The impact of a hospital-based special care unit on behavioural and psychological symptoms in older people living with dementia.

BACKGROUND: Hospital patients with behavioural and psychological symptoms of dementia (BPSD) are vulnerable to a range of adverse outcomes. Hospital-based Special Care Units (SCUs) are secure dementia-enabling environments providing specialised gerontological care. Due to a scarcity of research, their value remains unconfirmed. OBJECTIVE: To compare hospital based SCU management of BPSD with standard care. DESIGN: Single-case multiple baseline design. SETTING AND PARTICIPANTS: One-hundred admissions to an 8-bed SCU over 2 years in a large Australian public hospital. METHODS: Repeated measures of BPSD severity were undertaken prospectively by specialist dementia nurses for patients admitted to a general ward (standard care) and transferred to the SCU. Demographic and other clinical data, including diagnoses, medication use, and care-related outcomes were obtained from medical records retrospectively. Analysis used multilevel models to regress BPSD scores onto care-setting outcomes, adjusting for time and other factors. RESULTS: When receiving standard care, patients' BPSD severity was 6.8 (95% CI 6.04-7.64) points higher for aggression, 15.6 (95% CI 13.90-17.42) points higher for the neuropsychiatric inventory, and 5.8 (95% CI 5.14-6.50) points higher for non-aggressive agitation compared to SCU. Patients receiving standard care also experienced increased odds for patient-to-nurse violence (OR 2.61, 95% CI 1.67-4.09), security callouts (OR 5.39 95% CI 3.40-8.52), physical restraint (OR 17.20, 95% CI 7.94-37.25) and antipsychotic administration (OR 3.41, 95% CI 1.60-7.24). CONCLUSION: Clinically significant reductions in BPSD and psychotropic administration were associated with SCU care relative to standard ward care. These results suggest more robust investigation of hospital SCUs, and dementia-enabling design are warranted.

Higher blood nicotine concentrations following smokeless tobacco (pituri) and cigarette use linked to adverse pregnancy outcomes for Central Australian Aboriginal pregnancies.

BACKGROUND: In central Australia, Aboriginal women use wild tobacco plants, Nicotiana spp. (locally known as pituri) as a chewed smokeless tobacco, with this use continuing throughout pregnancy and lactation. Our aim was to describe the biological concentrations of nicotine and metabolites in samples from mothers and neonates and examine the relationships between maternal self-reported tobacco use and maternal and neonatal outcomes. METHODS: Central Australian Aboriginal mothers (and their neonates) who planned to birth at the Alice Springs Hospital (Northern Territory, Australia) provided biological samples: maternal blood, arterial and venous cord blood, amniotic fluid, maternal and neonatal urine, and breast milk. These were analysed for concentrations of nicotine and five metabolites. RESULTS: A sample of 73 women were enrolled who self-reported: no-tobacco use (n = 31), tobacco chewing (n = 19), or smoking (n = 23). Not all biological samples were obtained from all mothers and neonates. In those where samples were available, higher total concentrations of nicotine and metabolites were found in the maternal plasma, urine, breast milk, cord bloods and Day 1 neonatal urine of chewers compared with smokers and no-tobacco users. Tobacco-exposed mothers (chewers and smokers) with elevated blood glucose had higher nicotine and metabolite concentrations than tobacco-exposed mothers without elevated glucose, and this was associated with increased neonatal birthweight. Neonates exposed to higher maternal nicotine levels were more likely to be admitted to Special Care Nursery. By Day 3, urinary concentrations in tobacco-exposed neonates had reduced from Day 1, although these remained higher than concentrations from neonates in the no-tobacco group. CONCLUSIONS: This research provides the first evidence that maternal pituri chewing results in high nicotine concentrations in a wide range of maternal and neonatal biological samples and that exposure may be associated with adverse maternal and neonatal outcomes. Screening for the use of all tobacco and nicotine products during pregnancy rather than focusing solely on smoking would provide a more comprehensive assessment and contribute to a more accurate determination of tobacco and nicotine exposure. This knowledge will better inform maternal and foetal care, direct attention to targeted cessation strategies and ultimately improve long-term clinical outcomes, not only in this vulnerable population, but also for the wider population. NOTE TO READERS: In this research, the central Australian Aboriginal women chose the term 'Aboriginal' to refer to themselves, and 'Indigenous' to refer to the broader group of Australian First Peoples. That choice has been maintained in the reporting of the research findings.

Prognostic models to predict survival in patients with pancreatic cancer: a systematic review.

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) has poor survival. Current treatments offer little likelihood of cure or long-term survival. This systematic review evaluates prognostic models predicting overall survival in patients diagnosed with PDAC. METHODS: We conducted a comprehensive search of eight electronic databases from their date of inception through to December 2019. Studies that published models predicting survival in patients with PDAC were identified. RESULTS: 3297 studies were identified; 187 full-text articles were retrieved and 54 studies of 49 unique prognostic models were included. Of these, 28 (57.1%) were conducted in patients with advanced disease, 17 (34.7%) with resectable disease, and four (8.2%) in all patients. 34 (69.4%) models were validated, and 35 (71.4%) reported model discrimination, with only five models reporting values >0.70 in both derivation and validation cohorts. Many (n = 27) had a moderate to high risk of bias and most (n = 33) were developed using retrospective data. No variables were unanimously found to be predictive of survival when included in more than one study. CONCLUSION: Most prognostic models were developed using retrospective data and performed poorly. Future research should validate instruments performing well locally in international cohorts and investigate other potential predictors of survival.

Central Australian Aboriginal women's placental and neonatal outcomes following maternal smokeless tobacco, cigarette or no tobacco use.

OBJECTIVE: To describe the placental characteristics and neonatal outcomes of Central Australian Aboriginal women based on maternal self-report of tobacco use. METHODS: Placental and neonatal variables were collected from a prospective maternal cohort of 19 smokeless tobacco chewers, 23 smokers and 31 no-tobacco users. RESULTS: Chewers had the lowest placental weight (460 g) while the no-tobacco group had the heaviest placental weight (565 g). Chewers and the no-tobacco group had placental areas of similar size (285 cm2 and 288 cm2 , respectively) while the placentas of smokers were at least 13 cm2 smaller (272 cm2 ). There were two stillbirths in the study and more than one-third (36%) of neonates (newborns) were admitted to the Special Care Nursery, with the chewers' neonates having a higher admission rate compared with smokers' neonates (44% vs. 23%). The cohort mean birthweight (3348 g) was not significantly different between the groups. When stratified for elevated maternal glucose, the chewers' neonates had the lowest mean birthweight (2906 g) compared to the neonates of the no-tobacco group (3242 g) and smokers (3398 g). CONCLUSIONS: This research is the first to demonstrate that the maternal use of Australian Nicotiana spp. (pituri) as smokeless tobacco may negatively impact placental and neonatal outcomes. IMPLICATIONS FOR PUBLIC HEALTH: Maternal smokeless tobacco use is a potential source of placental and foetal nicotine exposure. Maternal antenatal screening should be expanded to capture a broader range of tobacco and nicotine products, and appropriate cessation support is required.

The association between quality care and outcomes for a real-world population of Australian patients diagnosed with pancreatic cancer.

BACKGROUND: This study: (i) assessed compliance with a consensus set of quality indicators (QIs) in pancreatic cancer (PC); and (ii) evaluated the association between compliance with these QIs and survival. METHODS: Four years of data were collected for patients diagnosed with PC. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). A multivariable analysis tested the relationship between significant patient and hospital characteristics, patient cluster effects within hospitals and survival. RESULTS: 1061 patients were eligible for this study. Significant association with improved survival were: (i) in the potentially resectable group having adjuvant chemotherapy administered following surgery or a reason documented (HR, 0.29; 95 CI, 0.19-0.46); (ii) in the locally advanced group included having chemotherapy ± chemoradiation, or a reason documented for not undergoing treatment (HR, 0.38; 95 CI, 0.25-0.58); and (iii) in the metastatic disease group included having documented performance status at presentation (HR, 0.65; 95 CI, 0.47-0.89), being seen by an oncologist in the absence of treatment (HR, 0.48; 95 CI, 0.31-0.77), and disease management discussed at a multidisciplinary team meeting (HR, 0.79; 95 CI, 0.64-0.96). CONCLUSION: Capture of a concise data set has enabled quality of care to be assessed.

Determining the CA19-9 concentration that best predicts the presence of CT-occult unresectable features in patients with pancreatic cancer: A population-based analysis.

BACKGROUND: Serum CA19-9 concentration may be useful in triaging patients with pancreatic cancer for more intensive staging investigations. Our aim was to identify the CA19-9 cut-point with the greatest accuracy for detecting unresectable features not identified by CT scan, and to examine the performance of this and other cut-points in predicting the outcome of staging laparoscopy (SL). METHODS: Patients with pancreatic cancer were drawn from two state-wide cancer registries between 2009 and 2011. We used classification and regression tree (CART) analysis to identify the CA19-9 cut-point which best predicted the presence of imaging-occult unresectable features, and compared its performance with that of a number of alternative cut-points. We then used logistic regression to test the association between CA19-9 concentration and detection of unresectable features in patients who underwent SL. RESULTS: From the CART analysis, the optimal CA19-9 cut-point was 440 U/mL. CA19-9 ≥ 150 U/mL had a similar Youden Index, but greater sensitivity (69% versus 47%). This remained true for those who had obstructive jaundice at the time of CA19-9 sampling. CA19-9 concentration greater than or equal to 110 U/mL, 150 U/mL and 200 U/mL was associated with significantly greater odds of unresectable features being detected during SL. CONCLUSION: Elevated serum CA19-9 concentration is a valid marker for CT-occult unresectable features; the most clinically appropriate cut-point appears to be ≥ 150 U/mL irrespective of the presence of jaundice. Clinical trials which evaluate the value of CA19-9 in the staging algorithm for pancreatic cancer are needed before it is routinely used in clinical practice.

Comparison of Opioid-Free Anesthesia Versus Opioid-Containing Anesthesia for Elective Laparoscopic Surgery (COFA: LAP): A Protocol Measuring Recovery Outcomes.

The administration of opioids is a central element in contemporary anesthetic techniques in Australia; however, opioids have a range of side effects. As an alternative, opioid-free anesthesia (OFA) is an emerging mode of anesthesia intended to avoid these side effects. This study is the first to publish the use of OFA in Australia and is conducted in a regional Queensland Health Service. The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy (n = 40) or tubal ligation (n = 40). Participant outcomes to be measured include: Quality of Recovery (QoR-15); Oral Morphine Equivalent Daily Dose (OMEDD) at 24-h post-operatively; time to first opioid (TTFO) dose; post-operative nausea and vomiting (PONV); Post Anesthetic Care Unit length of stay (PACU-LOS); and hospital length of stay (LOS). The findings may challenge the essentiality of opioids in the peri-operative period, which in turn would influence the future intra-operative management of surgical patients. Ultimately, a reduction in anesthesia-associated opioid use will support a more general decline in opioid use.

The association of missed nursing care and determinants of satisfaction with current position for direct-care nurses-An international study.

AIM: To describe the association of missed nursing care and to identify the determinants of satisfaction with current position for direct-care nurses. BACKGROUND: Missed nursing care and job satisfaction are important issues regarding quality patient care and safety in health care, globally. METHOD: This was a cross-sectional quantitative study using MISSCARE Survey data. Participants were 7,079 nursing staff providing direct patient care in hospitals in Australia, Iceland, Turkey and the USA. Multivariable nested models were used to identify the relationship between missed nursing care and nurses' satisfaction with current position. RESULTS: More missed nursing care was associated with less satisfaction with current position. Other determinants of job satisfaction included country, nursing experience, overtime worked, adequacy of staffing and the number of shifts missed during the previous 3 months. CONCLUSION(S): Internationally, more missed nursing care is associated with less nursing job satisfaction and is influenced by work experience, overtime worked, levels of staffing and absenteeism. IMPLICATIONS FOR NURSING MANAGEMENT: This study identifies that the association between missed nursing care and satisfaction with nursing position is of global concern. Other factors requiring the attention of nurse managers are staffing levels, absenteeism and work experience.

Determinants of nurse absenteeism and intent to leave: An international study.

AIM: To determine factors associated with nurses' intent to leave their positions and absenteeism. BACKGROUND: There is a recognized global shortage of nurses but limited data describing and determining factors associated with nurse absenteeism and intent to leave. METHODS: This study involved a secondary analysis of the results from direct-care registered nurses' responses to the MISSCARE Survey, with data from seven countries included. Multi-level modelling was used to determine nurse characteristics and working environment factors associated with nurse absenteeism and intent to leave. RESULTS: The level of absenteeism and intent to leave varied significantly across countries, with registered nurses in Lebanon reporting the highest intention to leave within 12 months (43%) and registered nurses in Iceland and Australia the highest level of absenteeism (74% and 73%, respectively). Factors associated with outcomes included perceived staffing adequacy of unit, job satisfaction, and age of the nurse. CONCLUSIONS: A significant difference between countries was identified in nurse absenteeism and intent to leave. Increased perception of unit staffing inadequacy, lower job satisfaction, less nurse experience, and younger age were significant contributors to nurse absenteeism and intent to leave. IMPLICATIONS FOR NURSING MANAGEMENT: These findings suggest that regardless of country and hospital, by ensuring that units are adequately staffed and increasing job satisfaction, younger, less experienced nurses can be retained and absenteeism reduced.

Are Postoperative Clinical Outcomes Influenced by Length of Stay in the Postanesthesia Care Unit?

PURPOSE: To compare clinical outcomes of patients who required a prolonged length of stay in the postanesthesia care unit (PACU) with a control group. DESIGN: A single-center purposive-sampled retrospective medical record and database audit. METHODS: Patients with prolonged PACU stays were compared to a group of patients whose stay was less than median for outcome measures: rapid response team (RRT) activation, cardiac arrest, unanticipated intensive care unit admissions, and survival to discharge. FINDINGS: A total of 1,867 patients were included in the analysis (n = 931 prolonged stay and n = 933 control group). Prolonged stay in PACU was higher among patients who were older, had higher American Society of Anesthesiologist score, and were discharged to wards during the afternoon or late nursing shift. RRT activation after discharge from PACU occurred in more patients in the study group compared with the control group (7% vs 1%, respectively). There were no cardiac arrests recorded in either group within the 24 hours after PACU discharge period. CONCLUSIONS: Prolonged stay in the PACU for 2 or more hours because of clinical reasons appears to be associated with a higher incidence of clinical deterioration in the ward setting requiring RRT intervention within 24 hours after discharge from PACU.

Chemotherapy in patients with unresected pancreatic cancer in Australia: A population-based study of uptake and survival.

AIM: Palliative chemotherapy improves symptom control and prolongs survival in patients with unresectable pancreatic cancer, but there is a paucity of data describing its use and effectiveness in everyday practice. We explored patterns of chemotherapy use in patients with unresected pancreatic cancer in Australia and the impact of use on survival. METHODS: We reviewed the medical records of residents of New South Wales or Queensland, Australia, diagnosed with unresectable pancreatic adenocarcinoma between July 2009 and June 2011. Associations between receipt of chemotherapy and sociodemographic, clinical and health service factors were evaluated using logistic regression. We used Cox proportional hazards models to analyze associations between chemotherapy use and survival. RESULTS: Data were collected for 1173 eligible patients. Chemotherapy was received by 44% (n = 184/414) of patients with localized pancreatic cancer and 53% (n = 406/759) of patients with metastases. Chemotherapy receipt depended on clinical factors, such as performance status and comorbidity burden, and nonclinical factors, such as age, place of residence, multidisciplinary team review and the type of specialist first encountered. Consultation with an oncologist mitigated most of the sociodemographic and service-related disparities in chemotherapy use. The receipt of chemotherapy was associated with prolonged survival in patients with inoperable pancreatic cancer, including after adjusting for common prognostic factors. CONCLUSIONS: These findings highlight the need to establish referral pathways to ensure that all patients have the opportunity to discuss treatment options with a medical oncologist. This is particularly relevant for health care systems covering areas with a geographically dispersed population.

Association between pancreatic cancer patients' perception of their care coordination and patient-reported and survival outcomes.

OBJECTIVE: People with pancreatic cancer have poor survival, and management is challenging. Pancreatic cancer patients' perceptions of their care coordination and its association with their outcomes have not been well-studied. Our objective was to determine if perception of care coordination is associated with patient-reported outcomes or survival. METHODS: People with pancreatic cancer who were 1-8 months postdiagnosis (52 with completed resection and 58 with no resection) completed a patient-reported questionnaire that assessed their perceptions of care coordination, quality of life, anxiety, and depression using validated instruments. Mean scores for 15 care-coordination items were calculated and then ranked from highest (best experience) to lowest (worst experience). Associations between care-coordination scores (including communication and navigation domains) and patient-reported outcomes and survival were investigated using general linear regression and Cox regression, respectively. All analyses were stratified by whether or not the tumor had been resected. RESULTS: In both groups, the highest-ranked care-coordination items were: knowing who was responsible for coordinating care, health professionals being informed about their history, and waiting times. The worst-ranked items related to: how often patients were asked about visits with other health professionals and how well they and their family were coping, knowing the symptoms they should monitor, having sufficient emotional help from staff, and access to additional specialist services. For people who had a resection, better communication and navigation scores were significantly associated with higher quality of life and less anxiety and depression. However, these associations were not statistically significant for those with no resection. Perception of cancer care coordination was not associated with survival in either group. SIGNIFICANCE OF RESULTS: Our results suggest that, while many core clinical aspects of care are perceived to be done well for pancreatic cancer patients, improvements in emotional support, referral to specialist services, and self-management education may improve patient-reported outcomes.

Biliary Stenting in Patients With Pancreatic Cancer: Results From a Population-Based Cohort Study.

OBJECTIVE: We aimed to describe management of biliary obstruction (BO) in the context of pancreatic cancer within a population-based cohort. METHODS: We examined management of BO in 1863 patients diagnosed as having pancreatic cancer in 2010/2011. We used descriptive statistics and logistic regression to describe patterns of biliary stent usage, complications and duration of patency, associations between preoperative stenting and surgical outcomes, and between patient factors and management of jaundice. RESULTS: Almost half of the people in the cohort (n = 909) were jaundiced within 12 months of diagnosis. Two-thirds of these had at least 1 stent inserted. Preoperative stenting, mostly with plastic stents, occurred for 72% of patients who experienced jaundice prior to an attempted resection but was not associated with surgical outcomes. Seventy percent of the jaundiced patients who did not have an attempted resection were stented. Metal stents were less frequently replaced within 30 days than plastic (9% vs 42%). Living in a rural area was associated with reduced likelihood of having jaundice managed. CONCLUSIONS: Plastic stents were still used frequently, despite guidelines recommending metal in most contexts. Patients living in rural areas were less likely to have BO managed. This work highlights the need to monitor current practice.

Factors associated with quality of care for patients with pancreatic cancer in Australia.

OBJECTIVES: To develop a composite score for the quality of care for patients with pancreatic cancer in Australia; to determine whether it was affected by patient and health service-related factors; to assess whether the score and survival were correlated. DESIGN, PARTICIPANTS AND SETTING: We reviewed medical records of patients diagnosed with pancreatic cancer during July 2009 - June 2011 and notified to the Queensland and New South Wales cancer registries. DESIGN AND MAIN OUTCOME MEASURES: Participants were allocated proportional quality of care scores based on indicators derived from a Delphi process, ranging from 0 (lowest) to 1 (highest quality care). Associations between patient and health service-related factors and the score were tested by linear regression, and associations between the score and survival with Kaplan-Meier and Cox proportional hazards methods. RESULTS: Proportional quality of care scores were assigned to 1571 patients. Scores for patients living in rural areas were significantly lower than for those in major cities (adjusted difference, 11%; 95% CI, 8-13%); they were higher for patients in the least socio-economically disadvantaged areas (v most disadvantaged areas: 8% higher; 95% CI, 6-11%), who were younger, had better Eastern Cooperative Oncology Group performance status, or who first presented to a hospital with a high pancreatic case volume. Higher scores were associated with improved survival; after adjusting for patient-related factors, each 10 percentage point increase in the score reduced the risk of dying by 6% (hazard ratio, 0.94; 95% CI, 0.91-0.97). CONCLUSION: Geographic category of residence may influence the quality of care received by patients with pancreatic cancer, and survival could be improved if they received optimal care.

Determinants of Outcomes Following Resection for Pancreatic Cancer-a Population-Based Study.

BACKGROUND: Patient and health system determinants of outcomes following pancreatic cancer resection, particularly the relative importance of hospital and surgeon volume, are unclear. Our objective was to identify patient, tumour and health service factors related to mortality and survival amongst a cohort of patients who underwent completed resection for pancreatic cancer. METHODS: Eligible patients were diagnosed with pancreatic adenocarcinoma between July 2009 and June 2011 and had a completed resection performed in Queensland or New South Wales, Australia, with either tumour-free (R0) or microscopically involved margins (R1) (n = 270). Associations were examined using logistic regression (for binary outcomes) and Cox proportional hazards or stratified Cox models (for time-to-event outcomes). RESULTS: Patients treated by surgeons who performed <4 resections/year were more likely to die from a surgical complication (versus ≥4 resections/year, P = 0.04), had higher 1-year mortality (P = 0.03), and worse overall survival up to 1.5 years after surgery (adjusted hazard ratio 1.58, 95 % confidence interval 1.07-2.34). Amongst patients who had ≥1 complication within 30 days of surgery, those aged ≥70 years had higher 1-year mortality compared to patients aged <60 years. Adjuvant chemotherapy treatment improved recurrence-free survival (P = 0.01). There were no significant associations between hospital volume and mortality or survival. CONCLUSIONS: Systems should be implemented to ensure that surgeons are completing a sufficient number of resections to optimize patient outcomes. These findings may be particularly relevant for countries with a relatively small and geographically dispersed population.

Using a Delphi process to determine optimal care for patients with pancreatic cancer.

AIM: Overall 5-year survival for pancreatic cancer is ∼5%. Optimizing the care that pancreatic cancer patients receive may be one way of improving outcomes. The objective of this study was to establish components of care which Australian health professionals believe important to optimally manage patients with pancreatic cancer. METHODS: Using a Delphi process, a multidisciplinary panel of 250 health professionals were invited to provide a list of factors they considered important for optimal care of pancreatic cancer patients. They were then asked to score and then rescore (from one [no importance/disagree] to 10 [very important/agree]) the factors. The mean and coefficient of variation scores were calculated and categorized into three levels of importance. RESULTS: Overall, 63 (66% of those sent the final questionnaire; 25% of those initially invited) health professionals from nine disciplines completed the final scoring of 55 statements/factors encompassing themes of presentation/staging, surgery and biliary obstruction, multidisciplinary team details and oncology. Mean scores ranged from 3.7 to 9.7 with the highest related to communication and patient assessment. There was substantial intra- and interdisciplinary variation in views about MDT membership and roles. CONCLUSION: Overall, the opinions of Australian health professionals reflect international guideline recommended care; however, they identified a number of additional factors focusing on where patients should be treated, the importance of clear communication and the need for multidisciplinary care which were not included in current clinical practice guidelines. Differences in priorities between specialty groups were also identified.

Describing Patterns of Care in Pancreatic Cancer: A Population-Based Study.

OBJECTIVES: Despite pancreatic cancer being the fifth highest cause of cancer death in developed regions, there is a paucity of population-based management details for patients with pancreatic cancer. The objective of this study was to reflect on current practice and outcomes to facilitate future improvement. METHODS: A comprehensive population-based patterns-of-care study in 2 Australian states was conducted. Patients diagnosed with pancreatic adenocarcinoma between July 2009 and June 2011 were identified by cancer registries, and detailed clinical data were collected from medical records. RESULTS: Data were collected for 1863 patients, 96% of those eligible. The majority resided in major cities; their median age was 72 years, and 54% were men. Over half of the cases (58%) had metastatic disease at diagnosis. Resection was attempted for 20% of patients but only completed in 15%. The uptake of adjuvant chemotherapy (76%) and the proportion alive at 1-year (22%) were higher than reported in previous population-based reports. Of those with no complete surgical resection, 43% received palliative chemotherapy. CONCLUSIONS: This population-based overview of the management of patients with pancreatic cancer suggests that, despite evidence that the proportion surviving and the use of adjuvant chemotherapy has increased, there may still be underutilization of cancer-directed therapies.

Melanoma brain metastases: the impact of nodal disease.

Brain metastases (BMs) are a major source of mortality and morbidity in patients with melanoma. This study assesses prognostic nodal factors in patients with nodal metastatic melanoma with respect to the development of BMs. The aim was to identify a high risk subset that may benefit from brain directed management. Prospective surgical and clinical trial databases identified patients who had had nodal dissections and were seen through the Princess Alexandra Hospital Melanoma clinic between August 1995 and June 2010. Patient data was collected and event data was updated from medical imaging and clinical records. The primary endpoint was the rate of development of BMs. 474 patients were identified as having nodal dissections. Two hundred and eighty-seven patients (61%) were male with a median age of 52 (39-66). The most common nodal dissection site was axilla 190 (40%), followed by groin 154 (32.5%) and neck 130 (27.5%). Adjuvant radiotherapy to the nodal basin was delivered to 134 patients (28%). BMs occurred in 61 patients (12.9%) with a median time of 13.87 months from dissection. No lymph node characteristics were significantly associated with the development of BMs including: nodal region (p=0.72), nodal size (p=0.08), number of involved nodes (p=0.36), presence of extra-capsular spread (p=0.47) and AJCC N stage. There was no significant association between primary ulceration (p=0.37) or location and development of BMs. It appears that for patients with resected stage III melanoma there is no histopathological lymph node feature associated with the development of BMs. This highlights the importance of identifying molecular markers in nodal melanoma which may predict for BMs to further direct site-specific therapy.

Is concurrent radiation therapy required in patients receiving preoperative chemotherapy for adenocarcinoma of the oesophagus? A randomised phase II trial.

INTRODUCTION: Preoperative chemotherapy (CT) and preoperative chemoradiation therapy (CRT) for resectable oesophageal cancer have been shown to improve overall survival in meta-analyses. There are limited data comparing these preoperative therapies. We report the outcomes of a randomised phase II trial comparing preoperative CT and CRT for resectable adenocarcinoma of the oesophagus and gastro-oesophageal junction. METHODS: Patients were randomised to receive preoperative CT with cisplatin (80 mg/m(2)) and infusional 5 fluorouracil (1000 mg/m(2)/d) on days 1 and 21, or preoperative CRT with the same drugs accompanied by concurrent radiation therapy commencing on day 21 of chemotherapy and the 5 fluorouracil reduced to 800 mg/m(2)/d. The radiation dose was 35 Gy in 15 fractions over 3 weeks. The endpoints were toxicity, response rates, resection (R) status, progression-free survival (PFS), overall survival (OS) and quality of life. RESULTS: Seventy-five patients were enrolled on the study: 36 received preoperative CT and 39 preoperative CRT. Toxicity was similar for CT and CRT. Eight patients (11%) did not proceed to resection. The histopathological response rate (CRT 31% versus CT 8%, p = 0.01) and R1 resection rate (CRT 0% versus CT 11%, p = 0.04) favoured those receiving CRT. The median PFS was 14 and 26 months for CT and CRT respectively (p = 0.37). The median OS was 29 months for CT compared with 32 months for CRT (p = 0.83). CONCLUSIONS: Despite no difference in survival, the improvement from preoperative CRT with respect to margin involvement makes this treatment a reasonable option for bulky, locally advanced resectable adenocarcinoma of the oesophagus.

A phase II trial of chemoradiation therapy with weekly oxaliplatin and protracted infusion of 5-fluorouracil for esophageal cancer.

BACKGROUND: Chemoradiation therapy using regimens containing cisplatin and 5-fluorouracil are most commonly used for inoperable cancer of the esophagus. Cisplatin is relatively toxic and is not suitable for many patients. Little data exists using platinum analogues together with protracted infusion 5-fluorouracil and radiation therapy in the curative setting. METHODS: Fourteen patients with localised oesophageal cancer suitable for curative chemoradiation therapy registered on the study. Chemotherapy consisted of 5-fluorouracil 225 mg/m(2) daily throughout radiation therapy, with oxaliplatin 60 mg/m(2) weekly. The radiation dose was 56 to 60 Gy in 28 to 30 fractions. RESULTS: The median age of the patients was 70.5 years. Therapy was associated with excessive grade 3 and 4 non-hematologic toxicity. There was one treatment related death. The median progression-free survival was 31.5 months and median overall survival 32.6 months. Six patients achieved a prolonged complete endoscopic and radiological response. CONCLUSIONS: Although weekly oxaliplatin in combination with infusional 5 fluorouracil produces durable remissions in esophageal cancer, the regimen used in this trial was not acceptable for routine use. Future protocols should incorporate lower chemotherapy doses.