Lasting Symptoms After Esophageal Resection (LASER): European Multicenter Cross-sectional Study.

OBJECTIVE: To identify the most prevalent symptoms and those with greatest impact upon health-related quality of life (HRQOL) among esophageal cancer survivors. BACKGROUND: Long-term symptom burden after esophagectomy, and associations with HRQOL, are poorly understood. PATIENTS AND METHODS: Between 2010 and 2016, patients from 20 European Centers who underwent esophageal cancer surgery, and were disease-free at least 1 year postoperatively were asked to complete LASER, EORTC-QLQ-C30, and QLQ-OG25 questionnaires. Specific symptom questionnaire items that were associated with poor HRQOL as identified by EORTC QLQ-C30 and QLQ-OG25 were identified by multivariable regression analysis and combined to form a tool. RESULTS: A total of 876 of 1081 invited patients responded to the questionnaire, giving a response rate of 81%. Of these, 66.9% stated in the last 6 months they had symptoms associated with their esophagectomy. Ongoing weight loss was reported by 10.4% of patients, and only 13.8% returned to work with the same activities.Three LASER symptoms were correlated with poor HRQOL on multivariable analysis; pain on scars on chest (odds ratio (OR) 1.27; 95% CI 0.97-1.65), low mood (OR 1.42; 95% CI 1.15-1.77) and reduced energy or activity tolerance (OR 1.37; 95% CI 1.18-1.59). The areas under the curves for the development and validation datasets were 0.81 ±â€Š0.02 and 0.82 ±â€Š0.09 respectively. CONCLUSION: Two-thirds of patients experience significant symptoms more than 1 year after surgery. The 3 key symptoms associated with poor HRQOL identified in this study should be further validated, and could be used in clinical practice to identify patients who require increased support.

Health-related quality of life one year after the diagnosis of oesophageal cancer: a population-based study from the Swedish National Registry for Oesophageal and Gastric Cancer.

BACKGROUND: Population-based patient reported outcome data in oesophageal cancer are rare. The main purpose of this study was to describe health-related quality of life (HRQOL) 1 year after the diagnosis of oesophageal cancer, comparing subgroups of curatively and palliatively managed patients. METHODS: This is a nationwide population-based cohort study, based on the Swedish National Registry for Oesophageal and Gastric Cancer (NREV) with prospectively registered data, including HRQOL instruments from the European Organisation for Research and Treatment of Cancer including the core and disease specific questionnaires (EORTC QLQ-C30 and QLQ-OG25). Patients diagnosed with oesophageal cancer between 2009 and 2016 and with complete HRQOL data at 1 year follow-up were included. HRQOL of included patients was compared to a reference population matched by age and gender to to a previous cohort of unselected Swedish oesophageal cancer patients. Linear regression was performed to calculate mean scores with 95% confidence intervals (CI) and adjusted linear regression analysis was used to calculate mean score differences (MD) with 95% CI. RESULTS: A total of 1156 patients were included. Functions and global health/quality of life were lower in both the curative and palliative cohorts compared to the reference population. Both curatively and palliatively managed patients reported a severe symptom burden compared to the reference population. Patients who underwent surgery reported more problems with diarrhoea compared to those treated with definitive chemoradiotherapy (dCRT) (MD -14; 95% CI - 20 to - 8). Dysphagia was more common in patiens treated with dCRT compared to surgically treated patients (MD 11; 95% CI 4 to 18). Those with palliative intent due to advanced tumour stage reported more problems with dysphagia compared to those with palliative intent due to frailty (MD -18; 95% CI - 33 to - 3). CONCLUSIONS: One year after diagnosis both curative and palliative intent patients reported low function scores and severe symptoms. Dysphagia, choking, and other eating related problems were more pronounced in palliatively managed patients and in the curative intent patients treated with dCRT.

Blood flow restriction Exercise in the perioperative setting to Prevent loss of muscle mass in patients with pancreatic, biliary tract, and liver cancer: study protocol for the PREV-Ex randomized controlled trial.

BACKGROUND: Patients diagnosed with pancreatic, biliary tract, and liver cancer often suffer from a progressive loss of muscle mass. Given the considerable functional impairments in these patients, high musculoskeletal weight loads may not be well tolerated by all individuals. The use of blood-flow restricted resistance training (BFR-T) which only requires low training loads may allow for a faster recovery of muscle due to avoidance of high levels of mechanical muscle stress associated with high-load resistance exercise. This study aims to investigate whether BFR-T can prevent or slow down the loss of skeletal muscle mass and enhance the functional capacity and mental health of patients with pancreatic, biliary tract, and liver cancer. METHODS: The PREV-Ex exercise trial is a multicenter two-armed randomized controlled trial. Patients will be randomized to an exercise program consisting of home-based low-load BFR-T during a combined pre- and postoperative period for a total of 6-10 weeks (prehabilitation and rehabilitation), or to a control group. Protein supplementation will be given to both groups to ensure adequate protein intake. The primary outcomes, skeletal muscle thickness and muscle cross-sectional area, will be assessed by ultrasound. Secondary outcomes include the following: (i) muscle catabolism-related and inflammatory bio-markers (molecular characteristics will be assessed from a vastus lateralis biopsy and blood samples will be obtained from a sub-sample of patients); (ii) patient-reported outcome measures (self-reported fatigue, health-related quality of life, and nutritional status will be assessed through validated questionnaires); (iii) physical fitness/performance/activity (validated tests will be used to evaluate physical function, cardiorespiratory fitness and maximal isometric muscle strength. Physical activity and sedentary behavior (assessed using an activity monitor); (iv) clinical outcomes: hospitalization rates and blood status will be recorded from the patients' medical records; (v) explorative outcomes of patients' experience of the exercise program which will be evaluated using focus group/individual interviews. DISCUSSION: It is worthwhile to investigate new strategies that have the potential to counteract the deterioration of skeletal muscle mass, muscle function, strength, and physical function, all of which have debilitating consequences for patients with pancreatic, biliary tract, and liver cancer. The expected findings could improve prognosis, help patients stay independent for longer, and possibly reduce treatment-related costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05044065. Registered on September 14, 2021.

Effects of neoadjuvant therapy on health-related quality of life for patients with gastroesophageal cancer.

BACKGROUND: Neoadjuvant therapy in combination with surgery increases survival in gastroesophageal cancer; however, little is known about its impact on health-related quality of life. This study compared the impact of neoadjuvant therapy with that of surgery alone on the health-related quality of life in patients treated for gastroesophageal cancer. METHODS: A single-centre cohort study with prospectively collected data from patients undergoing curative intended treatment for gastroesophageal cancer between 2013 and 2020 was performed. Health-related quality of life was assessed prior to surgery and patients stratified according to neoadjuvant therapy or surgery alone. The primary endpoint was self-assessed health-related quality of life, evaluated using validated cancer-specific questionnaires. A pre-specified multivariable model adjusted for age, ASA score, and clinical T- and N-stage was used. RESULTS: A total of 361 patients were included, of whom 239 (61%) were treated with neoadjuvant therapy. Patients treated with neoadjuvant therapy reported less difficulties with eating restrictions (-11.9, p = 0.005), pain (-10.9, p = 0.004), and insomnia (-12.6, p = 0.004) than patients treated with surgery alone. Patients with oesophageal cancer and neoadjuvant therapy reported less dysphagia (-16.6, p < 0.001), eating restrictions (-23.2, p < 0.001), and odynophagia (-18.0, p = 0.002) than those who underwent surgery alone. CONCLUSION: Neoadjuvant therapy was associated with a significant reduction in symptoms affecting malnutrition and improved health-related quality of life in patients with gastroesophageal cancer. These results indicates that more patients might be available for neoadjuvant therapy, despite the baseline burden of gastroesophageal cancer.

Partial stomach-partitioning gastrojejunostomy for gastric outlet obstruction: A cohort study based on consecutive case series from a single center.

BACKGROUND/OBJECTIVE: Gastric outlet obstruction can have a large impact on quality of life for patients with upper gastrointestinal cancer or benign obstruction. Partial stomach-partitioning gastrojejunostomy has previously shown promising outcomes compared to conventional gastrojejunostomy in terms of reduced delayed gastric emptying. The objective of the current study was to present outcomes of partial stomach-partitioning gastrojejunostomy in a single high-volume center for upper gastrointestinal cancer. METHODS: A retrospective cohort study including all consecutive patients who underwent partial stomach-partitioning gastrojejunostomy from 2013 to 2020. The primary outcome was oral intake tolerance. A subgroup analysis was performed in all patients with manifest gastric outlet obstruction comparing partial stomach-partitioning gastrojejunostomy to conventional gastrojejunostomy. RESULTS: Partial stomach-partitioning gastrojejunostomy was performed in 32 patients and laparoscopic technique was used in 19 patients (59%). The procedure improved oral intake tolerance defined by gastric outlet obstruction scoring system by 0.63 points on average (P = 0.041). No postoperative complications related to the procedure were observed. Recurrence of gastric outlet obstruction developed in six patients (19%), four patients (13%) required endoscopic reintervention but no patient required surgical reintervention. A comparison between partial stomach-partitioning gastrojejunostomy and conventional gastrojejunostomy showed no statistically significant differences regarding postoperative nutritional status, length of hospital stay, recurrence or reintervention. CONCLUSION: The results of the study show that partial stomach-partitioning gastrojejunostomy can be an effective surgical treatment for patients suffering from gastric outlet obstruction and that the procedure can be safely performed with laparoscopic technique.

Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL).

BACKGROUND: Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported. The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life. METHODS: The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20 mg three times per week for 9 months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status 0 to 2; main exclusion criteria are life expectancy less than 4 weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews. DISCUSSION: To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer. TRIAL REGISTRATION: EU Clinical Trial Register, EudraCT Number 2014-004552-64 . Registered on 19 January 2016. ClinicalTrials.gov NCT02948309 . Registered on 28 October 2016.