.

Assessment and validation of the internal gross tumour volume of gastroesophageal junction cancer during simultaneous integrated boost radiotherapy.

BACKGROUND: Respiratory motion may introduce errors during radiotherapy. This study aims to assess and validate internal gross tumour volume (IGTV) margins in proximal and distal borders of gastroesophageal junction (GEJ) tumours during simultaneous integrated boost radiotherapy. METHODS: We enrolled 10 patients in group A and 9 patients in group B. For all patients, two markers were placed at the upper and lower borders of the tumour before treatment. In group A, within the simulation and every 5 fractions of radiotherapy, we used 4-dimensional computed tomography (4DCT) to record the intrafractional displacement of the proximal and distal markers. By fusing the average image of each repeated 4DCT with the simulation image based on the lumbar vertebra, the interfractional displacement could be obtained. We calculated the IGTV margin in the proximal and distal borders of the GEJ tumour. In group B, by referring to the simulation images and cone-beam computed tomography (CBCT) images, the range of tumour displacement in proximal and distal borders of GEJ tumour was estimated. We calculated the proportion of marker displacement range in group B lay within the IGTV margin calculated based on the data obtained in group A to estimate the accuracy of the IGTV margin. RESULTS: The intrafractional displacement in the cranial-caudal (CC) direction was significantly larger than that in the anterior-posterior (AP) and left-right (LR) directions for both the proximal and distal markers of the tumour. The interfractional displacement in the AP and LR directions was larger than that in the CC direction (p = 0.001, p = 0.017) based on the distal marker. The IGTV margins in the LR, AP and CC directions were 9 mm, 8.5 mm and 12.1 mm for the proximal marker and 15.8 mm, 12.7 mm and 11.5 mm for the distal marker, respectively. In group B, the proportions of markers that located within the IGTV margin in the LR, AP and CC directions were 96.5%, 91.3% and 96.5% for the proximal marker and 100%, 96.5%, 93.1% for the distal marker, respectively. CONCLUSIONS: Our study proposed individualized IGTV margins for proximal and distal borders of GEJ tumours during neoadjuvant radiotherapy. The IGTV margin determined in this study was acceptable. This margin could be a reference in clinical practice.

Cost-effectiveness analysis of nivolumab plus standard chemotherapy versus chemotherapy alone for the first-line treatment of unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

Background Nivolumab plus standard chemotherapy has significant clinical benefits for unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC). However, nivolumab is expensive, necessitating a cost-effectiveness evaluation. Aim This study aimed to evaluate the cost-effectiveness of nivolumab plus standard chemotherapy vs. chemotherapy alone for unresectable advanced or metastatic GC/GEJC/EAC from the Chinese healthcare system perspective. This study was based on randomized clinical trial data from the CheckMate-649 clinical trial (NCT02872116) published in Lancet (June 2021). Method A Markov model was used to assess the cost-effectiveness of nivolumab plus standard chemotherapy versus chemotherapy alone for unresectable advanced or metastatic GC/GEJC/EAC. Drug costs were collected from Tianjin Medical Purchasing Center in 2021, and utility values of health states were obtained from the literature. The reliability of model was assessed with one-way and probabilistic sensitivity analyses. Main outcome measure The main outcomes were costs, quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratio (ICER). Results Over a 10-year horizon, the outputs were 1.19 QALYs at a cost of $78,814.9 and 0.88 QALYs at a cost of $19,522.3 with nivolumab plus chemotherapy and chemotherapy alone, respectively. The ICER for nivolumab plus chemotherapy versus chemotherapy alone was $191,266/QALY, exceeding the willingness-to-pay (WTP) threshold ($33,436/QALY). One-way sensitivity analysis revealed nivolumab cost was the most influential parameter. Conclusion Adding nivolumab is not cost-effective for unresectable advanced or metastatic GC/GEJC/EAC in the current Chinese healthcare environment.

Assessment of Health Related Quality of Life and Digestive Symptoms in Long-term, Disease Free Survivors After Esophagectomy.

OBJECTIVE: The aim of this study was to investigate long-term HRQOL and symptom evolution in disease free patients up to 20 years after esophagectomy. BACKGROUND: Esophagectomy has been associated with decreased HRQOL and persistent gastrointestinal symptoms. METHODS: The study cohort was identified from 2 high volume centers for the management of esophageal cancer. Patients completed HRQOL and symptom questionnaires, including: Digestive Symptom Questionnaire, EORTC QLQ-C30, EORTC QLQ-OG25 Euro QoL 5D, and SF36. Patients were assessed in 3 cohorts: <1 year; 1-5 years, and; >5 years after surgery. RESULTS: In total 171 of 222 patients who underwent esophagectomy between 1991 and 2017 who met inclusion criteria and were contactable, responded to the questionnaires, corresponding to a response rate of 77%. Median age was 66.2 years, and median time from operation to survey was 5.6 years (range 0.3-23.1). Early satiety was the most commonly reported symptom in all patients irrespective of timeframe (87.4%; range 82%-92%). Dysphagia was seen to decrease over time (58% at <2 years; 28% at 2-5 years; 20% at >5 years; P = 0.013). Weight loss scores demonstrated nonstatistical improvement over time. All other symptom scores including heartburn, regurgitation, respiratory symptoms, and pain scores remained constant over time. Average HRQOL did not improve from levels 1 year after surgery compared to patients up to 23 years after esophagectomy. CONCLUSION: With the exception of dysphagia, which improved over time, esophagectomy was associated with decreased HRQOL and lasting gastrointestinal symptoms up to 20 years after surgery. Pertinently however long-term survivors after oesophagectomy demonstrated comparable to improved HRQOL compared to the general population. The impact of esophagectomy on gastrointestinal symptoms and long-term HRQOL should be considered when counseling and caring for patients undergoing esophagectomy.

Assessment of esophagogastric junction morphology by dynamic real-time MRI: comparison of imaging features to high-resolution manometry.

PURPOSE: To assess the esophagogastric junction (EGJ) on real-time MRI and compare imaging parameters to EGJ morphology on high-resolution manometry (HRM). METHODS: A total of 105 of 117 eligible patients who underwent real-time MRI and high-resolution manometry for GERD-like symptoms between 2015 and 2018 at a single center were retrospectively evaluated (male n = 57; female n = 48; mean age 52.5 ± 15.4 years). Real-time MRI was performed at a median investigation time of 15 min (1 frame/40 ms). On HRM, EGJ morphology was assessed according to the Chicago classification of esophageal motility disorders. Real-time MRI was performed at 3 T using highly undersampled radial fast low-angle shot acquisitions with NLINV image reconstruction. A 10 mL pineapple juice bolus served as oral contrast agent at supine position. Real-time MRI films of the EGJ were acquired during swallowing events and during Valsalva maneuver. Anatomic and functional MRI parameters were compared to EGJ morphology on HRM. RESULTS: On HRM, n = 42 patients presented with EGJ type I (40.0%), n = 33 with EGJ type II (31.4%), and n = 30 with EGJ type III (28.6%). On real-time MRI, hiatal hernia was more common in patients with EGJ type III (66.7%) than in patients with EGJ type I (26.2%) and EGJ type II (30.3%; p < 0.001). Sliding hiatal hernia was more frequent in patients with EGJ type II (33.3%) than in patients with EGJ type III (16.7%) and EGJ type I (7.1%; p = 0.017). The mean esophagus-fundus angle of patients was 85 ± 31° at rest and increased to 101 ± 36° during Valsalva maneuver. CONCLUSION: Real-time MRI is a non-invasive imaging method for assessment of the esophagogastric junction. Real-time MRI can visualize dynamic changes of the EGJ during swallowing events.

The evaluation of the postoperative quality of life in patients undergoing radical gastrectomy for esophagogastric junction cancer using the Postgastrectomy Syndrome Assessment Scale-45: a nationwide multi-institutional study.

PURPOSE: This retrospective nationwide survey investigated the quality of life (QOL) of patients with esophagogastric junction cancer after gastrectomy using the Postgastrectomy Syndrome Assessment Scale-45. METHODS: The Postgastrectomy Syndrome Assessment Scale-45 comprises 45 questions classified into symptoms, living status, and QOL domains. A total of 1950 gastrectomized patients with upper-third gastric or esophagogastric junction cancer returned the completed forms. Among them, 224 eligible patients with esophagogastric junction cancer were selected, including 86, 120, and 18 patients who underwent total gastrectomy, proximal gastrectomy (reconstruction-esophagogastrostomy: 56; double-tract method: 51), and other procedures, respectively. RESULTS: The postoperative period was significantly shorter (47 ± 30 vs. 34 ± 30 months, p = 0.002), and the rates of early-stage disease and minimally invasive approaches significantly higher (both p < 0.001) in the proximal gastrectomy group than in the total gastrectomy group. Despite advantageous background factors for proximal gastrectomy, the postoperative QOL did not differ markedly between the groups. Compared to patients who underwent reconstruction with the double-tract method, patients who underwent esophagogastrostomy had significantly larger remnant stomachs but a similar QOL. CONCLUSION: Even with total gastrectomy, a postoperative QOL comparable to that with proximal gastrectomy can be maintained. Clarifying the optimal reconstruction methods for proximal gastrectomy for esophagogastric junction cancer is warranted. TRIAL REGISTRATION: This study was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; registration number: 000032221).