Mapping Information Needs over the Diagnosis, Treatment, and Survivorship Trajectory for Esophago-gastric Cancer Patients and Their Main Supporters: a Retrospective Survey.

This study reports preliminary data about the information needs of esophago-gastric cancer survivors and their supporters across diagnosis and treatment by identifying time-specific needs and whether the information provided aligned with the needs at each time point. Survivors (n = 26) and supporters (n = 15) were recruited from a public teaching hospital in South Australia. Both groups provided recall data describing personal information domain challenges at 6 clinically significant time points ranging from diagnosis to > 2 years post diagnosis. Responses were analyzed using descriptive statistics for non-normally distributed data. Needs relating to communication, tests, disease, and the physical effects information domains were consistently high across time and in groups. Supporters' overall needs were greater than those of survivors, particularly at times of high need. At times of low need, both groups reported information overload. Our results confirm that survivors and supporters require information throughout the cancer trajectory, up to 2 years after diagnosis, and supporters' needs are likely to be even greater. Results highlight the importance of timely and relevant information provision and provide a basis for the development of resources to empower survivors and supporters to identify and articulate their personal information needs. Patient navigators may provide an avenue to facilitate this approach.

Phase 1 trial of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases (IPGP study).

AIMS: Gastric cancer with peritoneal involvement has a poor prognosis. Intraperitoneal (IP) paclitaxel has shown promising results in these patients. However, this approach has only been studied in the Asian population, and in combination with S-1. We investigated the maximum tolerated dose of IP paclitaxel, with a standard chemotherapy combination, in the Australian population. METHODS: The study of the population included metastatic human epidermal growth factor receptor 2 (HER2) negative gastric adenocarcinoma with peritoneal involvement. Treatment included six 21-day cycles of cisplatin (80 mg/m2 IV, day 1) plus capecitabine (1000 mg/m2 PO BD, days 1-14) plus IP paclitaxel (days 1 and 8). IP paclitaxel doses for cohort 1-3 were 10, 20, and 30 mg/m2 , respectively, in a 3 + 3 standard dose-escalation design. RESULTS: Fifteen patients were enrolled of which 6 were female and the median age was 63. Two patients developed dose-limiting toxicities. No grade 4/5 toxicities were recorded. The maximum tolerated dose was not reached. Therefore, as defined by the study protocol, the recommended phase-2 dose for IP paclitaxel was determined to be 30 mg/m2 . The 12-month survival rate was 46.7%, and the median survival was 11.5 months (interquartile range [IQR]: 15.3-6.9). CONCLUSIONS: IP paclitaxel is safe in combination with cisplatin and capecitabine and the recommended phase-2 dose is 30 mg/m2 .

Patterns of care and outcomes for gastric and gastro-oesophageal junction cancer in an Australian population.

BACKGROUND: A single state-wide upper gastrointestinal (GI) cancer video-linked multidisciplinary team (MDT) meeting guides management and evidence-based care for all newly diagnosed upper GI cancer patients in South Australia. This study determined the patterns of care and outcomes for patients diagnosed with gastric and gastro-oesophageal junction (GOJ) cancers. METHODS: Patients diagnosed with gastric cancer and GOJ (Siewert III) cancer between June 2012 and June 2016 were included. Patient demographics, cancer stage, histology, diagnostic modalities and treatment data was analysed from a prospective database. Stage-specific survival outcomes were determined and analysed for each treatment modality. RESULTS: The study included 218 patients and at diagnosis 132 (61%) patients had stage I-III and 86 (39%) patients had stage IV disease. One hundred and ninety-five (89%) patients had gastric cancer and 23 (11%) had GOJ cancer (Siewert III). One hundred and nine (50%) patients underwent surgery, with 92% R0 resection rate. Forty-six patients received perioperative chemotherapy and 111 (51%) patients received palliative intent treatment. Median overall survival for stage II, III and IV cancers was 57.6 (95% CI 57.6-NR), 22.8 (95% CI 20.4-43.2), and 6.0 months (95% CI 4.8-8.4) respectively (p < 0.001). Median overall survival for patients who underwent perioperative chemotherapy and surgery was not reached as compared to 44.4 months (95% CI 28.8-NR) for patients who underwent surgery alone. CONCLUSION: Treatment outcomes for patients with gastric and GOJ cancer managed across South Australia met contemporary evidence-based practice. However, as most patients continue to present with late-stage disease, longer-term survival remains poor.

Comparison of oesophageal and gastric cancer in the evaluation of urgent endoscopy referral criteria.

BACKGROUND: The objective of the study is to identify differences in epidemiology and clinical presentation between oesophageal and gastric cancer and to evaluate the sensitivity of the Australian urgent endoscopy referral guidelines. METHODS: Design; Observational cohort study from February 2013 to October 2018. SETTING: A single tertiary specialist oesophago-gastric cancer centre: Flinders Medical Centre, South Australia. PARTICIPANTS: Patients with oesophageal and gastric cancer that had surgery with curative intent 61.9% oesophageal cancer, 38.1% gastric cancer. MAIN OUTCOME MEASURES: Differences between oesophageal and gastric cancer in terms of demographical variables, first presenting symptoms and sensitivity of the Australian urgent endoscopy referral guidelines. RESULTS: Oesophageal cancer presented at a median age of 64.4 years old, with a male: female ratio of 6:1, and dysphagia as the first presenting symptom in 61%. Gastric cancer presented at a median age of 69.5, with a 2:1 male: female ratio and predominantly non-specific symptoms-blood loss (36%), weight loss, nausea, and anorexia (21%) and epigastric pain (13%). The Australia urgent endoscopy referral guidelines had 76% sensitivity for oesophageal cancer detection compared with a 33% sensitivity for gastric cancer in this cohort. Delays from symptom onset to referral occurred for most patients with timeframes over four times the recommended 2-week timeframe. CONCLUSION: There should be a separate urgent referral guideline for oesophageal and gastric cancer. These should include dysphagia for oesophageal cancer and blood loss (anaemia, haematemesis, melaena) for gastric cancer. Delays from symptom onset to referral indicate the need for further education of the public and general practitioners on symptoms warranting urgent referral.

Phase I open-label trial of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases (IPGP study): study protocol.

INTRODUCTION: Gastric cancer with peritoneal metastasis has a poor outcome. Only a few studies have specifically investigated this group of patients. Japanese researchers have shown that chemotherapy with intraperitoneal paclitaxel (IPP) and oral S-1 (tegafur/gimeracil/oteracil) is active and well tolerated. These results have been achieved in a specific genetic pool (Japanese population), using regimens that may not be available in other parts of the world. We have designed this phase I trial to investigate IPP in combination with a standard chemotherapy combination in these patients. METHODS: We use a 3+3 expanded cohort dose escalation until a predefined number of dose-limiting toxicities are reached. Patients will have an intraperitoneal catheter placed surgically after trial enrolment. Chemotherapy includes a maximum of six cycles (21 days) of capecitabine (X) (1000 mg/m2 two times a day, days 1-14)+cisplatin (C) (intravenous 80 mg/m2 day 1) and IPP (days 1 and 8) with the following doses: cohort-1: 10 mg/m2, cohort-2: 20 mg/m2 and cohort-3: 30 mg/m2. Primary endpoint is to determine the maximum tolerated dose of IPP. Secondary endpoints include determining the safety and tolerability of IPP in combination with C and X, overall response rates, ascites response rate, progression-free survival, overall survival and effects on quality of life.Important inclusion criteria include age ≥18 years, human epidermal growth factor receptor 2 non-amplified gastric adenocarcinoma with histological or cytology-proven peritoneal involvement and adequate organ function. Exclusion criteria include previous malignancy within 5 years, recent abdominal or pelvic radiation treatment, significant abdominal adhesions or sepsis. ETHICS AND DISSEMINATION: The study is approved by Southern Adelaide Clinical Human Research Ethics Committee. A manuscript will be prepared for publication on the completion of the trial. This study will be conducted according to the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments (Therapeutic Goods Administration DSEB July 2000) and in compliance with applicable laws and regulations. The study will be performed in accordance with the NHMRC Statement on Ethical Conduct in Research Involving Humans (© Commonwealth of Australia 2007), and the NHMRC Australian Code for the Responsible Conduct of Research (©Australian Government 2007), and the principles laid down by the World Medical Assembly in the Declaration of Helsinki 2008. TRIAL REGISTRATION NUMBER: ACTRN12614001063606.

The role of rehabilitation in patients undergoing oesophagectomy for cancer and pre-malignant disease: A qualitative exploration of the views of patients, carers and healthcare providers.

OBJECTIVE: Oesophagectomy for cancer is associated with significant morbidity and mortality, and reduced quality of life. Structured rehabilitation potentially offers improved physical and psychological outcomes. We aimed to explore patient, carer and healthcare provider attitudes and preferences towards the role of rehabilitation. METHODS: We interviewed 15 patients who had undergone an oesophagectomy, 10 carers and 13 healthcare providers about perceived impacts of treatment; preferred components of a rehabilitation program; barriers/enablers of support provision; and participation in rehabilitation programs. Data were analysed using framework analysis. RESULTS: The overarching theme was "Getting back to normal." Diagnosis of disease signified a disruption to the normal trajectory of patients' lives and the post-treatment period was characterised as striving to return to normal. Patients and carers focused on rehabilitation needs post-treatment including dietary support, physiotherapy and healthcare provider support. Healthcare providers described rehabilitation as potentially beneficial from the pre-treatment phase and, along with carers, highlighted the importance of psychological support. Barriers included access to services, cost of service provision and appointment burden. CONCLUSION: A need for rehabilitation services was identified by healthcare providers from the point of diagnosis, rather than only after surgery. Implications include improved service provision by healthcare institutions for patients undergoing oesophagectomy.

Toward More Efficient Surveillance of Barrett's Esophagus: Identification and Exclusion of Patients at Low Risk of Cancer.

BACKGROUND: Endoscopic surveillance of Barrett's esophagus (BE) is probably not cost-effective. A sub-population with BE at increased risk of high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) who could be targeted for cost-effective surveillance was sought. METHODS: The outcome for BE surveillance from 2003 to 2012 in a structured program was reviewed. Incidence rates and incidence rate ratios for developing HGD or EAC were calculated. Risk stratification identified individuals who could be considered for exclusion from surveillance. A health-state transition Markov cohort model evaluated the cost-effectiveness of focusing on higher-risk individuals. RESULTS: During 2067 person-years of follow-up of 640 patients, 17 individuals progressed to HGD or EAC (annual IR 0.8%). Individuals with columnar-lined esophagus (CLE) ≥2 cm had an annual IR of 1.2% and >8-fold increased relative risk of HGD or EAC, compared to CLE <2 cm [IR-0.14% (IRR 8.6, 95% CIs 4.5-12.8)]. Limiting the surveillance cohort after the first endoscopy to individuals with CLE ≥2 cm, or dysplasia, followed by a further restriction after the second endoscopy-exclusion of patients without intestinal metaplasia-removed 296 (46%) patients, and 767 (37%) person-years from surveillance. Limiting surveillance to the remaining individuals reduced the incremental cost-effectiveness ratio from US$60,858 to US$33,807 per quality-adjusted life year (QALY). Further restrictions were tested but failed to improve cost-effectiveness. CONCLUSIONS: Based on stratification of risk, the number of patients requiring surveillance can be reduced by at least a third. At a willingness-to-pay threshold of US$50,000 per QALY, surveillance of higher-risk individuals becomes cost-effective.

Improving care for patients with oesophageal and gastric cancer: impact of a statewide multidisciplinary team.

BACKGROUND: To standardize management of upper gastrointestinal (GI) cancer in South Australia, a statewide video linked multidisciplinary team (MDT) meeting was established in late 2009. Although cancer MDTs are recognized as a standard of care, it is important to audit their impact. METHODS: A retrospective audit of MDT outcomes and recommendations for patients reviewed by the upper GI MDT between 1 January 2010 and 31 December 2011 was undertaken. The proportion of patients with new upper GI malignancies reviewed and the proportion reviewed within 2 weeks of diagnosis were determined. Recommendations from the MDT meetings regarding treatment intent, management, investigations and trial participation were audited. RESULTS: From 2010 to 2011, the proportion of newly diagnosed upper GI malignancies in South Australia reviewed by the MDT increased from 43.2% to 54.3%. More oesophageal than gastric cancer cases were reviewed by the MDT. The proportion of patients reviewed within 2 weeks of diagnosis increased from 20% to 50%. The proportion of patients referred for neoadjuvant or definitive chemoradiotherapy increased from 2010 to 2011. Fifty per cent of all patients reviewed were recommended to have further investigations. Recommendations for clinical trial participation increased from 0% in 2010 to 11% in 2011. CONCLUSION: A statewide upper GI cancer MDT is feasible. Implementation of the MDT was followed by an increase in the number of patients reviewed and the proportion reviewed within 2 weeks of diagnosis. Greater awareness of the MDT and access to it may be required to continue to increase the proportion of cancers reviewed.

Influence of operator experience and reporting time on the accuracy of esophageal capsule endoscopy screening for varices.

Conflicting data exist concerning the accuracy of esophageal capsule endoscopy (ECE) for the screening of varices. No study has examined the influence of operator factors on the accuracy of ECE reporting. The primary aims of this study were, therefore, to examine how operator experience with esophagogastroduodenoscopy (EGD) and operator reporting times of capsule videos influenced test accuracy. Twelve cirrhotic patients presenting for EGD had same-day ECE performed. The gold standard for variceal grade was determined using a panel of experienced endoscopists. Six novice capsule endoscopists, blinded to results of EGD, subsequently reported capsule videos for each of the 12 patients.Novice capsule endoscopists accurately identified high-risk varices. The mean area under the receiver operating characteristic curve for identifying high-risk varices for the six operators was 0.88 ±/-0.14. The mean sensitivity, specificity, positive, and negative predictive values for identifying high-risk varices for the six operators were 83%, 93%, 82%, and 97%, respectively. Years of prior EGD experience were not associated with accuracy of capsule reporting (OR = 0.9, 95% CI [0.74, 1.08]; p = .26). Time spent reporting capsule videos was associated with accuracy of capsule reporting for high-risk varices using British Society of Gastroenterology criteria (OR = 1.33, 95% CI [1.05, 1.08]; p = .018). Novice capsule endoscopists are able to accurately identify high-risk esophageal varices. Time taken to report capsule videos, but not amount of prior EGD experience, influenced capsule report accuracy. These findings may have implications for the design of further trials and the cost-effectiveness of ECE screening of varices.

Interval fecal immunochemical testing in a colonoscopic surveillance program speeds detection of colorectal neoplasia.

BACKGROUND & AIMS: Rapidly progressing or missed lesions can reduce the effectiveness of colonoscopy-based colorectal cancer surveillance programs. We investigated whether giving fecal immunochemical tests (FITs) for hemoglobin between surveillance colonoscopies resulted in earlier detection of neoplasia. METHODS: The study included 1736 patients with a family history or past neoplasia; they received at least 2 colonoscopy examinations and were followed for a total of 8863 years. Patients were excluded from the study if they had genetic syndromes, colorectal surgery, or inflammatory bowel disease. An FIT was offered yearly, in the interval between colonoscopies; if results were positive, the colonoscopy was performed earlier than scheduled. RESULTS: Among the 1071 asymptomatic subjects (61%) who received at least 1 FIT, the test detected 12 of 14 cancers (86% sensitivity) and 60 of 96 (63%) advanced adenomas. In patients with positive results from the FIT, the diagnosis of cancer was made 25 months (median) earlier and diagnosis of advanced adenoma 24 months earlier. Patients who had repeated negative results from FIT had an almost 2-fold decrease in risk for cancer and advanced adenoma compared with patients who were not tested (5.5% vs 10.1%, respectively, P = .0004). The most advanced stages of neoplasia, observed across the continuum from nonadvanced adenoma to late-stage cancer, were associated with age (increased with age), sex (increased in males), and FIT result. The probability of most advanced neoplastic stage was lowest among those with a negative result from the FIT (odds ratio, 0.68; P < .001). CONCLUSIONS: Interval examinations using the FIT detected neoplasias sooner than scheduled surveillances. Subjects with negative results from the FIT had the lowest risk for the most advanced stage of neoplasia. Interval FIT analyses can be used to detect missed or rapidly developing lesions in surveillance programs.

Outcome of endoscopy surveillance for Barrett's oesophagus.

BACKGROUND: Endoscopic surveillance of individuals with Barrett's oesophagus is undertaken to detect early stage oesophageal malignancy. The impact of a surveillance programme on endoscopy resources and disease detection is uncertain. METHODS: In 2004, we commenced a structured Barrett's oesophagus surveillance programme. The surveillance protocol specifies surveillance interval and number of oesophageal biopsies required according to previous endoscopy and biopsy findings. The first 3 years of surveillance were reviewed to assess programme adherence, impact on endoscopy resources and the incidence of high-grade dysplasia and adenocarcinoma in patients undergoing surveillance. RESULTS: Four hundred five patients were enrolled in the surveillance programme, and 776 patient years of endoscopy follow-up were analysed. Four-quadrant biopsies every 2 cm throughout the Barrett's oesophagus were performed in 89.8% of endoscopies. A total of 93.7% of patients had surveillance endoscopy performed at the appropriate time interval. Formalizing surveillance was followed by a decrease in the mean time interval for endoscopy surveillance from 16 months to 15 months, although the mode endoscopy surveillance interval lengthened from 1 year to 2 years. The mean number of biopsies per endoscopy increased from 5.9 to 7. In four patients, T1 stage oesophageal adenocarcinoma was identified, and in six patients, high-grade dysplasia was identified (combined incidence of adenocarcinoma/high-grade dysplasia 1 per 77.6 endoscopy years of follow-up). CONCLUSIONS: Structured Barrett's surveillance detects malignant progression at an early stage, which provides opportunities for curative surgical or endoscopic intervention. Formalizing surveillance resulted in a high rate of adherence to agreed guidelines and rationalized the use of endoscopy resources without significantly increasing workload.

Multi-wavelength source using low drive-voltage amplitude modulators for optical communications.

A simple and cost-effective technique for generating a flat, square-shaped multi-wavelength optical comb with 42.6 GHz line spacing and over 0.5 THz of total bandwidth is presented. A detailed theoretical analysis is presented, showing that using two concatenated modulators driven with voltages of 3.5 V(pi) are necessary to generate 11 comb lines with a flatness below 2dB. This performance is experimentally demonstrated using two cascaded Versawave 40 Gbit/s low drive voltage electro-optic polarisation modulators, where an 11 channel optical comb with a flatness of 1.9 dB and a side-mode-suppression ratio (SMSR) of 12.6 dB was obtained.

Improving surveillance for Barrett's oesophagus.

PROBLEM: A retrospective audit of surveillance for Barrett's oesophagus 1996-2001 identified the need to improve adherence to guidelines for the endoscopic surveillance of patients with Barrett's oesophagus. DESIGN: Prospective audit of the effect of disseminating guidelines in 2002. Prospective audit of the effect of introducing local guidelines and Barrett's oesophagus surveillance officers, 2003-2005. SETTING: Two general hospitals in Australia, 2002-5. All adult patients diagnosed with Barrett's oesophagus were included. KEY MEASURES FOR IMPROVEMENT: Proportions of patients in a Barrett's oesophagus surveillance programme who had appropriate time intervals between follow-up endoscopies and who had appropriate numbers of biopsies collected at endoscopy. STRATEGIES FOR CHANGE: Local guidelines were laid down. Surveillance coordinators for Barrett's oesophagus were introduced to manage the process according to a clinical protocol designed for each patient. EFFECTS OF CHANGE: Disseminating guidelines had little effect on practice. Six months after surveillance coordinators were introduced, adherence to the planned surveillance interval increased from 17% to 92% and the number of endoscopies at which sufficient biopsies were collected increased from 45% to 83%. These changes have been maintained. LESSONS LEARNT: Disseminating guidelines and results of an audit on endoscopic surveillance in Barrett's oesophagus had no effect on practice. Introducing coordinators who proactively managed the process greatly improved adherence to guidelines.

Clinical risk: discharging patients with no-one at home.

This article reports a study designed to assure if guidelines for discharge planning actually promoted optimal patient safety following endoscopic procedures. A flow chart was drafted to include discharge planning at the time of referral, immediately preprocedure, and postprocedure. A telephone survey was carried out postprocedure to see if patients were deemed to be safe at home, document pain and discomfort levels, and note if they thought they could have managed without their caregiver. Further education of endoscopists and nurses in the outpatient department was necessary to emphasize to patients preprocedure the need for a responsible adult to stay overnight following the procedure and to identify patients who may not be able to meet this requirement. The telephone survey showed a significant number of patients experienced a postprocedure issue. Planning and reviewing guidelines for patient discharge postendoscopically has significantly reduced potential problems and promoted safe practice for patients postprocedure.